Warning: Risk of Thyroid Tumors

Tirzepatide has been linked to thyroid tumors in animal studies, including instances of thyroid cancer. The potential for tirzepatide to lead to thyroid tumors or a specific type of thyroid cancer known as medullary thyroid carcinoma (MTC) in humans remains unclear. Notify your healthcare provider if you notice any lumps or swelling in your neck, experience hoarseness, difficulty swallowing, or shortness of breath, as these may indicate thyroid cancer. Do not take tirzepatide if you or any family member has a history of MTC or if you have a condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Approved Use of Tirzepatide

Tirzepatide is indicated for adult patients as part of a comprehensive weight management plan that includes a reduced-calorie diet and increased physical activity. It is authorized for those who have an initial body mass index (BMI) of:

• 30 kg/m² or higher (obesity)
• 27 kg/m² or higher (overweight) with at least one weight-related health issue (like high blood pressure, type 2 diabetes, dyslipidemia, or obstructive sleep apnea)

Limitations on Use

• Tirzepatide should not be used with other products containing tirzepatide or any other GLP-1 receptor agonists.
• Efficacy and safety of combining tirzepatide with other weight-loss medications haven't been established.
• There is limited research on the use in patients with a history of pancreatitis.

Who Should Avoid Tirzepatide?

Do not take tirzepatide if:

• You or a family member has a history of medullary thyroid carcinoma (MTC) or MEN 2.
• You are allergic to tirzepatide.

Administration of Tirzepatide

Tirzepatide can be taken with or without food. It is delivered via a pre-filled injector pen as a subcutaneous injection in the abdomen, thigh, or upper arm once weekly on the same day each week. Your provider will determine a dosage plan, including potential increases every four weeks. Please consult your healthcare provider before changing your dosing schedule or discontinuing use.

Communication with Your Provider

It's essential to inform your healthcare provider about all medications you are currently taking—this includes prescriptions, over-the-counter drugs, vitamins, and supplements. Special attention should be given to:

• Diabetes medications, including insulin or sulfonylureas.
• Other oral medications that may be affected by slowed gastric emptying.
• Hormonal birth control, as tirzepatide may diminish its effectiveness. It is advised to switch to a non-oral contraceptive method or use barrier protection for four weeks after initiating tirzepatide and for four weeks following any dose increase.
• Additional weight-loss products or GLP-1 medications like Mounjaro, Wegovy, or Ozempic.

Make sure to share your complete medical history, particularly if you have a history of:

• Type 1 or type 2 diabetes
• Thyroid cancer
• Gastrointestinal issues
• Pancreatitis
• Kidney problems
• Retinopathy
• Mental health concerns, including suicidal thoughts

Also, inform your provider if you are pregnant, planning to conceive, or breastfeeding.

If pregnant: Tirzepatide is not recommended during pregnancy due to potential risks to the fetus. There is no benefit for weight loss during this time.

If of reproductive potential: Consider alternative contraceptive methods, as tirzepatide may lessen the effectiveness of oral contraceptives.

If breastfeeding: Consult with your provider regarding the use of tirzepatide and its potential effects on breastfeeding.

Monitoring for Serious Side Effects

In case of a medical emergency, contact emergency services immediately.

Be vigilant for these serious side effects associated with tirzepatide, particularly in the initial stages of treatment or following dose adjustments:

• Thyroid Tumors: There is a concern regarding thyroid tumors in humans. If you experience neck swelling, hoarseness, trouble swallowing, or shortness of breath, seek medical advice immediately.
• Gastrointestinal Issues: Symptoms such as nausea, diarrhea, or stomach pain are common and may require monitoring, especially during dose increases.
• Kidney Injury: Dehydration from gastrointestinal symptoms could lead to kidney issues. Maintain proper hydration.
• Gallbladder Disease: Report any upper stomach pain, jaundice, fever, or changes in stool color to your provider.
• Pancreatitis: Be aware of persistent severe abdominal pain that may radiate to your back.
• Allergic Reactions: If you notice signs of a severe allergic reaction, such as swelling or difficulty breathing, stop using tirzepatide and seek immediate medical help.
• Hypoglycemia: Tirzepatide may lower blood glucose levels which can be dangerous, particularly for those on other diabetes medications.
• Visual Changes: Report any changes in vision, especially if you have a history of diabetic retinopathy.
• Mental Health Changes: Watch for any new or worsening mood changes, thoughts, or feelings that cause concern.

Common Side Effects

• Nausea
• Diarrhea
• Vomiting
• Constipation
• Stomach pain
• Indigestion
• Reactions at the injection site
• Fatigue
• Allergic reactions
• Belching

You’re encouraged to report any adverse effects related to tirzepatide directly to the FDA at www.fda.gov/medwatch or by calling 1-800-FDA-1088.

**Note:** This information is not exhaustive. For complete safety details, consult the full Prescribing Information.

In certain situations, healthcare providers may prescribe compounded medications prepared by state-licensed pharmacies. These compounded drugs are not FDA-approved and lack extensive safety and effectiveness assessments.

Zepbound and Wegovy are approved for weight loss management; Ozempic is approved for type 2 diabetes but can also be prescribed off-label for weight loss.