Fluvastatin

Fluvastatin comes as a capsule and an extended-release (long-acting) tablet to take by mouth. The capsule is usually taken with or without food once a day at bedtime or twice a day. The extended-release tablet is usually taken once a day with or without food. Take fluvastatin at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take fluvastatin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the extended-release tablets whole; do not split, chew, or crush them.

Your doctor may start you on a low dose of fluvastatin and gradually increase your dose, not more than once every 4 weeks.

Continue to take fluvastatin even if you feel well. Do not stop taking fluvastatin without talking to your doctor.

Lescol, Lescol XL

Fluvastatin is part of the drug class:

• HMG CoA reductase inhibitors

Fluvastatin has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from fluvastatin, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• other medications you are taking
• how you respond to this medication
• your age
• your renal function

The recommended dose range of fluvastatin is 20 mg to 80 mg/day.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For fluvastatin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to fluvastatin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fluvastatin in children 10 to 16 years of age. However, safety and efficacy have not been established in children younger than 10 years of age.

Teenage girls taking fluvastatin should be counseled on appropriate birth control methods to prevent pregnancy.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fluvastatin in the elderly. However, elderly patients are more likely to have age-related muscle problems, which may require caution in patients receiving fluvastatin.

Pregnancy

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using fluvastatin.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking fluvastatin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using fluvastatin with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Posaconazole

Using fluvastatin with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Atazanavir
• Bezafibrate
• Ceritinib
• Ciprofibrate
• Clofibrate
• Dalfopristin
• Danazol
• Daptomycin
• Darunavir
• Entacapone
• Fenofibrate
• Fenofibric Acid
• Fluconazole
• Fosphenytoin
• Gemfibrozil
• Phenytoin
• Pixantrone
• Quinupristin

Using fluvastatin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Colchicine
• Eltrombopag
• Glyburide
• Mifepristone
• Oat Bran
• Pectin
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of fluvastatin. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, or history of or
• Diabetes or
• Liver disease, history of—Use with caution. May cause side effects to become worse.

• Convulsions (seizures), not well-controlled or
• Electrolyte disorder, severe or
• Endocrine disorder, severe or
• Hypotension (low blood pressure) or
• Hypothyroidism (underactive thyroid), not adequately treated or
• Kidney disease, severe or
• Major surgery or
• Major trauma (injury) or
• Metabolic disorder, severe or
• Sepsis (severe infection in the blood)—Patients with these conditions may be at risk of developing muscle and kidney problems.

• Liver disease, active or
• Liver enzymes, persistently high levels—Should not be used in patients with these conditions.

(FLOO va sta tin)

• Lescol XL
• Lescol [DSC]

Peak effect: Maximal LDL-C reductions achieved within 4 weeks

Time to Peak

Immediate-release: <1 hour (delayed more than 2-fold when administered with food as compared to administering 4 hours after the evening meal)

Extended-release: ~3 hours (minimally affected by low-fat meals; however, with a high-fat meal, delayed by 2-fold)

Half-Life Elimination

Immediate-release: ~3 hours; Extended-release: 7.3 to 10.5 hours (due to prolonged absorption time) (Barilla 2004)

Protein Binding

98%

Use is contraindicated in active liver disease or unexplained transaminase elevations.

Frequency not always defined. The following adverse events were reported with fluvastatin capsules; in general, adverse reactions reported with fluvastatin extended release tablet were similar, but incidences were lower. Adverse reactions with an incidence of <1% include additional class-related events that were not necessarily reported with fluvastatin therapy.

