TM Owner Gilead Sciences
Odefsey 200mg + 25mg + 25mg Tablet
Global Shipping : Reliable Global Distribution Network
Express Delivery : Priority Shipping for Every Order
Secure Payments : Trusted Payment Protection System
Disclaimer
Secure Handling
24/7 Worldwide Support
Global Access
Worldwide Access to Health
Cold-Chain Expert
Excellence in Cold-Chain
Trusted Supply
Certified Medical Supply
Indications & Clinical Uses
- Odefsey 200mg/25mg/25mg is a single tablet combining emtricitabine, rilpivirine, and tenofovir alafenamide, a nucleoside/nucleotide reverse transcriptase inhibitor pair plus a non-nucleoside reverse transcriptase inhibitor, for the treatment of HIV-1 infection.
- In the US, Odefsey is approved as a complete regimen for people aged 12 years and older weighing at least 35 kg, either as initial therapy when the baseline HIV-1 RNA is 100,000 copies/mL or less, or to replace a stable antiretroviral regimen in patients who are already virologically suppressed (HIV-1 RNA below 50 copies/mL) for at least six months with no history of treatment failure.
- It is not approved for use in patients with chronic hepatitis B virus (HBV) co-infection.
- Odefsey contains the same tenofovir alafenamide and emtricitabine combination found in Descovy, paired with the non-nucleoside agent rilpivirine, and is taken once daily under the ongoing supervision of a healthcare provider experienced in HIV management.
Side Effects
- Odefsey carries a boxed warning: severe, potentially fatal exacerbations of hepatitis B can occur in patients coinfected with HIV-1 and HBV who stop taking products containing emtricitabine or tenofovir, so liver function must be monitored closely for several months after stopping treatment; the boxed warning also covers lactic acidosis and severe hepatomegaly with steatosis, a rare but serious reaction linked to nucleoside analogues.
- The most commonly reported side effects are headache and sleep disturbances such as insomnia or abnormal dreams; most reactions are mild to moderate.
- Depressive symptoms, including mood changes and, rarely, suicidal thoughts, have been reported, more often in adolescents than adults.
- New or worsening kidney problems, immune reconstitution inflammatory syndrome, and QT-interval changes at high doses can occur.
- Seek urgent medical attention for yellowing of the skin or eyes, dark urine, severe abdominal pain, unusual muscle pain, or new mood changes, and never stop Odefsey abruptly without medical advice.
Precautions & Warnings
- Before starting Odefsey, patients should be tested for HBV, HIV drug resistance, and renal function; treatment is not recommended if creatinine clearance is below 30 mL/min.
- Because stopping Odefsey can cause a severe flare of hepatitis B in coinfected patients, hepatic function must be monitored for several months after discontinuation, with re-treatment of hepatitis B started if needed.
- Odefsey should not be used with proton pump inhibitors, and antacids or H2-blockers must be timed carefully around dosing, because reduced stomach acid lowers rilpivirine absorption and can lead to virologic failure.
- It must be taken with a meal to ensure adequate absorption of tenofovir alafenamide.
- Depression and mood changes should be monitored, particularly in adolescents.
- Odefsey may be used in pregnancy when clinically appropriate, with a pregnancy exposure registry available; breastfeeding is not recommended due to the risk of HIV transmission and drug exposure to the infant.
- Regular monitoring of viral load, liver enzymes, and kidney function is required throughout treatment.
Avoid Interactions
- Odefsey must not be combined with strong CYP3A inducers such as rifampin, rifabutin, carbamazepine, phenytoin, or St. John's wort, as these significantly lower rilpivirine levels and can cause loss of viral control; systemic dexamethasone beyond a single dose should also be avoided for the same reason.
- Proton pump inhibitors are contraindicated with Odefsey, and H2-receptor blockers or antacids must be taken several hours apart from the dose, because reduced gastric acid impairs rilpivirine absorption.
- Drugs that prolong the QT interval should be used cautiously, since high-dose rilpivirine has been linked to QT prolongation.
- Other medicines that compete for the same kidney transport pathways may raise tenofovir alafenamide levels.
- Patients should tell their healthcare provider about all prescription medicines, over-the-counter products, herbal supplements, and recreational drug use before starting Odefsey, since many common medications require dose timing adjustments or should be avoided entirely.
References
Frequently Asked Questions
Odefsey combines emtricitabine, rilpivirine, and tenofovir alafenamide to treat HIV-1 infection. It's approved for people aged 12 and older weighing at least 35 kg, either as a first regimen when viral load is 100,000 copies/mL or less, or to continue treatment in patients already virally suppressed. It is not approved for hepatitis B.
Take one Odefsey tablet by mouth once daily with a meal; food improves absorption of one of its ingredients. Never take it on an empty stomach. Do not stop taking it without talking to your healthcare provider first, since stopping suddenly can cause serious liver problems in some patients.
The most common side effects are headache and trouble sleeping. Odefsey has a boxed warning: stopping it in people also infected with hepatitis B can trigger a severe, sometimes fatal flare of hepatitis B, so liver function is monitored for months after stopping. Report yellowing skin or severe stomach pain urgently.
Avoid proton pump inhibitors completely, as they stop Odefsey from working properly; antacids and H2-blockers need careful timing around your dose. Avoid rifampin, certain seizure medicines, and St. John's wort, which reduce drug levels. Never skip a meal with your dose, and never stop treatment without medical advice.
Before starting, you'll be tested for hepatitis B, HIV resistance, and kidney function. Odefsey isn't recommended if kidney function is significantly reduced. During treatment, your provider checks viral load, liver enzymes, and kidney function regularly, and monitors mood, since depression has been reported, especially in teenagers.
Odefsey may be continued or started during pregnancy when a healthcare provider judges it appropriate, and a pregnancy registry tracks outcomes. Breastfeeding is not recommended because HIV can pass to the infant through breast milk. Discuss contraception and pregnancy plans with your provider before starting treatment.
Trusted & Reliable – Your Partner in Global Distribution.
We provide comprehensive lines of pharmaceutical products to support all your healthcare distribution needs.
