Data from FDA - Curated by EPG Health - Last updated 02 June 2018

Indication(s)

1 INDICATIONS AND USAGE Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other non-pharmacologic measures alone has been inadequate. Fluvastatin sodium extended-release tablets are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: •Reduce elevated TC, LDL-C, Apo B, and TG, and to increase HDL-C in adult patients with primary hypercholesterolemia and mixed dyslipidemia (1.1) •Reduce elevated TC, LDL-C, and Apo B levels in boys and post-menarchal girls, 10 to 16 years of age, with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy (1.1) •Reduce the risk of undergoing revascularization procedures in patients with clinically evident CHD (1.2) •Slow the progression of atherosclerosis in patients with CHD (1.2) Limitations of Use: •Fluvastatin sodium extended-release tablets have not been studied in conditions where the major abnormality is elevation of chylomicrons, VLDL, or IDL (i.e., hyperlipoproteinemia Types I, III, IV, or V) (1.3) 1.1 Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia Fluvastatin sodium extended-release tablets are indicated •as an adjunct to diet to reduce elevated total cholesterol (Total-C), low-density lipoprotein cholesterol (LDL-C), triglyceride (TG) and apolipoprotein B (Apo B) levels, and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Type IIa and IIb). •as an adjunct to diet to reduce Total-C, LDL-C, and Apo B levels in adolescent boys and adolescent girls who are at least one year post-menarche, 10-16 years of age, with heterozygous familial hypercholesterolemia and the following findings are present: ▪LDL-C remains ≥ 190 mg/dL or ▪LDL-C remains ≥ 160 mg/dL and: •there is a positive family history of premature cardiovascular disease or •two or more other cardiovascular disease risk factors are present The NCEP classification of cholesterol levels in pediatric patients with a familial history of hypercholesterolemia or premature CVD is summarized below. Category Total-C (mg/dL) LDL-C (mg/dL) Acceptable <170 <110 Borderline 170-199 110-129 High ≥200 ≥130 Children treated with fluvastatin in adolescence should be re-evaluated in adulthood and appropriate changes made to their cholesterol-lowering regimen to achieve adult treatment goals. 1.2 Secondary Prevention of Cardiovascular Disease In patients with clinically evident CHD, fluvastatin sodium extended-release tablets are indicated to: •reduce the risk of undergoing coronary revascularization procedures •slow the progression of coronary atherosclerosis 1.3 Limitations of Use Fluvastatin sodium extended-release tablets have not been studied in conditions where the major abnormality is elevation of chylomicrons, VLDL, or IDL (i.e., hyperlipoproteinemia Types I, III, IV, or V).

