ABACAVIR 600 mg + LAMIVUDINE 300 mg Tablets

Fixed-Dose Combination (FDC) Antiretroviral – NRTI Backbone for HIV-1 Therapy

ATC Code: J05AR02 | Prescription Only | WHO-Recommended First-Line Therapy

---

Product Description:

Abacavir-Lamivudine is a fixed-dose combination (FDC) antiretroviral tablet that includes two nucleoside reverse transcriptase inhibitors (NRTIs):

• Abacavir (600 mg): a guanosine analog that inhibits HIV reverse transcriptase and DNA chain elongation
• Lamivudine (300 mg): a cytidine analog with potent and synergistic activity against HIV-1

This combination is used as the backbone component in first-line and second-line antiretroviral therapy (ART). It is recommended by WHO and national HIV guidelines, particularly in adults and adolescents who test negative for HLA-B*5701, due to the risk of abacavir hypersensitivity.

Available Presentation:

• Strength: Abacavir 600 mg + Lamivudine 300 mg
• Formulation: Film-coated tablet (color and shape may vary by manufacturer)
• Packaging: Bottle of 30 tablets (30-day supply; one tablet once daily)
• Route of Administration: Oral
• Storage Conditions: Store below 30°C; protect from excessive humidity

Uses:

• Used in combination with a third antiretroviral agent (e.g., dolutegravir, efavirenz, or raltegravir)
• Forms part of a once-daily, simplified ART regimen
• Appropriate for:
  • Adults and adolescents ≥25 kg
  • Pregnant women (when used in WHO-recommended combinations)
  • Transitioning stable patients to fixed-dose therapy
• Included in Post-Exposure Prophylaxis (PEP) and Prevention of Mother-to-Child Transmission (PMTCT) protocols

Indications:

• HIV-1 infection in adults, adolescents, and pediatric patients weighing ≥25 kg
• First-line ART in:
  • HLA-B*5701–negative individuals
  • Patients requiring tenofovir-sparing regimens (e.g., with renal impairment or osteoporosis risk)
• Maintenance therapy in virologically suppressed patients previously stabilized on abacavir + lamivudine
• Can be used in special populations including pregnant women and patients on TB treatment

Regulatory and Safety Profile:

• ATC Code: J05AR02
• Pharmacologic Class: NRTI Fixed-Dose Combination
• Pregnancy Category: B (lamivudine); Caution advised with abacavir (Category C/D)
• Black Box Warning:
  • Risk of hypersensitivity reaction (HSR) due to abacavir – screen for HLA-B*5701 before initiation
  • Risk of lactic acidosis and hepatomegaly with steatosis, particularly in pregnancy or hepatitis co-infection
• Common Side Effects: Nausea, headache, fatigue, diarrhea, insomnia, rash
• Serious Risks: Hypersensitivity reaction, liver toxicity, pancreatitis (rare in adults), mitochondrial toxicity
• Contraindications: Positive HLA-B*5701 test, history of abacavir HSR, moderate-to-severe hepatic impairment
• Monitoring Parameters: CBC, hepatic function, renal function (lamivudine clearance), viral load, adherence, HLA-B*5701 status

---

For ARV program inquiries, regulatory documentation, or NGO tender pricing, contact info@panamfarma.com.