Compounded Tirzepatide: Safety and Availability

What Is Tirzepatide?

Tirzepatide is one of the novel anti-diabetic drugs that recently received FDA approval (2022) after being patented by Eli Lilly and Co in 2016. Since then, the drug has become an important instrument in the management of patients with type 2 diabetes.

Tirzepatide is a 39 amino acid molecule that offers dual activity over two important endogenous peptides–these are Glucose-Dependent Insulinotropic Polypeptide (GIP) and Glucagon-Like Peptide-1 (GLP-1). GIP and GLP-1 are naturally secreted into the gut when the food is taken in. Once released, GIP causes pancreatic beta-cells to increase their insulin production, while at the same time it inhibits gastric emptying. Moreover, GIP is able to decrease the breakdown of lipids. GLP-1 also works similarly but through a slightly different mechanism. This ultimately slows down the sudden rise of glucose in the body after a meal. The slowed gastric emptying promotes satiety, thus improving weight loss. The dual action of tirzepatide mimicking both GIP and GLP-1 makes this molecule different and stronger than other GLP-1 analogs. This is supported by recent research by Juan P Frías and colleagues in which they proved that tirzepatide is superior to semaglutide, another potent GLP-1 analog.

Why Choose a Compounding Pharmacy for Tirzepatide?

Tirzepatide patent rights are with Eli Lilly and Co. and are sold under the brand names, Mounjaro and Zepbound. The drug is highly effective against diabetes and obesity. Since the drug is under patent, this can sometimes make it difficult for the company to fulfill the market demand–this leads to the drug being unavailable on the market. Compounded Mounjaro or tirzepatide provides an alternative in such situations where the patient directly requires the medicine. A tirzepatide compounding pharmacy provides the best alternative for branded tirzepatide as the drug is the closest to what an FDA-approved brand can provide. It is cheaper and easier to acquire as well.

How Tirzepatide Is Compounded

Tirzepatide is compounded by a pharmacist or any other person who is licensed to compound a drug. During compounding, the active ingredient is kept the same. However, there can be a slight modification to the content of the drug including the compounded tirzepatide dosage as well as the physical state of the drug. Other components may be added, mixed, or altered according to the requirements of the patient. In the case of tirzepatide, it can be compounded with other ingredients such as vitamin B12, which means you can get the benefits provided by both of these at the same time.

The Benefits of Using Compounded Tirzepatide

There are numerous benefits of compounded tirzepatide. Some of them are discussed below.

Personalized Medication Tailored to Patient Needs

Personalized medication is an emerging medical field that coincides with the idea of a holistic approach to treating a patient. The compounding allows the delivery of personalized medication tailored to the patient's needs. The dose can be adjusted to the requirements of the patient. Some patients may require a smaller or larger dose of the drug depending on their physical requirements. Mounjaro comes in prespecified doses of 2.5mg per 0.5 ml. Numerous trials have tested different doses of the drug as well. If a patient requires that unique dose, compounded tirzepatide can be used for that purpose. Similarly, nausea and vomiting are considered a serious side effect of tirzepatide use. Studies have shown that compounding Vitamin B12 with tirzepatide significantly reduces the incidence of gastrointestinal symptoms. At the same time, other ingredients can be added to tirzepatide–naturally, this means receiving all the extra benefits from these additions and also reducing the number of pills to be taken. The reduction in the number of doses enhances the patient's compliance to the different medicines as proven in different studies. Compounded tirzepatide weight loss results are also incredible and compounding can provide easier access to the drug.

Cost-Effectiveness Compared to Commercial Medications

The FDA-approved tirzepatide (Mounjaro) costs around 1300 USD per injection. The patent associated with the drug is the cause of this high value. Compounded tirzepatide does not undergo the strict checks and balances that come with an FDA-approved drug. This significantly reduces the cost of production of the drug. Tirzepatide compound price is estimated to be around 120 USD. Hence, compounded tirzepatide is very cost-effective when compared to the FDA-approved Mounjaro or Zepbound, making it a more affordable option for patients.

