Book NowIndications and Usage: Semaglutide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is also indicated to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.
Contraindications:
- Personal or family history of medullary thyroid carcinoma (MTC)
- Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- Hypersensitivity to semaglutide or any of its components
Warnings and Precautions:
- Thyroid C-cell Tumors: Semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether semaglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. Cases of MTC in patients treated with GLP-1 receptor agonists have been reported in the post-marketing period.
- Counsel patients regarding the potential risk of MTC with the use of semaglutide.
- Inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness).
- Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with semaglutide.
- Pancreatitis: Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been reported in patients treated with GLP-1 receptor agonists.
- Discontinue semaglutide promptly if pancreatitis is suspected.
- Do not restart if pancreatitis is confirmed.
- Consider other antidiabetic therapies in patients with a history of pancreatitis.
- Diabetic Retinopathy Complications: In patients with a history of diabetic retinopathy, rapid improvement in glycemic control has been associated with a temporary worsening of diabetic retinopathy.
- Monitor for progression of diabetic retinopathy in patients with a history of the condition.
- Hypoglycemia with Concomitant Use of Insulin or Insulin Secretagogues: When semaglutide is used with an insulin secretagogue (e.g., sulfonylurea) or insulin, consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemia.
- Acute Kidney Injury: There have been post-marketing reports of acute kidney injury and worsening of chronic renal failure, which may sometimes require hemodialysis, in patients treated with GLP-1 receptor agonists.
- Some of these events were reported in patients without known underlying renal disease.
- Monitor renal function when initiating or escalating doses of semaglutide in patients with renal impairment.
- Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported with GLP-1 receptor agonists. If hypersensitivity reactions occur, discontinue semaglutide and treat promptly per standard of care.
Adverse Reactions: The most common adverse reactions, reported in ≥5% of patients treated with semaglutide, are nausea, vomiting, diarrhea, abdominal pain, and constipation. These gastrointestinal adverse reactions are dose-dependent and are more common during the initiation of therapy.
Drug Interactions:
- Oral Medications: Semaglutide delays gastric emptying, and thereby has the potential to impact the absorption of concomitantly administered oral medications.
- Monitor the efficacy of oral medications concomitantly administered with semaglutide, especially those with a narrow therapeutic index or medications requiring careful clinical monitoring.
Use in Specific Populations:
- Pregnancy: Limited data with semaglutide use in pregnant women are insufficient to determine a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes.
- Lactation: There are no data on the presence of semaglutide in human milk, the effects on the breastfed infant, or the effects on milk production.
- Pediatric Use: Safety and effectiveness of semaglutide have not been established in pediatric patients under 18 years of age.
- Geriatric Use: No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Administration:
- Administer semaglutide subcutaneously once weekly, on the same day each week, at any time of day, with or without meals.
- Instruct patients to administer semaglutide in the abdomen, thigh, or upper arm.
- If a dose is missed, administer within 5 days after the missed dose. If more than 5 days have passed, skip the missed dose and resume with the next scheduled dose.
