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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].
- Liver Enzyme Abnormalities [see WARNINGS AND PRECAUTIONS].
Clinical Studies Experience in Adult Patients
Because clinical studies on LESCOL/LESCOL XL are conducted in varying study populations and study designs, the frequency of adverse reactions observed in the clinical studies of LESCOL/LESCOL XL 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 LESCOL placebo-controlled clinical trials database of 2326 patients treated with LESCOL1 (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 LESCOL 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 LESCOL XL database of controlled clinical trials of 912 patients treated with LESCOL XL (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 LESCOL XL 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 LESCOL and LESCOL XL controlled studies with a frequency > 2%, regardless of causality, included the following:
Table 1 : Clinical adverse
events reported in > 2% in patients treated with LESCOL/LESCOL XL and at an
incidence greater than placebo in placebo-controlled trials regardless of
causality (% of patients) Pooled Dosages
|Genitourinary||Urinary tract infection||1.6||1.1||2.7|
|1Controlled trials with LESCOL Capsules (20 and 40 mg daily
and 40 mg twice daily) compared to placebo
2Controlled trials with LESCOL XL 80 mg Tablets as compared to LESCOL Capsules
LESCOL Intervention Prevention Study
In the LESCOL Intervention Prevention Study (LIPS), the effect of LESCOL 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 LESCOL 40 mg (n=844) or placebo (n=833) given twice daily for a median of 3.9 years [see Clinical Studies].
Table 2 : Clinical adverse
events reported in ≥ 2% in patients treated with LESCOL/LESCOL XL and at
an incidence greater than placebo in the LIPS Trial regardless of causality (%
|LESCOL 40 mg b.i.d
|Cardiac disorders||Atrial fibrillation||2.4||2.0|
|Gastrointestinal disorders||Abdominal pain upper||6.3||4.5|
|Infections and infestations||Bronchitis||2.3||2.0|
|Musculoskeletal and connective tissue disorders||Arthralgia||2.1||1.8|
|Pain in extremity||4.1||2.7|
|Nervous system disorders||Dizziness||3.9||3.5|
|Respiratory disorders||Dyspnea exertional||2.8||2.4|
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 LESCOL capsules 20 mg -40 mg twice daily, or LESCOL XL 80 mg extended-release tablet [see Clinical Studies and Use In Specific Populations].
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.
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).
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.
Eye: progression of cataracts (lens opacities), ophthalmoplegia.
Laboratory abnormalities: elevated transaminases, alkaline phosphatase, gamma-glutamyl transpeptidase and bilirubin; thyroid function abnormalities.
Read the Lescol (fluvastatin sodium) Side Effects Center for a complete guide to possible side effects
Cyclosporine coadministration increases fluvastatin exposure. Therefore, in patients taking cyclosporine, therapy should be limited to LESCOL 20 mg twice daily [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].
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 LESCOL 20 mg twice daily [see CLINICAL PHARMACOLOGY].
Due to an increased risk of myopathy/rhabdomyolysis when HMG-CoA reductase inhibitors are coadministered with gemfibrozil, concomitant administration of LESCOL/LESCOL XL with gemfibrozil should be avoided.
Because it is known that the risk of myopathy during treatment with HMG-CoA reductase inhibitors is increased with concurrent administration of other fibrates, LESCOL/LESCOL XL should be administered with caution when used concomitantly with other fibrates [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].
The risk of skeletal muscle effects may be enhanced when LESCOL is used in combination with lipid-modifying doses ( ≥ 1 g/day) of niacin; a reduction in LESCOL dosage should be considered in this setting [see WARNINGS AND PRECAUTIONS].
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].
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].
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.
Cases of myopathy, including rhabdomyolysis, have been reported with fluvastatin coadministered with colchicine, and caution should be exercised when prescribing fluvastatin with colchicine.
Read the Lescol Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 3/12/2012
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