GNH USA

Europe — EMA

Odefsey (Emtricitabine, Tenofovir Alafenamide, Rilpivirine)

GNH USA supplies Odefsey (Emtricitabine, Tenofovir Alafenamide, Rilpivirine), a combination antiretroviral therapy for HIV‑1 infection

Request sourcing

1
Pack/s

What is Emtricitabine, Tenofovir Alafenamide, Rilpivirine?

Emtricitabine, Tenofovir alafenamide, and Rilpivirine, the active ingredients in Odefsey, is a combination antiretroviral therapy presented as a fixed‑dose tablet for oral use. It treats HIV‑1 infection in adults and adolescents weighing at least 35 kg.

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

What is Emtricitabine, Tenofovir Alafenamide, Rilpivirine used for?

Odefsey is a fixed‑dose combination antiretroviral indicated for the treatment of HIV‑1 infection in patients who have previously achieved viral suppression on a stable regimen. - HIV‑1 infection (treatment‑experienced): provides a complete, once‑daily regimen that maintains viral suppression. - HIV‑1 infection (maintenance therapy): simplifies therapy by combining three agents in one tablet, improving adherence. - HIV‑1 infection (adults and adolescents ≥35 kg): offers a single‑pill option that meets guideline‑recommended backbone and integrase‑strand‑inhibitor‑free regimens.

What are the side effects of Emtricitabine, Tenofovir Alafenamide, Rilpivirine?

Adverse reactions reported with Odefsey are generally mild to moderate and reflect the pharmacology of its components.

Common Side Effects: - Nausea: mild, transient gastrointestinal upset. - Headache: occasional, resolves without intervention. - Diarrhoea: loose stools, usually self‑limiting. - Fatigue: general tiredness reported by some patients. - Insomnia: difficulty falling or staying asleep. - Rash: mild skin erythema.

Serious or Rare Side Effects: - Severe hypersensitivity reactions: including Stevens‑Johnson syndrome. - Hepatic impairment: elevated transaminases or liver injury. - Lactic acidosis: rare metabolic complication. - Severe depression or suicidal ideation: reported in a minority of patients. - Renal toxicity: rare cases of kidney function decline. - QT‑interval prolongation: uncommon cardiac effect.

What precautions apply to Emtricitabine, Tenofovir Alafenamide, Rilpivirine?

When prescribing Odefsey, clinicians should consider several safety aspects. - Baseline laboratory testing: obtain hepatic, renal and viral load measurements before initiation. - Drug‑resistance testing: ensure the virus is susceptible to the components. - Co‑administration with acid‑reducing agents: may reduce rilpivirine exposure; monitor efficacy. - Pregnancy and lactation: weigh benefits against potential risks; consult guidelines. - Concomitant medications: review for interactions that may affect plasma levels. - Store at below 25°C: keep in the original container, protect from moisture and direct sunlight.

What does Emtricitabine, Tenofovir Alafenamide, Rilpivirine interact with?

Odefsey interacts with several drug classes; awareness of the interaction potential helps maintain therapeutic effectiveness.

Major Interactions (Avoid): - Antacids containing aluminium or magnesium: markedly reduce rilpivirine absorption. - Proton pump inhibitors (e.g., omeprazole): decrease rilpivirine exposure and may compromise viral suppression. - Rifampicin and other strong CYP3A inducers: lower plasma concentrations of rilpivirine.

Moderate Interactions (Monitor Closely): - H2‑receptor antagonists (e.g., ranitidine): may modestly reduce rilvivirine levels. - Lipid‑lowering agents (statins): increased risk of statin‑related myopathy. - Contraceptive hormones: potential reduction in hormonal efficacy. - Warfarin: possible alteration of INR values. - Antifungal azoles (e.g., ketoconazole): may increase rilpivirine concentrations.

Frequently asked questions

What is Odefsey used for?+
Odefsey is a fixed‑dose combination antiretroviral tablet indicated for the treatment and maintenance of HIV‑1 infection in adults and adolescents who are virologically suppressed on a stable regimen. It provides a single‑pill option that includes two nucleos(t)ide reverse‑transcriptase inhibitors and a non‑nucleoside reverse‑transcriptase inhibitor.
How does emtricitabine, tenofovir alafenamide and rilpivirine work?+
Emtricitabine and tenofovir alafenamide are nucleos(t)ide reverse‑transcriptase inhibitors that block the synthesis of viral DNA. Rilpivirine is a non‑nucleoside reverse‑transcriptase inhibitor that binds to a different site on the reverse‑transcriptase enzyme, preventing transcription of viral RNA. Together they interrupt multiple steps of the HIV replication cycle.
What is the usual dose of Odefsey?+
The dosing regimen for Odefsey is determined by the prescribing clinician based on the patient’s clinical status, weight, and prior therapy. The product is supplied as a once‑daily tablet; exact dosage and any adjustments should follow the prescriber’s instructions and local treatment guidelines.
Is Odefsey safe to use during pregnancy or breastfeeding?+
Safety data for Odefsey in pregnancy are limited. Clinicians should assess the potential benefits against possible risks and follow current obstetric and HIV treatment guidelines. Breastfeeding decisions should also consider maternal health, infant exposure, and local recommendations.
How do I order Odefsey from GNH USA?+
To request Odefsey, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.
How does Odefsey compare with other HIV regimens?+
Odefsey offers a single‑tablet regimen that combines two NRTIs with a NNRTI, eliminating the need for an integrase inhibitor‑based backbone. Compared with multi‑tablet or integrase‑inhibitor regimens, it may improve adherence but requires careful management of drug‑drug interactions, especially with acid‑reducing agents.
What are the storage requirements for Odefsey?+
Store Odefsey tablets at temperatures below 25 °C in the original packaging. Protect the tablets from moisture, excessive heat and direct sunlight to maintain product stability throughout its shelf life.
How is Odefsey administered?+
Odefsey is taken orally as a single tablet once daily, preferably with a meal to enhance rilpivirine absorption. Swallow the tablet whole with water; do not crush, split or chew the tablet.
What are the most serious risks associated with Odefsey?+
Serious adverse events reported with Odefsey include severe hypersensitivity reactions such as Stevens‑Johnson syndrome, hepatic impairment, lactic acidosis, renal toxicity, and rare cardiac effects like QT‑interval prolongation. Patients should be monitored regularly for signs of these conditions.
Who should not use Odefsey?+
Odefsey is contraindicated in patients with known hypersensitivity to any of its components, in those receiving contraindicated medications such as certain antacids or strong CYP3A inducers, and in individuals with uncontrolled severe hepatic disease. Clinicians should review each patient’s medical history before prescribing.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Emtricitabine, Tenofovir Alafenamide, Rilpivirine
Route
Oral Use
Manufacturer
Gilead Sciences Ireland Unlimited Company
Origin
EU

Related products