Uses
What is Odefsey used for?
Odefsey (emtricitabine/rilpivirine/tenofovir alafenamide) is commonly used to treat human immunodeficiency virus (HIV).
Odefsey may also be used for other conditions as determined by your healthcare provider.
How does Odefsey work (mechanism of action)?
People with HIV have a virus that spreads in their body and damages the immune system, making it easier for them to get very sick from other infections. Odefsey works to help stop the spread of HIV in your body. This helps protect and preserve the immune system and can prevent the virus from being spread to other people.
How is Odefsey supplied (dosage forms)?
Odefsey is available as 200 mg/25 mg/25 mg oral tablets that are taken by mouth.
How should I store Odefsey?
Odefsey should be stored in the original container at room temperature, below 86 F (30 C). Store tightly closed in a cool, dry place.
Side Effects
What are the most common side effects of Odefsey?
The most common side effects of Odefsey are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Headache
- Trouble sleeping
There may be other side effects of Odefsey that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Odefsey?
While less common, the most serious side effects of Odefsey are described below, along with what to do if they happen.
Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Odefsey. This can cause serious liver problems that can lead to death. Call your healthcare provider right away if you have any of the following symptoms of liver damage.
- Nausea or vomiting
- Stomach or belly pain
- Fever
- Weakness or unusual tiredness
- Itching
- Loss of appetite
- Light-colored poop
- Dark-colored urine (pee)
- Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
Depression. Depressed mood and suicidal thoughts have been reported in a small number of people taking one of the medicines in Odefsey. If you feel you are about to harm yourself or others, call 911 or call or text 988, the Suicide & Crisis Lifeline. Call your healthcare provider right away if you have any of the following symptoms.
- New or increased feelings of anxiety, depression, or other unusual changes in mood or behavior
- New or increased thoughts of suicide or death
- Suicide attempt
Kidney Damage. Kidney damage can happen when taking Odefsey. Call your healthcare provider right away if you have any of the following symptoms of kidney damage.
- Reduced need to pee
- Swelling in your feet, ankles, or legs
- Weakness or unusual tiredness
- Difficulty catching your breath or chest pain or pressure
- Confusion
- Nausea
- Seizures
Lactic Acidosis. Odefsey may cause lactic acidosis (a buildup of lactic acid in your blood), which can be serious. Stop taking Odefsey and get help right away if you have any of the following symptoms of lactic acidosis.
- General ill feeling
- Muscle pain
- Difficulty breathing
- Drowsiness
- Stomach pain
Immune System Changes. When you start Odefsey, your immune system might get stronger and start fighting infections that have been hiding inside your body for a long time. The type of symptoms you may have will depend on the infection. Tell your healthcare provider right away if you notice any of the following new symptoms of infection.
- Fever, sweats, chills, or muscle aches
- Swollen lymph nodes
- Vision problems
- Confusion, problems talking, or headache
- Skin problems such as a painful rash or warts
- Cough or coughing up blood
- Weakness or coordination problems
Severe Allergic Reactions. Odefsey may cause allergic reactions, including a specific type of allergic reaction called DRESS. DRESS stands for Drug Reaction with Eosinophilia and Systemic Symptoms. It is also sometimes called multi-organ hypersensitivity. This is a reaction that can affect multiple parts of the body including your liver, kidneys, and heart. Stop taking the medicine and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Itching, skin rash, or pale red bumps on the skin called hives
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Shortness of breath, trouble swallowing, or throat tightness
- Swelling in your feet, ankles, or legs
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
- Dark-colored pee
- Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
Warnings & Precautions
Who should not use Odefsey?
Allergies to Ingredients. People who are allergic to any of the following should not take Odefsey.
- Odefsey
- Emtricitabine
- Rilpivirine
- Tenofovir alafenamide
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Odefsey.
Drug Interactions. Odefsey should not be taken while you are using certain other medicines. Before taking Odefsey, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
What should I know about Odefsey before using it?
Do not take Odefsey unless it has been prescribed to you by a healthcare provider. Take it as prescribed.
