Legal

Medications Safety Information

Last updated: September 2024

Zepbound® (tirzepatide) Safety Information

Important Safety Information for Zepbound® (tirzepatide) injection
Warning: Risk of Thyroid C-Cell Tumors

In rats, Zepbound® (tirzepatide) caused thyroid tumors, including thyroid cancer. It is not known if Zepbound® (tirzepatide) will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
Do not use Zepbound® (tirzepatide) if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

‍

What is the FDA-approved use of Zepbound® (tirzepatide)?

Zepbound® (tirzepatide) is used along with a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:

• 30 kg/m^2 or greater (obesity) or
• 27 kg/m^2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea, or cardiovascular disease).

‍

Limitations of use:

• Zepbound® (tirzepatide) should not be used in combination with other tirzepatide-containing products or any other GLP-1 receptor agonist.
• The safety and efficacy of coadministration with other products for weight management have not been established.
• Zepbound® (tirzepatide) has not been studied in patients with a history of pancreatitis.

‍

Who should not use Zepbound® (tirzepatide)?

Do not use Zepbound® (tirzepatide) if:

• You or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• You have a known allergic reaction to Zepbound® (tirzepatide).

‍

How should I take Zepbound® (tirzepatide)?

You can take Zepbound® with or without food. The pre-filled injector pen is self-administered as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week. Your Fridays provider will guide you on a treatment regimen that may include an increase in dose every four weeks.
You should not change your dosing regimven or stop taking Zepbound® (tirzepatide) as prescribed without discussing with your provider first.

‍

What should I tell my Fridays provider before using Zepbound® (tirzepatide)?

Zepbound® (tirzepatide) has certain drug interactions.It’s important to tell your Fridays provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.

Some medications to watch out for include:

• Medications for diabetes:Medications used to treat type 1 or type 2 diabetes, including insulin or sulfonylureas (such as Amaryl or Glucotrol XL)
• Other oral medications: Zepbound® (tirzepatide) causes a delay in gastric emptying, so it has the potential to impact the absorption of medications that are taken by mouth at the same time. Your provider can guide you on how to schedule your medications.
  • Hormonal birth control:If you are using an oral hormonal contraceptive (birth control), Zepbound® (tirzepatide) may decrease its efficacy, especially after the first dose. Switch to a non-oral contraceptive method or use a barrier method of contraception for 4 weeks after starting Zepbound® (tirzepatide) and for 4 weeks after each dose escalation, until you reach a maintenance dose.
• Other GLP-1 medications, including WeGovy® (semaglutide), Ozempic® (semaglutide), Saxenda® (liraglutide), Zepbound® (tirzepatide), Mounjaro® (tirzepatide), Victoza® (liraglutide), Byetta® (exenatide), or Bydureon® (exenatide).
• Other products for weight loss:Including dietary supplements
• It’s important to share your entire medical history with your provider.In particular, tell your provider if you have a past history of:
  • Type 1 or type 2 diabetes
  • Thyroid cancer
  • Gastrointestinal disease
  • Pancreatitis
  • Kidney disease
  • Diabetic retinopathy
  • Depression
  • Suicidal thoughts or behavior
• Tell your provider if you are pregnant, planning to become pregnant, or breastfeeding.
  • If you are pregnant: Zepbound® (tirzepatide) should not be used during pregnancy. Based on animal studies, there may be potential risks to an unborn baby from exposure to Zepbound® (tirzepatide) during pregnancy. There is no benefit to weight loss during pregnancy and it may cause harm to the unborn baby.
  • If you are a female reproductive potential:Zepbound® (tirzepatide) may reduce the efficacy of oral hormonal contraceptives. Switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after starting medication and for 4 weeks after each dose escalation until you reach a maintenance dose.
  • If you are breastfeeding: It is not known if Zepbound® (tirzepatide) passes into breast milk. Talk to your provider first about the benefits and risks of using Zepbound® (tirzepatide) while breastfeeding.
• Pregnancy registry:There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Zepbound® (tirzepatide) during pregnancy. Pregnant patients exposed to Zepbound® (tirzepatide) and healthcare providers are encouraged to contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

‍

What are the most serious side effects that I or a caregiver should monitor for when taking Zepbound® (tirzepatide)?

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

These serious side effects are rare, but can occur with Zepbound® (tirzepatide). You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dose changes.

• Thyroid C-Cell Tumors: In rats, Zepbound® (tirzepatide) caused a dose-dependent and treatment-duration-dependent increase in thyroid C-cell tumors. It is unknown whether Zepbound® (tirzepatide) causes thyroid C-cell tumors in humans. Zepbound® (tirzepatide) is contraindicated in patients with a family history of medullary thyroid cancer (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
• Severe Gastrointestinal Disease: Zepbound® (tirzepatide) is associated with gastrointestinal side effects, such as nausea, diarrhea, vomiting, constipation, and stomach pain, and can sometimes be severe. It hasn’t been studied in patients with severe gastrointestinal disease and isn’t recommended in these patients. The majority of nausea, vomiting, and/or diarrhea events occurred during a dose increase and decreased over time.
• Acute Kidney Injury: Gastrointestinal side effects of Zepbound® (tirzepatide) like diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems if dehydration is severe. It is important for you to drink plenty of water to help reduce your chance of dehydration.
• Acute Gallbladder Disease: Zepbound® (tirzepatide), other GLP-1 receptor agonists, and weight loss are associated with an increased chance of acute gallbladder disease. Tell your provider right away if you have pain in your upper stomach, yellowing of skin or eyes (jaundice), fever, or clay-colored stools.
• Inflammation of Pancreas (Acute Pancreatitis): Monitor for signs of acute pancreatitis, including severe abdominal pain that does not go away, sometimes radiating to the back, with or without vomiting.
• Allergic Reactions: Stop using Zepbound® (tirzepatide) right away if you experience symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, severe rash or itching, very rapid heartbeat, problems breathing or swallowing, or fainting or feeling dizzy.
• Low Blood Sugar (Hypoglycemia): Zepbound® (tirzepatide) lowers blood glucose. It can cause too low blood sugar in patients with type 2 diabetes who also take another glucose control medication. Monitor your blood sugar and watch out for signs of too low blood sugar such as dizziness, blurred vision, mood changes, sweating, or fast heartbeat.
• Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy: Rapid improvement of glucose control has been associated with temporary worsening of diabetic retinopathy. Tell your provider right away if you experience changes in vision.
• Suicidal Behavior and Ideation: You should pay attention to any mental health changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.
• Never Share a Pen: Pen-sharing poses a risk of infection.

‍

What are the most common side effects of Zepbound® (tirzepatide)?

• Nausea
• Diarrhea
• Vomiting
• Constipation
• Stomach pain
• Indigestion
• Injection site reactions
• Feeling tired
• Allergic reactions
• Belching
• Hair loss
• Gastroesophageal reflux disease (heartburn)

You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

This information is not comprehensive. Please see the full Prescribing Information for complete safety information.

Disclaimer: Ozempic®, WeGovy®,  Saxenda® and Victoza® are registered trademarks of Novo Nordisk.  Zepbound® and Mounjaro® are registered trademarks of Eli Lilly.  Fridays Health has no affiliation with Novo Nordiskor Eli Lilly .  The compounded products available as part of Fridays Health’s Weight Loss Program are not made by Novo Nordiskor Eli Lilly  or any company affiliated with Novo Nordiskor Eli Lilly .

Wegovy® (Semaglutide) Safety Information

Warning: Risk of Thyroid C-Cell Tumors

• In studies with mice and rats, semaglutide (the active ingredient in Wegovy® and Ozempic®) caused thyroid tumors, including thyroid cancer. It is not known if Wegovy® (semaglutide) will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
• Do not use Wegovy® (semaglutide) if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

‍

What is the FDA-approved use of Wegovy® (semaglutide)?

Wegovy® (semaglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist for chronic weight management, along with a reduced calorie diet and increased physical activity, for people with an initial body mass index (BMI) of:

• 30 kg/m2 or greater (obesity) or
• 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).