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Advisory information

contraindications
4 CONTRAINDICATIONS •Hypersensitivity to any component of this medication (4) •Active liver disease or unexplained, persistent elevations in serum transaminases (4, 5.2) •Women who are pregnant or may become pregnant (4, 8.1) •Nursing mothers (4, 8.3) 4.1 Hypersensitivity to any Component of this Medication Fluvastatin sodium extended-release tablets are contraindicated in patients with hypersensitivity to any component of this medication. 4.2 Active Liver Disease Fluvastatin sodium extended-release tablets are contraindicated in patients with active liver disease or unexplained, persistent elevations in serum transaminases [see Warnings and Precautions (5.2)]. 4.3 Pregnancy Fluvastatin sodium extended-release tablets are contraindicated in women who are pregnant or may become pregnant. Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol or cholesterol derivatives are essential for fetal development. Fluvastatin sodium extended-release tablets may cause fetal harm when administered to pregnant women. 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. Fluvastatin sodium extended-release tablets should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards. If the patient becomes pregnant while taking this drug, fluvastatin sodium extended-release tablets should be discontinued and the patient should be apprised of the potential hazard to the fetus [see Use in Specific Populations (8.1)]. 4.4 Nursing Mothers Fluvastatin is secreted into the breast milk of animals and because HMG-CoA reductase inhibitors have the potential to cause serious adverse reactions in nursing infants, women who require treatment with fluvastatin sodium extended-release tablets should be advised not to breastfeed their infants [see Use in Specific Populations (8.3)].
Adverse reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the label: •Rhabdomyolysis with myoglobinuria and acute renal failure and myopathy (including myositis) [see Warnings and Precautions (5.1)]. •Liver Enzyme Abnormalities [see Warnings and Precautions (5.2)]. Most frequent adverse reactions (rate ≥2% and > placebo) are: headache, dyspepsia, myalgia, abdominal pain and nausea (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience in Adult Patients Because clinical studies on fluvastatin sodium extended-release tablets are conducted in varying study populations and study designs, the frequency of adverse reactions observed in the clinical studies of fluvastatin sodium extended-release tablets cannot be directly compared with that in the clinical studies of other statins and may not reflect the frequency of adverse reactions observed in clinical practice. In the immediate-release fluvastatin sodium placebo-controlled clinical trials database of 2326 patients treated with immediate-release fluvastatin sodium1 (age range 18-75 years, 44% women, 94% Caucasians, 4% Blacks, 2% other ethnicities) with a median treatment duration of 24 weeks, 3.4% of patients on immediate-release fluvastatin sodium and 2.3% patients on placebo discontinued due to adverse reactions regardless of causality. The most common adverse reactions that led to treatment discontinuation and occurred at an incidence greater than placebo were: transaminase increased (0.8%), upper abdominal pain (0.3%), dyspepsia (0.3%), fatigue (0.2%) and diarrhea (0.2%). In the fluvastatin sodium extended-release tablet database of controlled clinical trials of 912 patients treated with fluvastatin sodium extended-release tablets (age range 21-87 years, 52% women, 91% Caucasians, 4% Blacks, 5% other ethnicities) with a median treatment duration of 24 weeks, 3.9% of patients on fluvastatin sodium extended-release tablets discontinued due to adverse reactions regardless of causality. The most common adverse reactions that led to treatment discontinuation were abdominal pain (0.7%), diarrhea (0.5%), nausea (0.4%), dyspepsia (0.4%) and chest pain (0.3%). Clinically relevant adverse experiences occurring in the immediate-release fluvastatin sodium and fluvastatin sodium extended-release tablets controlled studies with a frequency ≥2%, regardless of causality, included the following: Table 1: Clinical Adverse Events Reported in >2% in Patients Treated with Immediate-Release Fluvastatin Sodium / Fluvastatin Sodium Extended-Release Tablets and at an Incidence Greater than Placebo in Placebo-Controlled Trials Regardless of Causality (% of patients) Pooled Dosages Immediate-Release Fluvastatin Sodium1 N=2326 (%) Placebo1 N=960 (%) Fluvastatin Sodium Extended-Release Tablets2 N=912 (%) Musculoskeletal Myalgia 5.0 4.5 3.8 Arthritis 2.1 2.0 1.3 Arthropathy NA NA 3.2 Respiratory Sinusitis 2.6 1.9 3.5 Bronchitis 1.8 1.0 2.6 Gastrointestinal Dyspepsia 7.9 3.2 3.5 Diarrhea 4.9 4.2 3.3 Abdominal pain 4.9 3.8 3.7 Nausea 3.2 2.0 2.5 Flatulence 2.6 2.5 1.4 Tooth disorder 2.1 1.7 1.4 Psychiatric Insomnia 2.7 1.4 0.8 Genitourinary Urinary