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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) 

 

December 2012

Summary View

 

BOXED WARNING

  • Serious Skin Reactions - Fatal and non-fatal serious skin reactions, including Stevens Johnson Syndrome (SJS), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), and Toxic Epidermal Necrolysis (TEN), have been reported in patients treated with Incivek combination treatment…
 

CONTRAINDICATIONS

  • Incivek is a strong inhibitor of CYP3A. Incivek is contraindicated when combined with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events (narrow therapeutic index)…
 

WARNINGS AND PRECAUTIONS

Serious Skin Reactions/Rash
  • Fatal and non-fatal serious skin reactions, including Stevens Johnson Syndrome (SJS), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), and Toxic Epidermal Necrolysis (TEN), have been reported in patients treated with Incivek combination treatment…
Anemia
  • Anemia has been reported with Peginterferon Alfa and Ribavirin therapy. The addition of Incivek to peginterferon alfa and ribavirin is associated with an additional decrease in hemoglobin concentrations…
 

PATIENT COUNSELING INFORMATION

Serious Skin Reaction/Rash
  • Patients should be informed that Incivek combination treatment may cause rash. The rash can be serious, may be accompanied by fever and skin breakdown, may require urgent treatment in a hospital, and may result in death [see also Boxed Warning and Warnings and Precautions (5.1)]. Patients should promptly report any skin changes or itching to their healthcare provider. Patients should not stop Incivek due to rash unless instructed by their healthcare provider. 

 

June 2012

Summary View 

WARNINGS and PRECAUTIONS

Anemia
  • Hemoglobin should be monitored prior to and at least at weeks 2, 4, 8 and 12 during Incivek combination treatment and as clinically appropriate
Laboratory Tests
  • Use of a sensitive real-time RT-PCR assay for monitoring HCV-RNA levels during treatment is recommended. The assay should have a lower limit of HCV-RNA quantification equal to or less than 25 IU per mL and a limit of HCV-RNA detection of approximately 10-15 IU per mL.

DRUG INTERACTIONS

  • No dose adjustment is needed for Incivek when given with either raltegravir or buprenorphine.

 

March 2012 

Summary View

 

WARNINGS and PRECAUTIONS

Drug Interactions

HMG-CoA REDUCTASE INHIBITORS

  • Plasma concentrations of atorvastatin are markedly increased when co-administered with telaprevir. Avoid concomitant administration of telaprevir and atorvastatin.