Important Safety Information for Tirzep® (tirzepatide) Injection
Warning: Risk of Thyroid C-Cell Tumors
In animal studies, Tirzep caused thyroid tumors, including thyroid cancer. It is unknown if Tirzep causes thyroid tumors or medullary thyroid carcinoma (MTC) in humans. Inform your healthcare provider immediately if you experience symptoms such as a lump or swelling in the neck, hoarseness, difficulty swallowing, or shortness of breath. These may be signs of thyroid cancer.
Do not use Tirzep if you or your family have ever had MTC or if you have an endocrine system condition known as Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
What is Tirzep Used For?
Tirzep is used along with a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity or in adults who are overweight and have a weight-related condition such as type 2 diabetes, high blood pressure, or high cholesterol.
Limitations of Use:
- Tirzep should not be used in combination with other GLP-1 receptor agonists or tirzepatide-containing medications.
- It has not been studied in combination with other weight-loss treatments or in individuals with a BMI below 27 kg/m².
Who Should Not Use Tirzep?
Do not use Tirzep if:
- You or your family have a history of MTC or MEN 2.
- You have had a serious allergic reaction to tirzepatide or any of its ingredients.
How Should I Take Tirzep?
- Tirzep is administered as a subcutaneous injection once weekly in the abdomen, thigh, or upper arm, preferably on the same day each week.
- You can take Tirzep with or without food.
- Follow your healthcare provider’s instructions regarding dosage increases, typically every four weeks until reaching the maintenance dose.
- Do not share pens or needles, as this may spread infections.
What Should I Tell My Provider Before Using Tirzep?
Inform your healthcare provider about your medical history, including:
- Thyroid cancer or endocrine conditions
- Type 1 or type 2 diabetes
- Gastrointestinal disorders
- Kidney disease
- Pancreatitis
- Gallbladder disease
- Depression or suicidal thoughts
- Pregnancy, plans to become pregnant, or breastfeeding
If you are pregnant or planning to become pregnant:
- Tirzep should not be used during pregnancy, as weight loss offers no benefit and may harm the unborn baby.
If you are breastfeeding:
- It is unknown if Tirzep passes into breast milk. Consult your healthcare provider to evaluate the risks and benefits.
What Are the Most Serious Side Effects?
Seek immediate medical attention if you experience:
- Thyroid C-Cell Tumors: Inform your provider if you notice a neck lump, hoarseness, difficulty swallowing, or shortness of breath.
- Severe Gastrointestinal Issues: Tirzep may cause nausea, vomiting, diarrhea, or constipation, which may be severe in some cases.
- Acute Pancreatitis: Monitor for severe, persistent abdominal pain that may radiate to the back, with or without vomiting.
- Gallbladder Problems: Report symptoms such as severe upper abdominal pain, jaundice, fever, or pale stools.
- Kidney Problems: Dehydration from gastrointestinal side effects can lead to kidney problems. Ensure adequate hydration.
- Severe Allergic Reactions: Stop using Tirzep and seek immediate medical help if you experience swelling of the face or throat, severe rash, difficulty breathing, or rapid heartbeat.
- Suicidal Behavior or Thoughts: Notify your healthcare provider if you experience changes in mood or behavior.
What Are the Most Common Side Effects of Tirzep?
- Nausea
- Diarrhea
- Vomiting
- Constipation
- Stomach pain
- Fatigue
- Headache
- Injection site reactions
Important Considerations
- Tirzep may delay gastric emptying, which could affect the absorption of oral medications. Inform your healthcare provider about all the medications, supplements, and vitamins you take.
- If you use hormonal birth control, Tirzep may reduce its effectiveness during dose escalations. Use a barrier method of contraception for four weeks after each dose escalation until the maintenance dose is achieved.
- Tirzep is not recommended for use during general anesthesia or surgeries requiring fasting, as delayed gastric emptying may increase the risk of aspiration.
Pregnancy Registry:
A registry will monitor pregnancy outcomes in women exposed to Tirzep during pregnancy. Pregnant individuals and healthcare providers are encouraged to contact the relevant registry or [manufacturer contact details].
This document provides critical safety information but is not exhaustive. Always follow your healthcare provider’s guidance and consult the full Prescribing Information for comprehensive details.
Report side effects: You can report adverse reactions to your local health authority.