tract infection 1.6 1.1 2.7 Miscellaneous Headache 8.9 7.8 4.7 Influenza-like symptoms 5.1 5.7 7.1 Accidental Trauma 5.1 4.8 4.2 Fatigue 2.7 2.3 1.6 Allergy 2.3 2.2 1.0 1Controlled trials with immediate-release fluvastatin sodium (20 and 40 mg daily and 40 mg twice daily) compared to placebo 2Controlled trials with fluvastatin sodium extended-release tablets 80 mg as compared to immediate-release fluvastatin sodium Fluvastatin Sodium Intervention Prevention Study In the Fluvastatin Sodium Intervention Prevention Study, the effect of immediate-release fluvastatin sodium 40 mg, administered twice daily on the risk of recurrent cardiac events was assessed in 1677 patients with CHD who had undergone a percutaneous coronary intervention (PCI) procedure. This was a multicenter, randomized, double-blind, placebo-controlled study, patients were treated with dietary/lifestyle counseling and either immediate-release fluvastatin sodium 40 mg (n=844) or placebo (n=833) given twice daily for a median of 3.9 years [see Clinical Studies (14.3)]. Table 2: Clinical Adverse Events Reported in ≥ 2% in Patients Treated with Immediate-Release Fluvastatin Sodium / Fluvastatin Sodium Extended-Release Tablets and at an Incidence Greater than Placebo in the Fluvastatin Intervention Prevention Study Trial Regardless of Causality (% of patients) Immediate-Release Fluvastatin Sodium 40 mg twice daily N=822 (%) Placebo N=818 (%) Cardiac disorders Atrial fibrillation 2.4 2.0 Gastrointestinal disorders Abdominal pain upper 6.3 4.5 Constipation 3.3 2.1 Dyspepsia 4.5 4.0 Gastric disorder 2.7 2.1 Nausea 2.7 2.3 General disorders Fatigue 4.7 3.8 Edema peripheral 4.4 2.9 Infections and infestations Bronchitis 2.3 2.0 Nasopharyngitis 2.8 2.1 Musculoskeletal and connective tissue disorders Arthralgia 2.1 1.8 Myalgia 2.2 1.6 Pain in extremity 4.1 2.7 Nervous system disorders Dizziness 3.9 3.5 Syncope 2.4 2.2 Respiratory disorders Dyspnea exertional 2.8 2.4 Vascular disorders Hypertension 5.8 4.2 Intermittent claudication 2.3 2.1 6.2 Clinical Studies Experience in Pediatric Patients In patients aged <18 years, efficacy and safety have not been studied for treatment periods longer than two years. In two open-label, uncontrolled studies, 66 boys and 48 girls with heterozygous familial hypercholesterolemia (9-16 years of age, 80% Caucasian, 19% Other [mixed ethnicity], 1% Asians) were treated with fluvastatin sodium administered as immediate-release fluvastatin sodium 20 mg - 40 mg twice daily, or fluvastatin sodium extended-release tablets 80 mg [see Clinical Studies (14.2) and Use in Specific Populations (8.4)]. 6.3 Postmarketing Experience Because adverse reactions from spontaneous reports are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following effects have been reported with drugs in this class. Not all the effects listed below have necessarily been associated with fluvastatin sodium therapy. Musculoskeletal: muscle cramps, myalgia, myopathy, rhabdomyolysis, arthralgias, muscle spasms, muscle weakness, myositis. There have been rare reports of immune-mediated necrotizing myopathy associated with statin use [see Warnings and Precautions (5.1)]. Neurological: dysfunction of certain cranial nerves (including alteration of taste, impairment of extra-ocular movement, facial paresis), tremor, dizziness, vertigo, paresthesia, hypoesthesia, dysesthesia, peripheral neuropathy, peripheral nerve palsy. There have been rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These cognitive issues have been reported for all statins. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks). Psychiatric: anxiety, insomnia, depression, psychic disturbances Respiratory: interstitial lung disease Hypersensitivity Reactions: An apparent hypersensitivity syndrome has been reported rarely which has included one or more of the following features: anaphylaxis, angioedema, lupus erythematosus-like syndrome, polymyalgia rheumatica, vasculitis, purpura, thrombocytopenia, leukopenia, hemolytic anemia, positive ANA, ESR (erythrocyte sedimentation rate) increase, eosinophilia, arthritis, arthralgia, urticaria, asthenia, photosensitivity reaction, fever, chills, flushing, malaise, dyspnea, toxic epidermal necrolysis, erythema multiforme, including Stevens-Johnson syndrome. Gastrointestinal: pancreatitis, hepatitis, including chronic active hepatitis, cholestatic jaundice, fatty change in liver, cirrhosis, fulminant hepatic necrosis, hepatoma, anorexia, vomiting, fatal and non-fatal hepatic failure. Skin: rash, dermatitis, including bullous dermatitis, eczema, alopecia, pruritus, a variety of skin changes (e.g. nodules, discoloration, dryness of skin/mucous membranes, changes to hair/nails). Reproductive: gynecomastia, loss of libido, erectile dysfunction. Eye: progression of cataracts (lens opacities), ophthalmoplegia. Laboratory abnormalities: elevated transaminases, alkaline phosphatase, gamma-glutamyl transpeptidase and bilirubin; thyroid function abnormalities.

