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].

Adults

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

SUSTIVA must be given in combination with other antiretroviral medications [see INDICATIONS AND USAGE, WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS, and CLINICAL PHARMACOLOGY].

Dosage Adjustment

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].

Pediatric Patients

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

Dosage Forms And Strengths

• Capsules
  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.
• Tablets
  600-mg tablets are yellow, capsular-shaped, film-coated tablets, with “SUSTIVA” printed on both sides.

Storage And Handling

Capsules

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

Tablets

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

Storage

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.