ZIAGEN Tablets and Oral Solution, in combination with other antiretroviral agents, are indicated for the treatment of HIV-1 infection.

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

• ZIAGEN is one of multiple products containing abacavir. Before starting ZIAGEN, 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.
• In one controlled study (CNA30021), more patients taking ZIAGEN 600 mg once daily had severe hypersensitivity reactions than patients taking ZIAGEN 300 mg twice daily. See WARNINGS, ADVERSE REACTIONS, and 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.

ZIAGEN may be taken with or without food.

Adults: The recommended oral dose of ZIAGEN for adults is 600 mg daily, administered as either 300 mg twice daily or 600 mg once daily, in combination with other antiretroviral agents.

Adolescents and Pediatric Patients: The recommended oral dose of ZIAGEN for adolescents and pediatric patients 3 months to up to 16 years of age is 8 mg/kg twice daily (up to a maximum of 300 mg twice daily) in combination with other antiretroviral agents.

Dose Adjustment in Hepatic Impairment: The recommended dose of ZIAGEN in patients with mild hepatic impairment (Child-Pugh score 5 to 6) is 200 mg twice daily. To enable dose reduction, ZIAGEN Oral Solution (10 mL twice daily) should be used for the treatment of these patients. The safety, efficacy, and pharmacokinetic properties of abacavir have not been established in patients with moderate to severe hepatic impairment, therefore ZIAGEN is contraindicated in these patients.

ZIAGEN is available as tablets and oral solution.

ZIAGEN Tablets: Each tablet contains abacavir sulfate equivalent to 300 mg abacavir. The tablets are yellow, biconvex, capsule-shaped, film-coated, and imprinted with “GX 623” on one side with no marking on the reverse side. They are packaged as follows:

Bottles of 60 tablets (NDC 0173-0661-01).

Unit dose blister packs of 60 tablets (NDC 0173-0661-00). Each pack contains 6 blister cards of 10 tablets each.

Store at controlled room temperature of 20° to 25°C (68° to 77°F) (see USP).

ZIAGEN Oral Solution: It is a clear to opalescent, yellowish, strawberry-banana-flavored liquid. Each mL of the solution contains abacavir sulfate equivalent to 20 mg of abacavir. It is packaged in plastic bottles as follows:

Bottles of 240 mL (NDC 0173-0664-00) with child-resistant closure. This product does not require reconstitution.

Store at controlled room temperature of 20 to 25 C (68 to 77 F) (see USP). DO NOT FREEZE. May be refrigerated.

GlaxoSmithKline, Research Triangle Park, NC 27709,.October 2006. FDA revision date: 5/7/2007

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