GLP-1 Safety Information

• 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).

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.

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 Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• You have a known allergic reaction to 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 Joi+Blokes 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 Zepbound® (tirzepatide) as prescribed without discussing with your provider first.

Zepbound® (tirzepatide) has certain drug interactions. It’s important to tell your Joi and Blokes 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.

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.

• 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. Byetta® and Bydureon® are registered trademarks of Amylin Pharmaceuticals. Joi+Blokes has no affiliation with Novo Nordisk, Eli Lilly or Amylin Pharmaceuticals. The compounded products available as part of Joi+Blokes Weight Loss Program are not made by Novo Nordisk, Eli Lilly or Amylin Pharmaceuticals or any company affiliated with Novo Nordisk, Eli Lilly or Amylin Pharmaceuticals.

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).

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.

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®?”.

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 Joi+Blokes 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.

• Ozempic® (semaglutide) has certain drug interactions. It’s important to tell your Remedy Meds 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 Ozempic® (semaglutide) before you use it for the first time.
• Talk to your healthcare provider about low blood sugar and how to manage it.
• have or have had problems with your pancreas or kidneys.
• have a history of diabetic retinopathy.
• Are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if Ozempic® (semaglutide) will harm your unborn baby or passes into your breast milk. You should stop using Ozempic® (semaglutide) 2 months before you plan to become pregnant.

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.
• Other GLP-1 medications, including WeGovy® (semaglutide), Ozempic® (semaglutide), Saxenda® (liraglutide), Zepbound® (tirzepatide), Mounjaro® (tirzepatide), Victoza® (liraglutide), Byetta® (exenatide), or Bydureon® (exenatide).
• 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.

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.
• 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 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.

• 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. Byetta® and Bydureon® are registered trademarks of Amylin Pharmaceuticals. Joi+Blokes has no affiliation with Novo Nordisk, Eli Lilly or Amylin Pharmaceuticals. The compounded products available as part of Joi+Blokes Weight Loss Program are not made by Novo Nordisk, Eli Lilly or Amylin Pharmaceuticals or any company affiliated with Novo Nordisk, Eli Lilly or Amylin Pharmaceuticals.

The following information is provided for general educational purposes only and is not intended to promote any specific product.

Important Safety Information for Compounded GLP-1

Your medical provider may recommend a specific dosage or formulation of compounded semaglutide based on your individual medical needs. Compounded drugs are not FDA approved and are not evaluated for safety, effectiveness, or quality standards by the FDA.

This page contains a summary of general information for educational purposes and does NOT include 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 state and federal law in certain circumstances. Your provider will determine whether compounded semaglutide is right for you following your medical evaluation.

This page contains a summary of product general information for educational purposes and does NOT include 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 GLP-1 is an injectable prescription medicine.
• Compounded GLP-1 should not be used with other GLP-1-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. Speak with your medical provider for more information.

Warning: Risk of Thyroid C-Cell Tumors

• 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).

Compounded semaglutide is not FDA approved and does not undergo the same rigorous efficacy and safety checks as FDA-approved medications. Compounded semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist which may be prescribed along with a reduced calorie diet and increased physical activity, based on your individual medical needs and goals.

• Compounded GLP-1 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.

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.

• Follow your provider’s instructions when taking this medication. Generally, 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, or a decrease depending on your clinical needs.
• You should not change your dosing regimen or stop taking compounded semaglutide as prescribed without discussing with your provider first.

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.

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. 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: Speak with your provider about whether to discontinue the medication before a planned pregnancy.
• If you are breastfeeding: Tell your provider if you are breastfeeding before you start compounded semaglutide. It is not known if compounded semaglutide passes into your breast milk. Your provider may recommend that you do not take 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.

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. 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 (such as 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:

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). While using 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.

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: 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 may 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 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.

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.

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

• 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 compounded semaglutide 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, unless prescribed otherwise or in another form.
• Use compounded semaglutide one (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.

Compounded GLP-1 (semaglutide) is not approved by the FDA. The FDA does not evaluate compounded products for safety, effectiveness, or quality.

The following information is provided for general educational purposes only and is not intended to promote any specific product.



Important Safety Information for Compounded GLP-1/GIP

Your medical provider may recommend a specific dosage or formulation of compounded tirzepatide based on your individual medical needs. Compounded drugs are not FDA approved and are not evaluated for safety, effectiveness, or quality standards.

This page contains document is a summary of product general information for educational purposes and does NOT include 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 state and federal law in certain circumstances but are not FDA-approved and do not undergo safety, effectiveness, or manufacturing review. Your provider will determine whether compounded tirzepatide is right for you following may recommend certain doses of compounded tirzepatide based on your medical evaluation.

• Compounded tirzepatide is an injectable prescription medication.
• 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.

Warning: Risk of Thyroid C-Cell Tumors

• 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).

Compounded tirzepatide is not FDA approved and does not undergo the same rigorous efficacy and safety checks as do FDA-approved medications. Compounded tirzepatide is a
glucagon-like peptide-1 (GLP-1) receptor agonist which may be prescribed along with a reduced calorie diet and increased physical activity, based on your individual medical needs and goals.

• 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.

Do not use compounded GLP-1/GIP 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.

• Follow your provider’s instructions when taking this medication. Generally, 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, or a decrease depending on your clinical needs.
• You should not change your dosing regimen or stop taking compounded tirzepatide as prescribed without discussing with your provider first.

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.

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. 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:  Speak with your provider about whether to discontinue the medication before a planned pregnancy.
• If you are breastfeeding: It is not known if compounded tirzepatide passes into your breast milk. Your provider may recommend that you do not take 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.

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 distention, reflux, headache, fatigue, and dizziness. Swelling, redness, and itchiness at the injection site may occur. 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 (such as 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:

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). While using 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.

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: 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 may 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.

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.

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

• 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 healthcare provider may recommend another type of birth control for 4 weeks after you start compounded semaglutide and 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, unless prescribed otherwise or in another form.
• Use compounded tirzepatide one (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.

Compounded GLP-1/GIP (tirzepatide) is not approved by the FDA. The FDA does not evaluate compounded products for safety, effectiveness, or quality.