ADVICOR has been discontinued. 

ADVICOR (niacin extended-release and lovastatin) is indicated for use when treatment with both NIASPAN and lovastatin is appropriate. As described in the labeling for Niaspan and lovastatin below, the components of ADVICOR are both indicated for the treatment of hypercholesterolemia. Patients receiving treatment with ADVICOR should be on a standard cholesterol-lowering diet and should continue on this diet during treatment.

NIASPAN (niacin extended-release):

Hypercholesterolemia:

• NIASPAN is indicated as an adjunct to diet for reduction of elevated TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia when the response to an appropriate diet has been inadequate.

Secondary Prevention of Cardiovascular Events:

• In patients with a history of myocardial infarction and hypercholesterolemia, niacin is indicated to reduce the risk of recurrent nonfatal myocardial infarction.

Hypertriglyceridemia:
 
• Niacin is also indicated as adjunctive therapy for treatment of adult patients with very high serum triglyceride levels who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Such patients typically have serum TG levels over 2000 mg/dL and have elevations of VLDL-C as well as fasting chylomicrons. Patients who consistently have total serum or plasma TG below 1000 mg/dL are unlikely to develop pancreatitis. Therapy with niacin may be considered for those patients with TG elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. Some patients with TG under 1000 mg/dL may, through dietary or alcohol indiscretion, convert to a pattern with massive TG elevations accompanying fasting chylomicronemia, but the influence of niacin therapy on risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with hyperlipoproteinemia, who have elevations of chylomicrons and plasma TG, but who have normal levels of VLDL-C. 

Lovastatin

Hypercholesterolemia:

• Lovastatin is indicated as an adjunct to diet for the reduction of elevated TC and LDL-C levels in patients with primary hypercholesterolemia when the response to diet restricted in saturated fat and cholesterol and to other nonpharmacological measures alone has been inadequate.

Primary Prevention of Cardiovascular Events:

• In individuals without symptomatic cardiovascular disease, average to moderately elevated TC and LDL-C, and below average HDL-C, Lovastatin is indicated to reduce the risk of: myocardial infarction, unstable angina and coronary revascularization procedures.

Secondary Prevention of Cardiovascular Events:

• Lovastatin is also indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower TC and LDL-C to target levels.

–ADVICOR is contraindicated in:

• Patients with a known hypersensitivity to niacin, lovastatin or any component of this medication, active liver disease or unexplained persistent elevations in serum transaminases, active peptic ulcer disease, or arterial bleeding.

• Concomitant administration with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin and nefazodone).

• Pregnancy and lactation – Atherosclerosis is a chronic process and the discontinuation of lipid lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia. ADVICOR is contraindicated in women who are pregnant and in lactating mothers. ADVICOR may cause fetal harm when administered to pregnant women. ADVICOR should be administered to women of childbearing age only when such patients are highly unlikely to conceive. If the patient becomes pregnant while taking this drug, ADVICOR should be discontinued immediately and the patient should be apprised of the potential hazard to the fetus.

–The combined use of lovastatin with gemfibrozil should be avoided.The use of lovastatin with cyclosporine should be avoided.

–ADVICOR should not be substituted for equivalent doses of immediate-release (crystalline) niacin. For patients switching from immediate-release niacin to NIASPAN, 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. Active liver disease or unexplained transaminase elevations are contraindications to the use of ADVICOR.

–Lovastatin and other inhibitors of HMG-CoA reductase occasionally cause myopathy, which is manifested as muscle pain or weakness associated with grossly elevated creatine kinase (> 10 times ULN). Rhabdomyolysis, with or without acute renal failure secondary to myoglobinuria, has been reported rarely and can occur at any time.

GoToSource

• Dosage greater than 2000 mg/40 mg daily. GoToSource

• Use in patients under the age of 18. GoToSource 

• Use as first-line therapy for management of mixed dyslipidemias. GoToSource

Myopathy (disease of muscle tissue) rhabdomyolysis (destruction of muscle tissue), increased blood sugar levels and new-onset diabetes. GoToSource

Liver injury. GoToSource

Muscle toxicity (including cramping, soreness, fatigue weakness and exercise-induced muscle damage). GoToSource

Cognitive impairment including memory loss, forgetfulness, amnesia, memory impairment and confusion. GoToSource

Lawsuits filed for severe muscle damage, myopathy, rhabdomyolysis, kidney and liver failure, type 2 diabetes and death.