ZIAGEN

Ziagen Generic Name & Formulations

Legal Class

General Description

Abacavir (as sulfate) 300mg; scored tabs.

Pharmacological Class

Nucleoside analogue (reverse transcriptase inhibitor).

How Supplied

Tabs—60; Soln—240mL

Manufacturer

ViiV Healthcare

Ziagen Indications

Indications

HIV-1 infection, in combination with other antiretroviral agents.

Ziagen Dosage and Administration

Adult

300mg twice daily or 600mg once daily. Mild hepatic impairment: 200mg twice daily (use oral soln for titration).

Children

<3mos: not established. ≥3mos (oral soln): 8mg/kg twice daily or 16mg/kg once daily; max 600mg daily. If able to swallow tabs: 14–<20kg: 300mg once daily or 150mg twice daily; ≥20–<25kg: 450mg once daily or 150mg in the AM and 300mg in the PM; ≥25kg: use Adult dose.

Ziagen Contraindications

Contraindications

Presence of HLA-B*5701 allele. Prior hypersensitivity reaction to abacavir (see full labeling). Moderate or severe hepatic impairment.

Ziagen Boxed Warnings

Boxed Warning

Hypersensitivity reactions.

Ziagen Warnings/Precautions

Warnings/Precautions

Screen for presence of HLA-B*5701 allele prior to starting therapy or reinitiation; if (+), abacavir is contraindicated. Discontinue immediately if hypersensitivity is suspected, regardless of HLA-B*5701 status and even when other diagnoses are possible. If hypersensitivity cannot be ruled out, do not restart. If stopped for reasons other than hypersensitivity, restart only if medical care can be readily accessed. Suspend if lactic acidosis or pronounced hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Possible risk of MI; minimize risk factors for coronary heart disease (eg, hypertension, hyperlipidemia, diabetes, smoking). Women. Obesity. Elderly. Pregnancy. Nursing mothers: not recommended.

Ziagen Pharmacokinetics

See Literature

Ziagen Interactions

Interactions

Potentiates riociguat. May be potentiated by ethanol. Antagonizes methadone.

Ziagen Adverse Reactions

Adverse Reactions

Nausea, vomiting, headache, malaise, fatigue, dreams/sleep disorders, diarrhea, fever, chills, rash (may be severe, eg, Stevens-Johnson), ear/nose/throat infections; hypersensitivity reactions (may be fatal), lactic acidosis, severe hepatomegaly with steatosis, immune reconstitution syndrome.

Ziagen

PAGE CONTENTS