INDICATIONS FOR SIMCOR^® (niacin extended-release/simvastatin)

• Lipid-altering agents 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.
• SIMCOR is indicated as an adjunct to diet to reduce total-C, LDL-C, Apo B, non–HDL-C, or TG, or to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia when treatment with simvastatin monotherapy or niacin extended-release monotherapy is considered inadequate.
• SIMCOR is indicated to reduce TG in patients with hypertriglyceridemia when treatment with simvastatin monotherapy or niacin extended-release monotherapy is considered inadequate.
• Limitations of Use: No incremental benefit of SIMCOR on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin monotherapy and niacin 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 SIMCOR

• SIMCOR is contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases, active peptic ulcer disease, or arterial bleeding; in women who are pregnant or may become pregnant; in nursing mothers; in patients with hypersensitivity to any product ingredient; and with concomitant administration of strong CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, posaconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, boceprevir, telaprevir, and nefazodone), gemfibrozil, cyclosporine, danazol, verapamil, or diltiazem.
• SIMCOR contains simvastatin, which occasionally causes myopathy manifested as muscle pain, tenderness, or weakness with CK levels above 10X ULN. Myopathy sometimes takes the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and rare fatalities have occurred. Risks of myopathy increase with higher doses, concomitant use of certain medicines (e.g. amiodarone, amlodipine, ranolazine, and colchicine), and consuming large quantities of grapefruit juice (>1 quart daily). Predisposing factors include advanced age (≥65), female gender, uncontrolled hypothyroidism, renal impairment, and Chinese ethnicity.
• Myopathy and/or rhabdomyolysis have been reported when simvastatin is used in combination with lipid-altering doses (≥1 g/day) of niacin. All patients starting therapy with SIMCOR, or whose dose of SIMCOR is being increased, should be advised of the risk of myopathy, including rhabdomyolysis, and told to report symptoms promptly. SIMCOR therapy should be discontinued if markedly elevated creatine phosphokinase (CPK) levels occur or myopathy is diagnosed or suspected. Periodic serum creatine kinase (CK) tests should be considered in this situation.
• SIMCOR should not be substituted for equivalent doses of immediate-release niacin. Severe hepatic toxicity has occurred in patients substituting sustained-release niacin for immediate-release niacin at equivalent doses. If switching from niacin preparations other than niacin extended-release, initiate with the lowest SIMCOR dose. The efficacy and safety of doses of SIMCOR >2000/40 mg daily have not been studied and are therefore not recommended.
• SIMCOR can increase serum transaminases. Check liver enzymes before initiating treatment and as clinically indicated thereafter. If serious liver injury with clinical symptoms occurs during treatment with SIMCOR, promptly interrupt therapy.
• SIMCOR should be used with caution in patients with renal disease, a past history of liver disease, and/or who consume substantial quantities of alcohol.
• SIMCOR can increase serum glucose levels. Glucose levels should be monitored in diabetic or potentially diabetic patients, particularly during the first few months of use.
• SIMCOR can reduce platelet count and phosphorus levels, and increase uric acid levels and prothrombin time (PT). In patients taking coumarin anticoagulants, monitor PT and INR before and during treatment.
• Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including simvastatin.
• The most common adverse event with SIMCOR is flushing (warmth, redness, itching, and/or tingling of the skin). Flushing 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.
• Other common adverse events reported by ≥3% of patients receiving SIMCOR were headache, pruritus, nausea, back pain, and diarrhea.

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