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SUSTIVA ® (efavirenz) in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. This indication is based on two clinical trials of at least one year duration that demonstrated prolonged suppression of HIV RNA [see Clinical Studies].
DOSAGE AND ADMINISTRATION
The recommended dosage of SUSTIVA (efavirenz) is 600 mg orally, once daily, in combination with a protease inhibitor and/or nucleoside analogue reverse transcriptase inhibitors (NRTIs). It is recommended that SUSTIVA be taken on an empty stomach, preferably at bedtime. The increased efavirenz concentrations observed following administration of SUSTIVA with food may lead to an increase in frequency of adverse reactions [see CLINICAL PHARMACOLOGY]. Dosing at bedtime may improve the tolerability of nervous system symptoms [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, and PATIENT INFORMATION].
Concomitant Antiretroviral Therapy
If SUSTIVA is coadministered with voriconazole, the voriconazole maintenance dose should be increased to 400 mg every 12 hours and the SUSTIVA dose should be decreased to 300 mg once daily using the capsule formulation (one 200-mg and two 50-mg capsules or six 50-mg capsules). SUSTIVA tablets should not be broken. See DRUG INTERACTIONS and CLINICAL PHARMACOLOGY.
If SUSTIVA is coadministered with rifampin to patients weighing 50 kg or more, an increase in the dose of SUSTIVA to 800 mg once daily is recommended [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].
It is recommended that SUSTIVA be taken on an empty stomach, preferably at bedtime. Table 1 describes the recommended dose of SUSTIVA for pediatric patients 3 years of age or older and weighing between 10 and 40 kg [see Use In Specific Populations]. The recommended dosage of SUSTIVA for pediatric patients weighing greater than 40 kg is 600 mg once daily.
Table 1: Pediatric Dose to be Administered Once Daily
|Body Weight||SUSTIVA Dose (mg)|
|10 to less than 15||22 to less than 33||200|
|15 to less than 20||33 to less than 44||250|
|20 to less than 25||44 to less than 55||300|
|25 to less than 32.5||55 to less than 71.5||350|
|32.5 to less than 40||71.5 to less than 88||400|
|at least 40||at least 88||600|
Dosage Forms And Strengths
200-mg capsules are gold color, reverse printed with “SUSTIVA” on the body and imprinted “200 mg” on the cap. 50-mg capsules are gold color and white, printed with “SUSTIVA” on the gold color cap and reverse printed “50 mg” on the white body.
600-mg tablets are yellow, capsular-shaped, film-coated tablets, with “SUSTIVA” printed on both sides.
Storage And Handling
SUSTIVA® (efavirenz) capsules are available as follows:
Capsules 200 mg are gold color, reverse printed with “SUSTIVA” on the body and imprinted “200 mg” on the cap.
Bottles of 90 NDC 0056-0474-92
Capsules 50 mg are gold color and white, printed with “SUSTIVA” on the gold color cap and reverse printed “50 mg” on the white body.
Bottles of 30 NDC 0056-0470-30
SUSTIVA® (efavirenz) tablets are available as follows:
Tablets 600 mg are yellow, capsular-shaped, film-coated tablets, with “SUSTIVA” printed on both sides.
Bottles of 30 NDC 0056-0510-30
SUSTIVA capsules and SUSTIVA tablets should be stored at 25° C (77° F); excursions permitted to 15°–30° C (59°–86° F) [see USP Controlled Room Temperature].
Distributed by: Bristol-Myers Squibb Company Princeton, NJ 08543 USA. Rev August 2012
Last reviewed on RxList: 8/29/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Sustiva Information
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