Important Safety Information

COMPOUNDED SEMAGLUTIDE is a 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:

  • >27 kg/m2 or greater (overweight or obesity)

Limitations of Use:

  • Co-administration with other COMPOUNDED SEMAGLUTIDE-containing products or any GLP-1 receptor agonist is not recommended.

  • The safety and efficacy of coadministration with other products for weight management have not been established.

  • COMPOUNDED SEMAGLUTIDE has not been studied in patients with a history of pancreatitis.

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning.

  • In rodents, SEMAGLUTIDE causes thyroid C-cell tumors in clinically relevant exposures. It is unknown whether SEMAGLUTIDE causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of SEMAGLUTIDE-induced rodent thyroid C-cell tumors has not been determined

  • SEMAGLUTIDE 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.

Do not take COMPOUNDED SEMAGLUTIDE if you:

  • Have a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN2).

  • Have been diagnosed with Diabetes (Type 1 or 2)

  • Have been diagnosed with pancreatitis or history of pancreatitis

  • Have a diagnosis or history of gastroparesis - severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food

  • Have a known allergy to semaglutide/any other GLP-1 drug or any of the inactive ingredients in COMPOUNDED SEMAGLUTIDE. Inactive ingredients include: di-sodium hydrogen phosphate dihydrate, sodium chloride, benzyl alcohol, hydrochloric acid, sodium hydroxide pellets and water.

  • Have a history of suicidal attempts or active suicidal ideation

WARNINGS AND PRECAUTIONS

  • Acute Pancreatitis: Has occurred in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.

  • Acute Gallbladder Disease: Has occurred in clinical trials. If cholelithiasis is suspected, gallbladder studies and clinical follow-up are indicated.

  • Gastroparesis: Uncommon, but more serious, gastrointestinal adverse effect may also occur more frequently with GLP-1 receptor agonists than with other weight loss agents.