Odefsey

Odefsey is a prescription medication used to treat HIV (Human Immunodeficiency Virus).

It is a single product containing 3 medications: emtricitabine, rilpivirine, and tenofovir alafenamide. 

Odefsey belongs to a group of drugs called antivirals. These help to decrease the amount of HIV in the blood. 

This medication comes in a tablet and is typically taken once a day, with food. 

Common side effects include depression, insomnia, headache, and nausea. 

Odefsey is a prescription medication used to treat HIV (Human Immunodeficiency Virus) in people 12 years of age and older:

• who have not received anti-HIV-1 medicines in the past and who have an amount of HIV-1 in their blood (this is called “viral load”) that is no more than 100,000 copies/mL, or
• to replace their current anti-HIV-1 medicines:
  • in people who have been on the same anti-HIV-1 medicine regimen for at least 6 months, and
  • who have an amount of HIV-1 in their blood that is less than 50 copies/mL, and
  • have never failed past HIV-1 treatment.

• Gilead Sciences, Inc.

The most common side effects of Odefsey include the following:

• trouble sleeping (insomnia)
• headache
• depression
• tiredness
• dizziness
• nausea
• stomach pain
• rash
• vomiting

This is not a complete list of Odefsey's side effects. Ask your doctor or pharmacist for more information.

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• an antacid medicine that contains aluminum, magnesium hydroxide, or calcium carbonate. If you take an antacid during treatment with Odefsey, take the antacid at least 2 hours before or at least 4 hours after you take Odefsey.
• a medicine to block the acid in your stomach, including cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), or ranitidine hydrochloride (Zantac). If you take one of these medicines during treatment with Odefsey, take the acid blocker at least 12 hours before or at least 4 hours after you take Odefsey.
• proton pump inhibitors such as dexlansoprazole (Dexilant), esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), and pantoprazole sodium (Protonix), and rabeprazole (Aciphex)
• carbamazepine (Tegretol, Carbatrol)
• dexamethasone (Decadron)
• oxcarbazepine (Trileptal)
• phenobarbital (Luminal), phenytoin (Dilantin), rifampin (Rifadin), and rifapentine (Priftin)
• St. John’s wort (Hypericum perforatum) or a product that contains St. John’s wort

If you take Odefsey, you should not take:

• other medicines that contain tenofovir (Viread, Truvada, Stribild, Atripla)
• other medicines that contain emtricitabine or lamivudine (Emtriva, Combivir, Epivir or Epivir-HBV, Epzicom, Trizivir, Atripla, Truvada, Stribild)
• rilpivirine (Edurant)
• adefovir (Hepsera)

This is not a complete list of all drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with this medication, including the following:

• Severe skin rash and allergic reactions. Skin rash is a common side effect of Odefsey. Rash can be serious. Call your healthcare provider right away if you get a rash. In some cases, rash and allergic reaction may need to be treated in a hospital. If you get a rash with any of the following symptoms, stop taking Odefsey and call your doctor or get medical help right away:
  • fever
  • skin blisters
  • swelling of the face, lips, mouth, or throat
  • trouble breathing or swallowing
  • mouth sores
  • pain on the right side of the stomach (abdominal) area
  • redness or swelling of the eyes (conjunctivitis)
  • dark “tea colored” urine
• Depression or mood changes. Tell your healthcare provider right away if you have any of the following symptoms:
  • feeling sad or hopeless
  • feeling anxious or restless
  • have thoughts of hurting yourself (suicide) or have tried to hurt yourself
• Change in liver enzymes. People with a history of hepatitis B or C virus infection or who have certain liver enzyme changes may have an increased risk of developing new or worsening liver problems during treatment with Odefsey. Liver problems can also happen during treatment with Odefsey in people without a history of liver disease. Your healthcare provider may need to do tests to check your liver enzymes before and during treatment with Odefsey.
• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider if you start having new symptoms after starting your HIV medicine.
• A build-up of an acid in your blood (lactic acidosis). Lactic acidosis can happen in some people who take Odefsey or similar (nucleoside analogs) medicines. Lactic acidosis is a serious medical emergency that can lead to death.
  • Lactic acidosis can be hard to identify early, because the symptoms could seem like symptoms of other health problems. Call your healthcare provider right away if you get any of the following symptoms which could be signs of lactic acidosis:
    • feeling very weak or tired
    • have unusual (not normal) muscle pain
    • have trouble breathing
    • have stomach pain with nausea (feel sick to your stomach)
    • vomiting
    • feel cold, especially in your arms and legs
    • feel dizzy or lightheaded
    • have a fast or irregular heartbeat
• Severe liver problems. Severe liver problems may happen in people who take Odefsey. In some cases, these liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis). Call your healthcare provider right away if you get any of the following symptoms of liver problems:
  • your skin or the white part of your eyes turns yellow (jaundice)
  • light-colored bowel movements (stools) o nausea o dark “tea-colored” urine
  • loss of appetite o pain, aching, or tenderness on the right side of your stomach area

