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TEVA-EFAVIRENZ is a brand name for Efavirenz, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Adverse Drug Reaction Overview Efavirenz has been studied in 9200 patients. The most significant adverse events observed in patients treated with efavirenz are nervous system symptoms, psychiatric symptoms, and rash. The long-term safety profile of efavirenz-containing regimens was evaluated in a controlled trial, in which patients received efavirenz + zidovudine + lamivudine (n = 412, median duration 180 weeks), efavirenz + indinavir (n = 415, median duration 102 weeks), or indinavir + zidovudine + lamivudine (n = 401, median duration 76 weeks).
Long-term use of efavirenz in this study was not associated with any new safety concerns. Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse drug reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Nervous System Symptoms Fifty-three percent of patients receiving efavirenz reported central nervous system symptoms (see WARNINGS AND PRECAUTIONS; Neurologic).
Table 2 lists the frequency of the symptoms of different degrees of severity, and gives the discontinuation rates in clinical trials for one or more of the following nervous system symptoms: dizziness, insomnia, impaired concentration, somnolence, abnormal dreaming, euphoria, confusion, agitation, amnesia, hallucinations, stupor, abnormal thinking, and depersonalization.
The frequencies of specific central and peripheral nervous system symptoms are provided in Table 2. Table 2 Percent of Patients with One or More Selected Nervous System Symptoms1,2 1 Includes events reported regardless of causality.
2 Data from Studies 006, 020 and two Phase II studies. 3 “Mild” = Symptoms which do not interfere with patient's daily activities. 4 “Moderate” = Symptoms which may interfere with daily activities. 5 “Severe” = Symptoms which interrupt patient's usual daily activities.
1 Page 12 of 54 of new-onset nervous system symptoms among efavirenz-treated patients were generally similar to those in the control arm. Psychiatric Symptoms Serious psychiatric adverse experiences have been reported in patients treated with efavirenz.
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3%) (see WARNINGS AND PRECAUTIONS; Psychiatric). Additional psychiatric symptoms observed at a frequency of >2% among patients treated with efavirenz or control regimens respectively, in controlled clinical trials were depression (19%, 16%), anxiety (13%, 9%) and nervousness (7%, 2%).
Skin Rash Rashes are usually mild-to-moderate maculopapular skin eruptions that occur within the first two weeks of initiating therapy with efavirenz. In most patients rash resolves with continuing efavirenz therapy within one month.
TEVA-EFAVIRENZ can be reinitiated in patients interrupting therapy because of Grades 1 and 2 rash. TEVA-EFAVIRENZ should be discontinued in patients developing severe rash associated with blistering, desquamation, mucosal involvement or fever.
The frequency of rash by NCI grade and the discontinuation rates as a result of rash are provided in Table 3. 3 1 Includes events reported regardless of causality. 2 Data from Studies 006, 020, and two Phase II studies. 3 NCI (National Cancer Institute) Grading System.
, more severe) (see WARNINGS AND PRECAUTIONS; Skin). Experience with efavirenz in patients who discontinued other antiretroviral agents of the NNRTI class is limited. Nineteen patients who discontinued nevirapine because of rash have been treated with efavirenz.
Nine of these patients developed mild-to-moderate rash while receiving therapy with efavirenz, and two of these patients discontinued because of rash. Selected clinical adverse experiences of moderate or severe intensity observed in ≥2% of efavirenz-treated patients in three controlled clinical trials are presented in Table 4.
Table 4 Selected Treatment-Emergent1 Adverse Events of Moderate or Severe Intensity Reported in ≥2% of Efavirenz -Treated Patients in Studies DMP 266-006, ACTG 364 and DMP 266-020 Adverse Events Study DMP 266-006 3TC, NNRTI and Protease Inhibitor-Naive Patients Study ACTG 364 NRTI-experienced NNRTI and Protease Inhibitor-Naive Patients Study […]