1% to 10%:

Central nervous system: Headache (9%), fatigue (3%), insomnia (3%)

Gastrointestinal: Dyspepsia (8%), abdominal pain (5%), diarrhea (5%), nausea (3%)

Genitourinary: Urinary tract infection (2%), cystitis (interstitial; Huang 2015)

Neuromuscular & skeletal: Myalgia (5%)

Respiratory: Sinusitis (3%), bronchitis (2%)

<1% (Limited to important or life-threatening): Alopecia, amnesia (reversible), anaphylaxis, angioedema, arthralgia, arthritis, cataract, cholestatic jaundice, cognitive dysfunction (reversible), depression, dermatomyositis, dysgeusia, dyspnea, elevated glycosylated hemoglobin (HbA1c), eosinophilia, erectile dysfunction, erythema multiforme, facial paresis, fever, fulminant hepatic necrosis, gynecomastia, hemolytic anemia, hepatic cirrhosis, hepatic neoplasm, hepatitis, hypersensitivity reaction, immune-mediated necrotizing myopathy (IMNM), impotence, increased creatine phosphokinase (>10x normal), increased erythrocyte sedimentation rate, increased serum glucose, increased serum transaminases, interstitial pulmonary disease, leukopenia, liver steatosis, lupus-like syndrome, memory impairment (reversible), muscle cramps, myopathy, nodule, ophthalmoplegia, pancreatitis, paresthesia, peripheral nerve palsy, peripheral neuropathy, polymyalgia rheumatica, positive ANA titer, pruritus, psychic disorder, purpura, reversible confusional state, rhabdomyolysis, skin discoloration, skin photosensitivity, skin rash, Stevens-Johnson syndrome, thrombocytopenia, thyroid dysfunction, toxic epidermal necrolysis, tremor, urticaria, vasculitis, vertigo

Applies to fluvastatin: oral capsule, oral tablet extended release

General

The most frequently reported side effects were headache, dyspepsia, abdominal pain, nausea, and myalgia.[Ref]

Musculoskeletal

Common (1% to 10%): Myalgia, arthritis, arthropathy, arthralgia, pain in extremity, back pain
Rare (0.01% to 0.1%): Muscular weakness, myopathy
Very rare (less than 0.01%): Rhabdomyolysis, myositis, lupus erythematosus-like syndrome
Frequency not reported: Immune-mediated necrotizing myopathy
Postmarketing reports: Muscle cramps, muscle spasms[Ref]

Hepatic

Common (1% to 10%): ALT increased, AST increased
Very rare (less than 0.01%): Hepatitis
Postmarketing reports: Chronic active hepatitis, cholestatic jaundice, fatty change in liver, cirrhosis, fulminant hepatic necrosis, fatal hepatic failure, nonfatal hepatic failure, gamma-glutamyl transpeptidase increased, bilirubin increased[Ref]

Gastrointestinal

Common (1% to 10%): Dyspepsia, diarrhea, abdominal pain, nausea, flatulence, tooth disorder, upper abdominal pain, constipation, gastric disorder
Very rare (less than 0.01%): Pancreatitis
Postmarketing reports: Vomiting[Ref]

Dermatologic

Common (1% to 10%): Rash
Rare (0.01% to 0.1%): Urticaria
Very rare (less than 0.01%): Angioedema, face edema, eczema, dermatitis, bullous exanthema
Postmarketing reports: Bullous dermatitis, alopecia, pruritus, skin nodules, skin discoloration, dry skin/mucous membranes, hair/nails changed[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (16.2%)
Common (1% to 10%): Sinusitis, bronchitis, nasopharyngitis, exertional dyspnea, pharyngitis, rhinitis, cough[Ref]

Other

Common (1% to 10%): Influenza-like symptoms, accidental trauma, fatigue, peripheral edema, blood transaminases increased, creatine phosphokinase increased
Uncommon (0.1% to 1%): Chest pain
Postmarketing reports: Vertigo, alkaline phosphatase increased[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness, syncope
Very rare (less than 0.01%): Paresthesia, dysesthesia, hypoesthesia
Postmarketing reports: Tremor, peripheral nerve palsy, peripheral neuropathy, dysfunction of cranial nerve, alteration of taste, extra-ocular movement impaired, facial paresis, cognitive impairment, memory loss, forgetfulness, amnesia, memory impairment[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection
Postmarketing reports: Erectile dysfunction, gynecomastia[Ref]

