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U.S. Department of Health and Human Services

Safety

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Advicor (niacin extended release/lovastatin) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – January 2011 and April 2012

 

April 2012

Summary View

 

CONTRAINDICATIONS

  • Concomitant administration with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin and nefazodone)
 

WARNINGS

Liver Dysfunction
  • It is recommended that liver enzyme tests be obtained prior to initiating therapy with ADVICOR and repeated as clinically indicated.
  • There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including lovastatin. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment with Advicor, promptly interrupt therapy. If an alternate etiology is not found do not restart Advicor.
 
Myopathy/Rhabdomylolysis
  • The risk of myopathy/rhabdomyolysis is increased by concomitant use of lovastatin with the following:
    • and Posaconazole…Boceprevir, Telaprevir…
  • Combination of these drugs with lovastatin is contraindicated. If treatment with itraconazole, ketoconazole, erythromycin, clarithromycin or telithromycin is unavoidable, therapy with lovatatin should be suspended during the course of treatment.
  • Although not studied clinically, voriconazole has been shown to inhibit lovastatin metabolism in vitro…
  • Advicor therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Advicor therapy should also be temporarily withheld in any patient experiencing an acute or serious condition predisposing to the development of renal failure secondary to rhabdomyolysis, e.g., sepsis; hypotension; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy.
 

PRECAUTIONS

Endocrine function
  • Increases in HbA1c and fasting serum glucose levels have been reported with HMGCoA reductase inhibitors, including lovastatin.
 
Information for Patients
Patients should be advised of the following:
  • to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice
 
Lovastatin
  • Lovastatin is metabolized by CYP3A4 but has no CYP3A4 inhibitory activity; therefore it is not expected to affect the plasma concentrations of other drugs metabolized by CYP3A4…
  • In vitro studies have demonstrated that voriconazole inhibits the metabolism of lovastatin. Adjustment of the lovastatin dose may be needed to reduce the risk of myopathy, including rhabdomyolysis, if voriconazole must be used concomitantly with lovastatin…
 
  • Gemfibrozil
  • Other Fibrates
  • Other Drug Interactions
  • Cyclosporine: The risk of myopathy/rhabdomyolysis is increased by concomitant administration of cyclosporine…
  • Danazol, Diltiazem, or Verapamil: The risk of myopathy/rhabdomyolysis is increased by concomitant administration of danazol, diltiazem, or verapamil particularly with higher doses of lovastatin…
Amiodarone: The risk of myopathy/rhabdomyolysis is increased when amiodarone is used concomitantly with a closely related member of the HMG-CoA reductase inhibitor class…
  • Colchicine – Cases of myopathy, including rhabdomyolysis, have been reported with lovastatin coadministered with colchicine.
  • Ranolazine – The risk of myopathy, including rhabdomyolysis, may be increased by concomitant administration of ranolazine
 

ADVERSE REACTIONS

Adverse Reactions Information
  • 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).

 

January 2011

Summary View

 

ADVERSE REACTIONS

Postmarketing Events
  • The following adverse reactions are being added: depression, peripheral nerve palsy, dermatomyositis, progression of cataracts.
  • the addition of the statement “See also the full prescribing information for niacin extended release (Niaspan) and lovastatin products.”