Odefsey (Emtricitabine / Rilpivirine Hydrochloride / Tenofovir Alafenamide)

Emtricitabine, Rilpivirine, and Tenofovir (em tri sit' uh bean) (ril'' pi vir' een) (te noe' fo veer) Complera® (as a combination product containing Emtricitabine, Rilpivirine, Tenofovir) Odefsey® (as a combination product containing Emtricitabine, Rilpivirine, Tenofovir) The combination of emtricitabine, rilpivirine, and tenofovir may cause life-threatening damage to the liver and a potentially life-threatening condition called lactic acidosis (buildup of lactic acid in the blood) when used alone or in combination with other medications that treat human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS). Tell your doctor if you have or have ever had liver disease. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: nausea, vomiting, pain in the upper right part of your stomach, loss of appetite, flu-like symptoms, extreme tiredness, unusual bleeding or bruising, weakness, dizziness, lightheadedness, fast or irregular heartbeat, trouble breathing, dark yellow or brown urine, light-colored bowel movements, yellowing of the skin or eyes, feeling cold, especially in the arms or legs, or muscle pain that is different than any muscle pain you usually experience. Emtricitabine, rilpivirine, and tenofovir should not be used to treat hepatitis B virus infection (HBV; an ongoing liver infection). Tell your doctor if you have or think you may have HBV. Your doctor may test you to see if you have HBV before you begin your treatment with emtricitabine, rilpivirine, and tenofovir. If you have HBV and you take emtricitabine, rilpivirine, and tenofovir, your condition may suddenly worsen when you stop taking emtricitabine, rilpivirine, and tenofovir. Your doctor will examine you and order lab tests regularly for several months after you stop taking emtricitabine, rilpivirine, and tenofovir to see if your HBV has worsened. Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to emtricitabine, rilpivirine, and tenofovir. Talk to your doctor about the risks of taking emtricitabine, rilpivirine, and tenofovir.

The combination of emtricitabine, rilpivirine, and tenofovir is used to treat HIV in adults and children 12 years of age and older. Emtricitabine, rilpivirine, and tenofovir are in a class of medications called nucleoside and nucleotide reverse transcriptase inhibitors (NRTIs). They work by slowing the spread of HIV in the body. Although emtricitabine, rilpivirine, and tenofovir will not cure HIV, these medications may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer. Taking these medications along with practicing safer sex and making other lifestyle changes may decrease the risk of getting or transmitting the HIV virus to other people.

