SUSTIVA

SUSTIVA — efavirenz tablet, film coated
Physicians Total Care, Inc.

1 INDICATIONS AND USAGE

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 (14) ].

2 DOSAGE AND ADMINISTRATION

2.1 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 (12.3) ]. Dosing at bedtime may improve the tolerability of nervous system symptoms [see Warnings and Precautions (5.5), Adverse Reactions (6.1), and Patient Counseling Information (17.4) ].

Concomitant Antiretroviral Therapy

SUSTIVA must be given in combination with other antiretroviral medications [see Indications and Usage (1), Warnings and Precautions (5.2), Drug Interactions (7.1), and Clinical Pharmacology (12.3) ].

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 (7.1, Table 7) and Clinical Pharmacology (12.3, Tables 8 and 9).

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 (7.1, Table 7) and Clinical Pharmacology (12.3, Table 9)].

2.2 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 (8.4) ]. 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)
kg lbs
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

3 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.

4 CONTRAINDICATIONS

4.1 Hypersensitivity

SUSTIVA is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (eg, Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of this product.

4.2 Contraindicated Drugs

For some drugs, competition for CYP3A by efavirenz could result in inhibition of their metabolism and create the potential for serious and/or life-threatening adverse reactions (eg, cardiac arrhythmias, prolonged sedation, or respiratory depression). Drugs that are contraindicated with SUSTIVA are listed in Table 2.

Table 2: Drugs That Are Contraindicated or Not Recommended for Use With SUSTIVA
Drug Class: Drug Name Clinical Comment
Antimigraine: ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine) Potential for serious and/or life-threatening reactions such as acute ergot toxicity characterized by peripheral vasospasm and ischemia of the extremities and other tissues.
Benzodiazepines: midazolam, triazolam Potential for serious and/or life-threatening reactions such as prolonged or increased sedation or respiratory depression.
Calcium channel blocker: bepridil Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
GI motility agent: cisapride Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
Neuroleptic: pimozide Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
St. John’s wort (Hypericum perforatum) May lead to loss of virologic response and possible resistance to efavirenz or to the class of non-nucleoside reverse transcriptase inhibitors (NNRTIs).

5 WARNINGS AND PRECAUTIONS

5.1 Drug Interactions

Efavirenz plasma concentrations may be altered by substrates, inhibitors, or inducers of CYP3A. Likewise, efavirenz may alter plasma concentrations of drugs metabolized by CYP3A or CYP2B6 [see Contraindications (4.2) and Drug Interactions (7.1) ].

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