February 10, 2016
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Ziagen

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Ziagen




Indications
Dosage
How Supplied

INDICATIONS

ZIAGEN tablets and oral solution, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection.

DOSAGE AND ADMINISTRATION

Screening for HLA-B*5701 Allele Prior to Starting ZIAGEN

Screen for the HLA-B*5701 allele prior to initiating therapy with ZIAGEN [see BOXED WARNING, WARNINGS AND PRECAUTIONS].

Recommended Dosage For Adult Patients

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

Recommended Dosage For Pediatric Patients

The recommended dosage of ZIAGEN oral solution in HIV-1-infected pediatric patients aged 3 months and older is 8 mg per kg orally twice daily or 16 mg per kg orally once-daily (up to a maximum of 600 mg daily) in combination with other antiretroviral agents.

ZIAGEN is also available as a scored tablet for HIV-1-infected pediatric patients weighing greater than or equal to 14 kg for whom a solid dosage form is appropriate. Before prescribing

ZIAGEN tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow ZIAGEN tablets, the oral solution formulation should be prescribed.

The recommended oral dosage of ZIAGEN tablets for HIV-1-infected pediatric patients is presented in Table 1.

Table 1: Dosing Recommendations for ZIAGEN Scored Tablets in Pediatric Patients

Weight (kg) Once-daily Dosing Regimena Twice-daily Dosing Regimen
AM Dose PM Dose Total Daily Dose
14 to < 20 1 tablet
(300 mg)
½ tablet
(150 mg)
½ tablet
(150 mg)
300 mg
≥ 20 to < 25 1½ tablets
(450 mg)
½tablet
(150 mg)
1 tablet
(300 mg)
450 mg
≥ 25 2 tablets
(600 mg)
1 tablet
(300 mg)
1 tablet
(300 mg)
600 mg
a Data regarding the efficacy of once-daily dosing is limited to subjects who transitioned from twice-daily dosing to once-daily dosing after 36 weeks of treatment [see Clinical Studies].

Recommended Dosage For Patients With Hepatic Impairment

The recommended dose of ZIAGEN in patients with mild hepatic impairment (Child-Pugh Class A) 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.

HOW SUPPLIED

Dosage Forms And Strengths

ZIAGEN tablets contain 300 mg of abacavir as abacavir sulfate. The tablets are yellow, biconvex, scored, capsule-shaped, film-coated, and imprinted with “GX 623” on both sides. ZIAGEN oral solution contains 20 mg per mL of abacavir as abacavir sulfate. The solution is a clear to opalescent, yellowish, strawberry-banana-flavored liquid.

Storage And Handling

ZIAGEN tablets, containing abacavir sulfate equivalent to 300 mg abacavir are yellow, biconvex, scored, capsule-shaped, film-coated, and imprinted with “GX 623” on both sides.

They are packaged as follows:

Bottles of 60 tablets (NDC 49702-221-18).
Unit dose blister packs of 60 tablets (NDC 49702-221-44). 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 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 49702-222-48) 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.

Manufactured for: ViiV Healthcare, Research Triangle Park, NC 27709. by: GlaxoSmithKline, Research Triangle Park, NC 27709. Revised: September 2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 10/23/2015

Indications
Dosage
How Supplied

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