‍

Limitations of use:

• Wegovy® (semaglutide) should not be used in combination with other semaglutide-containing products or any other GLP-1 receptor agonist
• The safety and efficacy of coadministration with other products for weight loss have not been established
• Wegovy® (semaglutide) has not been studied in patients with a history of pancreatitis

‍

Who should not use Wegovy® (semaglutide)?

Do not use Wegovy® (semaglutide) if:

• You or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• You have a known allergic reaction to semaglutide (the active ingredient in Wegovy® or Ozempic).

‍

How should Wegovy® (semaglutide) be administered?

You can take Wegovy® (semaglutide) with or without food. The pre-filled injector pen is self-administered as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week. Your Fridays provider will guide you on a treatment regimen that may include an increase in dose every four weeks.
You should not change your dosing regimen or stop taking Wegovy® (semaglutide) as prescribed without discussing with your provider first.

‍

What should I tell my Fridays provider before using Wegovy® (semaglutide)?

Wegovy® (semaglutide) has certain drug interactions. It’s important to tell your Fridays provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.

Some medications to watch out for include:

• Medications used to treat type 1 or type 2 diabetes, including insulin or sulfonylureas (such as Amaryl or Glucotrol XL)
• Wegovy® (semaglutide) causes a delay in gastric emptying, so it has the potential to impact the absorption of medications that are taken by mouth at the same time. Your provider can guide you on how to schedule your medications.
• Other GLP-1 medications, including WeGovy® (semaglutide), Ozempic® (semaglutide), Saxenda® (liraglutide), Zepbound® (tirzepatide), Mounjaro® (tirzepatide), Victoza® (liraglutide), Byetta® (exenatide), or Bydureon® (exenatide).
• If you’re using other products for weight loss, including dietary supplements

It’s important to share your entire medical history with your provider. In particular, tell your provider if you have a past history of:

• Type 1 or type 2 diabetes
• Thyroid cancer
• Pancreatitis
• Kidney disease
• Diabetic retinopathy
• Depression
• Suicidal thoughts or behavior

Tell your provider if you are pregnant, planning to become pregnant, or breastfeeding.

• If you are pregnant: Wegovy® (semaglutide) should not be used during pregnancy. Based on animal studies, there may be potential risks to an unborn baby from exposure to Wegovy® (semaglutide) during pregnancy. There is no benefit to weight loss during pregnancy and it may cause harm to the unborn baby.
• If you are a female or male of reproductive potential:Discontinue Wegovy® (semaglutide) at least 2 months before a planned pregnancy since the drug can stay in the bloodstream for a long time.
• If you are breastfeeding: Wegovy® (semaglutide) was found in the milk of lactating rats. Tell your Fridays provider if you are breastfeeding before you start Wegovy® (semaglutide).

Pregnancy registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to semaglutide (the active ingredient in Wegovy® and Ozempic®) during pregnancy. Pregnant women exposed to these products and healthcare providers are encouraged to contact Novo Nordisk at 1-800-727-6500.

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

‍

What are the most serious side effects that I or a caregiver should monitor for when taking Wegovy® (semaglutide)?

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

These serious side effects can occur with Wegovy® (semaglutide). You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dose changes.

• Thyroid C-Cell Tumors:In mice and rats, semaglutide (the active ingredient in Wegovy® and Ozempic®) caused an increase in thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). It is unknown whether Wegovy® (semaglutide)  causes thyroid C-cell tumors in humans. There were cases of MTC reported in patients who took liraglutide (the active ingredient in Victoza® and Saxenda®) after the drug was put on the market. Wegovy® (semaglutide) is contraindicated in patients with a family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
• Inflammation of Pancreas (Acute Pancreatitis): Monitor for signs of acute pancreatitis, including severe abdominal pain that does not go away, sometimes radiating to the back, with or without vomiting.
• Acute Gallbladder Disease:Wegovy® (semaglutide) may cause gallbladder problems, including gallstones. Some gallbladder problems require surgery. Tell your provider right away if you have pain in your upper stomach, yellowing of skin or eyes (jaundice), fever, or clay-colored stools.
• Low Blood Sugar (hypoglycemia): Wegovy® (semaglutide) lowers blood glucose. It can cause too low blood sugar in patients with type 2 diabetes who also take another glucose control medication. Monitor your blood sugar and watch out for signs of too low blood sugar such as dizziness, blurred vision, mood changes, sweating, or fast heartbeat.
• Acute Kidney Injury: In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse. It is important for you to drink plenty of water to help reduce your chance of dehydration.
• Serious Allergic Reactions: Stop using Wegovy® (semaglutide) right away if you experience symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, severe rash or itching, very rapid heartbeat, problems breathing or swallowing, or fainting or feeling dizzy.
• Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: If you have type 2 diabetes, tell your provider right away if you experience changes in vision.
• Increase in Heart Rate: Tell your provider right away if you have a racing heartbeat while at rest.
• Suicidal Behavior and Ideation:You should pay attention to any mental health changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.
• Never Share a Pen: Pen-sharing poses a risk of infection.

‍

What are the most common side effects of Wegovy® (semaglutide)?

• Nausea
• Diarrhea
• Vomiting
• Constipation
• Abdominal pain
• Headache
• Fatigue
• Dyspepsia
• Dizzyness
• Abdominal distension
• Eructation
• Hypoglycemia in patients with type 2 diabetes
• Flatulence
• Gastroenteritis
• Gastroesophageal reflux disease

You are encouraged to report negative side effects of prescription products:

• Contact Novo Nordisk Inc. at 1-833-934-6891
• Contact FDA MedWatch at 1-800-FDA-1088 or visit fda.gov/medwatch

This information is not comprehensive. Please see the full Prescribing Information for complete safety information.

Disclaimer: Ozempic®, WeGovy® and Saxenda® are registered trademarks of Novo Nordisk.  Zepbound® and Mounjaro® are registered trademarks of Eli Lilly.  Fridays Health has no affiliation with Novo Nordiskor Eli Lilly .  The compounded products available as part of Fridays Health’s Weight Loss Program are not made by Novo Nordiskor Eli Lilly  or any company affiliated with Novo Nordiskor Eli Lilly .

Mounjaro® (tirzepatide) Safety Information

Important Safety Information for Mounjaro® (tirzepatide) injection

Warning: Risk of Thyroid C-Cell Tumors

Mounjaro® (tirzepatide) injection may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.

• Do not use Mounjaro® (tirzepatide) injection if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
• Do not use Mounjaro® (tirzepatide) injection if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

‍

What is the FDA-approved use of Mounjaro® (tirzepatide) injection?

Mounjaro® (tirzepatide) injection (mown-JAHR-OH) is an injectable medicine for adults with type 2 diabetes used along with diet and exercise to improve blood sugar (glucose).

‍

Limitations of use:

It is not known if Mounjaro® (tirzepatide) injection can be used in people who have had inflammation of the pancreas (pancreatitis). Mounjaro® (tirzepatide) injection is not for use in people with type 1 diabetes. It is not known if Mounjaro® (tirzepatide) injection is safe and effective for use in children under 18 years of age.

‍

Who should not use Mounjaro® (tirzepatide) injection?

Do not use Mounjaro® (tirzepatide) injection if:

• You or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• You have a known allergic reaction to Mounjaro® (tirzepatide) injection.

‍

How should I take Mounjaro® (tirzepatide) injection?

You can take Mounjaro® (tirzepatide) injection with or without food. The pre-filled injector pen is self-administered as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week.  You should change your injection site each week.  Do not use the same site for each injection. Your Fridays provider will guide you on a treatment regimen that may include an increase in dose every four weeks.

You should not change your dosing regimen or stop taking Mounjaro® (tirzepatide) injection as prescribed without discussing with your provider first.  If you take too much Mounjaro® (tirzepatide) injection, call your healthcare provider or seek medical advice promptly.

‍

What should I discuss with my Fridays provider before using Mounjaro®?