Do not share Odefsey with other people, even if they have the same condition as you. It may harm them.
Keep Odefsey out of the reach of children.
Take each dose of Odefsey with food.
Taking antacids or supplements with Odefsey can make it not work as well. Talk with your healthcare provider about the best way to take antacids and supplements while taking Odefsey.
While Odefsey can help keep the HIV infection under control, it does not cure it. Also, Odefsey does not help protect against or prevent the spread of sexually transmitted infections (STI), like herpes, gonorrhea, or chlamydia.
If you have HIV and hepatitis B, stopping Odefsey can cause a serious flare-up, or worsening, of your hepatitis B. Your healthcare provider will test you for hepatitis B before or when starting this medicine. Do not run out of Odefsey or stop taking it without talking to your healthcare provider first. If you have HIV and hepatitis B and stop taking Odefsey, keep all appointments for blood work so your healthcare provider can check the health of your liver.
What should I tell my healthcare provider before using Odefsey?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Odefsey is right for you.
In particular, make sure that you discuss any of the following.
Current and Past Medical Conditions. Tell your healthcare provider if you have any of the following.
- Kidney problems
- Liver problems, including hepatitis B
- History of depression
Pregnancy. It is not known if or how Odefsey could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. If you become pregnant while taking Odefsey, you can register for the Antiretroviral Pregnancy Registry (APR) at www.apregistry.com. This registry collects safety information about the use of antiretroviral medicines during pregnancy.
Breastfeeding. Do not take Odefsey while you are breastfeeding. Odefsey passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. There may be risks with breastfeeding while taking Odefsey and having HIV.
How can I get more information about Odefsey?
For more information about Odefsey, you can visit the manufacturer’s website at www.odefsey.com or call them at 800-445-3235.
Interactions
Does Odefsey interact with foods or drinks?
There are no known interactions between Odefsey and foods or drinks.
It is unknown if drinking alcohol will affect Odefsey.
Does Odefsey interact with other medicines (drug interactions)?
Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are using any of the following before taking Odefsey.
- A medicine used to treat seizures, such as carbamazepine, oxcarbazepine, phenobarbital, or phenytoin
- Rifampin or rifapentine, which is a medicine commonly used to treat an infection called tuberculosis
- A proton pump inhibitor (PPI), such as esomeprazole (Nexium), lansoprazole (Prevacid), dexlansoprazole (Dexilant), omeprazole (Prilosec), pantoprazole (Protonix), or rabeprazole (Aciphex)
- An H2 blocker, such as cimetidine (Tagamet), famotidine (Pepcid, Zantac), or nizatidine (Axid)
- An antacid or supplement containing calcium, aluminum, or magnesium
- Dexamethasone, which is a medicine for certain inflammatory conditions
- St. John’s wort, which is a supplement that may be used to treat depression
- A nonsteroidal anti-inflammatory drug (NSAID), such as ibuprofen, naproxen, and others, which are contained in many prescription and OTC products for pain, swelling, and fever
- Any aminoglycoside antibiotic, such as amikacin or gentamicin, which is given by injection to treat infections
- A macrolide antibiotic, such as clarithromycin or erythromycin
- Fluconazole (Diflucan), ketoconazole, itraconazole (Sporanox, Tolsura), posaconazole (Noxafil), or voriconazole (Vfend), which is a medicine used for fungal infections
- Methadone, which is an opioid medicine used to treat pain or opioid use disorder
- Any antiviral medicine, such as acyclovir, valacyclovir, or ganciclovir
- Any other medicine for HIV or AIDS
- A medicine for hepatitis C
Some other medicines may alter the blood levels of Odefsey, and vice versa. Tell your healthcare provider about all medicines that you take or have recently taken.
This may not be a complete list of medicines that can interact with Odefsey. Always check with your healthcare provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Odefsey?
If you or someone else has used too much Odefsey, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Odefsey?
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.
Missing doses of Odefsey can cause it to not work as well over time. So it is important not to miss or skip doses.
Are you currently using Odefsey (emtricitabine/rilpivirine/tenofovir alafenamide)?
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