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. 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 combination antiretroviral therapy used in the management of HIV‑1 infection.

  • HIV‑1 infection in treatment‑naïve adults: improves viral suppression and CD4+ count.
  • HIV‑1 infection in treatment‑naïve adolescents (12 years and older): provides a complete regimen in a single tablet.
  • HIV‑1 infection in patients with prior virologic suppression on a compatible regimen: maintains viral control when switching to a single‑pill regimen.

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 terminate viral DNA chain elongation, while rilpivirine is a non‑nucleoside reverse‑transcriptase inhibitor that binds to the enzyme’s allosteric site, preventing transcription of viral RNA.

Side Effects

Adverse reactions to Odefsey are reported across a range of frequencies.

Common Side Effects

  • Nausea: mild to moderate gastrointestinal upset.
  • Headache: transient cranial discomfort.
  • Fatigue: generalised tiredness.
  • Diarrhoea: loose stools, usually self‑limiting.
  • Insomnia: difficulty initiating or maintaining sleep.

Serious or Rare Side Effects

  • Hepatic dysfunction: elevated transaminases or hepatitis.
  • Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.
  • Lactic acidosis: metabolic acidosis with elevated lactate.
  • Renal toxicity: worsening kidney function, especially in patients with pre‑existing impairment.
  • QT‑interval prolongation: cardiac conduction changes detectable on ECG.

Precautions & Warnings

When prescribing Odefsey, clinicians should consider several safety aspects.

  • Renal function: assess baseline creatinine clearance before initiating therapy.
  • Hepatic function: monitor liver enzymes in patients with hepatitis or alcohol use.
  • Pregnancy: weigh benefits against potential risks; consult current guidelines.
  • Concomitant medications: review for drugs that may affect rilpivirine plasma levels.
  • Adherence: emphasize the importance of daily dosing for viral suppression.
  • Store at ambient temperature: keep below 25°C, retain in original packaging, and protect from moisture.

Avoid Interactions

Odefsey may interact with several drug classes, requiring clinical vigilance.

Major Interactions (Avoid)

  • Antacids containing aluminium or magnesium: reduce rilpivirine absorption.
  • Proton pump inhibitors (e.g., omeprazole): markedly decrease rilpivirine exposure.
  • Rifampicin: induces metabolism leading to sub‑therapeutic rilpivirine levels.

Moderate Interactions (Monitor Closely)

  • HMG‑CoA reductase inhibitors (statins): may increase statin concentrations.
  • Warfarin: potential alteration of anticoagulant effect.
  • Contraceptive hormones: possible reduction in hormonal efficacy.

Frequently Asked Questions

Odefsey is a fixed‑dose combination tablet indicated for the treatment of HIV‑1 infection in treatment‑naïve adults and adolescents, as well as for patients who are already virologically suppressed and wish to switch to a single‑pill regimen.

The three components act on the HIV reverse‑transcriptase enzyme at different sites: emtricitabine and tenofovir alafenamide are nucleoside/nucleotide analogues that terminate DNA chain elongation, while rilpivirine binds to an allosteric site on the enzyme, blocking its activity and preventing viral replication.

The prescribed dose of Odefsey is determined by the treating clinician based on the patient’s age, weight, renal and hepatic function, and prior treatment history. Patients should follow the prescriber’s instructions exactly.

Safety data are limited; clinicians must balance the benefits of viral suppression against potential risks to the fetus or infant. Current guidelines recommend continuing effective antiretroviral therapy during pregnancy, but the decision should be individualized.

To request Odefsey, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any required import documentation.

Odefsey combines two nucleos(t)ide reverse‑transcriptase inhibitors with a non‑nucleoside agent, offering a high barrier to resistance and once‑daily dosing. Compared with alternatives such as Biktarvy or Triumeq, it differs in its specific NRTI backbone and the use of rilpivirine, which may have distinct drug‑interaction and fasting requirements.

Store Odefsey tablets at ambient temperature, below 25 °C, in the original blister pack or container. Protect the product from moisture and direct sunlight to maintain stability.

Odefsey is taken orally, once daily, with a meal containing at least 500 calories to ensure adequate absorption of rilpivirine. The tablet should be swallowed whole with water and not crushed or chewed.

Serious adverse events include hepatic dysfunction, severe skin reactions such as Stevens‑Johnson syndrome, lactic acidosis, renal toxicity and QT‑interval prolongation. Patients should be monitored regularly for signs of these conditions.

Odefsey is contraindicated in patients with known hypersensitivity to any of its components, in those with severe renal impairment (eGFR < 30 mL/min), and in individuals taking contraindicated medications such as certain antacids, proton‑pump inhibitors or rifampicin.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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