Description:

Xapavir 50mg tablets is a generic antiretroviral medication containing dolutegravir. It is an integrase strand transfer inhibitor (INSTI) used in combination with other antiretroviral drugs to treat HIV-1 infection in adults and children weighing at least 40 kg. It prevents HIV replication by blocking the integration of viral DNA into the host cell genome, helping suppress viral load, increase CD4 counts, and reduce HIV-related complications. It is a key component in first-line ART regimens due to high efficacy, good tolerability, and once-daily dosing.

Prescription: Prescription-only (Rx). Requires a doctor’s prescription (typically from an infectious disease specialist or HIV clinician) with HIV confirmation (viral load/CD4 testing), renal/hepatic assessment, and ongoing monitoring. In Ghana and many African markets, it is regulated and available through pharmacies or HIV clinics (imported generic).

Therapeutic Category:

Antiretroviral / Integrase strand transfer inhibitor (INSTI) (  for HIV-1 treatment in combination therapy).

Active Ingredients/Composition:

Each film-coated tablet contains: Dolutegravir sodium equivalent to dolutegravir 50 mg. Excipients: Standard tablet components (e.g., microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, magnesium stearate, hypromellose, titanium dioxide, iron oxides for coloring; refer to label for full list—no additional actives).

Vitamins: None.

Minerals: None.

Variant: 50 mg strength film-coated tablets (standard adult/adolescent dose; 30-tablet pack for monthly supply; differs from dispersible tablets for children or fixed-dose combinations like dolutegravir/lamivudine/tenofovir in other Natco products).

Consume Type:

Oral (tablet; swallow whole with water; can be taken with or without food).

Directions/Usage: Adults and adolescents ≥12 years and ≥40 kg: 50 mg (1 tablet) once daily, in combination with other antiretroviral (e.g., with abacavir/lamivudine, tenofovir/emtricitabine, or dolutegravir-based regimens). Take at the same time daily. Do not miss doses to maintain efficacy and prevent resistance. Adjust in renal impairment (no adjustment for CrCl ≥30 mL/min; limited data below). For certain co-medications (e.g., rifampin): May require 50 mg twice daily. Follow specialist instructions; complete full regimen; regular viral load monitoring required.

Common Side Effects:

• Headache
• Nausea, diarrhoea
• Insomnia, abnormal dreams
• Fatigue
• Rash
• Increased liver enzymes
• Weight gain (long-term) Serious rare: Hypersensitivity reactions (fever, rash, organ dysfunction), hepatotoxicity, immune reconstitution inflammatory syndrome (IRIS). Seek immediate help for severe rash, fever, or allergic symptoms.

Package Type:

Blister packs containing 30 film-coated tablets (often 3 x 10 strips or 30’s in carton with patient information leaflet).

Storage Advice: Store at room temperature (below 25-30°C), in the original packaging to protect from moisture and light. Keep tightly closed. Keep out of reach of children.

Safety Advice:

• Use only in combination with other antiretroviral—never monotherapy.
• Caution in severe hepatic impairment (limited data); monitor liver function.
• Risk of hypersensitivity (stop immediately if rash + fever/organ symptoms).
• Not for patients with dolutegravir resistance or certain co-medications without adjustment.
• Pregnancy: Use if benefits outweigh risks (some data suggest neural tube defect risk with dolutegravir at conception; consult specialist). Breastfeeding: Generally not recommended in high-resource settings.
• Interactions: Strong CYP3A/P-gp inducers (e.g., rifampin—dose adjustment); avoid with dofetilide.
• Regular monitoring: Viral load, CD4, renal/liver function, lipids/weight.
• Report any new/worsening symptoms promptly.

Product Substitutes: Other dolutegravir 50 mg tablets in Ghana/Africa: Tivicay (original ViiV/GSK), generic dolutegravir (various importers), or fixed-dose combinations like TLD (tenofovir/lamivudine/dolutegravir). Alternatives: Other INSTIs (e.g., raltegravir, bictegravir in Biktarvy) or non-INSTI regimens (e.g., efavirenz-based)—consult HIV specialist per national guidelines (e.g., Ghana ART guidelines favor dolutegravir-based first-line).

Manufacturer/Marketer:

Natco Pharma Limited (manufacturer; Natco is an Indian pharmaceutical company producing Xapavir as a generic dolutegravir). Marketed/distributed in Africa (including Ghana) via Natco affiliates, “We Care” branding (likely a local/export distributor tag), or importers/pharmacies.

Country of Origin:

India.