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  • Generic Name: (emtricitabine/rilpivirine/tenofovir alafenamide)
    Other Brands: N/A
  • Last Revised: 03/2016
    • What is this medication and its most common uses?

      Odefsey is a medicine used to treat HIV-1 infection. Odefsey contains three different medicines that work together: emtricitabine, rilpivirine, and tenofovir.

    • What should I know when beginning and continuing on this medication?

      How does this medication work?

      Odefsey works by blocking a chemical in your body that is needed for HIV-1 to multiply, thereby lowering the amount of HIV-1 in your blood.

      Odefsey does not cure HIV-1 infection or AIDS, and you may continue to experience illnesses associated with HIV-1 infection. See your healthcare provider regularly.

      What are the beneficial effects of this medication and when should I begin to have results?

      What: Odefsey may reduce the amount of HIV-1 in your blood, and increase the number of T cells (white blood cells that help your body fight infections).

      When: Everyone responds differently to treatment, so try to be patient and follow your healthcare provider's directions. It is important that you take Odefsey exactly as your healthcare provider has prescribed.

      How do I know it is working?

      Your healthcare provider may order tests regularly to check how well this medication is working.

    • What are the possible side effects of this medication?

      The following is not a full list of side effects. Side effects cannot be anticipated. If any develop or change in intensity, tell your healthcare provider as soon as possible. Only your healthcare provider can determine if it is safe for you to continue taking this medication.

      Odefsey can cause a serious condition called lactic acidosis (a build-up of an acid in the blood). This can be a medical emergency and may need to be treated in the hospital. Call your healthcare provider right away if you feel very weak, tired, dizzy, or lightheaded; have unusual muscle pain or stomach pain with nausea and vomiting; experience trouble breathing; feel cold, especially in your arms and legs; or have a fast or irregular heartbeat.

      Odefsey can also cause serious liver problems, with liver enlargement and fat in your liver. Call your healthcare provider right away if you develop yellowing of your skin or the whites of your eyes; dark-colored urine or light-colored stools; loss of appetite; nausea; or pain, aching, or tenderness on the right side of your stomach area.

      If you also have hepatitis B virus (HBV) infection and you stop taking Odefsey, you may get a "flare-up" of your hepatitis. A "flare-up" is when the disease suddenly returns in a worse way than before. If you have HBV and stop taking Odefsey, your healthcare provider may monitor you closely for several months to check for hepatitis that could be getting worse. Talk to your healthcare provider about appropriate HBV treatment if necessary.

      More common side effects may include: depressive disorders, trouble sleeping, headache, nausea.

      Less common side effects may include:

      Severe skin rash and allergic reactions, with symptoms such as fever; skin blisters; mouth sores; redness or swelling of the eyes; swelling of the face, lips, mouth, or throat; trouble breathing or swallowing; pain on the right side of the stomach area; or dark-colored urine.

      Depression or mood changes, with symptoms such as feeling sad or hopeless, feeling anxious or restless, having thoughts of hurting yourself, or trying to hurt yourself.

      Changes in body fat, with symptoms such as an increased amount of fat in the upper back and neck ("buffalo hump"), breast, and around the middle of your body (trunk).

      Changes in your immune system that 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.

      New or worse kidney problems, including kidney failure.

      Bone problems, with symptoms such as bone pain, softening, or thinning.

      Odefsey may also cause changes in your liver enzymes.

    • Who should not take this medication?

      Do not take Odefsey if you are allergic to it or any of its ingredients.

      Do not take Odefsey if you take certain medicines such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, dexamethasone, St. John's wort, or certain medicines that decrease the acidity in your stomach (such as omeprazole or lansoprazole).

    • What should I tell my healthcare provider before I take the first dose of this medication?

      Tell your healthcare provider about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Odefsey. Also, talk to your healthcare provider about your complete medical history, especially if you have liver problems (including hepatitis B or C virus infection), kidney or bone problems, or a history of depression or suicidal thoughts; or if you are pregnant, plan to become pregnant, or are breastfeeding.

