Indication

Type 2 Diabetes Mellitus

Administration

SC Administration\r\nAdminister SC to abdomen, thigh, or upper arm\r\n\r\nAdminister once weekly, on the same day each week, at any time of the day, with or without meals\r\n\r\nDay of weekly administration can be changed if necessary as long as the time between 2 doses is at least 2 days (>48 hours)\r\n\r\nUse a different injection site each week when injecting in the same body region

Adult Dose

Type 2 Diabetes Mellitus\r\nIndicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus\r\n\r\n0.25 mg SC qWeek for 4 weeks initially; THEN increase the dosage to 0.5 mg qWeekIf glycemic control not achieved after at least 4 weeks on 0.5-mg dose, can increase to 1 mg qWeek Hepatic impairment\r\nNo dosage adjustment required

Child Dose

<18 years: Safety and efficacy not established

Renal Dose

Renal impairment\r\nNo dosage adjustment required

Contraindication

Personal or family history of MTC or in patients with multiple endocrine neoplasia syndrome type 2 (MEN 2)\r\n\r\nKnown hypersensitivity to semaglutide or to any of the product components

Mode of Action

Glucagon-like peptide-1 (GLP-1) agonist\r\n\r\nIncretins, such as GLP-1, enhance glucose-dependent insulin secretion by pancreatic beta-cells, suppresses inappropriately elevated glucagon secretion, and slows gastric emptying

Precaution

Side Effect

>10%\r\nNausea (15.8-20.3% Documented symptomatic hypoglycemia, adjunctive therapy [≤70 mg/dL glucose threshold] (16.7-29.8%)\ Severe or symptomatic hypoglycemia, adjunctive therapy [≤56 mg/dL glucose threshold] ( 8.3-10.7%) 1-10%\r\nVomiting (5-9.2%)\r\n\r\nDiarrhea (8.5-8.8%) Abdominal pain (5.7-7.3% Constipation (3.1-5% Dyspepsia (2.7-3.5%)\r\n\r\nEructation (1.1-2.7%)\r\n\r\nDocumented symptomatic hypoglycemia, monotherapy [≤70 mg/dL glucose threshold] (1.6-3.8%) Flatulence (0.4-1.5%)\r\n\r\nGastroesophageal reflux disease (1.5-1.9%)\r\n\r\n<1%\r\nGastritis (0.4-0.8%)\r\n\r\nCholelithiasis (0.4%) Fatigue (>0.4%) Dysgeusia (>0.4%)\Dizziness (>0.4%)\r\n\r\nInjection site reaction (0.2%)

Pregnancy Category Note

Pregnancy\r\nData are limited regarding use in pregnant women\r\n\r\nBased on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy; should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus\r\n\r\nDiscontinue treatment in women at least 2 months before a planned pregnancy, owing to the long washout period for semaglutide\r\n\r\nClinical Considerations\r\nPoorly controlled diabetes during pregnancy increases maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, stillbirth, and delivery complications\r\nPoorly controlled diabetes increases fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity\r\nLactation\r\nThere are no data on the presence of semaglutide in human milk, the effects on the breastfed infant, or the effects on milk production\r\n\r\nIn lactating rats, semaglutide was detected in milk at levels 3- to 12-fold lower than in maternal plasma

Interaction

Coadministration with insulin secretagogues (eg, sulfonylureas) or insulin may increase the risk of hypoglycemia; consider a lower dose of the secretagogue or insulin to reduce risk of hypoglycemia in this setting\r\nExercise caution when semaglutide is concomitantly administered with oral medications; semaglutide causes a delay of gastric emptying, thereby potentially impacting oral absorption of such medications