- Patients with renal impairment
- Monitor renal function when initiating or escalating doses of Ozempic® in patients reporting severe, adverse gastrointestinal (GI) reactions
- Patients with hepatic impairment
- Patients ≥65 years
- 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
The safety of Ozempic® was evaluated in 8 clinical trials1,a
aIn addition to the CVOT (SUSTAIN 6) and glycemic control trials (SUSTAIN 1 through 5), 2 Japanese trials are incorporated into the pool of safety data within the FDA-approved label. These trials evaluated the use of Ozempic® as monotherapy and add-on therapy to oral medications or insulin.
- Incidence of severe hypoglycemia was ≤1.5% across all placebo-controlled trialsb
- The risk of hypoglycemia is increased when Ozempic® is used in combination with insulin secretagogues (eg, sulfonylureas) or insulin
- Patients may require a lower dose of secretagogue or insulin to reduce the risk of hypoglycemia in this setting
bSevere hypoglycemia adverse reactions are episodes requiring the assistance of another person.
- The most frequently reported reactions across all placebo-controlled trials were GI disorders including nausea, vomiting, and diarrhea and occurred mostly during dose escalation and decreased over time in most patients
- In placebo-controlled trials, discontinuation due to GI adverse reactions was 3.1% and 3.8% for the Ozempic® 0.5 mg and 1 mg dose, respectively, compared with 0.4% for placebo
Ozempic® is not indicated for reducing the risk of major adverse cardiovascular events (MACE).
CVOT=cardiovascular outcomes trial.