    • What is the usual dosage?

      The information below is based on the dosage guidelines your healthcare provider uses. Depending on your condition and medical history, your healthcare provider may prescribe a different regimen. Do not change the dosage or stop taking your medication without your healthcare provider's approval.

      Adults and children ≥12 years and ≥35 kilograms: The recommended dose is 1 tablet once a day.

    • How should I take this medication?

      Take Odefsey exactly as prescribed by your healthcare provider. Do not change your dose or stop taking Odefsey without first talking to your healthcare provider.

      Take Odefsey with a meal.

      When your medicine starts to run low, get more from your healthcare provider or pharmacy. Do not run out of Odefsey. The virus in your blood may increase and the virus may become harder to treat.

    • What should I avoid while taking this medication?

      Do not do anything that can spread HIV-1 to others, such as sharing needles or other injection equipment, sharing personal items that can have blood or body fluids on them (such as toothbrushes or razor blades), or having any kind of unprotected sex.

    • What are the possible food and drug interactions associated with this medication?

      If Odefsey is taken with certain other drugs, the effects of either could be increased, decreased, or altered. Odefsey may interact with numerous medications. Therefore, it is very important that you tell your healthcare provider about any other medications you are taking.

    • May I receive this medication if I am pregnant or breastfeeding?

      The effects of Odefsey during pregnancy are unknown. Odefsey can be found in your breast milk if you take it while breastfeeding. Mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk. Tell your healthcare provider immediately if you are pregnant, plan to become pregnant, or are breastfeeding.

      If you become pregnant while taking Odefsey, talk to your healthcare provider about registering with the Antiretroviral Pregnancy Registry. The purpose of this registry is to collect information about the safety of this medicine during pregnancy.

    • What should I do if I miss a dose of this medication?

      If you miss a dose of Odefsey, take it as soon as you remember. However, if it is almost time for your next dose, skip the one you missed and return to your regular dosing schedule. Do not take two doses at once.

    • How should I store this medication?

      Store at room temperature.

    • Who should I contact in case of emergency or overdose?
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      In the event of a medical emergency call your doctor or 9-1-1 immediately. In the event of overdose, call your doctor or poison control for further instructions.
      National Poison Control#: Call 1-800-222-1222

      This PDR+ drug information has been developed by the Physicians’ Desk Reference Network (PDRN), a source of medication information trusted by doctors for over 65 years.

      This monograph summarizes the most important information about your medication and does not cover all the information you may need. If you have any questions or concerns or want to learn more about your medication, ask your healthcare provider; he/she will be able to provide answers to your questions. This medication should only be used by the patient for whom it was prescribed and should not be shared with other people.
    • Additional patient resources.
      back to top Use your PDR® Pharmacy Discount Card when you or a family member fills a prescription and ask for your PDR® Discount every
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    This discount plan is NOT insurance or a Medicare prescription drug plan. The plan is not intended as a substitute for insurance and does not meet creditable coverage requirements under state or federal law. The plan provides discounts at participating pharmacies on certain pharmaceutical supplies, prescription drugs, or medical equipment and supplies. The range of discounts will vary depending on the products received. Members are obligated to pay the pharmacy the entire amount of the discounted rate for such products at the point of sale. The plan does not pay pharmacies for products provided to members. No enrollment or periodic fees apply. The pharmacy may pay the plan a fee from amounts the pharmacy collects from the member. The discount plan organization is ProCare Pharmacy Benefit Manager, Inc.,1267 Professional Parkway, ProCare Office Park, Gainesville, GA 30507, 1-888-299-5383. Customer service is provided by PDR, LLC., 5 Paragon Drive, Montvale, NJ, 07645, 1-800-232-7379, www.pdr.net/DiscountCard, customerservice@pdr.net.