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION •Dose range: 20 mg to 80 mg/ day (2.1) •Fluvastatin sodium extended-release tablets can be taken with or without food. Fluvastatin sodium extended-release tablets may be taken at any time of the day (2.1) •Do not break, crush or chew fluvastatin sodium extended-release tablets prior to administration (2.1) •Adults: the recommended starting dose is one fluvastatin sodium extended-release tablet 80 mg once daily) (2.2) •Do not take two doses of immediate-release fluvastatin sodium 40 mg at one time •Children with heterozygous familial hypercholesterolemia (ages 10 to 16, inclusive): the recommended starting dose is immediate-release fluvastatin sodium 20 mg once daily (2.3) 2.1 General Dosing Information Dose range: 20 mg to 80 mg/ day. Fluvastatin sodium extended-release tablets can be administered orally as a single dose, with or without food. Do not break, crush or chew fluvastatin sodium extended-release tablets prior to administration. Do not take two doses of immediate-release fluvastatin sodium 40 mg at one time. Since the maximal effect of a given dose is seen within 4 weeks, periodic lipid determinations should be performed at this time and dosage adjusted according to the patient’s response to therapy and established treatment guidelines. For patients requiring LDL-C reduction to a goal of ≥25%, the recommended starting dose is 40 mg as one dose in the evening, 80 mg as one fluvastatin sodium extended-release tablet administered as a single dose at any time of the day or 80 mg in divided doses of the 40 mg dose given twice daily. For patients requiring LDL-C reduction to a goal of <25% a starting dose of 20 mg may be used. 2.2 Adult Patients with Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia Adult patients can be started on either immediate-release fluvastatin sodium or fluvastatin sodium extended-release tablets. The recommended starting dose for immediate-release fluvastatin sodium is one 40 mg dose in the evening, or one immediate-release fluvastatin sodium 40 mg twice daily. Do not take two immediate-release fluvastatin sodium 40 mg doses at one time. The recommended starting dose for fluvastatin sodium extended-release tablets is one 80 mg tablet administered as a single dose at any time of the day. 2.3 Pediatric Patients (10-16 years of age) with Heterozygous Familial Hypercholesterolemia The recommended starting dose is one immediate-release fluvastatin sodium 20 mg dose. Dose adjustments, up to a maximum daily dose administered either as immediate-release fluvastatin sodium 40 mg dose twice daily or one fluvastatin sodium extended-release tablet 80 mg once daily should be made at 6 week intervals. Doses should be individualized according to the goal of therapy [see NCEP Pediatric Panel Guidelines and Clinical Studies (14)] 1. 1National Cholesterol Education Program (NCEP): Highlights of the Report of the Expert Panel on Blood Cholesterol Levels in Children and Adolescents. Pediatrics. 89(3):495-501. 1992. 2.4 Use with Cyclosporine Do not exceed a dose of 20 mg twice daily immediate-release fluvastatin sodium in patients taking cyclosporine [see Drug Interactions (7.1)]. 2.5 Use with Fluconazole Do not exceed a dose of 20 mg twice daily immediate-release fluvastatin sodium in patients taking fluconazole [see Drug Interactions (7.2)].
Use in special populations
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category X Fluvastatin sodium extended-release tablets are contraindicated in women who are or may become pregnant [see Contraindications (4)]. Lipid lowering drugs are contraindicated during pregnancy, because cholesterol and cholesterol derivatives are needed for normal fetal development. Serum cholesterol and triglycerides increase during normal pregnancy. Atherosclerosis is a chronic process, and discontinuation of lipid-lowering drugs during pregnancy should have little impact on long-term outcomes of primary hypercholesterolemia therapy. There are no adequate and well-controlled studies of use with fluvastatin sodium extended-release tablets during pregnancy. Rare reports of congenital anomalies have been received following intrauterine exposure to other statins. In a review2 of about 100 prospectively followed pregnancies in women exposed to other statins, the incidences of congenital anomalies, spontaneous abortions, and fetal deaths/stillbirths did not exceed the rate expected in the general population. The number of cases is adequate only to exclude a 3- to 4-fold increase in congenital anomalies over background incidence. In 89% of prospectively followed pregnancies, drug treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. Teratology studies with fluvastatin in rats and rabbits showed maternal toxicity at high dose levels, but there was no evidence of embryotoxic or teratogenic potential [see Non-Clinical Toxicology (13)]. Fluvastatin sodium extended-release tablets should be administered to women of child-bearing potential only when such patients are highly unlikely to conceive and have been informed of the potential hazards. If a woman becomes pregnant while taking fluvastatin sodium extended-release tablets, the drug should be discontinued and the patient advised again as to the potential hazards to the fetus. 8.3 Nursing Mothers Based on animal data, fluvastatin is present in breast milk in a 2:1 ratio (milk:plasma). Because of the potential for serious adverse reactions in nursing infants, nursing women should not take fluvastatin sodium extended-release tablets [see Contraindications (4)]. 8.4 Pediatric Use The safety and efficacy of fluvastatin sodium extended-release tablets in children and adolescent patients 9-16 years of age with heterozygous familial hypercholesterolemia have been evaluated in open-label, uncontrolled clinical trials for a duration of two years. The most common adverse events observed were influenza and infections. In these limited uncontrolled studies, there was no detectable effect on growth or sexual maturation in the adolescent boys or on menstrual cycle length in girls [see Clinical Studies (14.2), Adverse Reactions (6.3) and Dosage and Administration (2.2)]. Adolescent females should be counseled on appropriate contraceptive methods while on fluvastatin sodium therapy [see Contraindications (4)]. 8.5 Geriatric Use Fluvastatin exposures were not significantly different between the nonelderly and elderly populations (age ≥ 65 years) [see Clinical Pharmacology (12.3)]. Since advanced age (≥ 65 years) is a predisposing factor for myopathy, fluvastatin sodium extended-release tablets should be prescribed with caution in the elderly. 8.6 Hepatic Impairment Fluvastatin sodium extended-release tablets are contraindicated in patients with active liver disease or unexplained, persistent elevations in serum transaminases [see Clinical Pharmacology (12.3)]. 8.7 Renal Impairment Dose adjustments for mild to moderate renal impairment are not necessary. Fluvastatin has not been studied at doses greater than 40 mg in patients with severe renal impairment; therefore caution should be exercised when treating such patients at higher doses [see Clinical Pharmacology (12.3)].
Pregnancy and lactation
8.3 Nursing Mothers Based on animal data, fluvastatin is present in breast milk in a 2:1 ratio (milk:plasma). Because of the potential for serious adverse reactions in nursing infants, nursing women should not take fluvastatin sodium extended-release tablets [see Contraindications (4)].

