What is compounded tirzepatide? Benefits, considerations, and costs
Maximize your weight loss journey with compounded tirzepatide. Learn how it works, its benefits, risks, costs, and important safety considerations.
Key highlights
- Compounded tirzepatide is a custom-made medication prepared by compounding pharmacies to meet an individual patient's needs.
- Compounded tirzepatide has the same active ingredient as the FDA-approved brands Zepbound and Mounjaro. It may contain other ingredients such as vitamin B12.
- Compounded tirzepatide is affordable for most patients and easily accessible during drug shortages. It can be customized in different formulations and strengths.
- Always purchase compounded tirzepatide from reputable pharmacies and outsourcing facilities to ensure it is safe and meets quality standards.
- Consult a healthcare provider before starting the medication to discuss whether it is the right choice for you. Do not purchase products “for research purpose only” or “not for human consumption” labels or medications being sold without prescription.
Tirzepatide is a GLP-1 and GIP receptor agonist manufactured by Eli Lilly. It comes under two brand names: Mounjaro and Zepbound. Mounjaro is FDA-approved for promoting blood sugar control in patients with type 2 diabetes. Zepbound is indicated for chronic weight management in patients with obesity and overweight with at least one weight-related health condition and moderate to severe obstructive sleep apnea (OSA).
According to the U.S. KFF Health News, approximately 2 million patients are using GLP-1 medications for weight loss and type 2 diabetes, including semaglutide (Wegovy and Ozempic) and tirzepatide (Zepbound and Mounjaro). Due to high demand, Novo Nordisk (manufacturer of semaglutide) and Eli Lilly (tirzepatide manufacturer) have experienced drug shortages. This is where compounded drugs such as compounded semaglutide and compounded tirzepatide come into play to meet patient needs.
Compounded tirzepatide is a custom-made preparation of tirzepatide. It is dispensed by compounding pharmacies according to patients’ needs as prescribed by healthcare professionals. The medication has the same active ingredient as Zepbound and Mounjaro but is not FDA-approved. It has gained significant attention lately due to its lower price than Zepbound and Mounjaro and easy accessibility during drug shortages.
This article provides a comprehensive overview of compounded tirzepatide, including its benefits, risks, and key considerations.
What is compounded tirzepatide?
Compounded tirzepatide is a dual GIP (glucose-dependent insulinotropic peptide) and GLP-1 (glucagon-like peptide-1) receptor agonist used for chronic weight management in people with obesity and overweight. These hormones are naturally produced by the body after food intake to give you a feeling of “fullness” or satiety and release insulin from the beta cells of the pancreas. Tirzepatide mimics the effects of these hormones to regulate your appetite and promote blood sugar control.
Tirzepatide slows the rate of gastric emptying (the rate at which your stomach empties). The food stays in your stomach for a longer time, which suppresses appetite and reduces hunger cravings. The medication inhibits glucagon release from the liver and affects the hunger control centre (lateral hypothalamus) of the brain to promote appetite suppression and blood sugar control.
Compounded tirzepatide is a custom-made medication that is made by compounding pharmacies. The U.S. Food and Drug Administration (FDA) has not approved or reviewed its safety and effectiveness. Compounding is a practice in which licensed pharmacists, health providers, and people working under the direct supervision of licensed pharmacists mix, combine, dispense, or alter a few ingredients of the medication in state-licensed pharmacies or federally registered outsourcing facilities to meet the specific needs of patients.
Compounded medications are generally cheaper than FDA-approved medications and are tailored to individual patient needs. For example, Zepbound and Mounjaro do not contain vitamin B12, but compounded tirzepatide may contain vitamin B12 for patients who need it for nausea, a common side effect.
Zepbound and Mounjaro come in the form of single-use injection pens. In contrast, compounded tirzepatide injections are available in vials and oral tablets.
What does compounded mean?
Drug compounding involves the preparation of customized versions of a medication. This is done by a licensed pharmacist or healthcare provider to accommodate the patient’s needs.
Compounding is used to dispense dosages that are not commercially available in FDA-approved medications or allergen-free formulations. If the patient is allergic to any inactive ingredient of the medication, compounding pharmacies can prepare the allergen-free medication. FDA-approved drugs such as Zepbound and Mounjaro have higher costs which are not affordable for many patients. Compounded tirzepatide is a cheaper alternative to these medications.
The FDA allows compounding pharmacies to compound medications during drug shortages. In 2022, the FDA determined that there was a shortage of Zepbound and Mounjaro. Many patients switched to compounded tirzepatide to avoid disruptions to their treatment.
