Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- Table 5: Established and Other Potentially Significant Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Studies or Predicted Interaction
- Atovaquone/proguanil: Concomitant administration is not recommended.
- Protease inhibitor: Simeprevir added to Table 5
Use in Specific Populations
- Pregnancy section updated
5 WARNINGS AND PRECAUTIONS
5.1 Drug Interactions
- ...added...Likewise, efavirenz may alter plasma concentrations of drugs metabolized by CYP3A or CYP2B6. The most prominent effect of efavirenz at steady-state is induction of CYP3A and CYP2B6. [See Dosage and Administration (2.1) and Drug Interactions (7.1).]
7 DRUG INTERACTIONS
7.1 Drug-Drug Interactions
- ...revision of Table 5: lopinavir/ritonavir information; saquinavir information; new antimalarial (artemether/lumefantrine) information
7.2 Cannabinoid Test Interaction..revised
8 USE IN SPECIFIC POPULATIONS
8.3 Nursing Mothers...revised
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.
WARNINGS AND PRECAUTIONS
- For patients who have had a life-threatening cutaneous reaction (eg, Stevens- Johnson syndrome), alternative therapy should be considered.
- 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.
- 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.
USE IN SPECIFIC POPULATIONS
- Sustiva is not recommended for patients with moderate or severe hepatic impairment because there are insufficient data to determine whether dose adjustment is necessary...