. (4, 5.2, 8.5)
Patients should be advised to report promptly any symptoms of myopathy. 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 Recommendations
Strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, boceprevir, telaprevir, nefazodone), gemfibrozil, cyclosporine, danazol Contraindicated with JUVISYNC
Verapamil, diltiazem Do not exceed 100 mg/10 mg JUVISYNC daily
Amiodarone, amlodipine, ranolazine Do not exceed 100 mg/20 mg JUVISYNC daily
Grapefruit juice Avoid large quantities of grapefruit juice (>1 quart daily)
Coumarin anticoagulants: Concomitant use with simvastatin prolongs INR. Achieve stable INR prior to starting JUVISYNC. Monitor INR frequently until stable upon initiation or alteration of JUVISYNC therapy. (7.6)
Other Lipid-lowering Medications: Use with other fibrate products or lipid-modifying doses (≥1 g/day) of niacin increases the risk of adverse skeletal muscle effects. Caution should be used when prescribing with JUVISYNC. (5.2, 7.2, 7.4).
USE IN SPECIFIC POPULATIONS
Safety and effectiveness of JUVISYNC in children under 18 years have not been established. (8.4)
There are no adequate and well-controlled studies in pregnant women. (8.1)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide
Revised: 04/20 |
