Odefsey, illustration of tablet form (not a photo of the actual pack)

Illustrative image.

Odefsey

Emtricitabine; Rilpivirine; Tenofovir Alafenamide

Prescription required

$3555.00

3 × 30 tablets · 3 months supply

BrandBranded medicine· By Janssen Cilag

$1185.00 per month

How long a supply?

1 month$1185.00 a month
3 months$1185.00 a month
6 months$1185.00 a month
Supplied from Israel

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Annual cost

$14220a year at this pack size

Prescription required

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FDA boxed warningPost treatment acute exacerbation of hepatitis b

Severe acute exacerbations of hepatitis B have been reported in patients with HIV-1 and HBV who have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of ODEFSEY.

Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients with HIV-1 and HBV who discontinue ODEFSEY. If appropriate, anti-hepatitis B therapy may be warranted.

Read this with the rest of the clinical information

About Odefsey

Overview

Odefsey is a prescription tablet containing emtricitabine, rilpivirine and tenofovir alafenamide, used as a complete treatment for HIV-1 in adults and children weighing at least 25 kg. It can be used as initial treatment in people who have not taken HIV medicines before and have an HIV-1 viral load of no more than 100,000 copies/mL. It can also replace a stable HIV treatment when the viral load has stayed below 50 copies/mL for at least six months, with no history of treatment failure or known resistance to its ingredients. Its three active ingredients work by blocking an HIV enzyme called reverse transcriptase.

What it treats

HIV-1 infection in adults and children weighing at least 25 kg, as a complete treatment regimen: - For people who have not previously received antiretroviral treatment and have an HIV-1 viral load of 100,000 copies/mL or less. - To replace a stable antiretroviral regimen when the HIV-1 viral load has remained below 50 copies/mL for at least 6 months, with no history of treatment failure and no known resistance to any Odefsey component.

Safety information

Side effects

Common side effects of Odefsey include headache and sleep disturbances. Serious side effects include severe skin or allergic reactions, liver injury, severe depression, new or worsening kidney problems, lactic acidosis (a buildup of lactic acid in the blood), and severe liver enlargement with fat buildup. Severe worsening of hepatitis B and immune reconstitution syndrome, in which the immune system reacts as it recovers, are also listed. Contact a doctor promptly if you suspect a serious side effect. Severe depression needs immediate medical evaluation. Stop treatment and seek immediate medical attention if you develop a severe allergic reaction or a rash with symptoms affecting other parts of the body. Taking Odefsey with medicines known to prolong the QTc interval, a measure of the heart’s electrical activity, may increase the risk of a serious abnormal heart rhythm called Torsade de Pointes. Kidney tests are needed before and during treatment; liver monitoring may also be needed.

FDA boxed warning

Post treatment acute exacerbation of hepatitis b

Severe acute exacerbations of hepatitis B have been reported in patients with HIV-1 and HBV who have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of ODEFSEY.

Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients with HIV-1 and HBV who discontinue ODEFSEY. If appropriate, anti-hepatitis B therapy may be warranted.

A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.

When to call your doctor

- Seek medical attention immediately for a rash accompanied by symptoms affecting other parts of your body. - Seek medical attention immediately for severe depression.

If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.

Before taking this medicine

Do not take Odefsey with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, systemic dexamethasone given as more than a single dose, or St. John’s wort. Do not take it with proton pump inhibitors such as dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole or rabeprazole. These combinations can reduce treatment effectiveness and may lead to drug resistance. Odefsey requires caution in people with liver disease, abnormal liver tests or kidney problems. Liver monitoring may be needed, and kidney function should be assessed before and during treatment. Taking Odefsey with medicines known to prolong the QT interval can increase the risk of a serious abnormal heart rhythm called torsade de pointes. Severe skin and allergic reactions have been reported. Stop treatment and seek immediate medical attention if an allergic reaction develops, or if a rash occurs with symptoms affecting the rest of the body or abnormal liver tests. Severe depression requires immediate medical evaluation. Treatment must also be stopped if symptoms or test results suggest lactic acidosis (a buildup of lactic acid in the blood) or significant liver toxicity. Immune reconstitution syndrome may require further assessment and treatment. Odefsey is not recommended for patients weighing less than 25 kg. During pregnancy, exposure to rilpivirine is generally lower than after delivery.

Interactions

Odefsey is a complete treatment regimen for HIV-1, so taking it with other antiretroviral medicines for HIV-1 is not recommended. Ask your doctor to check the full prescribing information for important drug interactions before and during treatment.

Using Odefsey

Dosing

Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.

Storage

Store below 25°C in a dry place, in the original pack, away from direct light and moisture. Do not keep it in a bathroom. Keep all medicines out of the sight and reach of children.

Clinical information on this page is summarised from the US FDA label ODEFSEY (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR ALAFENAMIDE) TABLET [GILEAD SCIENCES, INC.] (DailyMed, retrieved 19 September 2026).

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