Cardiovascular

Common (1% to 10%): Atrial fibrillation, hypertension, intermittent claudication
Very rare (less than 0.01%): Vasculitis[Ref]

Hematologic

Very rare (less than 0.01%): Thrombocytopenia[Ref]

Renal

Frequency not reported: Myoglobinuria, acute renal failure[Ref]

Immunologic

Common (1% to 10%): Allergy
Very rare (less than 0.01%): Anaphylactic reaction[Ref]

Hypersensitivity

An apparent hypersensitivity syndrome was reported rarely and included one or more of the following: anaphylaxis, angioedema, lupus erythematosus-like syndrome, polymyalgia rheumatica, vasculitis, purpura, thrombocytopenia, leukopenia, hemolytic anemia, positive antinuclear antibodies, erythrocyte sedimentation rate increased, eosinophilia, arthritis, arthralgia, urticaria, asthenia, photosensitivity reaction, fever, chills, flushing, malaise, dyspnea, toxic epidermal necrolysis, erythema multiforme, and Stevens-Johnson syndrome.[Ref]

Rare (less than 0.1%): Hypersensitivity reaction[Ref]

Oncologic

Postmarketing reports: Hepatoma[Ref]

Endocrine

Postmarketing reports: Thyroid function abnormal[Ref]

Psychiatric

Common (1% to 10%): Insomnia
Postmarketing reports: Anxiety, depression, psychic disturbances, loss of libido, confusion[Ref]

Metabolic

Frequency not reported: HbA1c increased, serum glucose increased
Postmarketing reports: Anorexia[Ref]

Ocular

Postmarketing reports: Cataracts progressed, lens opacity, ophthalmoplegia[Ref]

Some side effects of fluvastatin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Immediate Release Capsules:
-Low-density lipoprotein cholesterol (LDL-C) reduction to a goal of 25% or greater: Initial dose of 40 mg orally once a day in the evening or 40 mg orally twice a day
-LDL-C reduction to a goal of less than 25%: Initial dose of 20 mg orally once a day
-Maintenance dose: 20 mg to 80 mg per day

Comments:
-Two 40 mg immediate release capsules should not be taken at one time.

Extended Release Tablets:
80 mg orally once a day, at any time of day

Use: 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)

Immediate Release Capsules:
-Low-density lipoprotein cholesterol (LDL-C) reduction to a goal of 25% or greater: Initial dose of 40 mg orally once a day in the evening or 40 mg orally twice a day
-LDL-C reduction to a goal of less than 25%: Initial dose of 20 mg orally once a day
-Maintenance dose: 20 mg to 80 mg per day

Comments:
-Two 40 mg immediate release capsules should not be taken at one time.

Extended Release Tablets:
80 mg orally once a day, at any time of day

Use: 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)

10 to 16 years:
-Initial dose: 20 mg orally once a day
-Maintenance dose: 20 mg to 80 mg per day
-Maximum dose: 40 mg twice a day (immediate release); 80 mg once a day (extended release)

Comments:
-Dose adjustments up to the maximum daily dose should be made at 6 week intervals and should be individualized based on goals of therapy.

Use: As an adjunct to diet to reduce Total-C, LDL-C, and ApoB levels in adolescent boys and adolescent girls who are at least 1 year post-menarche, 10 to 16 years of age, with heterozygous familial hypercholesterolemia and the following findings are present: LDL-C remains at 190 mg/dL or greater, or LDL-C remains at 160 mg/dL or greater and there is a positive family history of premature cardiovascular disease (CVD) or 2 or more other CVD risk factors are present

Safety and efficacy have not been established in patients younger than 10 years.

Consult WARNINGS section for additional precautions.

LactMed Record Number

483

Last Revision Date

20130907

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