Interactions

7 DRUG INTERACTIONS • Cyclosporine: Combination increases fluvastatin exposure. Limit immediate-release fluvastatin sodium dose to 20 mg (2.4, 7.1) • Fluconazole: Combination increases fluvastatin exposure. Limit immediate-release fluvastatin sodium dose to 20 mg (2.5, 7.2) • Concomitant lipid-lowering therapies: Use with fibrates or lipid-modifying doses (≥1 g/day) of niacin increases the risk of adverse skeletal muscle effects. Caution should be used when prescribing with fluvastatin sodium extended-release tablets (5.1, 7.3, 7.4) • Glyburide: Monitor blood glucose levels when fluvastatin dose is changed (7) • Phenytoin: Monitor plasma phenytoin levels when fluvastatin treatment is initiated or when the dosage is changed (7) • Warfarin and coumarin derivates: Monitor prothrombin times when fluvastatin co-administration is initiated, discontinued, or the dosage changed (7) 7.1 Cyclosporine Cyclosporine coadministration increases fluvastatin exposure. Therefore, in patients taking cyclosporine, therapy should be limited to immediate-release fluvastatin sodium 20 mg twice daily [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)]. 7.2 Fluconazole Administration of fluvastatin 40 mg single dose to healthy volunteers pre-treated with fluconazole for 4 days results in an increase of fluvastatin exposure. Therefore, in patients taking fluconazole, therapy should be limited to immediate-release fluvastatin sodium 20 mg twice daily [see Clinical Pharmacology (12.3)]. 7.3 Gemfibrozil Due to an increased risk of myopathy/rhabdomyolysis when HMG-CoA reductase inhibitors are coadministered with gemfibrozil, concomitant administration of fluvastatin sodium extended-release tablets with gemfibrozil should be avoided. 7.4 Other Fibrates Because it is known that the risk of myopathy during treatment with HMG-CoA reductase inhibitors is increased with concurrent administration of other fibrates, fluvastatin sodium extended-release tablets should be administered with caution when used concomitantly with other fibrates [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)]. 7.5 Niacin The risk of skeletal muscle effects may be enhanced when immediate-release fluvastatin sodium is used in combination with lipid-modifying doses (≥1 g/day) of niacin; a reduction in immediate-release fluvastatin sodium dosage should be considered in this setting [see Warnings and Precautions (5.1)]. 7.6 Glyburide Concomitant administration of fluvastatin and glyburide increased glyburide exposures. Patients on concomitant therapy of glyburide and fluvastatin should continue to be monitored appropriately [see Clinical Pharmacology (12.3)]. 7.7 Phenytoin Concomitant administration of fluvastatin and phenytoin increased phenytoin exposures. Patients should continue to be monitored appropriately when fluvastatin therapy is initiated or when fluvastatin dose is changed [see Clinical Pharmacology (12.3)]. 7.8 Warfarin Bleeding and/or increased prothrombin times have been reported in patients taking coumarin anticoagulants concomitantly with other HMG-CoA reductase inhibitors. Therefore, patients receiving warfarin-type anticoagulants should have their prothrombin times closely monitored when fluvastatin sodium is initiated or the dosage of fluvastatin sodium is changed. 7.9 Colchicine Cases of myopathy, including rhabdomyolysis, have been reported with fluvastatin coadministered with colchicine, and caution should be exercised when prescribing fluvastatin with colchicine.

More information

Category Value
Authorisation number NDA021192
Agency product number PYF7O1FV7F
Orphan designation No
Product NDC 0781-8017
Date Last Revised 30-08-2017
Type HUMAN PRESCRIPTION DRUG
Marketing authorisation holder Sandoz Inc