Important Safety Information

Compounded tirzepatide is a glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist used as a treatment 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).

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 Fighting Weight-affiliated provider may recommend certain doses of tirzepatide based on your medical evaluation.

IMPORTANT: This is a summary and does not have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Limitations of Use:

• 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.
• Tirzepatide has not been studied in patients with a history of pancreatitis.

WARNING: RISK OF THYROID C-CELL TUMORS

See full prescribing information for complete boxed warning.

• In rats, tirzepatide causes thyroid C-cell tumors. It is unknown whether tirzepatide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined.
• Tirzepatide is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors.

Do not take tirzepatide if you:

• Have a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN2).
• Have been diagnosed with insulin-dependent diabetes.
• Have been diagnosed with pancreatitis or history of pancreatitis.
• Have a known allergy to tirzepatide/any other GLP-1 drug or any of the inactive ingredients in tirzepatide. Inactive ingredients include: di-sodium hydrogen phosphate dihydrate, sodium chloride, benzyl alcohol, hydrochloric acid, sodium hydroxide pellets and water.
• Have a history of suicidal attempts or active suicidal ideation.

WARNINGS AND PRECAUTIONS

• Severe Gastrointestinal Disease: Use has been associated with gastrointestinal adverse reactions, sometimes severe. Has not been studied in patients with severe gastrointestinal disease and is not recommended in these patients.
• Acute Kidney Injury: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion.
• Acute Gallbladder Disease: Has been reported in clinical trials. If cholecystitis is suspected, gallbladder studies and clinical follow-up are indicated.
• Acute Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.
• Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported postmarketing with tirzepatide. If suspected, advise patients to promptly seek medical attention and discontinue tirzepatide.
• Hypoglycemia: Concomitant use with an insulin secretagogue or insulin may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing dose of insulin secretagogue or insulin may be necessary. Inform all patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.
• Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus: Has not been studied in patients with non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy, or diabetic macular edema. Monitor patients with a history of diabetic retinopathy for progression.
• Suicidal Behavior and Ideation: Monitor for depression or suicidal thoughts. Discontinue tirzepatide if symptoms develop.

Side Effects: The most common adverse reactions, reported in ≥5% of patients treated with tirzepatide are: nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, injection site reactions, fatigue, hypersensitivity reactions, eructation, hair loss, gastroesophageal reflux disease.

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS: Tirzepatide delays gastric emptying. May impact absorption of concomitantly administered oral medications. Use with caution.

USE IN SPECIFIC POPULATIONS

• Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue tirzepatide.
• Females of Reproductive Potential: Advise females using oral contraceptives to switch to a non-oral contraceptive method or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation.