n): 100 mg/10 mg, 100 mg/20 mg, 100 mg/40 mg, 50 mg/10 mg, 50 mg/20 mg, and 50 mg/40 mg (3)
CONTRAINDICATIONS
•History of a serious hypersensitivity reaction, such as anaphylaxis or angioedema, to any component of this medication. (4, 5.6, 6.2)
•Concomitant administration of strong CYP3A4 inhibitors. (4, 5.2)
•Concomitant administration of gemfibrozil, cyclosporine, or danazol. (4, 5.2)
•Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels. (4, 5.3)
•Women who are pregnant or may become pregnant. (4, 8.1)
•Nursing mothers. (4, 8.3)
WARNINGS AND PRECAUTIONS
•There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, promptly discontinue JUVISYNC. (5.1)
•Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with higher doses and concomitant use of certain medicines. Predisposing factors include advanced age (≥65), female gender, uncontrolled hypothyroidism, and renal impairment. (4, 5.2, 8.5)
•Patients should be advised to report promptly any unexplained and/or persistent muscle pain, tenderness, or weakness. JUVISYNC therapy should be discontinued immediately if myopathy is diagnosed or suspected. See Drug Interaction table. (5.2)
•Liver enzyme abnormalities: Persistent elevations in hepatic transaminase can occur. Check liver enzyme tests before initiating therapy and as clinically indicated thereafter. (5.3)
•There have been postmarketing reports of acute renal failure, sometimes requiring dialysis, in patients treated with sitagliptin. Assessment of renal function is recommended prior to initiation of JUVISYNC and periodically thereafter. (5.4, 6.2)
•There is an increased risk of hypoglycemia when JUVISYNC is added to an insulin secretagogue (e.g., sulfonylurea) or insulin therapy. Consider lowering the dose of the sulfonylurea or insulin to reduce the risk of hypoglycemia. (2.3, 5.5)
•There have been postmarketing reports of serious allergic and hypersensitivity reactions in patients treated with sitagliptin such as anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. In such cases, promptly stop JUVISYNC, assess for other potential causes, institute appropriate monitoring and treatment, and initiate alternative treatment. (5.6, 6.2)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥5%) with simvastatin are: upper respiratory infection, headache, abdominal pain, constipation, and nausea. Adverse reactions reported in ≥5% of patients treated with sitagliptin and more commonly than in patients treated with placebo are: upper respiratory tract infection, nasopharyngitis and headache. In the add-on to sulfonylurea and add-on to insulin studies, hypoglycemia was also more commonly reported in patients treated with sitagliptin compared to placebo. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Drug Interactions Associated with Increased Risk of Myopathy/Rhabdomyolysis (2.4, 4, 5.2, 7.1, 7.2, 7.3, 12.3) Interacting Agents Prescribing Recommenda |