• Mounjaro® (tirzepatide) injection has certain drug interactions.It’s important to tell your Fridays provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.
• Your healthcare provider should show you how to use Mounjaro® (tirzepatide) injection before you use it for the first time.
• Talk to your healthcare provider about low blood sugar and how to manage it.
• If you take birth control pills by mouth, talk to your healthcare provider before you use Mounjaro® (tirzepatide) injection. Birth control pills may not work as well while using Mounjaro® (tirzepatide) injection. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Mounjaro® (tirzepatide) injection and for 4 weeks after each increase in your dose of Mounjaro® (tirzepatide) injection.

Some medications to watch out for include:

• Medications for diabetes: Medications used to treat type 1 or type 2 diabetes, including insulin or sulfonylureas (such as Amaryl or Glucotrol XL)
• Other oral medications: Mounjaro® (tirzepatide) injection causes a delay in gastric emptying, so it has the potential to impact the absorption of medications that are taken by mouth at the same ti Your provider can guide you on how to schedule your medications.
• Hormonal birth control:If you are using an oral hormonal contraceptive (birth control), Mounjaro® (tirzepatide) injection may decrease its efficacy, especially after the first dose. Switch to a non-oral contraceptive method or use a barrier method of contraception for 4 weeks after starting Mounjaro® (tirzepatide) injection and for 4 weeks after each dose escalation, until you reach a maintenance dose.
• Other GLP-1 medications: Including Zepbound® (tirzepatide) injection, Wegovy® (semaglutide), Ozempic® (semaglutide), Saxenda® (liguratide), Victoza® (liguratide), Byetta® (Exenatide), Bydureon ® (Exenatide), or compounded GLP-1 formularies. These medications should not be taken with Mounjaro® (tirzepatide) injection.
• Other products for weight loss: Including dietary supplements
• It’s important to share your entire medical history with your provider. In particular, tell your provider if you have a past history of:
• Type 1 or type 2 diabetes
• Thyroid cancer
• Gastrointestinal disease
• Pancreatitis
• Kidney disease
• Diabetic retinopathy
• Depression
• Suicidal thoughts or behavior
• Tell your provider if you are pregnant, planning to become pregnant, or breastfeeding. 
• If you are pregnant: Mounjaro® (tirzepatide) injection should not be used during pregnancy. Based on animal studies, there may be potential risks to an unborn baby from exposure to Mounjaro® (tirzepatide) injection during pregnancy. There is no benefit to weight loss during pregnancy and it may cause harm to the unborn baby.
• If you are a female reproductive potential:Mounjaro® (tirzepatide) injection may reduce the efficacy of oral hormonal contraceptives. Switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after starting medication and for 4 weeks after each dose escalation until you reach a maintenance dose.
• If you are breastfeeding:It is not known if Mounjaro® (tirzepatide) injection passes into breast milk. Talk to your provider first about the benefits and risks of using Mounjaro® (tirzepatide) injection while breastfeeding.
• Pregnancy registry:There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Mounjaro® (tirzepatide) injection during pregnancy. Pregnant patients exposed to Mounjaro® (tirzepatide) injection and healthcare providers are encouraged to contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

‍

What are the most serious side effects that I or a caregiver should monitor for when taking Mounjaro® (tirzepatide) injection?

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.
These serious side effects are rare, but can occur with Mounjaro® (tirzepatide) injection. You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dose changes.

• Thyroid C-Cell Tumors: In rats, Mounjaro® (tirzepatide) injection caused a dose-dependent and treatment-duration-dependent increase in thyroid C-cell tumors. It is unknown whether Mounjaro® causes thyroid C-cell tumors in humans. Mounjaro® (tirzepatide) injection is contraindicated in patients with a family history of medullary thyroid cancer (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
• Severe Gastrointestinal Disease: Mounjaro® (tirzepatide) injection is associated with gastrointestinal side effects, such as nausea, diarrhea, vomiting, constipation, and stomach pain, and can sometimes be severe. It hasn’t been studied in patients with severe gastrointestinal disease and isn’t recommended in these patients. The majority of nausea, vomiting, and/or diarrhea events occurred during a dose increase and decreased over time.
• Inflammation of the pancreas (pancreatitis). Stop using Mounjaro® (tirzepatide) injection and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
• Low blood sugar (hypoglycemia).Your risk for getting low blood sugar may be higher if you use Mounjaro® (tirzepatide) injection with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, or mood changes, hunger, weakness and feeling jittery.
• Serious allergic reactions.Stop using Mounjaro® (tirzepatide) injection and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, and very rapid heartbeat.
• Kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration.
• Severe stomach problems.Stomach problems, sometimes severe, have been reported in people who use Mounjaro® (tirzepatide) injection. Tell your healthcare provider if you have stomach problems that are severe or will not go away.
• Changes in vision.Tell your healthcare provider if you have changes in vision during treatment with Mounjaro® (tirzepatide) injection.
• Gallbladder problems.Gallbladder problems have happened in some people who use Mounjaro® (tirzepatide) injection. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), and clay-colored stools.
• Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy: Rapid improvement of glucose control has been associated with temporary worsening of diabetic retinopathy. Tell your provider right away if you experience changes in vision.
• Suicidal Behavior and Ideation: You should pay attention to any mental health changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.
• Never Share a Pen: Pen-sharing poses a risk of infection.

‍

What are the most common side effects of Mounjaro® (tirzepatide) injection?

• Nausea
• Diarrhea
• Vomiting
• Constipation
• Stomach pain
• Indigestion
• Injection site reactions
• Feeling tired
• Allergic reactions
• Belching
• Hair loss
• Gastroesophageal reflux disease (heartburn)

You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

This information is not comprehensive. Please see the full Prescribing Information for complete safety information.

Disclaimer: Ozempic®, WeGovy® and Saxenda® are registered trademarks of Novo Nordisk.  Zepbound® and Mounjaro® are registered trademarks of Eli Lilly. Fridays Health has no affiliation with Novo Nordiskor Eli Lilly .  The compounded products available as part of Fridays Health’s Weight Loss Program are not made by Novo Nordiskor Eli Lilly  or any company affiliated with Novo Nordiskor Eli Lilly .

Ozempic® (semaglutide) Safety Information

Important Safety Information for Ozempic® (semaglutide) injection

Warning: Risk of Thyroid C-Cell Tumors

Mounjaro® (tirzepatide) injection may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.

Ozempic® (semaglutide) may cause serious side effects, including: Possible thyroid tumors, including cancer. Tell your health care provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, Ozempic®  (semaglutide) and medicines that work like Ozempic®  (semaglutide) caused thyroid tumors, including thyroid cancer. It is not known if Ozempic®  (semaglutide) will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.

Do not use Ozempic®  (semaglutide) if you or any of your family have ever had MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

‍

What is the FDA-approved use of Ozempic® (semaglutide)?

Ozempic® (semaglutide) injection 0.5 mg, 1 mg, or 2 mg is an injectable prescription medicine used:

• along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes.
• to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes with known heart disease.

‍

Limitations of use:

It is not known if Ozempic® (semaglutide) can be used in people who have had pancreatitis. Ozempic® (semaglutide) is not for use in people with type 1 diabetes. It is not known if Ozempic® (semaglutide) is safe and effective for use in children under 18 years of age.

‍

Who should not use Ozempic® (semaglutide)?

Do not use Ozempic® (semaglutide) if:

• you or any of your family have ever had MTC or if you have MEN 2.
• you are allergic to semaglutide or any of the ingredients in Ozempic®. See symptoms of serious allergic reaction in “What are the possible side effects of Ozempic®?”.

‍

How should I take Ozempic® (semaglutide)?

You can take Ozempic® (semaglutide) with or without food. The pre-filled injector pen is self-administered as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week.  You should change your injection site each week.  Do not use the same site for each injection. Your Fridays provider will guide you on a treatment regimen that may include an increase in dose every four weeks.

You should not change your dosing regimen or stop taking Ozempic® (semaglutide) as prescribed without discussing with your provider first.  If you take too much Ozempic® (semaglutide), call your healthcare provider or seek medical advice promptly.

‍

What should I discuss with my Fridays provider before using Ozempic® (semaglutide)?

