Safety
?
-
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
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
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
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
-
-
