Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2. Known hypersensitivity to semaglutide or any of the components in this preparation.
The most common adverse reactions, reported in ≥5% of patients treated with Semaglutide are: nausea, abdominal pain, diarrhea, decreased appetite, vomiting and constipation.
Pregnancy: May cause fetal harm.
Lactation: Breastfeeding not recommended.
Females and Males of Reproductive Potential: Discontinue Semaglutide in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide.
Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.
Diabetic Retinopathy Complications: Has been reported in a cardiovascular outcomes trial with semaglutide injection. Patients with a history of diabetic retinopathy should be monitored.
Hypoglycemia: When semaglutide is used with an insulin secretagogue or insulin, consider lowering the dose of the secretagogue or insulin to reduce the risk of hypoglycemia.
Acute Kidney Injury: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions.
Hypersensitivity Reactions: Discontinue semaglutide if suspected and promptly seek medical advice.
Pediatric Use: Safety and efficacy of Semaglutide have not been established in pediatric patients (younger than 18 years).
Geriatric Use: No overall differences in safety or efficacy were detected between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Renal Impairment: The safety and efficacy of Semaglutide was evaluated in a 26-week clinical study that included 324 patients with moderate renal impairment (eGFR 30 to 59 mL/min/1.73 m2). In patients with renal impairment including end-stage renal disease (ESRD), no clinically relevant change in semaglutide pharmacokinetics (PK) was observed. No dose adjustment of Semaglutide is recommended for patients with renal impairment.
Hepatic Impairment: In a study in subjects with different degrees of hepatic impairment, no clinically relevant change in semaglutide pharmacokinetics (PK) was observed. No dose adjustment of Semaglutide is recommended for patients with hepatic impairment.
In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the long half-life of Semaglutide of approximately 1 week.