• Mounjaro® (tirzepatide) injection has certain drug interactions.It’s important to tell your Fridays provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.
• Your healthcare provider should show you how to use Mounjaro® (tirzepatide) injection before you use it for the first time.
• Talk to your healthcare provider about low blood sugar and how to manage it.
• If you take birth control pills by mouth, talk to your healthcare provider before you use Mounjaro® (tirzepatide) injection. Birth control pills may not work as well while using Mounjaro® (tirzepatide) injection. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Mounjaro® (tirzepatide) injection and for 4 weeks after each increase in your dose of Mounjaro® (tirzepatide) injection.

Some medications to watch out for include:

• Medications for diabetes: Other medications used to treat type 1 or type 2 diabetes, including insulin or sulfonylureas (such as Amaryl or Glucotrol XL)
• Other oral medications: Ozempic® (semaglutide) causes a delay in gastric emptying, so it has the potential to impact the absorption of medications that are taken by mouth at the same time. Your provider can guide you on how to schedule your medications.
• Hormonal birth control:Other GLP-1 medications have been shown to potentially decrease the efficacy of oral birth control pills.  If you are using an oral hormonal contraceptive (birth control), Ozempic® (semaglutide) may decrease its efficacy, especially after the first dose. Switch to a non-oral contraceptive method or use a barrier method of contraception for 4 weeks after starting Ozempic® (semaglutide) and for 4 weeks after each dose escalation, until you reach a maintenance dose.
• Other GLP-1 medications:Including Zepbound® (tirzepatide), Mounjaro® (tirzepatide), Wegovy® (semaglutide), Saxenda® (liraglutide), Victoza® (liraglutide), Byetta® (exenatide), Bydureon® (exenatide), or compound GLP-1 formularies. These medications should not be taken with Ozempic® (semaglutide).
• Other products for weight loss: Including dietary supplements
• It’s important to share your entire medical history with your provider. In particular, tell your provider if you have a past history of:
• Type 1 or type 2 diabetes
• Thyroid cancer
• Gastrointestinal disease
• Pancreatitis
• Kidney disease
• Diabetic retinopathy
• Depression
• Suicidal thoughts or behavior
• Tell your provider if you are pregnant, planning to become pregnant, or breastfeeding. 
• If you are pregnant: Ozempic® (semaglutide) should not be used during pregnancy. Based on animal studies, there may be potential risks to an unborn baby from exposure to Ozempic® (semaglutide) during pregnancy. There is no benefit to weight loss during pregnancy and it may cause harm to the unborn baby.
• If you are a female reproductive potential:Ozempic® (semaglutide) may reduce the efficacy of oral hormonal contraceptives. Switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after starting medication and for 4 weeks after each dose escalation until you reach a maintenance dose.
• If you are breastfeeding: It is not known if Ozempic® (semaglutide) passes into breast milk. Talk to your provider first about the benefits and risks of using Ozempic® (semaglutide) while breastfeeding.

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

‍

What are the most serious side effects that I or a caregiver should monitor for when taking Ozempic® (semaglutide)?

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

These serious side effects are rare, but can occur with Ozempic® (semaglutide). You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dose changes.

• Thyroid C-Cell Tumors: In rats, Ozempic® (semaglutide) caused a dose-dependent and treatment-duration-dependent increase in thyroid C-cell tumors. It is unknown whether Ozempic® (semaglutide) causes thyroid C-cell tumors in humans. Ozempic® (semaglutide) is contraindicated in patients with a family history of medullary thyroid cancer (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
• Severe Gastrointestinal Disease: Ozempic® (semaglutide) is associated with gastrointestinal side effects, such as nausea, diarrhea, vomiting, constipation, and stomach pain, and can sometimes be severe. It hasn’t been studied in patients with severe gastrointestinal disease and isn’t recommended in these patients. The majority of nausea, vomiting, and/or diarrhea events occurred during a dose increase and decreased over time.
• Inflammation of your pancreas (pancreatitis): Stop using Ozempic® (semaglutide) and call your health care provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
• Low blood sugar (hypoglycemia): Your risk for getting low blood sugar may be higher if you use Ozempic® (semaglutide) with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include: dizziness or lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery.
• Kidney problems (kidney failure): In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration.
• Serious allergic reactions: Stop using Ozempic® (semaglutide) and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat.
• Gallbladder problems: Gallbladder problems have happened in some people who take Ozempic® (semaglutide). Tell your health care provider right away if you get symptoms which may include: pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools.
• Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Ozempic® (semaglutide). Tell your healthcare provider if you have stomach problems that are severe or will not go away.
• Changes in vision. Tell your healthcare provider if you have changes in vision during treatment with Ozempic® (semaglutide).
• Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy: Rapid improvement of glucose control has been associated with temporary worsening of diabetic retinopathy. Tell your provider right away if you experience changes in vision.
• Suicidal Behavior and Ideation: You should pay attention to any mental health changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.
• Never Share a Pen: Pen-sharing poses a risk of infection.

‍

What are the most common side effects of Ozempic® (semaglutide)?

• Nausea
• Diarrhea
• Vomiting
• Constipation
• Stomach pain
• Indigestion
• Injection site reactions
• Feeling tired
• Allergic reactions
• Belching
• Hair loss
• Gastroesophageal reflux disease (heartburn)

You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

This information is not comprehensive. Please see the full Prescribing Information for complete safety information.

Disclaimer: Ozempic®, WeGovy®, Saxenda® and Victoza® are registered trademarks of Novo Nordisk. Zepbound® and Mounjaro® are registered trademarks of Eli Lilly. Fridays Health has no affiliation with Novo Nordiskor Eli Lilly . The compounded products available as part of Fridays Health’s Weight Loss Program are not made by Novo Nordiskor Eli Lilly or any company affiliated with Novo Nordiskor Eli Lilly .

Saxenda® (liraglutide) Safety Information

Important Safety Information for Saxenda® (liraglutide) injection

Warning: Risk of Thyroid C-Cell Tumors

Saxenda® (liraglutide) may cause serious side effects, including: Possible thyroid tumors, including cancer. Tell your health care professional if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats and mice, Saxenda® (liraglutide) and medicines that work like Saxenda® (liraglutide) caused thyroid tumors, including thyroid cancer. It is not known if Saxenda® (liraglutide) will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.

Do not use Saxenda® (liraglutide) if you or any of your family have ever had MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

‍

What is the FDA-approved use of Saxenda® (liraglutide)?

Saxenda® (liraglutide) injection 3 mg is an injectable prescription medicine used for adults with excess weight (BMI ≥27) who also have weight-related medical problems or obesity (BMI ≥30), and children aged 12-17 years with a body weight above 132 pounds (60 kg) and obesity to help them lose weight and keep the weight off. Saxenda® (liraglutide) should be used with a reduced calorie diet and increased physical activity.

‍

Limitations of use:

• Saxenda® and Victoza® have the same active ingredient, liraglutide, and should not be used together or with other GLP-1 receptor agonist medicines
• It is not known if Saxenda®  (liraglutide) is safe and effective when taken with other prescription, over-the-counter medicines, or herbal weight-loss products
• It is not known if Saxenda®  (liraglutide) is safe and effective in children under 12 years of age
• It is not known if Saxenda®  (liraglutide) is safe and effective in children aged 12 to 17 years with type 2 diabetes

‍

Who should not use Saxenda® (liraglutide)?

Do not use Saxenda® (liraglutide)  if:

• you or any of your family have ever had MTC or if you have MEN 2
• you have had a serious allergic reaction to liraglutide or any of the ingredients in Saxenda® (liraglutide).
• you are pregnant or plan to become pregnant. Saxenda®  (liraglutide) may harm your unborn baby

‍

How should I take Saxenda® (liraglutide)?

Read the Instructions for Use that comes with Saxenda® (liraglutide). Inject your dose of Saxenda® (liraglutide)  under the skin (subcutaneously) in your stomach area (abdomen), upper leg (thigh), or upper arm, as instructed by your health care provider. Do not inject into a vein or muscle. Change (rotate) your injection site within the area you choose with each injection to reduce your risk of getting lumps under the skin (cutaneous amyloidosis). Do not use the same site for each injection

You should not change your dosing regimen or stop taking Saxenda® (liraglutide) as prescribed without discussing with your provider first.  If you take too much Saxenda® (liraglutide), call your healthcare provider or seek medical advice promptly.

