Label Changes for:

Sustiva (efavirenz) capsules and tablets

December 2011

Changes have been made to the PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) November 2010, September and December 2011

 

December 2011

 

DRUG INTERACTIONS

  • If Sustive is coadministered with rifampin to patients weighing 50 kg or more, an increase in the dose of SUSTIVA to 800 mg once daily is recommended.

 

September 2011

 

DRUG INTERACTIONS

Table7
  • Bupropion: The effect of efavirenz on bupropion exposure is thought to be due to the induction of bupropion metabolism. Increases in bupropion dosage should be guided by clinical response, but the maximum recommended dose of bupropion should not be exceeded.

 

November 2010


USE IN SPECIFIC POPULATIONS

Hepatic Impairment
  • Sustiva is not recommended for patients with moderate or severe hepatic impairment because there are insufficient data to determine whether dose adjustment is necessary...

ADVERSE REACTIONS

Postmarketing Experience
  • Vertigo

 

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