About ADVICOR® (niacin extended-release/lovastatin tablets)

ADVICOR^Ž (niacin extended-release/lovastatin tablets) is a fixed-dose combination product and is not indicated for initial therapy. Initial single-agent therapy is indicated as an adjunct to diet for patients who respond inadequately to restrictions in saturated fat and cholesterol and to other nonpharmacologic measures alone.

ADVICOR is indicated for the treatment of primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Frederickson Types IIa and IIb) in patients treated with (1) lovastatin who require further TG-lowering or HDL-C-raising who may benefit from having niacin added to their regimen, or (2) niacin who require further LDL-C-lowering who may benefit from having lovastatin added to their regimen.

The effect of combined therapy with niacin and lovastatin on cardiovascular morbidity and mortality has not been determined. Epidemiological investigations have established that cardiovascular morbidity and mortality vary directly with the level of TC and LDL-C, and inversely with the level of HDL-C.

IMPORTANT SAFETY INFORMATION

ADVICOR is contraindicated in patients with a hypersensitivity to product components; active liver disease or unexplained persistent elevations in serum transaminases; active peptic ulcer disease; arterial bleeding; nursing or pregnant.

ADVICOR should not be substituted for equivalent doses of immediate-release (crystalline) niacin. For patients switching from immediate-release niacin to NIASPAN^Ž (niacin extended-release tablets), therapy with NIASPAN should be initiated with low doses (i.e., 500 mg once daily at bedtime) and the NIASPAN dose should then be titrated to the desired therapeutic response. Cases of severe hepatic toxicity, including fulminant hepatic necrosis, have occurred in patients who have substituted sustained-release (modified-release, timed-release) niacin products for immediate-release (crystalline) niacin at equivalent doses.

ADVICOR should be used with caution in patients who consume substantial quantities of alcohol and/or have a past history of liver disease. Liver function tests should be performed on all patients during therapy with ADVICOR. Serum transaminase levels should be monitored before treatment begins, every 6 to 12 weeks for the first 6 months, and periodically thereafter.

Myopathy and/or rhabdomyolysis have been reported when lovastatin is used in combination with lipid-altering doses (≥1g/day) of niacin. The incidence and severity of myopathy may be increased by concomitant administration of ADVICOR with drugs that can cause myopathy when given alone, such as gemfibrozil and other fibrates. Periodic CK determinations may be considered in such situations, but there is no assurance that such monitoring will prevent myopathy. ADVICOR therapy should be discontinued if myopathy is diagnosed or suspected.

Flushing episodes (i.e., warmth, redness, itching and/or tingling) were the most common treatment-emergent adverse events in controlled clinical studies occurring in 53% to 83% of patients; 8% of patients discontinued because of flushing. Spontaneous reports with NIASPAN and clinical studies with ADVICOR suggest that flushing may also be accompanied by symptoms of dizziness or syncope, tachycardia, palpitations, shortness of breath, sweating, chills, and/or edema. Other common adverse events (≥5% patients) with ADVICOR included asthenia, flu, headache, infection, pain, diarrhea, nausea, pruritus, and rash.

Diabetic patients may experience a dose-related rise in fasting blood sugar. Diabetic or potentially diabetic patients should be observed closely during treatment with ADVICOR, and adjustment of diet and/or hypoglycemic therapy may be necessary.

Please see full prescribing information for ADVICOR.
ADVICOR is a registered trademark of Kos Pharmaceuticals, Inc.
701611 01/07 Š 2007 Kos Pharmaceuticals, Inc., Cranbury, NJ 08512

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