Compounded Tirzepatide
Important Safety Information
Read the following safety information carefully before starting treatment. Discuss any questions or concerns with your healthcare provider.
Indications and Use
Tirzepatide is a glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP‑1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m² or greater (obesity), or 27 kg/m² or greater (overweight) in the presence of at least one weight-related comorbid condition.
WARNING: Thyroid C-Cell Tumors
In rodents, tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether tirzepatide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined.
Tirzepatide is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors.
FDA Approval Status
Compounded tirzepatide is not an FDA-approved drug. It is prepared by a compounding pharmacy and is not subject to the same FDA review and approval process as commercially manufactured drugs. Compounded medications are tailored to individual patient needs and may differ from commercially available products in formulation, strength, or delivery method.
Limitations
- Has not been studied in patients with a history of pancreatitis. Consider other therapies in patients with a history of pancreatitis.
- Not indicated for use in combination with any other GLP-1 receptor agonist.
- Has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis.
Who Should Not Use Tirzepatide
Do not use tirzepatide if you:
- Have a personal or family history of medullary thyroid carcinoma (MTC).
- Have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- Are allergic to tirzepatide or any of the ingredients in the medication.
- Are pregnant or planning to become pregnant.
- Are breastfeeding.
Administration
Tirzepatide is administered as a subcutaneous injection once weekly. The injection can be given in the abdomen, thigh, or upper arm. Rotate injection sites with each dose. Tirzepatide may be taken at any time of day, with or without meals. It should be taken on the same day each week. If a dose is missed, administer it as soon as possible within 4 days after the missed dose. If more than 4 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day.
Drug Interactions
Tirzepatide delays gastric emptying, which may affect the absorption of concomitantly administered oral medications. Use with caution in patients receiving oral medications that require rapid gastrointestinal absorption. When used with insulin or an insulin secretagogue (e.g., sulfonylurea), consider lowering the dose of the insulin or insulin secretagogue to reduce the risk of hypoglycemia. Patients using oral hormonal contraceptives should switch to a non-oral contraceptive method, or add a barrier method of contraception, for 4 weeks after initiation and for 4 weeks after each dose escalation step.
Medical History
Before starting tirzepatide, tell your healthcare provider about all your medical conditions, including if you:
- Have or have had problems with your pancreas or kidneys.
- Have a history of diabetic retinopathy.
- Have or have had depression, suicidal thoughts, or mental health problems.
- Have any other medical conditions.
- Are taking any prescription or over-the-counter medications, vitamins, or herbal supplements.
Pregnancy and Breastfeeding
Tirzepatide should not be used during pregnancy. Discontinue tirzepatide at least 2 months before a planned pregnancy due to its long half-life. There are no data on the presence of tirzepatide in human milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed infant, breastfeeding is not recommended during treatment with tirzepatide.
Side Effects
The most common side effects of tirzepatide include:
- Nausea
- Diarrhea
- Vomiting
- Constipation
- Abdominal pain
- Dyspepsia (indigestion)
- Injection site reactions
- Fatigue
- Hypersensitivity reactions
- Eructation (belching)
- Hair loss
- Gastroesophageal reflux disease
Serious side effects may include pancreatitis, gallbladder problems, hypoglycemia, kidney problems, serious allergic reactions, changes in vision in patients with type 2 diabetes, and depression or suicidal thoughts. Contact your healthcare provider immediately if you experience severe abdominal pain, symptoms of an allergic reaction, or changes in mood or behavior.
Dosing Schedule
The recommended dose escalation schedule for tirzepatide is as follows:
| Weeks | Weekly Dose |
|---|---|
| Weeks 1–4 | 2.5 mg |
| Weeks 5–8 | 5 mg |
| Weeks 9–12 | 7.5 mg |
| Weeks 13–16 | 10 mg |
| Weeks 17–20 | 12.5 mg |
| Weeks 21–24 | 15 mg |
Your healthcare provider may adjust the dose escalation schedule based on your tolerability.
Legal Disclaimers
The information provided on this page is for educational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified healthcare provider with any questions you may have regarding a medical condition or treatment.
Compounded medications are not FDA-approved. They are prepared by licensed compounding pharmacies in accordance with applicable state and federal regulations. The safety and efficacy of compounded medications have not been verified by the FDA.
Individual results may vary. Weight loss results depend on various factors, including adherence to a reduced-calorie diet and increased physical activity.