Tirzepatide

Important Safety Information

Your safety is our top priority. Below you will find key information about your medication, including side effects and other essential details. If deemed medically appropriate by your provider, you may receive a compounded version of tirzepatide. Please note that compounded tirzepatide has not been approved or evaluated for safety and effectiveness by the FDA.

Common Side Effects

Nausea, diarrhea, vomiting, constipation, abdominal pain, indigestion, injection site reactions, fatigue, allergic reactions, belching, hair loss, and heartburn.

Important Safety Information Regarding Compounded Tirzepatide Products: Please note that compounded drugs are not FDA-approved and do not undergo the same clinical studies for safety and efficacy as FDA-approved commercially available products. However, compounded products can still be legally prescribed based on your medical consultation.

About Tirzepatide: Tirzepatide is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist. It is used for chronic weight management, along with a reduced-calorie diet and increased physical activity, for individuals with an initial body mass index (BMI) of:

• 30 kg/m² or greater (obesity), or
• 27 kg/m² or greater (overweight) with at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, dyslipidemia, obstructive sleep apnea, or cardiovascular disease).

Consult Your Healthcare Provider: Discuss with your healthcare provider to determine if tirzepatide is right for you. Tirzepatide may cause serious side effects, including:

• Possible thyroid tumors, including cancer: Inform your healthcare provider if you notice a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. In rodent studies, tirzepatide caused thyroid C-cell tumors. It is unknown if it causes thyroid C-cell tumors or medullary thyroid carcinoma (MTC) in humans.

Who Should Not Use Tirzepatide

• Do not use tirzepatide if you or a family member has had medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Avoid tirzepatide if you have had a serious allergic reaction to it in the past.

Medical Conditions to Disclose Before Starting Tirzepatide: Before starting tirzepatide, inform your healthcare provider if you have any other medical conditions, including:

• Pancreatic or kidney problems
• Severe stomach issues, such as gastroparesis.
• A history of diabetic retinopathy.
• Depression, suicidal thoughts, or mental health issues.
• Pregnancy or plans to become pregnant. Tirzepatide should not be used during pregnancy.
• Breastfeeding or plans to breastfeed. It is unknown if tirzepatide passes into breast milk.

Medication Interactions: Inform your healthcare provider about all the medicines you take, including prescription medications, over-the-counter drugs, vitamins, and herbal supplements, as tirzepatide may interact with them.

Serious Side Effects

• Thyroid C-Cell Tumors: Report any neck lump, hoarseness, trouble swallowing, or shortness of breath.
• Gastroparesis: Symptoms include feeling full quickly, nausea, and vomiting. Contact your healthcare provider if these occur.
• Pancreatitis: Seek immediate medical attention for severe abdominal pain.
• Gallbladder problems: Symptoms include upper abdominal pain, fever, jaundice, or clay-colored  stools.
• Hypoglycemia in patients with type 2 diabetes: Symptoms include dizziness, blurred vision, mood changes, and shaking.
• Kidney problems: Maintain hydration to avoid worsening kidney issues.
• Serious allergic reactions: Seek immediate medical attention for symptoms such as facial swelling, breathing issues, or severe rash.
• Changes in vision for people with type 2 diabetes: Report any vision changes to your healthcare provider.
• Depression or suicidal thoughts: Report any sudden changes in mood or behavior to your healthcare provider.

Emergency Situations: In a medical emergency, call 911 or seek immediate medical attention.

Reporting Side Effects: Report negative side effects of prescription products to FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Tirzepatide Administration: Tirzepatide is self-administered as a subcutaneous injection once a week. Consult your healthcare provider for detailed instructions and do not change your dosing regimen without their guidance.

This information is not comprehensive. Please discuss any questions or concerns with your healthcare provider.

Mechanism of Action: Tirzepatide is a GIP and GLP-1 receptor agonist. It binds to and activates these receptors, aiding in the regulation of blood sugar.

Adverse Reactions: Common side effects include nausea, diarrhea, decreased appetite, vomiting, constipation, indigestion, and abdominal pain. Discuss any side effects or concerns with your physician before starting tirzepatide.