Ozempic®

Prescribing Information and Black Box Warning

Important Safety Information

OZEMPIC® (semaglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as:

• an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use:

• Co-administration with other semaglutide-containing products or any GLP-1 receptor agonist is not recommended.
• OZEMPIC® has not been studied in patients with a history of pancreatitis.
• OZEMPIC® is not indicated for use in patients with type 1 diabetes mellitus.

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning.

• In rodents, semaglutide causes thyroid C-cell tumors in clinically relevant exposures. It is unknown whether OZEMPIC® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined
• OZEMPIC® is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors.

Do not take OZEMPIC® if you:

• Have a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN2).
• Have been diagnosed with Diabetes (Type 1)
• Have been diagnosed with pancreatitis or history of pancreatitis
• Have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food
• Have a known allergy to semaglutide/any other GLP-1 drug or any of the inactive ingredients in OZEMPIC®. Inactive ingredients include: di-sodium phosphate dihydrate, propylene glycol, phenol, and water for injection.
• Have a history of suicidal attempts or active suicidal ideation

WARNINGS AND PRECAUTIONS

• Acute Pancreatitis: Has occurred in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.
• Acute Gallbladder Disease: Has occurred in clinical trials. If cholelithiasis is suspected, gallbladder studies and clinical follow-up are indicated.
• Hypoglycemia: Concomitant use with an insulin secretagogue or insulin may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing the dose of insulin secretagogue or insulin may be necessary. Inform all patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.
• Acute Kidney Injury: Has occurred. Monitor renal function when initiating or escalating doses of OZEMPIC® in patients reporting severe adverse gastrointestinal reactions or in those with renal impairment reporting severe adverse gastrointestinal reactions.
• Hypersensitivity Reactions: Anaphylactic reactions and angioedema have been reported postmarketing. Discontinue OZEMPIC® if suspected and promptly seek medical advice.
• Females and males of reproductive potential: Discontinue OZEMPIC® at least 2 months before a planned pregnancy because of the long half-life of semaglutide.
• Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue OZEMPIC® immediately
• Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: Has been reported in trials with OZEMPIC®. Patients with a history of diabetic retinopathy should be monitored.
• Heart Rate Increase: Monitor heart rate at regular intervals.
• Suicidal Behavior and Ideation: Monitor for depression or suicidal thoughts. Discontinue OZEMPIC® if symptoms develop.

Side Effects Most common side effects (incidence ≥ 5%) in adults or pediatric patients aged 12 years and older are: nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, gastroesophageal reflux disease, and nasopharyngitis.

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS OZEMPIC® delays gastric emptying. May impact absorption of concomitantly administered oral medications. Use with caution.

USE IN SPECIFIC POPULATIONS

• Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue OZEMPIC®.
• Females and Males of Reproductive Potential: Discontinue OZEMPIC® at least 2 months before a planned pregnancy because of the long half-life of semaglutide.