In October 2024, the FDA removed tirzepatide from the shortage list and restricted compounding the medication, except for limited exceptions such as allergies to certain ingredients or the need for personalized dosing that isn’t commercially available. The Outsourcing Facilities Organization filed a lawsuit against the FDA over the sudden removal of tirzepatide from the shortage list before any prior notice and despite the agency’s warning of “localized supply disruption”.
Why is tirzepatide compounded?
Tirzepatide is compounded due to the following reasons:
- Accessibility: Since 2022, Eli Lilly, the manufacturer of Mounjaro and Zepbound, has experienced drug shortages due to high demand. Patients have shifted to compounded tirzepatide due to unavailability of the FDA-approved form of tirzepatide. Compounded tirzepatide is widely accessible to patients.
- Customization: FDA-approved tirzepatide is available only in the form of single-use injection pens. Compounding allows for personalized formulations such as different strengths and doses, and combinations with other medications such as vitamin B12. Compounded tirzepatide is available as injections and oral dissolving tablets.
- Addressing individual patient needs: Compounding can address specific patient needs, such as if the patient is allergic to certain ingredients in brand-name products, Mounjaro and Zepbound. Compounding pharmacies can prepare the medication without that allergen. Some patients need personalized dosing that isn’t commercially available and compounded medications can meet those individual needs.
The list price of Mounjaro is $1,079.77. The average selling price ranges between $1,100 and $1,300, depending on the pharmacy. These high prices are challenging for some patients. Compounded tirzepatide costs around $300 to $400 per month, which is more affordable.
Is compounded tirzepatide the same as Mounjaro and Zepbound?
Compounded tirzepatide has the same active ingredient (tirzepatide) as Mounjaro and Zepbound, but it may contain other ingredients not present in FDA-approved tirzepatide such as vitamin b12. The medication is not approved by the FDA, which means the FDA has not tested or reviewed it for safety, quality, and effectiveness.
In comparison, Zepbound and Mounjaro have undergone rigorous testing in various clinical trials to obtain FDA approval. The FDA ensures that these medications are safe and effective for humans.
Compounded tirzepatide: Benefits and risks
Compounded tirzepatide has both pros and cons:
Benefits
- Compounded tirzepatide is cost-effective compared to brand-name tirzepatide, Mounjaro and Zepbound. The list prices for Mounjaro and Zepbound are $1,079.77 and $1,086.37 respectively. The average retail prices at local pharmacies range from $1,100 to $1,300 or more. Compounded tirzepatide costs around $300 to $400 for a monthly supply, which is more affordable for patients who cannot afford the brand-name medication.
- During drug shortages, compounded tirzepatide may be more readily available than Mounjaro and Zepbound.
- Compounded tirzepatide can be personalized in customized dosages and formulations for individual patient needs. In contrast, you cannot get personalized formulations of FDA-approved medications.
Risks
- Compounded tirzepatide is not FDA-approved and has not undergone the same rigorous testing as brand-name versions to test its safety and quality. It may contain other ingredients, which might be harmful to humans.
- Compounded tirzepatide may have potential safety concerns and risks associated with compoundings, such as contamination, inaccurate dosing, ineffective formulations, and variations in quality.
- As the ingredients of compounded tirzepatide are unknown, its effectiveness may vary and not be equivalent to FDA-approved products. Pharmacies may be using unauthorized forms of medication or counterfeit products.
- Insurance companies usually cover FDA-approved medications. However, compounded tirzepatide is generally not covered by insurance plans.
Is compounded tirzepatide safe? Safety and regulations
Compounded tirzepatide made by licensed compounding pharmacies should be safe. However, the FDA issues some safety concerns regarding compounded medications. By Nov 30, 2024, the FDA received more than 215 reports of adverse events with compounded tirzepatide.
The FDA issued a warning letter to stop the distribution of illegally marketed compounded tirzepatide. The agency states that:
- These products may be counterfeit.
- The product may contain a dose of tirzepatide that is too high or too low.
- The product may not contain any active ingredient at all.
- The medication may have expired.
- The medication may have unknown safety and quality.
- The medication may have contaminants.
- The product may have variable ingredients.
The FDA has warned that products sold “for research purposes only” and “not for human consumption” should not be used as they have unknown ingredients and quality.