‍

What should I discuss with my Fridays provider before using Saxenda® (liraglutide)?

• Saxenda® (liraglutide) has certain drug interactions.It’s important to tell your Fridays provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.
• Your healthcare provider should show you how to use Saxenda® (liraglutide) before you use it for the first time.  You should also discuss if you have medical conditions including:
• have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food
• have or have had problems with your pancreas, kidneys or liver
• have or have had depression or suicidal thoughts, or mental health issues
• are breastfeeding or plan to breastfeed. It is not known if Saxenda® (liraglutide) passes into your breast milk. You and your health care provider should decide if you will use Saxenda®  (liraglutide) or breastfeed

Some medications to watch out for include:

• Medications for diabetes: Other medications used to treat type 1 or type 2 diabetes, including insulin or sulfonylureas (such as Amaryl or Glucotrol XL)
• Other oral medications: Saxenda® (liraglutide) causes a delay in gastric emptying, so it has the potential to impact the absorption of medications that are taken by mouth at the same time. Your provider can guide you on how to schedule your medications.
• Hormonal birth control:Other GLP-1 medications have been shown to potentially decrease the efficacy of oral birth control pills.  If you are using an oral hormonal contraceptive (birth control), Saxenda® (liraglutide) may decrease its efficacy, especially after the first dose. Switch to a non-oral contraceptive method or use a barrier method of contraception for 4 weeks after starting Saxenda® (liraglutide) and for 4 weeks after each dose escalation, until you reach a maintenance dose.
• Other GLP-1 medications:Including Zepbound® (tirzepatide), Mounjaro®  (tirzepatide) injection, Wegovy® (semaglutide), Ozempic® (semaglutide), Victoza® (liguratide), Byetta® (exenatide), Bydureon® (exenatide), or compound GLP-1 formularies. These medications should not be taken with Saxenda® (liraglutide).
• Other products for weight loss: Including dietary supplements
• It’s important to share your entire medical history with your provider. In particular, tell your provider if you have a past history of:
  • Type 1 or type 2 diabetes
  • Thyroid cancer
  • Gastrointestinal disease
  • Pancreatitis
  • Kidney disease
  • Diabetic retinopathy
  • Depression
  • Suicidal thoughts or behavior
• Tell your provider if you are pregnant, planning to become pregnant, or breastfeeding. 
  • If you are pregnant: Saxenda® (liraglutide) should not be used during pregnancy. Based on animal studies, there may be potential risks to an unborn baby from exposure to Saxenda® (liraglutide) during pregnancy. There is no benefit to weight loss during pregnancy and it may cause harm to the unborn baby.
• If you are a female reproductive potential:Saxenda® (liraglutide) may reduce the efficacy of oral hormonal contraceptives. Switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after starting medication and for 4 weeks after each dose escalation until you reach a maintenance dose.
• If you are breastfeeding: It is not known if Saxenda® (liraglutide) passes into breast milk. Talk to your provider first about the benefits and risks of using Saxenda® (liraglutide) while breastfeeding.

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

‍

What are the most serious side effects that I or a caregiver should monitor for when taking Saxenda® (liraglutide)?

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

These serious side effects are rare, but can occur with Saxenda® (liraglutide). You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dose changes.

• Thyroid C-Cell Tumors: In rats, Saxenda® (liraglutide) caused a dose-dependent and treatment-duration-dependent increase in thyroid C-cell tumors. It is unknown whether Saxenda® (liraglutide) causes thyroid C-cell tumors in humans. Saxenda® (liraglutide) is contraindicated in patients with a family history of medullary thyroid cancer (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
• Severe Gastrointestinal Disease: Saxenda® (liraglutide) is associated with gastrointestinal side effects, such as nausea, diarrhea, vomiting, constipation, and stomach pain, and can sometimes be severe. It hasn’t been studied in patients with severe gastrointestinal disease and isn’t recommended in these patients. The majority of nausea, vomiting, and/or diarrhea events occurred during a dose increase and decreased over time.
• Inflammation of the pancreas (pancreatitis): Stop using Saxenda® (liraglutide) and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your stomach area (abdomen) to your back
• Gallbladder problems: Saxenda® (liraglutide)  may cause gallbladder problems, including gallstones. Some gallbladder problems need surgery. Call your health care provider if you have any of the following symptoms: pain in your upper stomach (abdomen), fever, yellowing of your skin or eyes (jaundice), or clay-colored stools.
• Increased risk of low blood sugar (hypoglycemia): In adults with type 2 diabetes who also take medicines to treat type 2 diabetes such as sulfonylureas or insulin.  Increased risk of low blood sugar (hypoglycemia) in children who are 12 years of age and older without type 2 diabetes.  Signs and symptoms of low blood sugar may include: shakiness, sweating, headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, and feeling jittery. You should check your blood sugar before you start taking Saxenda® (liraglutide) and while you take Saxenda® (liraglutide)
• Increased heart rate: Saxenda® (liraglutide)  can increase your heart rate while you are at rest. Your health care provider should check your heart rate while you take Saxenda® (liraglutide). Tell your health care professional if you feel your heart racing or pounding in your chest and it lasts for several minutes
• Kidney problems (kidney failure): Saxenda® (liraglutide)  may cause nausea, vomiting, or diarrhea leading to loss of fluids (dehydration). Dehydration may cause kidney failure, which can lead to the need for dialysis. This can happen in people who have never had kidney problems before. Drinking plenty of fluids may reduce your chance of dehydration. Call your health care provider right away if you have nausea, vomiting, or diarrhea that does not go away, or if you cannot drink liquids by mouth
• Serious allergic reactions: Stop using Saxenda® (liraglutide)  and get medical help right away if you have any symptoms of a serious allergic reaction including swelling of your face, lips, tongue, or throat, fainting or feeling dizzy, very rapid heartbeat, problems breathing or swallowing, or severe rash or itching
• Depression or thoughts of suicide: You should pay attention to any mental changes, especially sudden changes, in your mood, behaviors, thoughts, or feelings. Call your health care provider right away if you have any mental changes that are new, worse, or worry you
• Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Saxenda® (liraglutide). Tell your healthcare provider if you have stomach problems that are severe or will not go away.
• Changes in vision. Tell your healthcare provider if you have changes in vision during treatment with Saxenda® (liraglutide).
• Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy: Rapid improvement of glucose control has been associated with temporary worsening of diabetic retinopathy. Tell your provider right away if you experience changes in vision.
• Never Share a Pen: Pen-sharing poses a risk of infection.

‍

What are the most common side effects of Saxenda® (liraglutide)?

• Nausea
• Diarrhea
• Vomiting
• Constipation
• Stomach pain
• Indigestion
• Injection site reactions
• Feeling tired
• Allergic reactions
• Belching
• Hair loss
• Gastroesophageal reflux disease (heartburn)

You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

This information is not comprehensive. Please see the full Prescribing Information for complete safety information.

Disclaimer: Ozempic®, WeGovy®, Saxenda® and Victoza® are registered trademarks of Novo Nordisk. Zepbound® and Mounjaro® are registered trademarks of Eli Lilly. Fridays Health has no affiliation with Novo Nordiskor Eli Lilly . The compounded products available as part of Fridays Health’s Weight Loss Program are not made by Novo Nordiskor Eli Lilly or any company affiliated with Novo Nordiskor Eli Lilly .

Compound Semaglutide Safety Information

Your medical provider may recommend personalized dosages of compounded semaglutide based on a medical review. Compounded drugs are not FDA approved and are not evaluated for safety, effectiveness, or quality standards.This document is a summary of product information and does NOT have all possible information and potential side effects of the product. This is not medical advice and does not substitute advice from your health care provider.Compounded drugs are permitted to be prescribed under federal law but are not FDA-approved and do not undergo safety, effectiveness, or manufacturing review. Your provider may recommend certain doses of compounded semaglutide based on your medical evaluation

‍

Indications and Use:

Compounded semaglutide is an injectable prescription medicine that may help adults and adolescents with obesity and excess weight (overweight) – who may also have weight-related medical problems – lose weight and keep it off. It should be used with a reduced-calorie diet and increased physical activity.Compounded semaglutide is a synthetic glucagon-like peptide-1 (GLP-1) receptor agonist used for chronic weight management, along with a reduced calorie diet and increased physical activity, for people with an initial body mass index (BMI) of 27 kg/m2 or higher.Compounded semaglutide should not be used with other semaglutide-containing products or any other GLP-1/GIP receptor agonist medicines. It is not known if compounded semaglutide is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products. It is not known if compounded semaglutide can be used in people who have had pancreatitis. It is not known if compounded semaglutide is safe and effective for use in children under 18 years of age.

