Label Changes for:

Lescol (fluvastatin sodium) Capsules,

February 2012

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February 2012

 

 

WARNINGS AND PRECAUTIONS

Liver Enzymes
  • It is recommended that liver enzyme tests be performed prior to the initiation of Lescol/Lescol XL, and if signs or symptoms of liver injury occur.
  • There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including fluvastatin. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment with Lescol/Lescol XL, promptly interrupt therapy. If an alternate etiology is not found do not restart Lescol/Lescol XL.

Endocrine Effects

  • Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including Lescol/Lescol XL.

 

ADVERSE REACTIONS

Postmarketing Experience
  • 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.

 

 

DRUG INTERACTIONS

  • Gemfibrozil: 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.
  • 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, Lescol/Lescol XL should be administered with caution when used concomitantly with other fibrates
  • Niacin: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.
  • Glyburide: Concomitant administration of fluvastatin and glyburide increased glyburide exposures. Patients on concomitant therapy of glyburide and fluvastatin should continue to be monitored appropriately.
  • Colchicine: Cases of myopathy, including rhabdomyolysis, have been reported with fluvastatin coadministered with colchicine, and caution should be exercised when prescribing fluvastatin with colchicine.
Drug-Drug Interactions
  • itraconazole
  • clopidogrel

 

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