After shortages of Zepbound and Mounjaro in 2022, the FDA allowed compounding pharmacies and outsourcing facilities to manufacture compounded tirzepatide under sections 503A and 503B due to drug shortages. In November 2024, the FDA determined that tirzepatide is no longer included in the shortage list and restricted pharmacies from compounding tirzepatide. The Outsourcing Facilities Association filed a lawsuit against the FDA order. As a result, the FDA has agreed to reevaluate the decision.
If you are considering buying compounded tirzepatide, choose a reliable outsourcing facility or certified state-licensed compounding pharmacy. FDA-regulated outsourcing facilities adhere to the same strict rules and regulations as pharmaceutical manufacturers. Compounded GLP-1 drugs from these facilities may be safe and effective compared to others.
Compounded tirzepatide: What to consider
When starting treatment with compounded tirzepatide, keep the following considerations in mind:
- Consult with your doctor: Always consult with your healthcare provider before starting any medication. Your doctor will assess your body mass index, body weight, blood sugar levels, and vital stats before prescribing the medication. They will create a customized treatment plan for you. If you plan to start compounded semaglutide, consult with your healthcare provider first to discuss if it is a good choice for you.
- Choosing a pharmacy: As compounded versions of medications are not tested and reviewed by the FDA, always choose a reputable pharmacy that meets the quality standards. The quality and effectiveness of the medication depend on the compounding pharmacy. You can also ask your healthcare provider to recommend a reliable pharmacy.
- Understanding the risks: Keep in mind that some versions of compounded tirzepatide might not be as effective as Zepbound and Mounjaro. The medication may have other ingredients, and unknown quality or effectiveness. It may not contain the same strength as labeled.
- Insurance coverage: Generally, compounded medications are not covered by insurance, as insurance companies typically cover FDA-approved medications. Verify with your insurance company if they cover compounded tirzepatide for weight loss or type 2 diabetes.
Who should use compounded tirzepatide?
Healthcare professionals can prescribe compounded tirzepatide to adults with obesity and overweight with at least one weight-related condition such as heart disease, high blood pressure, type 2 diabetes, and high levels of cholesterol. It can also prescribed for the management of type 2 diabetes in adults.
When prescribed by a licensed healthcare provider, compounded tirzepatide is suitable for patients who cannot access the FDA-approved tirzepatide brands, Zepbound and Mounjaro, due to shortages or if they require a personalized form or dose that is not commercially available.
If you are allergic to a certain ingredient or preservative of Zepbound or Mounjaro, you can get a customized formulation of compounded tirzepatide free of that ingredient.
During shortages of Zepbound and Mounjaro, you can easily access compounded tirzepatide after consulting with a licensed healthcare professional.
Never start compounded medications on your own. They can cause various adverse effects and might not be suitable for you. Always consult a healthcare provider to discuss if compounded tirzepatide is the right choice for you.
Compounded tirzepatide vs. brand name drugs
Here are some key differences between compounded tirzepatide, Zepbound and Mounjaro:
| Zepbound and Mounjaro | Compounded tirzepatide | |
|---|---|---|
| FDA approval | FDA approved | Not approved by the FDA |
| Ingredients | Same active and inactive ingredients as labeled on Zepbound and Mounjaro | Tirzepatide as an active ingredient. May contain other ingredients such as Vitamin B12. Exact ingredients are not known. |
| Mode of delivery | Single use injectable pens | Vials and tablets |
| Form | Injectables only | Injections and oral dissolving tablets |
| Price | $,1100 to $,1300 per month | $300 to $400 per month |
| Manufacturers | Eli Lilly | Compounding pharmacies and outsourcing facilities |
| Accessibility | Not easily accessible due to drug shortages | Easily accessible even during drug shortages |
| Storage | Follows standard storage requirements | Storage requirements may differ between compounding pharmacies (usually needs to be stored in the fridge) |
| Customization | Cannot be customized | Can be customized according to patients' needs |
| Insurance Coverage | May be covered by insurance with additional savings by using the Mounjaro saving card, Zepbound saving card, and pharmacy discount coupons | Generally not covered by insurance |
How to safely access compounded tirzepatide
Find a reputable compounding pharmacy or an outsourcing facility as the quality of the medication depends on where you are getting it from. Look for pharmacies accredited to perform sterile compounding. You can verify the accreditation of a compounding pharmacy by following these tips:
- Submit an online form with the pharmacy name and location to The National Association of Boards of Pharmacy (NABP). They will respond to you with a detailed report on whether your chosen pharmacy is accredited for compounding.
