Medication Guide App

Label Changes for:

Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) Tablets

June 2008

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


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

CONTRAINDICATIONS

  • Contraindicated Drugs
    • Table 1

WARNINGS AND PRECAUTIONS

  • Drug Interactions
  • Nervous System Symptoms

ADVERSE REACTIONS

  • Adverse Reactions from Clinical Trials Experience
    • Table 2
    • Effavirenz
      • Abnormal Dreams
  • Laboratory Abnormalities
    • Table 3
    • Hepatic Events
  • Postmarketing Experience
    • Tenofovir Disoproxil Fumarate
      • Hepatobiliary Disorders
        • Increased liver enzymes (most commonly AST, ALT, gamma GT)...

DRUG INTERACTIONS

  • Emtricitabine and Tenofovir Disoproxil Fumarate
  • Efavirenz Assay Interference
    • Cannabinoid Test Interaction

USE IN SPECIFIC POPULATIONS

  • Hepatic Impairment

PATIENT COUNSELING INFORMATION

  • Lactic Acidosis/Severe Hepatomegaly with Steatosis
  • Patients Coinfected with HIV-1 and HBV
  • New Onset or Worsening Renal Impairment
  • Decreases in Bone Mineral Density
  • Dosing Instructions

PATIENT PACKAGE INSERT

  • Medicines You Should Not Take With Atripla
    • ...Reyataz is not recommended with Atripla...

CONTRAINDICATIONS

See Table 1 in prescribing information.

WARNINGS AND PRECAUTIONS

Drug Interactions

Efavirenz plasma concentrations may be altered by substrates, inhibitors, or inducers of CYP3A. Likewise, efavirenz may alter plasma concentrations of drugs metabolized by CYP3A...

Nervous System Symptoms

Fifty-three percent (531/1008) of patients receiving efavirenz in controlled trials reported central nervous system symptoms (any grade, regardless of causality) compared to 25% (156/635) of patients receiving control regimens. These symptoms included dizziness (28.1% of the 1008 patients)...

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