Fluvastatin

Fluvastatin sodium extended-release tablets are indicated: • To reduce the risk of undergoing coronary revascularization procedures and slow the progression of coronary atherosclerosis in adults with clinically evident coronary heart disease. • As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. • As an adjunct to diet to reduce LDL-C in adults and pediatric patients 10 years of age and older with heterozygous familial hypercholesterolemia (HeFH) who require 80 mg of fluvastatin daily. Fluvastatin sodium extended-release tablets are indicated: • To reduce the risk of undergoing coronary revascularization procedures and slow the progression of coronary atherosclerosis in adults with clinically evident coronary heart disease.

Fluvastatin is a competitive inhibitor of HMG-CoA reductase, the rate limiting enzyme that converts 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) to mevalonate, a precursor of cholesterol.

• Fluvastatin sodium extended-release tablets can be taken with or without food and may be taken at any time of the day. • Do not break, crush or chew fluvastatin sodium extended-release tablets prior to administration. • Adults: The recommended starting dose is 80 mg (administered as one 80 mg fluvastatin sodium extended-release tablet once daily). Children: The recommended dose is 80 mg once daily in pediatric patients 10 years of age and older who require 80 mg of fluvastatin. Fluvastatin sodium extended-release tablets are not recommended for dosage initiation in pediatric patients because the recommended starting dosage cannot be achieved with the available strength of 80 mg.

Fluvastatin sodium extended-release tablets are contraindicated in patients with: • Acute liver failure or decompensated cirrhosis. • Hypersensitivity to fluvastatin or any of the excipients in fluvastatin sodium extended-release tablets. Hypersensitivity reactions, including anaphylaxis, angioedema, and Stevens-Johnson syndrome have been reported. • Acute liver failure or decompensated cirrhosis. • Hypersensitivity to fluvastatin or any excipient in fluvastatin sodium extended-release tablets

• Myopathy and Rhabdomyolysis: Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, and concomitant use with certain other drugs. Discontinue fluvastatin sodium extended-release tablets if markedly elevated creatine kinase (CK) levels occur, or myopathy is diagnosed or suspected. Temporarily discontinue fluvastatin sodium extended-release tablets in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing fluvastatin sodium extended-release tablets dosage. Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever.

The following serious adverse reactions are discussed in greater detail in other sections of the label: • Myopathy and Rhabdomyolysis • Immune-Mediated Necrotizing Myopathy • Hepatic Dysfunction • Increases in HbA1c and Fasting Serum Glucose Levels Most frequent adverse reactions occurring in ≥ 2.5% of subjects treated with fluvastatin sodium extended-release tablets and more than placebo are: influenza-like symptoms, sinusitis, dyspepsia, urinary tract infection, bronchitis, and nausea.

• Gemfibrozil: Avoid use with fluvastatin sodium extended-release tablets. • Cyclosporine and Fluconazole: Avoid use with fluvastatin sodium extended-release tablets. • Fibrates, Lipid-modifying doses (≥ 1 g/day) of Niacin, and Colchicine: Consider if the benefit of concomitant use with fluvastatin sodium extended-release tablets outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dose titration. • Warfarin: Obtain an International Normalized Ratio (INR) before starting and frequently enough after initiation or discontinuation to ensure that no significant alteration in INR occurs. Once the INR is stable, monitor INR at regular intervals.

Store and Dispense Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted between 15ºC to 30ºC (59ºF to 86ºF). Protect from light.