- Use an online tool provided by the Pharmacy Compounding Accreditation Board (PCAB) to check if your selected pharmacy is on the list of accredited pharmacies.
- Contact The Joint Commission to confirm if the pharmacy is certified for compounding.
- Search for licensed pharmacists in your state who can compound medication by using the Board of Pharmacy Specialists (BPS) online tool.
You can also ask your healthcare provider or pharmacist about reliable compounding pharmacies in your area.
Watch for red flags such as lack of transparency, unverified sources, no prescription required, products “for research purpose only” or “not for human consumption” labels. Never buy those compounded products as they have unknown ingredients and quality.
Alternatives to compounded tirzepatide
You can discuss these alternatives to compounded tirzepatide with your doctor:
- If you have prescription drug insurance, you can consider buying the brand-name drugs, Mounjaro and Zepbound.
- You can consider other GLP-1 receptor agonists such as semaglutide (Wegovy, Ozempic, and Rybelsus) and liraglutide (Saxenda and Victoza) as alternatives. Semaglutide and liraglutide are also FDA-approved for chronic weight management and treatment of type 2 diabetes.
- You can try lifestyle changes such as increased physical activity, exercise, and a reduced-calorie diet to lose weight and manage blood sugar levels.
- Other anti-diabetes medications such as insulin and sulfonylureas can also be used to manage blood sugar levels.
Compounded tirzepatide side effects
Compounded tirzepatide has similar side effects to Zepbound and Mounjaro. The most common side effects are:
- Nausea
- Vomiting
- Diarrhea
- Constipation
- Abdominal discomfort
- Thinning or loss of hair
- Reduced blood pressure
- Injection site reactions such as pain, itching, burning, and bruising
- Increased heart rate
- Excessive burping
The severe side effects include the following:
- Hypoglycemia (low blood sugar levels)
- Changes in vision
- Acute pancreatitis
- Gallbladder problems
- Acute kidney injury
- Worsening mental health conditions
- Suicidal ideation
- Allergic or hypersensitivity reaction to the medication
If you experience any severe side effects of the medication such as allergic reaction or low blood sugar levels, immediately visit a nearby healthcare facility to seek medical attention. Do not take the next scheduled dose before consulting your healthcare provider.
Compounded tirzepatide is not recommended for patients with a history of thyroid cell tumors such as medullary thyroid cancer (MTC) and MEN 2 syndrome (Multiple endocrine neoplasia type 2 syndrome). Additionally, the medication is not suitable for pregnant and lactating females and children.
Frequently asked questions
Is compounded tirzepatide safe?
Compounded tirzepatide made by licensed and certified pharmacies and outsourcing facilities should be safe. However, compounded medications are not tested for safety and effectiveness by the FDA. Always choose reputable pharmacies to purchase your medication to ensure it is safe. Compounded tirzepatide for “research purpose only” or “not for human consumption” labels are not considered safe.
Does compounded tirzepatide expire?
Yes, compounded tirzepatide has an expiration date. Check for the beyond-the-use (BOD) on the medication packaging. Use the medication before that date. Generally, compounded tirzepatide can be stored for 30 days or more.
Does compounded tirzepatide need to be refrigerated?
Yes, keep compounded tirzepatide in the refrigerator but do not freeze it. Keep it in the fridge between 36°F to 46°F and avoid exposure to extreme temperatures. Do not use the medication if it is frozen.
How much does compounded tirzepatide cost compared to Mounjaro?
Compounded tirzepatide costs approximately $300 to $400 for a monthly supply. In comparison, Mounjaro costs $1,100 to $1,300 or more per month, depending on the prices of the chosen pharmacy.
Can compounded tirzepatide be used for weight loss?
Yes, compounded tirzepatide can be used for weight loss if you are obese and overweight with at least one weight-related health condition. Consult your healthcare provider for a medical assessment before starting the medication. They will decide if compounded tirzepatide is right for you.
Bottom line
Compounded tirzepatide is a tailor-made medication with the same active ingredient as Zepbound and Mounjaro. It is available to patients during drug shortages and when a personalized dose or form is not commercially available.
Always buy from reputable sources such as state-licensed pharmacies accredited for compounding and outsourcing facilities to ensure the compounded medication meets quality standards.
Avoid purchasing tirzepatide from unverified online sellers, websites that sell without a prescription, and sellers that supply products for “research purposes only” or “not for human consumption” labels as these medications can be unsafe.
Always consult a healthcare professional before starting compounded tirzepatide to determine if the medication is right for you.
