What are the recommendations for compounded Tirzepatide (glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist)?

From the Guidelines

I strongly advise against using compounded tirzepatide due to the lack of FDA approval and quality control standards, which are crucial for ensuring safety, efficacy, and consistency. The FDA-approved version of tirzepatide, such as Mounjaro or Zepbound, has undergone rigorous testing and has demonstrated its safety profile and effectiveness for weight management or type 2 diabetes 1. Compounded medications, on the other hand, may have inconsistent potency, unknown impurities, or stability issues that could affect both safety and efficacy. Additionally, insurance typically won't cover compounded versions, and there are potential legal and ethical concerns with using compounded medications when FDA-approved alternatives exist. Some studies have shown that GLP-1 receptor agonists, such as tirzepatide, have beneficial effects on mortality, cardiovascular outcomes, and renal outcomes 1. However, these benefits are only guaranteed with FDA-approved products, and compounded versions may not provide the same level of efficacy and safety. If cost is a barrier to accessing FDA-approved tirzepatide, patient assistance programs from the manufacturer or discussing alternative GLP-1 medications with your healthcare provider would be more appropriate options than turning to compounded versions. It is essential to prioritize the safety and well-being of patients by using FDA-approved medications, and compounded tirzepatide should not be considered a viable alternative. Key points to consider include:

• Lack of FDA approval and quality control standards for compounded tirzepatide
• Potential inconsistent potency, unknown impurities, or stability issues with compounded medications
• Limited coverage by insurance and potential legal and ethical concerns
• Availability of patient assistance programs and alternative GLP-1 medications for those who cannot access FDA-approved tirzepatide.

From the FDA Drug Label

The FDA drug label does not answer the question.

From the Research

Compounded Tirzepatide Recommendations

• The use of compounded tirzepatide for weight loss has been studied in a health economics and outcomes research analysis 2, which found that a 7.5 mg weekly dose over four weeks resulted in a 5% reduction in body weight, but the weight was regained within two weeks after the conclusion of the study.
• The study also reported side effects similar to those of the GLP-1 RA class of injectable drugs, including generalized bloating and flatulence, carbohydrate-specific temporary weight gain and bloating, and intestinal rapid emptying 2.
• Another study compared the efficacy and safety of tirzepatide to insulin degludec in patients with type 2 diabetes, and found that tirzepatide was superior to insulin degludec in reducing HbA1c and body weight, with a lower risk of hypoglycemia 3.
• A systematic review and meta-analysis examined the pancreatic safety of tirzepatide and its effects on islet cell function, and found that tirzepatide had identical risks of pancreatitis to placebo and insulin, but caused greater increases in pancreatic amylase and lipase than placebo and insulin 4.
• A review of tirzepatide's efficacy and safety in clinical trials found that it improved blood pressure, reduced LDL cholesterol and triglycerides, and had a positive effect on islet cell functions and insulin resistance 5.
• However, the safety of compounded medications, including tirzepatide, is a concern due to lesser regulatory oversight, and they should be prescribed only when an FDA-approved medication cannot be used, and the benefits outweigh the risks 6.

Dosage and Administration

• The study on compounded tirzepatide used a dose of 7.5 mg per week for four weeks 2.
• Another study used doses of 5,10, and 15 mg of tirzepatide per week, and found that all doses were effective in reducing HbA1c and body weight 3.

Side Effects and Safety

• The most common side effects of tirzepatide include nausea, diarrhea, decreased appetite, and vomiting 3.
• The study on compounded tirzepatide reported side effects similar to those of the GLP-1 RA class of injectable drugs, including generalized bloating and flatulence, carbohydrate-specific temporary weight gain and bloating, and intestinal rapid emptying 2.
• A systematic review and meta-analysis found that tirzepatide had identical risks of pancreatitis to placebo and insulin, but caused greater increases in pancreatic amylase and lipase than placebo and insulin 4.