Important Safety Information for Compounded Semaglutide

Your medical provider may recommend personalized dosages of compounded semaglutide based on a medical review. Compounded drugs are not FDA approved and are not evaluated by the FDA for safety, effectiveness, or quality standards.

This document is a summary of product information and does NOT have all possible information and potential side effects of the product. This is not medical advice and does not substitute advice from your health care provider.

Compounded drugs are permitted to be prescribed under federal law but are not FDA-approved and do not undergo safety, effectiveness, or manufacturing review. Your provider may recommend certain doses of compounded semaglutide based on your medical evaluation.

Indications and Use:

Compounded semaglutide is an injectable prescription medicine that may help adults and adolescents with obesity and excess weight (overweight) - who may also have weight-related medical problems - lose weight and keep it off. It should be used with a reduced-calorie diet and increased physical activity.

Compounded semaglutide is a synthetic glucagon-like peptide-1 (GLP-1) receptor agonist used for chronic weight management, along with a reduced calorie diet and increased physical activity, for people with an initial body mass index (BMI) of 27 kg/m² or higher.

Compounded semaglutide should not be used with other semaglutide-containing products or any other GLP-1/GIP receptor agonist medicines. It is not known if compounded semaglutide is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products. It is not known if compounded semaglutide can be used in people who have had pancreatitis. It is not known if compounded semaglutide is safe and effective for use in children under 18 years of age.

At lower (micro) doses, compounded semaglutide may also be beneficial for patients who:

• Have side effects at higher doses
• Would like to reduce cardiovascular disease risk
• Would like to reduce inflammation
• Would like to improve gastrointestinal conditions such as inflammatory bowel disease (IBD) or irritable bowel syndrome (IBS)
• Would like to protect against Alzheimer's or Parkinson's disease
• Would like to reduce the use of alcohol or tobacco

Warning: Risk of Thyroid C-Cell Tumors

In studies with mice and rats, semaglutide caused thyroid tumors, including thyroid cancer. It is not known if compounded semaglutide will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.

Do not use compounded semaglutide if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Is Compounded Semaglutide FDA-approved?

Compounded semaglutide is not FDA approved and does not undergo the same rigorous efficacy and safety checks as do FDA-approved medications. Compounded semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist which may be used for chronic weight management, along with a reduced calorie diet and increased physical activity, for people with an initial body mass index (BMI) of 27 kg/m² or higher.

Limitations of Use:

• Compounded semaglutide should not be used in combination with other semaglutide-containing products or any other GLP-1/GIP receptor agonist medicines.
• The safety and efficacy of coadministration with other products for weight loss have not been established.
• Compounded semaglutide has not been studied in patients with a history of pancreatitis.

Note: Compounded medications are not FDA approved and do not have indications for treatment as an FDA approved medication would.

HOW IS COMPOUNDED SEMAGLUTIDE PRESCRIBED?

Compounded semaglutide typically starts at a low dose that is gradually increased over time. The typical dosing schedule of compounded semaglutide is:

• Weeks 1–4: 0.25 mg once a week
• Weeks 5–8: 0.5 mg once a week
• Weeks 9–12: 1 mg once a week
• Weeks 13–16: 1.7 mg once a week
• Weeks 17–20: 2.4 mg once a week

Depending on your specific situation, your maintenance dose could be lower than 2.4 mg once a week.

Oral forms of compounded semaglutide are typically dosed between 5-10 mg daily.

Follow the dosing instructions from your provider, as they may personalize your plan for your individual needs.