tions
Strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, boceprevir, telaprevir, nefazodone), gemfibrozil, cyclosporine, danazol Contraindicated with JUVISYNC
Verapamil, diltiazem, dronedarone Do not exceed 10 mg simvastatin (100 mg/10 mg or 50 mg/10 mg JUVISYNC) daily
Amiodarone, amlodipine, ranolazine Do not exceed 20 mg simvastatin (100 mg/20 mg or 50 mg/20 mg JUVISYNC) daily
Grapefruit juice Avoid grapefruit juice
•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: 02/2013
FULL PRESCRIBING INFORMATION: CONTENTS *
1 INDICATIONS AND USAGE
1.1 Sitagliptin
1.2 Simvastatin
1.3 Important Limitations of Use
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
2.2 Patients with Renal Impairment
2.3 Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin
2.4 Coadministration with Other Drugs
2.5 Patients with Homozygous Familial Hypercholesterolemia
2.6 Chinese Patients Taking Lipid-Modifying Doses (greater than or equal to 1 g/day Niacin) of Niacin-Containing Products
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Pancreatitis
5.2 Myopathy/Rhabdomyolysis
5.3 Liver Dysfunction
5.4 Renal Impairment
5.5 Use with Medications Known to Cause Hypoglycemia
5.6 Hypersensitivity Reactions
5.7 Endocrine Function
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Strong CYP3A4 Inhibitors, Cyclosporine, or Danazol
7.2 Lipid-Lowering Drugs That Can Cause Myopathy When Given Alone 7.3 Amiodarone, Dronedarone, Ranolazine, or Calcium Channel Blockers
7.4 Niacin
7.5 Digoxin
7.6 Coumarin Anticoagulants
7.7 Colchicine
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Sitagliptin Clinical Studies
14.2 Simvastatin Clinical Studies
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Instructions
17.2 Laboratory Tests
17.3 Muscle Pain
17.4 Pregnancy
17.5 Breastfeeding
*
Sections or subsections omitted from the full prescribing information are not listed.
FUL
