Indications for: VYTORIN

Adjunct to diet in primary hyperlipidemia (heterozygous familial and non-familial) or mixed hyperlipidemia: to reduce elevated total-C, LDL-C, apo B, TG and non-HDL-C, and to increase HDL-C. Adjunct to or when other lipid-lowering treatments for homozygous familial hypercholesterolemia (HoFH) are not available: to reduce elevated total-C and LDL-C.

Limitations of Use:

No incremental benefit on cardiovascular morbidity/mortality over and above that demonstrated for simvastatin has been established. Not studied in Fredrickson type I, III, IV, and V dyslipidemias.

Adult Dosage:

Take once daily in the PM. ≥17yrs: Initially 10mg/10mg or 10mg/20mg; for LDL-C reduction >55%: may start at 10mg/40mg; monitor lipids after 2 wks then periodically. HoFH: 10mg/40mg. Concomitant verapamil, diltiazem, dronedarone: max 10mg/10mg. Concomitant amiodarone, amlodipine, ranolazine: max 10mg/20mg. Concomitant bile acid sequestrants: give Vytorin dose either ≥2hrs before or ≥4hrs after bile acid sequestrant administration. Concomitant lomitapide: reduce Vytorin dose by 50%; max 10mg/20mg daily (or 10mg/40mg daily for those previously taken simvastatin 80mg/day chronically). Renal impairment (eGFR<60mL/min/1.73m2): 10mg/20mg/day. Restrict 10mg/80mg dose to chronic users (≥12mos) without evidence of muscle toxicity; if currently tolerating Vytorin 10mg/80mg dose and need to start a contraindicated drug or one associated with a simvastatin dose cap: switch to an alternative statin with less potential drug interaction. If patients unable to achieve their LDL-C goal using Vytorin 10/40mg: do not titrate to 10mg/80mg dose, switch to alternative regimen that provides greater LDL-C lowering.

Children Dosage:

<10yrs or premenarchal: not studied. 10–17yrs: see full labeling.

VYTORIN Contraindications:

Concomitant strong CYP3A4 inhibitors (eg, itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone, cobicistat-containing agents), gemfibrozil, cyclosporine, danazol. Active liver disease. Unexplained persistent elevated hepatic transaminases. Pregnancy (Cat.X). Nursing mothers.

VYTORIN Warnings/Precautions:

Increased risk of myopathy/rhabdomyolysis with simvastatin 80mg doses including predisposing factors (eg, age ≥65yrs, female gender, uncontrolled hypothyroidism, renal impairment). Discontinue if markedly elevated CPK (>10xULN) levels occur or myopathy diagnosed or suspected. Temporarily withhold if acute or serious condition predisposing to the development of renal failure secondary to rhabdomyolysis occurs. Immune-mediated necrotizing myopathy; monitor. Monitor liver function prior to initation and repeat as clinically indicated. Interrupt therapy if serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs; do not restart if alternate etiology not found. History of liver disease. Substantial alcohol consumption. Moderate to severe renal impairment. Chinese patients (may be at higher risk for myopathy): monitor. Elderly. Advise women of childbearing potential to use effective contraception; discontinue if pregnancy occurs.

VYTORIN Classification:

Cholesterol absorption inhibitor + HMG-CoA reductase inhibitor.

VYTORIN Interactions:

See Contraindications, Adults. Avoid concomitant grapefruit juice. Caution with fenofibrates, lomitapide (in HoFH patients), colchicine, amiodarone, dronedarone, verapamil, diltiazem, amlodipine, or ranolazine. Antagonized by cholestyramine. Concomitant lipid-modifying doses (≥1g/day) of niacin: not recommended in Chinese patients. Increased risk of rhabdomyolysis with concomitant daptomycin: suspend Vytorin temporarily. Monitor digoxin, coumarin anticoagulants.

Adverse Reactions:

Headache, increased ALT, myalgia, upper respiratory tract infection, diarrhea, pain in extremity, influenza; myopathy, rhabdomyolysis, increased HbA1c and fasting serum glucose.

Generic Drug Availability:


How Supplied:

Tabs 10mg/10mg—30, 90, 10000; 10mg/20mg, 10mg/40mg, 10mg/80mg—30, 90