Important Safety Information for Zepbound® (tirzepatide)

Warning: Risk of Thyroid C-Cell Tumors

In animal studies, Zepbound® (tirzepatide) has been associated with thyroid tumors, including thyroid cancer. While it's not known if it causes these tumors in humans, it's crucial to inform your healthcare provider if you notice any lumps or swelling in your neck, hoarseness, difficulty swallowing, or shortness of breath, as these could be signs of thyroid cancer.

Do not use Zepbound® (tirzepatide) if you or any family members have had medullary thyroid carcinoma (MTC) or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

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

Zepbound® (tirzepatide) is approved for chronic weight management in adults, to be used alongside a reduced-calorie diet and increased physical activity. It’s suitable for those with an initial body mass index (BMI) of:

  • 30 kg/m^2 or greater (obesity)

  • 27 kg/m^2 or greater (overweight) with at least one weight-related condition like hypertension, type 2 diabetes, dyslipidemia, obstructive sleep apnea, or cardiovascular disease.

Limitations of Use:

  • Do not combine Zepbound® (tirzepatide) with other tirzepatide-containing products or GLP-1 receptor agonists.

  • The safety and efficacy of using Zepbound® with other weight management products haven’t been established.

  • Zepbound® (tirzepatide) hasn’t been studied in patients with a history of pancreatitis.

Who should not use Zepbound® (tirzepatide)?

Avoid using Zepbound® (tirzepatide) if:

  • You or a family member has had medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

  • You have an allergy to Zepbound® (tirzepatide).

How should I take Zepbound® (tirzepatide)?

Zepbound® (tirzepatide) can be taken 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. Your healthcare provider will guide your treatment regimen, which may include increasing the dose every four weeks.

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

It’s important to inform your healthcare provider about all the medications you’re currently taking, including prescription, over-the-counter medications, vitamins, and supplements. Be aware of potential interactions, particularly with:

  • Diabetes medications

  • Oral medications due to delayed gastric emptying

  • Hormonal birth control, as its efficacy may be reduced; switch to a non-oral contraceptive or use a barrier method for the first four weeks after starting and during dose escalation.

  • Other GLP-1 medications and weight loss products

Share your full medical history, especially if you have:

  • Type 1 or type 2 diabetes

  • Thyroid cancer

  • Gastrointestinal disease

  • Pancreatitis

  • Kidney disease

  • Diabetic retinopathy

  • Depression or suicidal thoughts

If you are pregnant or breastfeeding:

  • Avoid Zepbound® (tirzepatide) during pregnancy as it may pose risks to the unborn baby.

  • If breastfeeding, discuss the potential risks and benefits with your healthcare provider.

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

Monitor for:

  • Thyroid C-Cell Tumors: Report any neck lumps, hoarseness, difficulty swallowing, or shortness of breath to your provider.

  • Severe Gastrointestinal Disease: Be cautious if you have severe GI conditions; nausea and vomiting may occur, especially during dose increases.

  • Acute Kidney Injury: Ensure adequate hydration to prevent kidney issues due to dehydration.

  • Acute Gallbladder Disease: Report symptoms like upper stomach pain, jaundice, fever, or clay-colored stools.

  • Pancreatitis: Watch for severe, persistent abdominal pain.

  • Allergic Reactions: Stop using if you experience serious allergic reactions such as swelling, severe rash, or difficulty breathing.

  • Hypoglycemia: Monitor blood sugar levels, particularly if you’re on diabetes medications.

  • Diabetic Retinopathy: Report any changes in vision.

  • Suicidal Thoughts: Be alert to any mental health changes.

What are the most common side effects?

  • Nausea

  • Diarrhea

  • Vomiting

  • Constipation

  • Stomach pain

  • Indigestion

  • Injection site reactions

  • Fatigue

  • Allergic reactions

  • Belching

  • Hair loss

  • GERD (heartburn)

Reporting Side Effects:

Report negative side effects to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.

For complete safety information, please see the full Prescribing Information.

Disclaimer: Affordahealth Pain Relief & Wellness is not affiliated with Novo Nordisk, Eli Lilly, or Amylin Pharmaceuticals.