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U.S. Department of Health and Human Services

Safety

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Simvastatin Interaction with Lomitapide, October 2013 Label Change

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

-Vytorin (ezetimibe/simvastatin) Tablets

-Juvisync (sitagliptin phosphate and simvastatin) tablets

-Zocor (simvastatin) Tablets

 

October 2013

Summary View

WARNINGS AND PRECAUTIONS

Myopathy/Rhabdomyolysis
  • The benefits of the combined use of Vytorin/Zocor/Juvisync with the following drugs should be carefully weighed against the potential risks of combinations: other lipid-lowering drugs (other fibrates, =1 g/day of niacin, or, for patients with HoFH, lomitapide), amiodarone, dronedarone, verapamil, diltiazem, amlodipine, or Ranolazine

Table 1: Drug Interactions Associated with Increased Risk of Myopathy/Rhabdomyolysis

  • Lomitapide

PATIENT INFORMATION

Taking Vytorin/Juvisync with certain substances can increase the risk of muscle problems. It is especially important to tell your doctor if you take

  • lomitapide (a medicine used to treat a serious and rare genetic cholesterol condition)