Active Ingredient: Efavirenz
Efavirenz is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV-1) infected adults, adolescents and children 3 years of age and older.
Efavirenz has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts <50 cells/mm³, or after failure of protease inhibitor (PI) containing regimens. Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI based combination therapy after failure of regimens containing efavirenz.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, between 300 milligrams efavirenz and 800 milligrams efavirenz, once daily at the end of the day.
Efavirenz must be given in combination with other antiretroviral medicines.
The recommended dose of efavirenz in combination with nucleoside analogue reverse transcriptase inhibitors (NRTIs) with or without a PI is 600 mg orally, once daily.
If efavirenz is coadministered with voriconazole, the voriconazole maintenance dose must be increased to 400 mg every 12 hours and the efavirenz dose must be reduced by 50%, i.e., to 300 mg once daily. When treatment with voriconazole is stopped, the initial dose of efavirenz should be restored.
If efavirenz is coadministered with rifampicin to patients weighing 50 kg or more, an increase in the dose of efavirenz to 800 mg/day may be considered.
It is recommended that efavirenz be taken on an empty stomach. The increased efavirenz concentrations observed following administration of efavirenz with food may lead to an increase in frequency of adverse reactions.
In order to improve the tolerability of nervous system adverse reactions, bedtime dosing is recommended.
For:
Regimen A: In case that patient age in years is ≥ 3 and patient weight is ≥ 13 kg and patient weight is ≤ 15 kg, oral, 200 milligrams efavirenz, once daily at the end of the day.
Regimen B: In case that patient age in years is ≥ 3 and patient weight is ≥ 15 kg and patient weight is ≤ 20 kg, oral, 250 milligrams efavirenz, once daily at the end of the day.
Regimen C: In case that patient age in years is ≥ 3 and patient weight is ≥ 20 kg and patient weight is ≤ 25 kg, oral, 300 milligrams efavirenz, once daily at the end of the day.
Regimen D: In case that patient age in years is ≥ 3 and patient weight is ≥ 25 kg and patient weight is ≤ 32.5 kg, oral, 350 milligrams efavirenz, once daily at the end of the day.
Regimen E: In case that patient age in years is ≥ 3 and patient weight is ≥ 32.5 kg and patient weight is ≤ 40 kg, oral, 400 milligrams efavirenz, once daily at the end of the day.
Regimen F: In case that patient age in years is ≥ 3 and patient weight is ≥ 40 kg, oral, 600 milligrams efavirenz, once daily at the end of the day.
The recommended dose of efavirenz in combination with a PI and/or NRTIs for patients between 3 and 17 years of age is described in the following table.
Paediatric dose to be administered once daily:
| Body Weight kg | Efavirenz Dose (mg) |
|---|---|
| 13 to <15 | 200 |
| 15 to <20 | 250 |
| 20 to <25 | 300 |
| 25 to <32.5 | 350 |
| 32.5 to <40 | 400 |
| ≥40 | 600 |
It is recommended that efavirenz be taken on an empty stomach. The increased efavirenz concentrations observed following administration of efavirenz with food may lead to an increase in frequency of adverse reactions.
In order to improve the tolerability of nervous system adverse reactions, bedtime dosing is recommended.
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