Important Regulatory Note:
Compounded tirzepatide is not FDA-approved. It is prepared by licensed U.S. compounding pharmacies under a prescription when FDA-approved medications are unavailable or unsuitable for a patient’s clinical needs. These formulations do not undergo FDA review for safety, effectiveness, or quality.

Formulation Note:
 This medication may be compounded with vitamin B12 or glycine based on your individual needs and provider recommendations.

• Vitamin B12 may be added to support energy metabolism and optimize nutrient balance during weight loss.
• Glycine may be included to promote gut health, reduce nausea, and support liver detoxification.

These enhancements are selected by your prescribing provider based on your medical intake questionnaire and clinical judgment to help improve tolerability and support long-term success.

Intended Use:
Compounded tirzepatide may be prescribed as part of a chronic weight management program for adults with:

• A body mass index (BMI) ≥30 kg/m² (obesity), or
• A BMI ≥27 kg/m² (overweight) with at least one weight-related comorbid condition (e.g., type 2 diabetes, hypertension, or dyslipidemia).
  It is intended for use with a reduced-calorie diet and increased physical activity.

Contraindications:
Do not use compounded tirzepatide if:

• You or a family member has ever had medullary thyroid carcinoma (MTC)
• You have been diagnosed with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• You are allergic to tirzepatide or any ingredients in the compounded formulation

Warnings & Serious Risks:

• Thyroid tumors, including cancer: Risk observed in rodent studies. The relevance to human patients is unknown.
• Pancreatitis: Discontinue use and seek immediate medical attention for persistent or severe abdominal pain.
• Gallbladder disease: Includes potential for gallstones or inflammation of the gallbladder.
• Kidney impairment: Vomiting, diarrhea, or dehydration may worsen kidney function.
• Hypoglycemia: May occur when combined with insulin or sulfonylureas.
• Vision changes: Particularly in individuals with diabetic retinopathy.
• Mental health effects: Monitor for mood changes, depression, or suicidal thoughts.
• Gastrointestinal disorders: Not recommended in patients with severe GI conditions such as gastroparesis.
  
  

Common Side Effects:

• Nausea
• Vomiting
• Diarrhea
• Constipation
• Abdominal pain
• Headache
• Fatigue
• Injection site redness or discomfort
• Decreased appetite
• Flatulence or indigestion

These effects typically improve with continued use and dose adjustment.

Drug Interactions:
Tirzepatide may slow gastric emptying, which could alter the absorption of oral medications. Use caution when taking:

• Insulin or insulin secretagogues (risk of hypoglycemia)
• Oral contraceptives (additional contraception may be required temporarily)
• Medications with narrow therapeutic windows (e.g., warfarin)
  
  

Pregnancy & Breastfeeding:

• Do not use during pregnancy. Discontinue at least 2 months prior to attempting conception.
• Unknown whether tirzepatide passes into breast milk; use while nursing only with medical supervision.
  
  

Administration:
Inject subcutaneously into the abdomen, thigh, or upper arm once per week. Administer on the same day each week. Rotate injection sites weekly to reduce the risk of irritation. Follow your provider’s instructions for dose escalation and proper injection technique.

Storage:
Keep refrigerated at 36°F to 46°F (2°C to 8°C). Do not freeze. Protect from light. Storage requirements may vary depending on the compounding pharmacy—always follow your pharmacy’s specific guidance.

Emergency Situations:
Contact your healthcare provider immediately or call 911 if you experience symptoms of a serious allergic reaction, pancreatitis, severe vomiting, or hypoglycemia.

Disclaimer:
This safety information is intended for educational purposes only. Compounded tirzepatide is prescribed off-label and has not been reviewed by the FDA. It should only be used under the guidance of a licensed healthcare provider. Report adverse effects to your provider or to the FDA via 1-800-FDA-1088 or www.fda.gov/medwatch.