Product image of Odefsey (Emtricitabine, Tenofovir Alafenamide, Rilpivirine) supplied by GNH India

Odefsey

Active Ingredient:
Emtricitabine, Tenofovir Alafenamide, Rilpivirine
Origin:
EU

Odefsey (Emtricitabine, Tenofovir Alafenamide, Rilpivirine)

Emtricitabine, the active ingredient in Odefsey, is a nucleoside reverse transcriptase inhibitor presented as a fixed‑dose combination tablet for oral use. It treats HIV‑1 infection in adults and adolescents when used with other antiretrovirals. GNH India supplies Odefsey as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

GNH India supplies Odefsey as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Gilead Sciences Ireland Unlimited Company

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Indications & Clinical Uses

Odefsey is a fixed‑dose antiretroviral regimen that targets the HIV‑1 replication pathway.

  • HIV‑1 infection (adults and adolescents): provides a complete, once‑daily regimen that suppresses viral load when combined with other antiretrovirals.
  • Treatment‑naïve patients: offers a convenient single‑tablet option to achieve and maintain viral suppression.
  • Patients switching from other regimens: facilitates a simplified dosing schedule while maintaining efficacy.

How It Works

  • Odefsey combines three agents that inhibit HIV replication at distinct stages: emtricitabine and tenofovir alafenamide are nucleoside/nucleotide reverse‑transcriptase inhibitors that block viral DNA synthesis, while rilpivirine is a non‑nucleoside reverse‑transcriptase inhibitor that binds to a separate site on the reverse‑transcriptase enzyme, preventing transcription of viral RNA.

Side Effects

Adverse reactions to Odefsey are reported across clinical studies and post‑marketing surveillance.

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Diarrhea: loose stools, usually transient.
  • Headache: mild tension‑type headache.
  • Fatigue: general tiredness.
  • Insomnia: difficulty falling or staying asleep.
  • Rash: mild skin erythema.

Serious or Rare Side Effects

  • Hepatic dysfunction: elevated liver enzymes or hepatitis.
  • Severe hypersensitivity: rash with systemic involvement, possibly Stevens‑Johnson syndrome.
  • Renal impairment: worsening kidney function, especially in patients with pre‑existing disease.
  • Bone mineral density loss: decreased bone density with long‑term use.
  • Lactic acidosis: rare metabolic acidosis with high lactate levels.
  • QT prolongation: potential cardiac rhythm disturbance.

Precautions & Warnings

When prescribing Odefsey, clinicians should consider several safety aspects.

  • Renal function assessment: evaluate baseline kidney function before initiation.
  • Hepatic monitoring: check liver enzymes periodically, especially in patients with hepatitis.
  • Pregnancy counseling: discuss potential risks and benefits with women of childbearing potential.
  • Drug‑interaction review: assess concomitant medications for possible interactions.
  • Adherence support: emphasize the importance of daily dosing for viral suppression.
  • Store at below 25°C: keep in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Odefsey may interact with other medicines that affect its absorption, metabolism, or excretion.

Major Interactions (Avoid)

  • Antacids containing aluminum or magnesium: reduce rilpivirine absorption.
  • Proton pump inhibitors (e.g., omeprazole): lower rilpiviri ne levels.
  • Rifampin and other strong CYP3A inducers: markedly decrease rilpivirine concentrations.

Moderate Interactions (Monitor Closely)

  • H2‑blockers (cimetidine, ranitidine): may modestly reduce rilpivirine exposure.\n- Lipid‑lowering agents (statins such as rosuvastatin): increased statin exposure due to tenofovir alafenamide.
  • Contraceptive hormones: potential reduction in hormonal efficacy.
  • Warfarin: possible alteration of INR values.
  • Methotrex ​

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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