The combination of emtricitabine, rilpivirine, and tenofovir comes as a tablet to take by mouth. It is usually taken with a meal (not just a protein drink) once a day. Take emtricitabine, rilpivirine, and tenofovir at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take emtricitabine, rilpivirine, and tenofovir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Your doctor may prescribe or recommend a calcium and vitamin D supplement to take during your treatment. You should take these supplements every day as directed by your doctor. Continue to take emtricitabine, rilpivirine, and tenofovir even if you feel well. Do not stop taking emtricitabine, rilpivirine, and tenofovir without talking to your doctor. Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Before taking emtricitabine, rilpivirine, and tenofovir, tell your doctor and pharmacist if you are allergic to emtricitabine, rilpivirine, and tenofovir, any other medications, or any of the ingredients in emtricitabine, rilpivirine, and tenofovir tablets. Ask your pharmacist for a list of the ingredients. tell your doctor if you are taking adefovir (Hepsera), carbamazepine (Carbatrol, Equetro, Tegretol, others), dexamethasone, dexlansoprazole (Dexilant), esomeprazole (Nexium, Vimovo), lansoprazole (Prevacid, in Prevpac), omeprazole (Prilosec, in Zegerid), oxcarbazepine (Oxtellar XR, Trileptal), pantoprazole (Protonix), phenobarbital, phenytoin (Dilantin, Phenytek), rabeprazole (AcipHex), rifampin (Rifadin, Rimactane, in Rifamate, in Rifater), rifapentine (Priftin), or St. John's wort. Your doctor will probably tell you not to take emtricitabine, rilpivirine, and tenofovir if you are taking one or more of these medications. tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: amiodarone (Cordarone, Nexterone, Pacerone); antibiotics such as clarithromycin (Biaxin, in Prevpac), erythromycin (E.E.S., Ery-Tab, Erythrocin, others), gentamicin, and telithromycin (Ketek); antifungal medications such as fluconazole (Diflucan), itraconazole (Onmel, Sporanox), ketoconazole (Extina, Nizoral), posaconazole (Noxafil), and voriconazole (Vfend); anti-tuberculosis (anti-TB) medications such as rifabutin (Mycobutin) and rilpivirine (Edurant); antiviral medications such as acyclovir (Sitavig, Zovirax), cidofovir, ganciclovir (Cytovene), valacyclovir (Valtrex), and valganciclovir (Valcyte); aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); cyclosporine (Gengraf, Neoral, Sandimmune); other medications for HIV or AIDS; and methadone (Dolophine). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. if you are taking antacids containing calcium, magnesium, or aluminum (Maalox, Mylanta, Tums, others), take the antacid 2 hours before or at least 4 hours after you take emtricitabine, rilpivirine, and tenofovir. if you are taking a medication for indigestion, heartburn, or ulcers such as cimetidine (Tagamet), famotidine (Pepcid, in Duexis), nizatidine (Axid), or ranitidine (Zantac), take it at least 12 hours before or at least 4 hours after emtricitabine, rilpivirine, and tenofovir. tell your doctor if you have or have ever had the conditions mentioned in the IMPORTANT WARNING section, kidney disease, depression or other mental illness, bone problems including osteoporosis (a condition in which the bones become thin and weak and break easily) or bone fractures, or any type of infection that does not go away or that comes and goes such as tuberculosis (TB; a type of lung infection) or cytomegalovirus (CMV; a viral infection that may cause symptoms in people with weak immune systems). tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking emtricitabine, rilpivirine, and tenofovir, call your doctor. You should not breastfeed if you are infected with HIV or if you are taking emtricitabine, rilpivirine, and tenofovir. you should know that emtricitabine, rilpivirine, and tenofovir may cause changes in your thoughts, behavior, or mental health. Call your doctor immediately if you develop any of the following symptoms while you are taking emtricitabine, rilpivirine, and tenofovir: new or worsening depression; feeling sad, hopeless, anxious, or restless; or thinking about killing yourself or planning or trying to do so. you should be aware that your body fat may increase or move to different areas of your body, such as your upper back, neck (''buffalo hump''), breasts, and around your stomach. You may notice a loss of body fat from your face, legs, and arms. you should know that while you are taking medications to treat HIV infection, your immune system may get stronger and begin to fight other infections that were already in your body. This may cause you to develop symptoms of those infections. If you have new or worsening symptoms at any time during your treatment with emtricitabine, rilpivirine, and tenofovir, be sure to tell your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it with food. However, if it has been more than 12 hours since your last dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Emtricitabine, rilpivirine, and tenofovir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away: difficulty falling asleep or staying asleep unusual dreams change in skin color pain, burning or tingling in the hands or feet headache diarrhea mild rash Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, call your doctor immediately or get emergency medical treatment: swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs ongoing or worsening bone pain muscle pain or weakness decreased urination If you develop a severe rash with any of the following symptoms, stop taking emtricitabine, rilpivirine, and tenofovir and call your doctor immediately or get emergency medical treatment: swollen face, lips, mouth, tongue or throat difficulty swallowing or breathing mouth sores or blisters on your body pink and swollen eyes fever dark urine pain on the right-side of stomach area yellowing of the skin or eyes Emtricitabine, rilpivirine, and tenofovir may cause other side effects. Call your doctor if you have any unusual problems while taking this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. Keep a supply of emtricitabine, rilpivirine, and tenofovir on hand. Do not wait until you run out of medication to refill your prescription. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.