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Label Changes for:

Evotaz (atazanavir/cobicistat)

July 2016

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

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

July 2016

CONTRAINDICATIONS

Table 1: Drugs that are Contraindicated with EVOTAZ
  • Anticonvulsants Drug Class added to table containing the following drugs: carbamazepine, phenobarbital and phenytoin with the following clinical comment: Potential for decreased atazanavir plasma concentrations, which may result in loss of therapeutic effect and development of resistance.

WARNINGS AND PRECAUTIONS

Subsection Rash changed to Severe Skin Reactions

DRUG INTERACTIONS

Table 5: Established and Other Potentially Significant Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Studiesa or Predicted Interactions
  • Addition of Anticonvulsants concomitant Drug Class to table, including: 
    • Anticonvulsants with CYP3A induction effects that are NOT contraindicated (eslicarbazepine, and oxcarbazepine).
    • Anticonvulsants that are metabolized by CYP3A (clonazepam)
    • Other anticonvulsants (lamotrigine)

Please refer to table 5 for effects on concentration and clinical comments.

PATIENT COUNSELING INFORMATION

Rash changed to Severe Skin Reactions

PATIENT INFORMATION

Who should not take EVOTAZ?

Do not take EVOTAZ if you:

  • are taking any of the following medicines…: (additions)
    • carbamazepine (CARBATROL®, EPITOL®, EQUETRO®, TEGRETOL®)
    • phenobarbital (LUMINAL®)
    • phenytoin (DILANTIN®, PHENYTEX®)

 

July 2015

WARNINGS AND PRECAUTIONS

Risk of Serious Adverse Reactions or Loss of Virologic Response Due to Drug Interactions
  • * updated with information related to the co-administration of Evotaz and other medications metabolized by CPY3A

DRUG INTERACTIONS

Established and Other Potentially Significant Drug Interactions
  • * updated with information for patients initiating Evotaz while taking quetiapine and for patients initiating quetiapine while taking Evotaz
     

 

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