ZIAGEN ORAL SOLUTION Dosage & Rx Info

Ziagen Oral Solution Generic Name & Formulations

Legal Class

General Description

Abacavir (as sulfate) 20mg/mL; strawberry-banana flavor; contains parabens, propylene glycol.

Pharmacological Class

Nucleoside analogue (reverse transcriptase inhibitor).

How Supplied

Tabs—Contact supplier; Soln—240mL

Manufacturer

ViiV Healthcare

Mechanism of Action

Abacavir is a carbocyclic synthetic nucleoside analogue. Abacavir is converted by cellular enzymes to the active metabolite, carbovir triphosphate (CBV-TP), an analogue of deoxyguanosine-5′-triphosphate (dGTP). CBV-TP inhibits the activity of HIV-1 reverse transcriptase (RT) both by competing with the natural substrate dGTP and by its incorporation into viral DNA.

Ziagen Oral Solution Indications

Indications

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

Ziagen Oral Solution 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 Oral Solution Contraindications

Contraindications

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

Ziagen Oral Solution Boxed Warnings

Boxed Warning

Hypersensitivity reactions.

Ziagen Oral Solution 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 Oral Solution Pharmacokinetics

Absorption

Absolute bioavailability: 83%.

Distribution

Volume of distribution: 0.86 ± 0.15 L/kg. Plasma protein bound: ~50%.

Metabolism

Hepatic.

Elimination

Renal, fecal. Half-life: 1.54 ± 0.63 hours.

Ziagen Oral Solution Interactions

Interactions

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

Ziagen Oral Solution 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 Oral Solution

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