DOLUTEGRAVIR 50 mg Tablets

Integrase Strand Transfer Inhibitor (INSTI) – Antiretroviral Agent

ATC Code: J05AX12 | Prescription Only | WHO First-Line HIV Therapy

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Product Description:

Dolutegravir is a second-generation integrase strand transfer inhibitor (INSTI) indicated for the treatment of HIV-1 infection. It blocks the integrase enzyme required for the integration of viral DNA into the host genome, thereby halting HIV replication. Dolutegravir exhibits a high genetic barrier to resistance, potent viral suppression, and excellent tolerability, making it a WHO-preferred first-line agent in combination antiretroviral therapy (cART).

The 50 mg tablet is typically administered once daily in treatment-naïve patients and may be given twice daily in certain treatment-experienced cases with known INSTI resistance.

Available Presentation:

• Strength: 50 mg per film-coated tablet
• Formulation: Oral solid dose
• Packaging: Bottle of 30 tablets (once-daily dosing)
• Route of Administration: Oral
• Storage Conditions: Store below 30°C; protect from moisture

Uses:

• First-line therapy in adults and adolescents living with HIV-1
• Used in combination with two NRTIs (e.g., tenofovir + lamivudine or abacavir + lamivudine)
• Safe for:
  • Adults and adolescents weighing ≥25 kg
  • Pregnant women (WHO- and PEPFAR-endorsed)
  • People co-infected with tuberculosis (with dose adjustment)

Indications:

• HIV-1 infection in adults and pediatric patients ≥25 kg, including:
  • Treatment-naïve individuals
  • Treatment-experienced patients with no evidence of INSTI resistance
• Alternative regimens in patients intolerant to NNRTIs or PIs
• Preferred in Prevention of Mother-to-Child Transmission (PMTCT)
• Used in Post-Exposure Prophylaxis (PEP) as part of 3-drug therapy

Regulatory and Safety Profile:

• ATC Code: J05AX12
• Pharmacologic Class: Integrase Strand Transfer Inhibitor (INSTI)
• Pregnancy Category: B – Recommended for use during pregnancy under WHO guidance
• Common Adverse Effects: Insomnia, headache, dizziness, nausea, fatigue
• Serious Risks: Hypersensitivity reactions, hepatotoxicity, immune reconstitution inflammatory syndrome (IRIS)
• Contraindications: Coadministration with dofetilide (QT prolongation risk)
• Monitoring Parameters: HIV viral load, renal and liver function, weight gain trends (in long-term use), and drug interactions (especially with rifampin, metformin, antacids)

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