TRIZIVIR is indicated in combination with other antiretrovirals or alone for the treatment of HIV-1 infection.

Additional important information on the use of TRIZIVIR for treatment of HIV-1 infection:

• TRIZIVIR is one of multiple products containing abacavir. Before starting TRIZIVIR, review medical history for prior exposure to any abacavir-containing product in order to avoid reintroduction in a patient with a history of hypersensitivity to abacavir.
• Limited data exist on the use of TRIZIVIR alone in patients with higher baseline viral load levels (>100,000 copies/mL, see Description of Clinical Studies).

A Medication Guide and Warning Card that provide information about recognition of hypersensitivity reactions should be dispensed with each new prescription and refill. To facilitate reporting of hypersensitivity reactions and collection of information on each case, an Abacavir Hypersensitivity Registry has been established. Physicians should register patients by calling 1-800-270-0425.

The recommended oral dose of TRIZIVIR for adults and adolescents is 1 tablet twice daily. TRIZIVIR is not recommended in adolescents who weigh less than 40 kg because it is a fixed-dose tablet.

Dose Adjustment: Because it is a fixed-dose tablet, TRIZIVIR should not be prescribed for patients requiring dosage adjustment such as those with creatinine clearance <50 mL/min, patients with hepatic impairment, or patients experiencing dose-limiting adverse events.

TRIZIVIR is available as tablets. Each tablet contains 300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine. The tablets are blue-green capsule-shaped, film-coated, and imprinted with GX LL1 on one side with no markings on the reverse side. They are packaged as follows:

Bottles of 60 Tablets (NDC 0173-0691-00).

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature).

GlaxoSmithKline., Research Triangle Park, NC 27709
Lamivudine is manufactured under agreement from: Shire Pharmaceuticals Group plc., Basingstoke, UK
©2006, GlaxoSmithKline. All rights reserved. October 2006
FDA rev date: 5/7/2007

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