Compounded Semaglutide Safety Information

COMPOUNDED SEMAGLUTIDE is a GLP-1 receptor agonist indicated for chronic weight management in adults with an initial body mass index (BMI) of:≥ 27 kg/m² (overweight or obesity)
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Limitations of Use:
Co-administration with other semaglutide products or GLP-1 receptor agonists is not recommended.
The safety and efficacy of coadministration with other weight management products have not been established.
COMPOUNDED SEMAGLUTIDE has not been studied in patients with a history of pancreatitis.
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WARNING: RISK OF THYROID C-CELL TUMORS
In rodents, SEMAGLUTIDE causes thyroid C-cell tumors. The relevance to humans is unknown.
SEMAGLUTIDE is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Do not take COMPOUNDED SEMAGLUTIDE if you:
Have a history of MTC or MEN 2.
Have type 1 or type 2 diabetes.
Have pancreatitis or a history of pancreatitis.
Are allergic to semaglutide or any inactive ingredients.
Have a history of suicidal attempts or active suicidal ideation.
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WARNINGS AND PRECAUTIONS
Acute Pancreatitis: Discontinue if suspected.
Acute Gallbladder Disease: Conduct gallbladder studies if cholelithiasis is suspected.
Hypoglycemia: Inform patients of the risk and educate them on the signs.
Acute Kidney Injury: Monitor renal function.
Hypersensitivity Reactions: Discontinue if suspected.
Reproductive Potential: Discontinue at least 2 months before planned pregnancy.
Pregnancy: May cause fetal harm. Discontinue immediately if pregnancy is recognized.
Diabetic Retinopathy: Monitor patients with a history of diabetic retinopathy.
Heart Rate Increase: Monitor heart rate regularly.
Suicidal Behavior and Ideation: Monitor for depression or suicidal thoughts. Discontinue if symptoms develop.
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Side Effects
Common side effects include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, gastroesophageal reflux disease, and nasopharyngitis.
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To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS
COMPOUNDED SEMAGLUTIDE delays gastric emptying and may impact the absorption of oral medications.
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USE IN SPECIFIC POPULATIONS
Pregnancy: May cause fetal harm. Discontinue if pregnancy is recognized.
Reproductive Potential: Discontinue at least 2 months before planned pregnancy due to long half-life.