At lower (micro) doses, compounded semaglutide may also be beneficial for patients who:

• Have side effects at higher doses
• Would like to reduce cardiovascular disease risk
• Would like to reduce inflammation
• Would like to improve gastrointestinal conditions such as inflammatory bowel disease (IBD) or irritable bowel syndrome (IBS)
• Would like to protect against Alzheimer’s or Parkinson’s disease
• Would like to reduce the use of alcohol or tobacco

‍

Important Safety Information for Compounded Tirzepatide Injection

Warning: Risk of Thyroid C-Cell Tumors

In studies with mice and rats, semaglutide caused thyroid tumors, including thyroid cancer. It is not known if compounded semaglutide will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.Do not use compounded semaglutide if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

‍

Is Compounded Semaglutide FDA Approved?

Compounded semaglutide is not FDA approved and does not undergo the same rigorous efficacy and safety checks as do FDA-approved medications.  Compounded semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist which may be used for chronic weight management, along with a reduced calorie diet and increased physical activity, for people with an initial body mass index (BMI) of of 27 kg/m2 or higher.

‍

Limitations of Use:

Compounded semaglutide should not be used in combination with other semaglutide-containing products or any other GLP-1/GIP receptor agonist medicines.The safety and efficacy of coadministration with other products for weight loss have not been established.Compounded semaglutide has not been studied in patients with a history of pancreatitis.Note: Compounded medications are not FDA approved and do not have indications for treatment as an FDA approved medication would.

‍

Who should not use compounded semaglutide?

Do not use compounded semaglutide if:

You or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).You have a known allergic reaction to compounded semaglutide.

‍

How should compounded semaglutide be administered?

You can take compounded semaglutide with or without food. The pre-filled vial is self-administered with a needle and syringe as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week. Your provider will guide you on a treatment regimen that may include an increase in dose every four weeks.You should not change your dosing regimen or stop taking compounded semaglutide as prescribed without discussing with your provider first.

‍

What should I tell my provider before using compounded semaglutide?

Compounded semaglutide has certain drug interactions. It’s important to tell your provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.

‍

Some medications to watch out for include:

Medications used to treat type 1 or type 2 diabetes, including insulin or sulfonylureas (such as Amaryl or Glucotrol XL).Compounded semaglutide causes a delay in gastric emptying, so it has the potential to impact the absorption of medications that are taken by mouth at the same time. Your provider can guide you on how to schedule your medications.

Other GLP-/GIP medications, including Wegovy® (semaglutide), Ozempic® (semaglutide), Saxenda® (liraglutide), Zepbound® (tirzepatide), Mounjaro® (tirzepatide), Victoza® (liraglutide), Byetta® (exenatide), or Bydureon® (exenatide).If you’re using other products for weight loss, including dietary supplements.

‍

It’s important to share your entire medical history with your provider.

In particular, tell your provider if you have a past history of:

• Type 1 or type 2 diabetes
• Thyroid cancer
• Pancreatitis
• Kidney disease
• Diabetic retinopathy
• Depression
• Suicidal thoughts or behavior

‍

Tell your provider if you are pregnant, planning to become pregnant, or breastfeeding.

If you are pregnant: Compounded semaglutide should not be used during pregnancy. Based on animal studies, there may be potential risks to an unborn baby from exposure to compounded semaglutide during pregnancy. There is no benefit to weight loss during pregnancy and it may cause harm to the unborn baby.

If you are a female or male of reproductive potential: Discontinue compounded semaglutide at least 2 months before a planned pregnancy since the drug can stay in the bloodstream for a long time.

If you are breastfeeding: Compounded semaglutide was found in the milk of lactating rats. Tell your provider if you are breastfeeding before you start compounded semaglutide. At this time, we do not recommend taking compounded semaglutide if you are breastfeeding or bottle-feeding with breastmilk.

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

‍

What are the most serious side effects that I or a caregiver should monitor for when taking compounded semaglutide?

The most common side effects are typically mild and usually resolve after the first several weeks of treatment. These can include nausea, vomiting, diarrhea, constipation, abdominal pain, upset stomach, abdominal distension, reflux, headache, fatigue, and dizziness. Swelling, redness, and itchiness at the injection site may occur. The FDA has issued its most serious warning (called a BOXED WARNING)

that GLP-1s may be associated with a type of thyroid cancer called medullary thyroid carcinoma. So far, this side effect has primarily been seen in laboratory studies using rodents, so the risk to humans has not been determined.

‍

SIDE EFFECTS:

Nausea, vomiting, stomach upset, diarrhea, tiredness, dizziness, or constipation may occur. Nausea usually lessens as you continue to use semaglutide. If any of these effects last or get worse, tell your provider or pharmacist promptly. Remember that this medication has been prescribed because your provider has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Vomiting/diarrhea that doesn’t stop may result in dehydration. Contact your provider promptly if you notice any symptoms of dehydration, such as unusual dry mouth/thirst or dizziness/ lightheadedness. Tell your provider right away if you have any serious side effects, including: signs of kidney problems (such as change in the amount of urine), vision changes (suchas decreased/blurred vision), fast heartbeat, mental/mood changes (such as depression, thoughts of suicide), signs of low blood sugar (sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, tingling hands/feet).

Get medical help right away if you have any very serious side effects, including: signs of pancreas or gallbladder disease (such as nausea/vomiting that doesn’t stop, severe stomach/abdominal pain). A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your provider or pharmacist.In the US –  Call your provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch

‍

WARNING:

This medication has been found to cause a certain type of thyroid tumor (thyroid C-cell tumors) in rats and mice. It is unknown if this medication can cause similar tumors in humans. Talk with your provider about the benefits and risks of treatment with this medication. This medication should not be used by

people with a personal/family history of a certain type of cancer (medullary thyroid carcinoma) or by people with a certain inherited disease (Multiple Endocrine Neoplasia syndrome type 2 or MEN 2). Whileusing this medication, tell your provider right away if you notice any signs or symptoms of thyroid tumors, including unusual growth or lump in the neck, difficulty swallowing, shortness of breath, or unusual/lasting hoarseness.

‍

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

‍

These serious side effects can occur with compounded semaglutide. You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dose changes.

‍

Thyroid C-Cell Tumors: In mice and rats, semaglutide caused an increase in thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). It is unknown whether compounded semaglutide causes thyroid C-cell tumors in humans. There were cases of MTC reported in patients who took liraglutide (the active ingredient in Victoza® and Saxenda®) after the drug was put on the market. Compounded semaglutide is contraindicated in patients with a family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.

‍

Inflammation of Pancreas (Acute Pancreatitis): Monitor for signs of acute pancreatitis, including severe abdominal pain that does not go away, sometimes radiating to the back, with or without vomiting.

‍

Acute Gallbladder Disease: Compounded semaglutide may cause gallbladder problems, including gallstones. Some gallbladder problems require surgery. Tell your provider right away if you have pain in your upper stomach, yellowing of skin or eyes (jaundice), fever, or clay-colored stools.

‍

Low Blood Sugar (Hypoglycemia): Compounded semaglutide lowers blood glucose. It can cause low blood sugar in patients with type 2 diabetes who also take another glucose control medication. Monitor your blood sugar and watch out for signs of too low blood sugar such as dizziness, blurred vision, mood changes, sweating, or fast heartbeat.

‍

Acute Kidney Injury: In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse. It is important for you to drink plenty of water to help reduce your chance of dehydration.

‍

Serious Allergic Reactions: Stop using compounded semaglutide right away if you experience symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, severe rashor itching, very rapid heartbeat, problems breathing or swallowing, or fainting or feeling dizzy.