You may be more likely to get lactic acidosis or severe liver problems if you are female, very overweight (obese), or have been taking Odefsey or a similar medicine containing nucleoside analog for a long time. 

• Worsening of Hepatitis B virus infection. Odefsey is not for use to treat chronic hepatitis B virus (HBV) infection. If you have hepatitis B virus (HBV) infection and take Odefsey, your HBV may get worse (flare-up) if you stop taking Odefsey. A “flare-up” is when your HBV infection suddenly returns in a worse way than before. 
• New or worse kidney problems, including kidney failure, can happen in some people who take Odefsey. Your healthcare provider should do blood tests to check your kidneys before starting treatment with Odefsey. If you have had kidney problems in the past or need to take another medicine that can cause kidney problems, your healthcare provider may need to do blood tests to check your kidneys during your treatment with Odefsey.

Do not take this medication if you are:

• allergic to Odefsey or to any of its ingredients
• taking the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin
• taking the antimycobacterials rifampin or rifapentine
• taking proton pump inhibitors, such as dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole
• taking the glucocorticoid systemic dexamethasone (more than a single dose)
• taking St. John's wort (Hypericum perforatum)

If you take Odefsey, you should not take:

• other medicines that contain tenofovir (Viread, Truvada, Stribild, Atripla)
• other medicines that contain emtricitabine or lamivudine (Emtriva, Combivir, Epivir or Epivir-HBV, Epzicom, Trizivir, Atripla, Truvada, Stribild)
• rilpivirine (Edurant)
• adefovir (Hepsera)

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Odefsey, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Odefsey, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Odefsey or to any of its ingredients
• have liver problems, including hepatitis B or C virus infection
• have kidney problems
• have ever had a mental health problem
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

There are insufficient human data on the use of this medication during pregnancy to inform a drug-associated risk of birth defects and miscarriage. 

There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is advisable to avoid breastfeeding because at least one of the drugs contained in this medication can be passed to the baby in breast milk. It is not known whether this could harm the baby.

Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in breast milk.

Talk with your healthcare provider about the best way to feed your baby.

Take Odefsey exactly as your healthcare provider tells you to take it.

• Stay under the care of your healthcare provider during treatment with Odefsey.
• Always take Odefsey with a meal. Taking Odefsey with a meal is important to help get the right amount of medicine in your body. A protein drink does not replace a meal.
• Do not change your dose or stop taking Odefsey without first talking with your healthcare provider. See your healthcare provider regularly while taking Odefsey.
• Do not take more than your prescribed dose to make up for a missed dose.
• When your Odefsey supply starts to run low, get more from your healthcare provider or pharmacy. It is very important not to run out of Odefsey. The amount of virus in your blood may increase if the medicine is stopped for even a short time.
• If you take too much Odefsey, contact your local poison control center or go to the nearest hospital emergency room right away.
• Do not stop taking Odefsey without first talking to your healthcare provider.
• If you stop taking Odefsey, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking Odefsey.

Avoid doing things that can spread HIV-1 infection to others.

• Do not share or re-use needles or other injection equipment.
• Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
• Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions, or blood.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose of Odefsey is one tablet taken once daily with a meal.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Odefsey below 68 °F (30 °C).
• Keep Odefsey in its original container and keep the container tightly closed.
• Keep this and all other medications out of the reach of children.

BOXED WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

• Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs in combination with other antiretrovirals.
• Odefsey is not approved for the treatment of chronic hepatitis B virus (HBV) infection, and the safety and efficacy of Odefsey have not been established in patients coinfected with HIV-1 and HBV. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine 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 who are coinfected with HIV-1 and HBV and discontinue Odefsey. If appropriate, initiation of anti-hepatitis B therapy may be warranted.