Odefsey (Emtricitabine / Rilpivirine / Tenofovir alafenamide)

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According to the European Medicines Agency, brand name Odefsey originating from Europe is manufactured at the following site(s):Gilead Sciences Ireland UC IDA Business and Technology Park Carrigtohill County Cork Ireland

Information about Odefsey (Emtricitabine / Rilpivirine / Tenofovir Alafenamide)

Odefsey is a fixed-dose combination tablet containing three active ingredients: emtricitabine, rilpivirine, and tenofovir alafenamide (TAF). It is primarily used in the treatment of HIV-1 (Human Immunodeficiency Virus) infection in adults and children aged 12 years and older, who are HIV-positive and have no prior antiretroviral treatment (ART) history or whose viral load is well-controlled with other ART regimens.

Odefsey combines these three antiretroviral drugs into a single tablet to simplify treatment regimens, improve adherence, and offer potent HIV suppression. It works by inhibiting enzymes that are essential for the replication of HIV, reducing the viral load in the blood and improving immune system function.

Product Highlights

• Odefsey is indicated for the treatment of HIV-1 infection in adults and pediatric patients (weighing at least 35 kg) who have no prior antiretroviral therapy history or have well-controlled viral loads on stable ART.
• It is used as part of a complete regimen to reduce the viral load and maintain long-term viral suppression.
• Odefsey is not recommended for patients who have HIV strains resistant to emtricitabine, rilpivirine, or tenofovir.

Key Ingredients

• Emtricitabine
• Rilpivirine
• Tenofovir Alafenamide (TAF)

Key Benefits

• Odefsey combines three potent antiretroviral drugs into a single tablet taken once daily, improving adherence to HIV treatment.
• The combination of emtricitabine, rilpivirine, and tenofovir alafenamide effectively reduces the HIV viral load, with many patients achieving undetectable viral loads.
• The use of tenofovir alafenamide (TAF) in place of older tenofovir (TDF) formulations reduces the risk of kidney problems and bone density loss.
• Compared to older HIV regimens, Odefsey tends to have fewer gastrointestinal and renal side effects due to the use of TAF.
• With a once-daily dosing schedule, Odefsey provides convenience for patients, which can help improve adherence to treatment.

Direction of Use

• The recommended dose of Odefsey for adults and adolescents (weighing at least 35 kg) is one tablet taken once daily with food.
• Take the tablet with a meal, as food helps with the absorption of rilpivirine, one of the key ingredients in the combination.
• It’s important to take Odefsey consistently every day to achieve and maintain viral suppression.
• If a dose is missed, take it as soon as you remember, unless it's almost time for the next dose. Do not take two doses at the same time to make up for a missed dose.

Safety Concerns

• In patients with prior hepatitis B infection, stopping Odefsey may lead to reactivation of hepatitis B. Regular liver function monitoring is advised.
• Rilpivirine, one of the components of Odefsey, has been associated with depression, mood changes, and suicidal thoughts. Patients should be closely observed for these symptoms.
• Liver function should be monitored in all patients, particularly those with a history of liver disease.
• Although TAF is associated with a lower risk of renal and bone issues than older formulations of tenofovir, renal and bone health should still be monitored during treatment.
• Odefsey may interact with other medications, including certain anticonvulsants, antibiotics, and antifungals. Make sure to tell your healthcare provider about all the medications you are currently taking.

Avoid Odefsey (Emtricitabine / Rilpivirine / Tenofovir Alafenamide) If

• Odefsey should not be used in individuals with moderate or severe hepatic impairment (Child-Pugh B or C) due to potential risks of liver toxicity.
• If you are allergic to any of the ingredients in Odefsey (emtricitabine, rilpivirine, or tenofovir alafenamide), you should not take the medication.
• People with active hepatitis B infection should not use Odefsey unless they are being treated for both HIV and hepatitis B, as stopping therapy can lead to liver complications.
• Odefsey should not be used in patients with HIV-1 strains that are resistant to rilpivirine, emtricitabine, or tenofovir.
• Odefsey is contraindicated in patients with a creatinine clearance (CrCl) of less than 30 mL/min, as the kidney’s ability to eliminate the drug is impaired in such cases.