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Important Safety Information for Tirzepatide (Generic Zepbound) Injection

Warning: Risk of Thyroid C-Cell Tumors

Tirzepatide has been associated with thyroid tumors, including thyroid cancer, in rats. It is uncertain whether Tirzepatide can lead to thyroid tumors or a specific type of thyroid cancer known as medullary thyroid carcinoma (MTC) in humans. If you experience a lump or swelling in your neck, hoarseness, difficulty swallowing, or shortness of breath, inform your healthcare provider promptly, as these could be signs of thyroid cancer.

Who Should Not Use Tirzepatide?

Avoid using Tirzepatide if you or any of your family members have a history of medullary thyroid carcinoma (MTC) or if you have a condition known as Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Additionally, do not take Tirzepatide if you have had a known allergic reaction to the medication.

FDA-Approved Use of Tirzepatide

Tirzepatide is prescribed, in conjunction 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 higher (obesity) or 27 kg/m^2 or higher (overweight) with at least one weight-related comorbid condition.

How to Take Tirzepatide?

Tirzepatide can be administered with or without food via a pre-filled injector pen as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day each week. Your healthcare provider will determine the treatment plan, which may involve a dose increase every four weeks. It is essential to consult your provider before altering your dosage regimen or discontinuing Tirzepatide.

Precautions Before Using Tirzepatide

Inform your healthcare provider about all medications, including over-the-counter products, vitamins, and supplements. Pay special attention to medications for diabetes, oral medications affected by delayed gastric emptying, and hormonal birth control methods. Disclose your complete medical history, especially if you have a history of diabetes, thyroid cancer, gastrointestinal disease, pancreatitis, kidney disease, diabetic retinopathy, depression, or suicidal thoughts.

Most Serious Side Effects to Monitor

Watch for rare but severe side effects of Tirzepatide, such as thyroid C-cell tumors, severe gastrointestinal issues, acute kidney injury, acute gallbladder disease, inflammation of the pancreas, allergic reactions, low blood sugar, diabetic retinopathy complications, and suicidal behavior. Seek immediate medical attention if you experience any of these symptoms.

Common Side Effects of Tirzepatide

Common side effects of Tirzepatide include nausea, diarrhea, vomiting, constipation, stomach pain, injection site reactions, fatigue, allergic reactions, belching, hair loss, heartburn, and indigestion.

For comprehensive safety information, refer to the full Prescribing Information for Tirzepatide. If you encounter negative side effects, report them to the FDA at

www.fda.gov/medwatch or call 1-800-FDA-1088.

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