‍

Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: If you have type 2 diabetes, tell your provider right away if you experience changes in vision.

‍

Increase in Heart Rate: Tell your provider right away if you have a racing heartbeat while at rest.Suicidal Behavior and Ideation: You should pay attention to any mental health changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.

‍

Never Share a Vial/Needle/Syringe: Sharing poses a risk of infection.

‍

Current/Recent Prescriptions

If you have any current/recent prescriptions for either compounded or brand name weight loss medications, do not take both medications. You will be asked to provide evidence of the current/recent prescription including dose specifics. Taking two or more GLP-1/GIP medications at the same time increases the risk of potentially serious side effects. Notify your provider immediately if you have any current or previous prescriptions for compounded or brand name weight loss medications.

‍

Medical History

Failure to fully disclose your medical history to your provider may result in serious side effects, includingdeath.

‍

Before using Compounded Semaglutide

Your healthcare provider will direct you to instructions on how to administer your GLP-1 therapy.

Tell your healthcare provider if you are taking medicines to treat diabetes including insulin or sulfonylureas which could increase your risk of low blood sugar. Talk to your healthcare provider about low blood sugar levels and how to manage them.

If you take birth control pills by mouth, talk to your healthcare provider before you use compounded semaglutide. Birth control pills may not work as well while using compounded semaglutide. Your healthcare provider may recommend another type of birth control for 4 weeks after you start compoundedsemaglutide and for 4 weeks after each increase in your dose of compounded semaglutide.

‍

Review these questions with your healthcare provider:

• Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis)or problems digesting food?
• Do you take diabetes medicines, such as insulin or sulfonylureas?
• Do you have a history of diabetic retinopathy?
• Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?
• Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? Compounded semaglutide may harm your unborn baby. Tell your healthcare provider if you become pregnant while using compounded semaglutide. It is not known if compounded semaglutide passes into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using compounded semaglutide.

‍

How to take:

• Read the instructions that come with compounded semaglutide.
• Use compounded semaglutide exactly as your healthcare provider says.
• Compounded semaglutide is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm.
• Use compounded semaglutide 1 time each week on the same day every week.
• Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection.
• If you take too much compounded semaglutide, call your healthcare provider, seek medical advice promptly, or contact a Poison Center expert right away at 1-800-222-1222

‍

HOW IS COMPOUNDED SEMAGLUTIDE PRESCRIBED?

Compounded semaglutide typically starts at a low dose that is gradually increased overtime. The typical dosing schedule of compounded semaglutide is:

Weeks 1–4:

0.25 mg once a week

Weeks 5–8:

0.5 mg once a week

Weeks 9–12:

1 mg once a week

Weeks 13–16:

1.7 mg once a week

Weeks 17–20:

2.4 mg once a week

Depending on your specific situation, your maintenance dose could be lower than 2.4 mg once a week.

Oral forms of compounded semaglutide are typically dosed between 5-10 mg daily.

Follow the dosing instructions from your provider, as they may personalize your plan for your individual needs.

‍‍

Legal Disclaimers:

Compounded semaglutide is not approved by the FDA. The FDA does not evaluate compounded productsfor safety, effectiveness, or quality.

Zepbound and Mounjaro is a registered trademark of Eli Lilly and Company. Ozempic, Wegovy, Saxenda, and Victoza are registered trademarks of Novo Nordisk A/S. Byetta and Bydureon are registeredtrademarks of Amylin Pharmaceuticals, Inc.

Compound Tirzepatide Safety Information

Your medical provider may recommend personalized dosages of compounded tirzepatide based on a medical review. Compounded drugs are not FDA approved and are not evaluated for safety, effectiveness,or quality standards.This document is a summary of product information and does NOT have all possible information and potential side effects of the product. This is not medical advice and does not substitute advice from your health care provider.Compounded drugs are permitted to be prescribed under federal law but are not FDA-approved and do not undergo safety, effectiveness, or manufacturing review. Your provider may recommend certain doses of compounded tirzepatide based on your medical evaluation.

‍

Indications and Use:

Compounded tirzepatide is an injectable prescription medicine that may help adults and adolescents with obesity and excess weight (overweight) – who may also have weight-related medical problems – lose weight and keep it off. It should be used with a reduced-calorie diet and increased physical activity.Compounded tirzepatide is a synthetic glucagon-like peptide-1 (GLP-1) receptor agonist used for chronic weight management, along with a reduced calorie diet and increased physical activity, for people with an initial body mass index (BMI) of 27 kg/m2 or higher.

Compounded tirzepatide should not be used with other tirzepatide-containing products or any other GLP-1/GIP receptor agonist medicines. It is not known if compounded tirzepatide is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products. It is not known if compounded tirzepatide can be used in people who have had pancreatitis. It is not known if compounded tirzepatide is safe and effective for use in children under 18 years of age.

At lower (micro) doses, compounded tirzepatide may also be beneficial for patients who:

• Have side effects at higher doses
• Would like to reduce cardiovascular disease risk
• Would like to reduce inflammation
• Would like to improve gastrointestinal conditions such as inflammatory bowel disease (IBD) or irritable bowel syndrome (IBS)
• Would like to protect against Alzheimer’s or Parkinson’s disease
• Would like to reduce the use of alcohol or tobacco

‍

Important Safety Information for Compounded Tirzepatide Injection

Warning: Risk of Thyroid C-Cell Tumors

In studies with mice and rats, tirzepatide caused thyroid tumors, including thyroid cancer. It is not known if compounded tirzepatide will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.Do not use compounded tirzepatide if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

‍

Is Compounded Tirzepatide FDA Approved?

Compounded tirzepatide is not FDA approved and does not undergo the same rigorous efficacy and safetychecks as do FDA-approved medications.  Compounded tirzepatide is a glucagon-like peptide-1 (GLP-1) receptor agonist which may be used for chronic weight management, along with a reduced calorie diet and increased physical activity, for people with an initial body mass index (BMI) of of 27 kg/m2 or higher.

‍

Limitations of Use:

Compounded tirzepatide should not be used in combination with other tirzepatide-containing products or any other GLP-1/GIP receptor agonist medicines.

The safety and efficacy of coadministration with other products for weight loss have not been established.

Compounded tirzepatide has not been studied in patients with a history of pancreatitis.

Note: Compounded medications are not FDA approved and do not have indications for treatment as an FDA approved medication would.

‍

Who should not use compounded semaglutide?

Do not use compounded tirzepatide if:

You or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).You have a known allergic reaction to compounded tirzepatide.

‍

How should compounded tirzepatide be administered?

You can take compounded tirzepatide with or without food. The pre-filled vial is self-administered with a needle and syringe as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week. Your provider will guide you on a treatment regimen that may include an increase in dose every four weeks.

You should not change your dosing regimen or stop taking compounded tirzepatide as prescribed without discussing with your provider first.

‍

What should I tell my provider before using compounded tirzepatide?

Compounded tirzepatide has certain drug interactions. It’s important to tell your provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.

‍

Some medications to watch out for include:

Medications used to treat type 1 or type 2 diabetes, including insulin or sulfonylureas (such as Amaryl or Glucotrol XL).Compounded tirzepatide causes a delay in gastric emptying, so it has the potential to impact the absorption of medications that are taken by mouth at the same time. Your provider can guide you on how to schedule your medications.

Other GLP-/GIP medications, including Wegovy® (tirzepatide), Ozempic® (tirzepatide), Saxenda® (liraglutide), Zepbound® (tirzepatide), Mounjaro® (tirzepatide), Victoza® (liraglutide), Byetta® (exenatide), or Bydureon® (exenatide).If you’re using other products for weight loss, including dietary supplements.

‍

It’s important to share your entire medical history with your provider.

In particular, tell your provider if you have a past history of:

• Type 1 or type 2 diabetes
• Thyroid cancer
• Pancreatitis
• Kidney disease
• Diabetic retinopathy
• Depression
• Suicidal thoughts or behavior

‍

Tell your provider if you are pregnant, planning to become pregnant, or breastfeeding.

