Indications and Important Safety Information You Should Know About NIASPAN^® (niacin extended-release tablets)¹

INDICATIONS FOR NIASPAN^® (niacin extended-release tablets)

• NIASPAN should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and other nonpharmacological measures alone has been inadequate.
• NIASPAN is indicated to reduce elevated TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia.
• NIASPAN in combination with simvastatin or lovastatin is indicated for the treatment of primary hyperlipidemia and mixed dyslipidemia when treatment with NIASPAN, simvastatin, or lovastatin monotherapy is considered inadequate.
• In patients with a history of myocardial infarction and hyperlipidemia, niacin is indicated to reduce the risk of recurrent nonfatal myocardial infarction.
• In patients with a history of coronary artery disease and hyperlipidemia, niacin, in combination with a bile acid-binding resin, is indicated to slow progression or promote regression of atherosclerotic disease.
• Limitations of Use: No incremental benefit of NIASPAN coadministered with simvastatin or lovastatin on cardiovascular morbidity and mortality over and above that demonstrated for niacin, simvastatin, or lovastatin monotherapy has been established.

The AIM-HIGH study (terminated due to futility) showed no cardiovascular outcome benefit in patients with well-controlled LDL-C (40-80 mg/dL) using niacin extended-release/simvastatin vs. simvastatin.²

IMPORTANT SAFETY INFORMATION FOR NIASPAN

• NIASPAN is contraindicated in patients with active liver disease or unexplained persistent elevations in hepatic transaminases, active peptic ulcer disease, arterial bleeding, and hypersensitivity to any product ingredients.
• Do not substitute NIASPAN for equivalent doses of immediate-release (crystalline) niacin. Severe hepatic toxicity, including fulminant hepatic necrosis, can occur. Patients switching from immediate release niacin to NIASPAN should start with NIASPAN 500 mg at bedtime and then be titrated to the desired therapeutic response.
• NIASPAN should be used with caution in patients who consume substantial quantities of alcohol and/or have a past history of liver disease.
• Persistent elevations in hepatic transaminases can occur. Monitor liver enzymes before and during treatment and discontinue NIASPAN if they show evidence of progression, particularly to 3 times ULN and are persistent, or if they occur with symptoms of nausea, fever, and/or malaise.
• Myopathy has been reported in patients taking NIASPAN. The risk for myopathy and rhabdomyolysis increases when a statin is coadministered with NIASPAN, particularly in elderly patients and patients with diabetes, renal failure, or uncontrolled hypothyroidism. Advise patients to report muscle pain, tenderness, or weakness, particularly during the initial months of therapy and during upward dosage titration of either drug. Periodic serum creatine phosphokinase (CPK) and potassium determinations should be considered in such situations.
• Use caution in patients with unstable angina or in the acute phase of an MI; renal impairment; a past history of jaundice, hepatobiliary disease, or peptic ulcer.
• NIASPAN can increase serum glucose levels. Closely monitor glucose levels in diabetic or potentially diabetic patients, particularly during the first few months of use or during dose adjustment.
• NIASPAN can reduce platelet counts and increase prothrombin time; accordingly, carefully evaluate patients undergoing surgery. Monitor prothrombin time and platelet counts in patients receiving anticoagulants.
• NIASPAN can increase uric acid levels; use with caution in patients predisposed to gout. Transient, but statistically significant decreases in serum phosphorus have also been reported with NIASPAN. Phosphorus levels should be monitored periodically in patients at risk for hypophosphatemia.
• Bile acid sequestrants should be taken at least 4-6 hours apart from NIASPAN administration.
• The most common adverse reactions (incidence >5% and greater than placebo) are flushing, diarrhea, nausea, vomiting, increased cough, and pruritus. Flushing (warmth, redness, itching, and/or tingling of the skin) may vary in severity and is more likely to occur with initiation of therapy or during dose increases. Advise patients of the symptoms of flushing and how they differ from the symptoms of an MI.

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References:

• NIASPAN [package insert]. North Chicago, IL: Abbott Laboratories.
• U.S. Food and Drug Administration. FDA Statement on the AIM-HIGH Trial.
  http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm256841.htm. Accessed September 2, 2011.