ABACAVIR 300 mg Tablets (Box of 60)

Nucleoside Reverse Transcriptase Inhibitor (NRTI) – Antiretroviral Agent

ATC Code: J05AF06 | Prescription Only | WHO Essential Medicine

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Product Description:

Abacavir is a synthetic carbocyclic nucleoside analog classified as a nucleoside reverse transcriptase inhibitor (NRTI) used in combination antiretroviral therapy (cART) for the treatment of HIV-1 infection. It inhibits the activity of reverse transcriptase, an HIV enzyme, by competing with endogenous nucleosides and causing DNA chain termination. Abacavir is well-absorbed orally, has good CNS penetration, and is dosed twice daily or once daily in combination with other antiretroviral drugs.

It is a preferred agent in pediatric regimens and adult patients who test negative for HLA-B*5701, as this gene is associated with a potentially life-threatening hypersensitivity reaction (HSR) to abacavir.

Available Presentation:

• Strength: 300 mg per tablet
• Formulation: Film-coated tablet
• Packaging: Bottle containing 60 tablets (30-day supply for BID dosing)
• Route of Administration: Oral
• Storage Conditions: Store at room temperature below 30°C; protect from excessive humidity

Uses:

• Part of combination antiretroviral therapy (ART) in adults and children
• Often co-formulated with lamivudine or as part of fixed-dose combinations (FDCs)
• Used in first-line and second-line regimens under WHO and national HIV treatment guidelines
• Safe for use in pregnancy and pediatric patients

Indications:

• Treatment of HIV-1 infection in adults, adolescents, and children weighing ≥25 kg
• Used in:
  • Initial ART regimens in HLA-B*5701–negative individuals
  • Maintenance regimens in virologically suppressed patients
  • Pediatric HIV regimens in weight-band dosing (WHO-recommended)

Regulatory and Safety Profile:

• ATC Code: J05AF06
• Pharmacologic Class: Nucleoside Reverse Transcriptase Inhibitor (NRTI)
• Pregnancy Category: B – No evidence of harm in humans; acceptable for use in pregnancy
• Black Box Warning: Risk of hypersensitivity reaction (HSR), which may be fatal; screen for HLA-B*5701 before initiation
• Common Adverse Effects: Nausea, fatigue, headache, fever, rash
• Serious Risks: Hypersensitivity reaction, lactic acidosis, hepatomegaly with steatosis
• Contraindications: Positive HLA-B*5701 status or history of abacavir-associated hypersensitivity
• Monitoring Parameters: HLA-B*5701 genetic testing prior to therapy; hepatic function; adherence and viral load monitoring

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