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U.S. Department of Health and Human Services

Safety

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Sustiva (efavirenz) Tablets and Capsules

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) November 2010, September and December 2011, June and August 2012

 

August 2012

Summary View

 

WARNINGS AND PRECAUTIONS

Coadministration with Related Products
  • Coadministration of SUSTIVA with ATRIPLA (efavirenz 600 mg/emtricitabine 00 mg/tenofovir disoproxil fumarate 300 mg) is not recommended unless needed for dose adjustment (eg, with rifampin), since efavirenz is one of its active ingredients.
 
Immune Reconstitution Syndrome
  • Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable, and can occur many months after initiation of treatment.

 

June 2012

Summary View

 

WARNINGS AND PRECAUTIONS

Rash
  • For patients who have had a life-threatening cutaneous reaction (eg, Stevens- Johnson syndrome), alternative therapy should be considered.

 

December 2011

Summary View

 

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

Summary View

 

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

Summary View


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