Flexibility in Formulation

When a drug is compounded, its formulation can be adjusted according to the personal requirements of the patient. This allows for an easy administration of the drug. This flexibility does not come with the FDA-approved drug. 

Potential Risks and Considerations

Although compounded tirzepatide has many benefits, it does not come without any risk involved. Some of them are discussed below.

Possible Side Effects and Contraindications

The most common side effects seen with tirzepatide use include gastrointestinal symptoms such as nausea, vomiting, and diarrhea. Rarely cardiac and renal side effects are also seen. The drug is contraindicated in patients who have medullary thyroid carcinoma as well as those with multiple endocrine neoplasia syndrome type-2 (MEN-2). Patients using compounded tirzepatide should be aware of these side effects. Being a non-FDA-approved formulation, the risks of the side effects increase slightly with compounded tirzepatide. The physician must be consulted immediately in case of any severe reaction that is presumed to be due to the initiation of the drug. Sometimes the altered or added components may also be a cause of an allergic or adverse reaction. As such, it is highly recommended to get the medicine from a certified compounder or pharmacy only.

Regulatory Concerns and FDA Guidelines on Compounding

As the compounded tirzepatide is not FDA-approved, the drug bypasses the rigorous check and balance that is a hallmark of an FDA-approved drug. This may jeopardize the quality of the drug. Although most of the compounded tirzepatide is produced by licensed compounders and pharmacists, some illegal pharmacies or compounders may produce compounded tirzepatide that is low in quality or ineffective–naturally, this can pose a health risk to the patient, and strict caution is advised.

How to Ensure the Safety and Efficacy of Compounded Tirzepatide

In order to appropriately use tirzepatide, always request an evaluation by a certified physician–they will make sure it is safe to use and will produce the results you are looking for. Moreover, if you are looking to use compounded tirzepatide, it should be bought from a compounder or pharmacist who possesses a license of the respective type to compound the drug. Make sure to keep the drug in a dry place and at room temperature as indicated by the provider, so that the drug remains effective for a longer period. Do not use the drug if it has expired or has changed its color. These are some of the tips to ensure the safety and efficacy of tirzepatide.

How to Choose the Right Compounding Pharmacy for Tirzepatide

Key Factors to Consider

When choosing a compounder make sure that the compounder has a good record and history. Many times the treating physician can refer you to a specific compounder or pharmacy as physicians can sometimes identify and understand which compounding pharmacy can provide the quality compounded drug. Also, make sure to buy the drug from the compounder who is under license by the state agency or other authority to make the compounded tirzepatide. Sometimes a compounder may offer to provide a compounded tirzepatide which is very cheap. This may be because the drug's integrity is compromised. Always be aware of this in order to get a good quality product when it comes to compounded tirzepatide.

Questions to Ask Your Compounding Pharmacist

You can ask several questions to the compounding pharmacist about your drug. These include the following:

·        Is the pharmacy accredited by the state board?

·        Is there a quality control check system to assess the different batches that are being produced? And if present, how efficiently do they work?

·        Is there any outsider or third-party company involved in checking and assessing the quality of the compounded tirzepatide?

·        Is there any research and development department working with the compounding pharmacy to provide better medication?

·        How does the tirzepatide compounding pharmacy determine the date of expiry of the produced compounded medication?

·        Are the cold chain and other prerequisites fulfilled during the production of compounded tirzepatide?

·        Are there any harmful side effects reported by the users of the compounded tirzepatide?

Answers to these questions can help you identify the right compounder for your tirzepatide.

Importance of Working With Healthcare Providers

The availability of compounded drugs is possible through a close working network between different healthcare workers–this includes physicians and compounding pharmacists. If you are planning to start using compounding tirzepatide, it is advised to ask your physician for guidance and suggestions on this matter.

Compounding tirzepatide by pharmacies that are working under the accreditation of state boards is legal and ethical. Compounded drugs provided by these pharmacies are easy to acquire, safe to use, and have almost similar side effect profiles as FDA-approved tirzepatide.