Semaglutide

DEA Class; Rx

Common Brand Names; Ozempic, Rybelsus, Wegovy

Personal or family history of MTC or in patients with multiple endocrine neoplasia syndrome type 2

Known hypersensitivity to semaglutide or to any of the product components

(SC, Ozempic)

• Nausea (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%)

(SC, Wegovy)

• Nausea (44%)
• Diarrhea (30%)
• Vomiting (24%)
• Constipation (24%)
• Abdominal pain (20%)
• Headache (14%)
• Fatigue (11%)

(PO)

• Nausea (11-20%)
• Abdominal pain (10-11%)

Based on findings in rats and mice, semaglutide may cause thyroid C-cell tumors, including MTC, in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined

In control trials, acute pancreatitis was reported (0.3 events [SC] and 0.1 events [PO] per 100 patient years); after initiating treatment, monitor for signs and symptoms of pancreatitis (eg, persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting); if pancreatitis suspected, discontinue semaglutide and do not restart if confirmed

Patients treated with semaglutide showed an increased risk of diabetic retinopathy complications compared with placebo/comparator; rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy

Semaglutide pens must never be shared between patients, even if the needle is changed; pen-sharing poses a risk for transmission of blood-borne pathogens

Postmarketing reports describe acute kidney injury and worsening of chronic renal failure, which may sometimes require hemodialysis in patients treated with GLP-1 receptor agonists; a majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration; monitor renal function when initiating or escalating doses of semaglutide in patients reporting severe adverse GI reactions

Serious hypersensitivity reactions (eg, anaphylaxis, angioedema) have been reported with GLP-1 receptor agonists; if hypersensitivity reactions occur, discontinue treatment, treat promptly, and monitor until signs and symptoms resolve

Acute gallbladder disease events (eg, cholelithiasis, cholecystitis) reported in GLP-1 receptor agonist trials and postmarketing surveillance; if suspected, gallbladder studies and appropriate clinical follow-up are indicated

Data are insufficient regarding use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes

There are no data on the presence of semaglutide in human milk, the effects on the breastfed infant, or the effects on milk production