lysis with acute renal failure secondary to myoglobinuria have been reported. (4, 5.1, 8.5, 8.6)
Patients should be advised to report promptly any unexplained and/or persistent muscle pain, tenderness, or weakness. ZOCOR therapy should be discontinued immediately if myopathy is diagnosed or suspected. See Drug Interaction table. (5.1)
Liver enzyme abnormalities: Persistent elevations in hepatic transaminases can occur. Check liver enzyme tests before initiating therapy and as clinically indicated thereafter. (5.2)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥5.0%) are: upper respiratory infection, headache, abdominal pain, constipation, and nausea. (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 (2.3, 2.4, 4, 5.1, 7.1, 7.2, 7.3, 12.3) Interacting Agents Prescribing Recommendations
* For patients with HoFH who have been taking 80 mg simvastatin chronically (e.g., for 12 months or more) without evidence of muscle toxicity, do not exceed 40 mg simvastatin when taking lomitapide.
Strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, boceprevir, telaprevir, nefazodone, cobicistat-containing products), gemfibrozil, cyclosporine, danazol Contraindicated with simvastatin
Verapamil, diltiazem, dronedarone Do not exceed 10 mg simvastatin daily
Amiodarone, amlodipine, ranolazine Do not exceed 20 mg simvastatin daily
Lomitapide For patients with HoFH, do not exceed 20 mg simvastatin daily*
Grapefruit juice Avoid grapefruit juice
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 simvastatin. (5.1, 7.2, 7.4)
Coumarin anticoagulants: Concomitant use with ZOCOR prolongs INR. Achieve stable INR prior to starting ZOCOR. Monitor INR frequently until stable upon initiation or alteration of ZOCOR therapy. (7.6)
USE IN SPECIFIC POPULATIONS
Severe renal impairment: patients should be started at 5 mg/day and be closely monitored. (2.6, 8.6)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 3/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Reductions in Risk of CHD Mortality and Cardiovascular Events 1.2 Hyperlipidemia 1.3 Adolescent Patients with Heterozygous Familial Hypercholesterolemia (HeFH) 1.4 Limitations of Use 2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing 2.2 Restricted Dosing for 80 mg 2.3 Coadministration with Other Drugs 2.4 Patients with Homozygous Familial Hypercholesterolemia 2.5 Adolescents (10-17 years of age) with Heterozygous Familial Hypercholesterolemia 2.6 Patients with Renal Impairment 2.7 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 Myopathy/Rhabdomyolysis 5.2 Liver Dysfunction 5.3 Endocrine Function 6 ADVERSE REACTIONS
6.1 Clinical Trials Experience 6.2 Postmarketing Experience 7 DRUG
