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Important Safety Information for
Semaglutide
Indications: Semaglutide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Contraindications: Semaglutide is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). It should not be used in patients with a history of severe gastrointestinal disease, including gastroparesis.
Warnings and Precautions:
- Risk of Thyroid C-Cell Tumors: Cases of MTC have been reported in patients treated with GLP-1 receptor agonists, including semaglutide. Patients should be assessed for risk factors prior to initiation and monitored for signs and symptoms of thyroid tumors.
- Pancreatitis: Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been reported with GLP-1 receptor agonists. Patients should be informed of the characteristic symptoms of pancreatitis and advised to discontinue semaglutide and seek medical attention if symptoms occur.
- Hypoglycemia with Concomitant Use of Insulin and Insulin Secretagogues: The risk of hypoglycemia is increased when semaglutide is used in combination with insulin or insulin secretagogues. Dose adjustments may be required to minimize the risk.
- Acute Kidney Injury: Cases of acute renal failure and worsening of chronic renal failure have been reported with GLP-1 receptor agonists. Patients should be monitored for changes in renal function, and caution should be exercised in patients with renal impairment.
- Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria, have been reported with semaglutide. If a hypersensitivity reaction occurs, discontinue semaglutide and initiate appropriate medical treatment.
- Gastrointestinal Adverse Reactions: Nausea, vomiting, diarrhea, and constipation may occur with semaglutide. These adverse reactions may decrease over time or with dose reduction.
Adverse Reactions:The most common adverse reactions (≥5%) associated with semaglutide include nausea, vomiting, diarrhea, abdominal pain, and constipation.
Pregnancy and Lactation: Semaglutide should not be used during pregnancy as it may cause fetal harm. It is unknown whether semaglutide is excreted in human milk, and caution should be exercised when administering semaglutide to breastfeeding women.
Drug Interactions:Caution should be exercised when co-administering semaglutide with other drugs that affect gastrointestinal motility or absorption, as well as drugs that may increase the risk of hypoglycemia.
Patient Counseling Information:Patients should be counseled on the risks and benefits of semaglutide therapy, including the potential for gastrointestinal adverse reactions, hypoglycemia, and the importance of adherence to diet and exercise. Patients should also be educated on the signs and symptoms of thyroid tumors, pancreatitis, and hypersensitivity reactions.
For more information about side effects of Semaglutide please visit HERE.