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Emtricitabine / Rilpivirine / Tenofovir Alafenamide

Emtricitabine / Rilpivirine / Tenofovir Alafenamide

Brand Name: Odefsey Other Names: FTC / RPV / TAF, emtricitabine / rilpivirine / tenofovir AF, emtricitabine / rilpivirine / tenofovir alafenamide fumarate, emtricitabine / rilpivirine hydrochloride / tenofovir AF, emtricitabine / rilpivirine hydrochloride / tenofovir alafenamide, emtricitabine / rilpivirine hydrochloride / tenofovir alafenamide fumarate Drug Class: Combination Drugs

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WARNING:

WARNING:

Odefsey can cause serious, life-threatening side effects. These include lactic acidosis (buildup of lactic acid in the blood), liver problems, severe skin rash and allergic reactions, and depression or mood changes.

Contact your health care provider right away if you have any of the following symptoms that could be signs of lactic acidosis:

  • Weakness or tiredness
  • Unusual (not normal) muscle pain
  • Trouble breathing
  • Stomach pain with nausea and vomiting
  • Feeling cold, especially in your arms and legs
  • Dizziness or lightheadedness
  • Fast or irregular heartbeat

Contact your health care provider right away if you have any of the following symptoms that could be signs of liver problems:

  • Yellowing of your skin or the whites of your eyes (jaundice)
  • Dark-colored urine
  • Light-colored bowel movements
  • Loss of appetite
  • Nausea
  • Pain, aching, or tenderness on the right side of your stomach area (abdominal pain)

If you get a rash with any of the following symptoms, stop taking Odefsey and call your health care provider or get medical help right away:

  • Fever
  • Skin blisters
  • Mouth sores
  • Redness or swelling of the eyes (conjunctivitis)
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble breathing or swallowing
  • Pain on the right side of the stomach (abdominal) area
  • Dark-colored urine

Contact your health care provider right away if you have any of the following symptoms that could be signs of depression or mood changes:

  • Feeling sad or hopeless
  • Feeling anxious or restless
  • Having thoughts of or having attempted to commit suicide or hurt yourself

Odefsey is not approved for the treatment of hepatitis B virus (HBV) infection. If you have both HIV and HBV infection and take Odefsey, your HBV infection may get worse (flare up) if you stop taking Odefsey.

While taking Odefsey, it is important to keep all of your appointments with your health care provider.

What is Odefsey?

What is Odefsey?

Odefsey is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the following uses:

  • To treat HIV infection in adults and children 12 years of age and older who:
    • have never taken HIV medicines before, and
    • have a viral load (the amount of HIV in a sample of blood) that is no more than 100,000 copies/mL.
  • To replace currently used HIV medicines in adults and children 12 years of age and older who:
    • have been on the same HIV medicine regimen for at least 6 months, and
    • have a viral load that is less than 50 copies/mL, and
    • have never had treatment failure (treatment failure is when an HIV treatment regimen is unable to control HIV infection), and
    • have no drug resistance mutations associated with any of the HIV medicines in Odefsey (drug resistance mutations are changes in the genetic material of HIV that cause the virus to become insensitive to certain HIV medicines).

Odefsey is a complete regimen for the treatment of HIV infection and should not be used with other HIV medicines.

Odefsey contains the following three different medicines combined in one pill:

Both NNRTIs (such as rilpivirine) and NRTIs (such as emtricitabine and tenofovir alafenamide) block an HIV enzyme called reverse transcriptase. (An enzyme is a protein that starts or increases the speed of a chemical reaction.) By blocking reverse transcriptase, the three drugs in combination prevent HIV from multiplying and can reduce the amount of HIV in the body.

HIV medicines can’t cure HIV/AIDS, but taking a combination of HIV medicines (called an HIV regimen) every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission.

What should I tell my health care provider before taking Odefsey?

What should I tell my health care provider before taking Odefsey?

Before taking Odefsey, tell your health care provider:

  • If you are allergic to any of the HIV medicines in Odefsey (emtricitabine, rilpivirine, or tenofovir alafenamide) or any other medicines.
  • If you have liver problems, including hepatitis B virus (HBV) infection or hepatitis c virus (HCV) infection.
  • If you have kidney problems.
  • If you have a history of depression or suicidal thoughts.
  • If you have bone problems.
  • If you have any other medical conditions.
  • If you are pregnant or plan to become pregnant. Whether Odefsey can harm an unborn baby is unknown. Talk to your health care provider about possible risks with taking Odefsey when pregnant.
  • If you are breastfeeding or plan to breastfeed. Do not breastfeed if you are infected with HIV or are taking Odefsey.
  • If you are using hormone-based birth control (such as pills, implants, or vaginal rings). For more information about using birth control and HIV medicines at the same time, view the AIDSinfo HIV and Birth Control infographic.
  • About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Odefsey may affect the way other medicines or products work, and other medicines or products may affect how Odefsey works. Taking Odefsey together with certain medicines or products may cause serious side effects.

How should I take Odefsey?

How should I take Odefsey?

Odefsey comes in tablet form. Each tablet contains:

Take Odefsey according to your health care provider’s instructions.

Take Odefsey one time each day with a meal. Do not take Odefsey with other HIV medicines.

If you take too much Odefsey, contact your health care provider or local poison control center (1-800-222-1222) right away, or go to the nearest hospital emergency room.

For more information on how to take Odefsey, see the FDA drug label from DailyMed. (DailyMed is a federal website that includes the most recent drug labels submitted to FDA.)

What should I do if I forget a dose?

What should I do if I forget a dose?

If you miss a dose of Odefsey, take the missed dose as soon as you remember it. But if it is almost time for your next dose, skip the missed dose and just take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose.

What side effects can Odefsey cause?

What side effects can Odefsey cause?

Odefsey may cause side effects. Most side effects from Odefsey are manageable, but a few can be serious. Serious side effects of Odefsey include lactic acidosis (buildup of lactic acid in the blood), liver problems, severe skin rash and allergic reactions, and depression or mood changes. (See the WARNING box above).

Other possible side effects of Odefsey include:

  • Changes in liver enzyme levels in the blood.
  • New or worsening kidney problems, including kidney failure.
  • Bone problems (bone pain, softening, or thinning [osteopenia]).
  • Changes in body fat (including gain or loss of fat).
  • Immune reconstitution inflammatory syndrome (IRIS), a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.
  • Nausea.
  • Trouble sleeping (insomnia).
  • Headache.

Tell your health care provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Odefsey. To learn more about possible side effects of Odefsey, read the drug label or package insert or talk to your health care provider or pharmacist.

The AIDSinfo fact sheet on HIV Medicines and Side Effects also includes information that may apply to Odefsey.

You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online at https://www.accessdata.fda.gov/scripts/medwatch/.

How should Odefsey be stored?

How should Odefsey be stored?

  • Store Odefsey below 86°F (30°C).
  • Keep Odefsey in the container that it came in and keep the container tightly closed. If the container has a small packet of drying agent (called a desiccant), do not remove it. The desiccant protects the medicine from moisture.
  • Do not use Odefsey if the original seal over the container opening is broken or missing.
  • Throw away Odefsey that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
  • Keep Odefsey and all medicines out of reach of children.

Where can I find more information about Odefsey?

Where can I find more information about Odefsey?

More information about Odefsey is available:

Manufacturer Information

Gilead Sciences, Inc.
Main number: 800-445-3235
Patient assistance: 800-226-2056

The above Patient Version drug summary is based on the following FDA label(s): Tablet.

Last Reviewed: January 25, 2017

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