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U.S. Department of Health and Human Services

Safety

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Incivek (Telaprevir) Film Coated Tablets

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

 

October 2013

Summary View

CONTRAINDICATIONS

  • Table 3: Drugs that are Contraindicated with INCIVEK
  • Anticonvulsants: Carbamazepine, phenobarbital, phenytoin

DRUG INTERACTIONS

  • Table 5: Established and Other Potentially Significant Drug Interactions: Alterations in Dose or Regimen May Be Recommended Based on Drug Interaction Trials or Predicted Interaction
  • ANALGESICS: alfentanil, fentanyl
  • Drug interactions with carbamazepine and phenytoin were added 

 

April 2013

Summary View

 

WARNINGS AND PRECAUTIONS

  • Hematology evaluations (including hemoglobin, white cell differential, and platelet count) are recommended prior to and at weeks 2, 4, 8 and 12 and as clinically appropriate. Chemistry evaluations (including electrolytes, serum creatinine, uric acid, hepatic enzymes, bilirubin, and TSH) are recommended as frequently as hematology evaluations or as clinically appropriate.