HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use LIPTRUZET safely and effectively. See full prescribing information for LIPTRUZET.
LIPTRUZET™ (ezetimibe and atorvastatin) tablets for oral use
Initial U.S. Approval: 2013
INDICATIONS AND USAGE
LIPTRUZET, which contains a cholesterol absorption inhibitor and an HMG-CoA reductase inhibitor (statin), is indicated as adjunctive therapy to diet to:
reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. (1.1)
reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments. (1.2)
Limitations of Use
No incremental benefit of LIPTRUZET on cardiovascular morbidity and mortality over and above that demonstrated for atorvastatin has been established. LIPTRUZET has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias. (1.3)
DOSAGE AND ADMINISTRATION
Dosage range is 10/10 mg/day through 10/80 mg/day. (2.1)
Recommended starting dose is 10/10 mg/day or 10/20 mg/day. (2.1)
Recommended starting dose is 10/40 mg/day for patients requiring a >55% reduction in LDL-C. (2.1)
Dosing of LIPTRUZET should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant. (2.3, 7.11)
DOSAGE FORMS AND STRENGTHS
Tablets (ezetimibe mg/atorvastatin mg): 10/10, 10/20, 10/40, 10/80. (3)
CONTRAINDICATIONS
Active liver disease or unexplained persistent elevations of hepatic transaminase levels. (4, 5.2)
Hypersensitivity to any component of LIPTRUZET. (4, 6.2)
Women who are pregnant or may become pregnant. (4, 8.1)
Nursing mothers. (4, 8.3)
WARNINGS AND PRECAUTIONS
Patients should be advised to report promptly any unexplained and/or persistent muscle pain, tenderness, or weakness. LIPTRUZET should be discontinued immediately if myopathy is diagnosed or suspected. (5.1)
Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with higher doses and concomitant use of certain CYP3A4 inhibitors, fibric acid derivatives, and cyclosporine. Predisposing factors include advanced age (>65), uncontrolled hypothyroidism, and renal impairment. Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported. (5.1, 8.5)
Liver enzyme abnormalities: Persistent elevations in hepatic transaminase can occur. Check liver enzyme tests before initiating therapy and as clinically indicated thereafter. (5.2)
ADVERSE REACTIONS
Common adverse reactions (incidence ≥2% and greater than placebo) are: increased ALT, increased AST, and musculoskeletal pain. (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 with Atorvastatin (2.3, 5.1, 7, 12.3) Interacting Agents Prescribing Recommendations for LIPTRUZET
Cyclosporine, HIV protease inhibitors (tipranavir plus ritonavir), hepatitis C protease inhibitor (telaprevir), gemfibrozil Avoid LIPTRUZET
HIV protease inhibitor (lopinavir plus ritonavir) Use with caution and lowest dose necessar |
