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U.S. Department of Health and Human Services

Safety

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Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) Tablets


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


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

BOXED WARNING

WARNINGS

  • Patients Coinfected with HIV and HBV
  • Renal Impairment

PRECAUTIONS

  • Bone Effects
    • Cases of osteomalacia (associated with proximal renal tubulopathy)...
  • Drug Interactions
    • ...Suppression of CD4 cell counts has been observed in patients receiving tenofovir DF with didanosine at a dose of 400 mg daily.

ADVERSE REACTIONS

  • Postmarketing Experience
  • Tenofovir Disoproxil Fumarate
    • Skin and Subcutaneous Tissue Disorders
      • Rash
    • Musculoskeletal and Connective Tissue Disorders
      • Myopathy, Osteomalacia...
    • Renal and Urinary Disorders
      • Interstitial Nephritis...
    • General Disorders and Administration Site Conditions
      • Asthenia

PATIENT PACKAGE INSERT

  • Medicines You Should Not Take With Atripla
    • Atripla also should not be used with Combivir (lamivudine/zidovudine),
      Emtriva, Epivir, Epivir-HBV (lamivudine), Epzicom (abacavir sulfate/lamivudine), Trizivir (abacavir sulfate/lamivudine/zidovudine),
      Sustiva, Truvada, or Viread.

BOXED WARNING

...Atripla is not approved for the treatment of chronic Hepatitis B Virus (HBV) infection and the safety and efficacy of Atripla have not been established in patients coinfected with HBV and HIV. Severe acute exacerbations of Hepatitis B have been reported in patients who have discontinued Emtriva or Viread which are components of Atripla...

WARNINGS

Patients Coinfected with HIV and HBV

...Severe acute exacerbations of
hepatitis B have been reported in patients who are coinfected with HBV and HIV and have discontinued Emtriva or Viread. In some of these patients treated with Emtriva, the exacerbations of hepatitis B were associated with liver decompensation
and liver failure...

Renal Impairment

Emtricitabine and tenofovir are principally eliminated by the kidney, however efavirenz is not. Since Atripla is a combination product and the dose of the individual components cannot be altered, patients with creatinine clearance <50 mL/min should not receive Atripla.

Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported in association with the use of tenofovir DF...

It is recommended that creatinine clearance be calculated in all patients prior to initiating therapy and as clinically appropriate during therapy with Atripla...