"The U.S. Food and Drug Administration today approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection.
Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. "...
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 [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS].
DOSAGE AND ADMINISTRATION
- A Medication Guide and Warning Card that provide information about recognition of hypersensitivity reactions should be dispensed with each new prescription and refill.
- ZIAGEN may be taken with or without food.
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.
The recommended oral dose of ZIAGEN oral solution in HIV-1-infected pediatric patients aged 3 months and older is 8 mg per kg twice daily (up to a maximum of 300 mg twice 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 Tablets in
|Weight (kg)||Dosage Regimen Using Scored Tablet||Total Daily Dose|
|AM Dose||PM Dose|
|14 to 21||½ tablet (150 mg)||½ tablet (150 mg)||300 mg|
|> 21 to < 30||½ tablet (150 mg)||1 tablet (300 mg)||450 mg|
|≥ 30||1 tablet (300 mg)||1 tablet (300 mg)||600 mg|
Patients With 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.
Dosage Forms And Strengths
ZIAGEN tablets contain 300 mg of abacavir as abacavir sulfate. The tablets are yellow, biconvex, functionally 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, functionally 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: February 2015
Last reviewed on RxList: 3/6/2015
This monograph has been modified to include the generic and brand name in many instances.
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