Oral medications

Abstract

——— DOSAGE FORMS AND STRENGTHS ——— Injection: 2 mg/1.5 mL (1.34 mg/mL) available in: • Single-patient-use pen that delivers 0.25 mg or 0.5 mg per injection (3). • Single-patient-use pen that delivers 1 mg per injection (3). ——— CONTRAINDICATIONS ——— • Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2 (4). • Known hypersensitivity to OZEMPIC® or any of the product components (4). ——— WARNINGS AND PRECAUTIONS ——— • Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed (5.2). • Diabetic Retinopathy Complications: Has been reported in a clinical trial. Patients with a history of diabetic retinopathy should be monitored (5.3). • Never share an OZEMPIC® pen between patients, even if the needle is changed (5.4). • Hypoglycemia: When OZEMPIC® is used with an insulin secretagogue or insulin, consider lowering the dose of the secretagogue or insulin to reduce the risk of hypoglycemia (5.5). • Acute Kidney Injury: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions (5.6). • Hypersensitivity Reactions: Discontinue OZEMPIC® if suspected and promptly seek medical advice (5.7). ——— ADVERSE REACTIONS ——— The most common adverse reactions, reported in ≥5% of patients treated with OZEMPIC® are: nausea, vomiting, diarrhea, abdominal pain and constipation (6.1). To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc., at 1-888693-6742 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.