Convulsions have been observed in patients receiving efavirenz, generally in the presence of known medical history of seizures. Caution must be taken in any patient with a history of seizures.
Patients who are receiving concomitant anticonvulsant medications primarily metabolized by the liver, such as phenytoin and phenobarbital, may require periodic monitoring of plasma levels [See Drug Interactions (7.3)].
Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including the components of ATRIPLA. During the initial phase of combination antiretroviral treatment, patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections [such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia (PCP), or tuberculosis], which may necessitate further evaluation and treatment.
Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and “cushingoid appearance” have been observed in patients receiving antiretroviral therapy. The mechanism and long-term consequences of these events are currently unknown. A causal relationship has not been established.
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate: The following adverse reactions are discussed in other sections of the labeling:
- Lactic Acidosis/Severe Hepatomegaly with Steatosis [See Boxed Warning, Warnings and Precautions (5.1)].
- Severe Acute Exacerbations of Hepatitis B [See Boxed Warning, Warnings and Precautions (5.2)].
- Psychiatric Symptoms [See Warnings and Precautions (5.5)].
- Nervous System Symptoms [See Warnings and Precautions (5.6)].
- New Onset or Worsening Renal Impairment [See Warnings and Precautions (5.7)].
- Rash [See Warnings and Precautions (5.9)].
- Decreases in Bone Mineral Density [See Warnings and Precautions (5.11)].
- Immune Reconstitution Syndrome [See Warnings and Precautions (5.13)].
- Drug Interactions [See Contraindications (4.2), Warnings and Precautions (5.3) and Drug Interactions (7)].
For additional safety information about SUSTIVA (efavirenz), EMTRIVA (emtricitabine), or VIREAD (tenofovir DF) in combination with other antiretroviral agents, consult the prescribing information for these products.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Study 934 was an open-label active-controlled study in which 511 antiretroviral-naive subjects received either emtricitabine + tenofovir DF administered in combination with efavirenz (N=257) or zidovudine/lamivudine administered in combination with efavirenz (N=254).
The most common adverse reactions (incidence ≥ 10%, any severity) occurring in Study 934 include diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash. Adverse reactions observed in Study 934 were generally consistent with those seen in previous studies of the individual components (Table 2).
|FTC + TDF + EFV †||AZT/3TC + EFV|
|General Disorders and Administration Site Condition|
|Infections and Infestations|
|Upper respiratory tract infections||8%||5%|
|Nervous System Disorders|
|Skin and Subcutaneous Tissue Disorders|
|Rash Event ‡||7%||9%|
In Study 073, subjects with stable, virologic suppression on antiretroviral therapy and no history of virologic failure were randomized to receive ATRIPLA or to stay on their baseline regimen. The adverse reactions observed in Study 073 were generally consistent with those seen in Study 934 and those seen with the individual components of ATRIPLA when each was administered in combination with other antiretroviral agents.
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