If you are pregnant: Compounded tirzepatide should not be used during pregnancy. Based on animal studies, there may be potential risks to an unborn baby from exposure to compounded tirzepatide during pregnancy. There is no benefit to weight loss during pregnancy and it may cause harm to the unborn baby.

If you are a female or male of reproductive potential: Discontinue compounded tirzepatide at least 2 months before a planned pregnancy since the drug can stay in the bloodstream for a long time.

If you are breastfeeding: Compounded tirzepatide was found in the milk of lactating rats. Tell your provider if you are breastfeeding before you start compounded tirzepatide. At this time, we do not recommend taking compounded tirzepatide if you are breastfeeding or bottle-feeding with breastmilk.

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

‍

What are the most serious side effects that I or a caregiver should monitor for when taking compounded tirzepatide?

The most common side effects are typically mild and usually resolve after the first several weeks of treatment. These can include nausea, vomiting, diarrhea, constipation, abdominal pain, upset stomach, abdominal distension, reflux, headache, fatigue, and dizziness. Swelling, redness, and itchiness at the injection site may occur. The FDA has issued its most serious warning (called a BOXED WARNING)

that GLP-1s may be associated with a type of thyroid cancer called medullary thyroid carcinoma. So far, this side effect has primarily been seen in laboratory studies using rodents, so the risk to humans has not been determined.

‍

SIDE EFFECTS:

Nausea, vomiting, stomach upset, diarrhea, tiredness, dizziness, or constipation may occur. Nausea usually lessens as you continue to use tirzepatide. If any of these effects last or get worse, tell your provider or pharmacist promptly. Remember that this medication has been prescribed because your provider has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Vomiting/diarrhea that doesn’t stop may result in dehydration. Contact your provider promptly if you notice any symptoms of dehydration, such as unusual dry mouth/thirst or dizziness/ lightheadedness. Tell your provider right away if you have any serious side effects, including: signs of kidney problems (such as change in the amount of urine), vision changes (suchas decreased/blurred vision), fast heartbeat, mental/mood changes (such as depression, thoughts of suicide), signs of low blood sugar (sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, tingling hands/feet).

Get medical help right away if you have any very serious side effects, including: signs of pancreas or gallbladder disease (such as nausea/vomiting that doesn’t stop, severe stomach/abdominal pain). A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your provider or pharmacist.

In the US –  Call your provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch

‍

WARNING:

This medication has been found to cause a certain type of thyroid tumor (thyroid C-cell tumors) in rats and mice. It is unknown if this medication can cause similar tumors in humans. Talk with your provider about the benefits and risks of treatment with this medication. This medication should not be used by

people with a personal/family history of a certain type of cancer (medullary thyroid carcinoma) or by people with a certain inherited disease (Multiple Endocrine Neoplasia syndrome type 2 or MEN 2). Whileusing this medication, tell your provider right away if you notice any signs or symptoms of thyroid tumors, including unusual growth or lump in the neck, difficulty swallowing, shortness of breath, or unusual/lasting hoarseness

‍

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

‍

These serious side effects can occur with compounded semaglutide. You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dose changes.

‍

Thyroid C-Cell Tumors: In mice and rats, tirzepatide caused an increase in thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). It is unknown whether compounded tirzepatide causes thyroid C-cell tumors in humans. There were cases of MTC reported in patients who took liraglutide (the active ingredient in Victoza® and Saxenda®) after the drug was put on the market. Compounded tirzepatide is contraindicated in patients with a family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.

‍

Inflammation of Pancreas (Acute Pancreatitis): Monitor for signs of acute pancreatitis, including severe abdominal pain that does not go away, sometimes radiating to the back, with or without vomiting.

‍

Acute Gallbladder Disease: Compounded tirzepatide may cause gallbladder problems, including gallstones. Some gallbladder problems require surgery. Tell your provider right away if you have pain in your upper stomach, yellowing of skin or eyes (jaundice), fever, or clay-colored stools.

‍

Low Blood Sugar (Hypoglycemia): Compounded tirzepatide lowers blood glucose. It can cause low blood sugar in patients with type 2 diabetes who also take another glucose control medication. Monitor your blood sugar and watch out for signs of too low blood sugar such as dizziness, blurred vision, mood changes, sweating, or fast heartbeat.

‍

Acute Kidney Injury: In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse. It is important for you to drink plenty of water to help reduce your chance of dehydration.

‍

Serious Allergic Reactions: Stop using compounded tirzepatide right away if you experience symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, severe rash or itching,very rapid heartbeat, problems breathing or swallowing, or fainting or feeling dizzy.

‍

Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: If you have type 2 diabetes, tell your provider right away if you experience changes in vision.

‍

Increase in Heart Rate: Tell your provider right away if you have a racing heartbeat while at rest.

‍

Suicidal Behavior and Ideation: You should pay attention to any mental health changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.

‍

Never Share a Vial/Needle/Syringe: Sharing poses a risk of infection.

‍

Current/Recent Prescriptions

If you have any current/recent prescriptions for either compounded or brand name weight loss medications, do not take both medications. You will be asked to provide evidence of the current/recent prescription including dose specifics. Taking two or more GLP-1/GIP medications at the same time increases the risk of potentially serious side effects. Notify your provider immediately if you have any current or previous prescriptions for compounded or brand name weight loss medications.

‍

Medical History

Failure to fully disclose your medical history to your provider may result in serious side effects, including death.

‍

Before using Compounded Tirzepatide

Your healthcare provider will direct you to instructions on how to administer your GLP-1 therapy.

Tell your healthcare provider if you are taking medicines to treat diabetes including insulin or sulfonylureas which could increase your risk of low blood sugar. Talk to your healthcare provider about low blood sugar levels and how to manage them.

If you take birth control pills by mouth, talk to your healthcare provider before you use compounded tirzepatide. Birth control pills may not work as well while using compounded tirzepatide. Your healthcareprovider may recommend another type of birth control for 4 weeks after you start compounded tirzepatideand for 4 weeks after each increase in your dose of compounded tirzepatide.

‍

Review these questions with your healthcare provider:

• Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis)or problems digesting food?
• Do you take diabetes medicines, such as insulin or sulfonylureas?
• Do you have a history of diabetic retinopathy?
• Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?
• Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? Compounded tirzepatide may harm your unborn baby. Tell your healthcare provider if you become pregnant while using compounded tirzepatide. It is not known if compounded tirzepatide passes into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using compounded tirzepatide.

‍

How to take:

• Read the instructions that come with compounded tirzepatide.
• Use compounded tirzepatide exactly as your healthcare provider says.
• Compounded tirzepatide is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm.
• Use compounded tirzepatide 1 time each week on the same day every week.
• Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection.
• If you take too much compounded tirzepatide, call your healthcare provider, seek medical advice promptly, or contact a Poison Center expert right away at 1-800-222-1222.

‍

HOW IS COMPOUNDED TIRZEPATIDE PRESCRIBED?

Compounded tirzepatide typically starts at a low dose that is gradually increased overtime. The typical dosing schedule of compounded tirzepatide is:

Weeks 1–4:

2.5 mg once a week

Weeks 5–8:

5 mg once a week

Weeks 9–12:

7.5 mg once a week

Weeks 13–16:

10 mg once a week

Weeks 17–20:

12.5 mg once a week

Weeks 21-24

15 mg once a week

‍

Depending on your specific situation, your maintenance dose could be lower than 15 mg once a week.

Follow the dosing instructions from your provider, as they may personalize your plan for your individual needs.

Oral forms of compounded tirzepatide are typically dosed between 3-6 mg daily.

For micro-dosing purposes, compounded tirzepatide dosing starts at 1.25 mg once or twice weekly. Orally micro-dosed tirzepatide is typically at 1.5 mg daily

‍‍

Legal Disclaimers:

Compounded tirzepatide is not approved by the FDA. The FDA does not evaluate compounded products for safety, effectiveness, or quality. Zepbound and Mounjaro is a registered trademark of Eli Lilly and Company. Ozempic, Wegovy, Saxenda, and Victoza are registered trademarks of Novo Nordisk A/S. Byetta and Bydureon are registeredtrademarks of Amylin Pharmaceuticals, Inc..