Rosuvastatin

CRESTOR is indicated: • To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for these events. • As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C): ∘ in adults with hypercholesterolemia. ∘ and slow the progression of atherosclerosis in adults. ∘ in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). ∘ in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). • As an adjunct to diet for the treatment of adults with: ∘ Primary dysbetalipoproteinemia. ∘ Hypertriglyceridemia.

CRESTOR is an inhibitor of HMG‑CoA reductase, the rate-limiting enzyme that converts 3‑hydroxy‑3‑methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol.

Take orally with or without food, at any time of day. Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating CRESTOR, and adjust dosage if necessary. Adults: Recommended dosage range is 5 to 40 mg once daily. Pediatric Patients with HeFH: Recommended dosage range is 5 to 10 mg once daily for patients aged 8 to less than 10 years of age, and 5 to 20 mg once daily for patients aged 10 years and older. Pediatric Patients with HoFH: Recommended dosage is 20 mg once daily for patients aged 7 years and older. Asian Patients: Initiate at 5 mg once daily. Consider risks and benefits of treatment if not adequately controlled at dosages up to 20 mg once daily. Patients with Severe Renal Impairment (not on hemodialysis): Initiate at 5 mg once daily, do not exceed 10 mg once daily.

CRESTOR is contraindicated in patients with: • Acute liver failure or decompensated cirrhosis. • Hypersensitivity to rosuvastatin or any excipients in CRESTOR. Hypersensitivity reactions including rash, pruritus, urticaria, and angioedema have been reported with CRESTOR. Acute liver failure or decompensated cirrhosis. Hypersensitivity to rosuvastatin or any excipients in CRESTOR.

• Myopathy and Rhabdomyolysis: Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher CRESTOR dosage. Asian patients may be at higher risk for myopathy. Discontinue CRESTOR if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue CRESTOR 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 CRESTOR dosage. Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. • Immune-Mediated Necrotizing Myopathy (IMNM): Rare reports of IMNM, an autoimmune myopathy, have been reported with statin use.

The following important adverse reactions are described below and elsewhere in the labeling: Myopathy and Rhabdomyolysis Immune-Mediated Necrotizing Myopathy Hepatic Dysfunction Proteinuria and Hematuria Increases in HbA1c and Fasting Serum Glucose Levels Most frequent adverse reactions (rate ≥2%) are headache, nausea, myalgia, asthenia, and constipation.

See full prescribing information for details regarding concomitant use of CRESTOR with other drugs that increase the risk of myopathy and rhabdomyolysis. Aluminum and Magnesium Hydroxide Combination Antacids: Administer CRESTOR at least 2 hours before the antacid. Warfarin: Obtain INR prior to starting CRESTOR. Monitor INR frequently until stable upon initiation, dosage titration or discontinuation.

Storage Store at controlled room temperature, 20ºC to 25ºC (68ºF to 77ºF), excursions permitted between 15°C and 30°C (59°F and 86°F). Protect from moisture.