Finished product reference
Abacavir
Solution · Oral · 20 mg/1mL · 60 mL
- List code
- 53530
- Salt form
- Sulfate
WARNING: HYPERSENSITIVITY REACTIONS Serious and sometimes fatal hypersensitivity reactions, with multiple organ involvement, have occurred with abacavir. Patients who carry the HLA-B*5701 allele are at a higher risk of a hypersensitivity reaction to abacavir; although, hypersensitivity reactions have occurred in patients who do not carry the HLA-B*5701 allele .
What it is and how it works
Mechanism of Action Abacavir is an antiretroviral agent .
Indications
Abacavir oral solution, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection. Abacavir oral solution, a nucleoside analogue human immunodeficiency virus (HIV-1) reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Dosage and administration (summary)
• Before initiating abacavir, screen for the HLA-B*5701 allele. • Adults: 600 mg daily, administered as either 300 mg twice daily or 600 mg once daily. • Pediatric Patients Aged 3 Months and Older: Administered either once or twice daily. Dose should be calculated on body weight (kg) and should not exceed 600 mg daily. • Patients with Hepatic Impairment: Mild hepatic impairment - 200 mg twice daily. Screening for HLA-B*5701 Allele prior to Starting Abacavir Screen for the HLA-B*5701 allele prior to initiating therapy with abacavir .
Contraindications
Abacavir oral solution is contraindicated in patients: • who have the HLA-B*5701 allele . • with prior hypersensitivity reaction to abacavir . • with moderate or severe hepatic impairment . • Presence of HLA-B*5701 allele. • Prior hypersensitivity reaction to abacavir. • Moderate or severe hepatic impairment.
Warnings and precautions
• Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues. • Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy. Hypersensitivity Reactions Serious and sometimes fatal hypersensitivity reactions have occurred with abacavir. These hypersensitivity reactions have included multi-organ failure and anaphylaxis and typically occurred within the first 6 weeks of treatment with abacavir (median time to onset was 9 days).
Pregnancy
Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir during pregnancy. Healthcare Providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263.
Storage and supply
Abacavir oral solution USP is a clear yellowish, strawberry-banana flavored liquid filled in 250 cc HDPE opaque bottles. Each mL of the solution contains abacavir sulfate USP equivalent to 20 mg of abacavir. They are supplied in: Bottles of 240 mL with Induction Sealing FSE Wad (NDC 31722-562-24). This product does not require reconstitution.
Source: Abacavir (Abacavir) — US FDA prescribing information, 2026-08-13, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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