Label Changes for:

Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) tablets

September 2011

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

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

 

September 2011

WARNINGS and PRECAUTIONS


Coadministration with Related Products
  • include complera (emtricitabine/rilpivirine/tenofovir DF)

ADVERSE REACTIONS

Postmarketing Experience
  • Ear and Labyrinth Disorders: vertigo
Use In Specific Populations
Hepatic Impairment
  • Atripla is not recommended for patients with moderate or severe hepatic impairment because there are insufficient data. Patients with mild hepatic impairment may be treated with Atripla at the approved dose. Because of the extensive cytochrome P450-mediated metabolism of efavirenz and limited clinical experience in patients with hepatic impairment, caution should be exercised in administering Atripla to these patients.

 

August 2010

WARNINGS and PRECAUTIONS

Reproductive Risk Potential
  • Efavirenz: As of July 2009, the Antiretroviral Pregnancy Registry has received prospective reports of 661 pregnancies exposed to efavirenz-containing regimens, nearly all of which were first-trimester exposures (606 pregnancies). Birth defects occurred in 14 of 501 live births (first-trimester exposure) and 2 of 55 live births (second/third-trimester exposure). One of these prospectively reported defects with first-trimester exposure was a neural tube defect. A single case of anophthalmia with first-trimester exposure to efavirenz has also been prospectively reported; however, this case included severe oblique facial clefts and amniotic banding, a known association with anophthalmia. There have been six retrospective reports of findings consistent with neural tube defects, including meningomyelocele.
Hepatotoxicity
  • Monitoring of liver enzymes before and during treatment is recommended for patients with underlying hepatic disease, including hepatitis B or C infection; patients with marked transaminase elevations; and patients treated with other medications associated with liver toxicity. A few of the postmarketing reports of hepatic failure occurred in patients with no pre-existing hepatic disease or other identifiable risk factors. Liver enzyme monitoring should also be considered for patients without pre-existing hepatic dysfunction or other risk factors.

ADVERSE REACTIONS

Postmarketing Experience
  • Liver and Biliary System: A few of the postmarketing reports of hepatic failure, including cases in patients with no pre-existing hepatic disease or other identifiable risk factors, were characterized by a fulminant course, progressing in some cases to transplantation or death.

DRUG INTERACTIONS

  • Posaconazole: Avoid concomitant use unless the benefit outweighs the risks
  • Maraviroc: Efavirenz decreases plasma concentrations of maraviroc. Refer to the full prescribing information for maraviroc for guidance on coadministration with efavirenz.

USE IN SPECIFIC POPULATIONS

Hepatic Impairment
  • The pharmacokinetics of efavirenz,emtricitabine, or tenofovir, have not been adequately studied in patients with hepatic impairment. Because of the extensive cytochrome P450-mediated metabolism of efavirenz and limited clinical experience in patients with hepatic impairment, caution should be exercised in administering Atripla to these patients

PATIENT PACKAGE INSERT (PPI)

What are the possible side effects of Atripla?
  • Liver problems. Some patients have experienced serious liver problems including liver failure resulting in transplantation or death. Most of these serious side effects occurred in patients with a chronic liver disease such as hepatitis infection, but there have also been a few reports in patients without any existing liver disease.

 

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