and because the emtricitabine, rilpivirine, and tenofovir Generic Name: emtricitabine, rilpivirine, and tenofovir (em trye SYE ta been, RIL pi VIR een, and ten OF oh vir) Brand Name: Complera, Odefsey Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings User Reviews Support Group Q & A What is emtricitabine, rilpivirine, and tenofovir? Emtricitabine, rilpivirine, and tenofovir are antiviral medicines that prevent human immunodeficiency virus (HIV) from multiplying in your body. Emtricitabine, rilpivirine, and tenofovir is a combination medicine used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). This medicine is not a cure for HIV or AIDS. This medicine is for use in adults and children who are at least 12 years old and who have never taken HIV medicines before. Emtricitabine, rilpivirine, and tenofovir should not be taken together with other antiviral medications to treat HIV or AIDS. Emtricitabine, rilpivirine, and tenofovir may also be used for purposes not listed in this medication guide. Slideshow Save Your Blushes - The FAQ's On STDs What is the most important information I should know about this medicine? There are many other drugs that can make rilpivirine less effective and should not be used at the same time. Tell your doctor about all your the medicines you use. This medicine may cause a serious condition called lactic acidosis. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired. If you have hepatitis B you may develop liver symptoms after you stop taking this medicine. Your doctor may want to check your liver function for several months after you stop using this medicine. What should I discuss with my healthcare provider before taking this medicine? You should not take this medicine if you are allergic to emtricitabine, rilpivirine, or tenofovir. Do not take this medicine with other medicines that also contain emtricitabine, rilpivirine, tenofovir, adefovir, or lamivudine. There are many other drugs that can make rilpivirine less effective and should not be used at the same time: dexamethasone; St. John's wort; tuberculosis medication--rifabutin, rifampin, rifapentine; seizure medicine--carbamazepine, oxcarbazepine, phenobarbital, phenytoin; or stomach acid reducers--dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole. To make sure this medicine is safe for you, tell your doctor if you have ever had: kidney disease; liver disease (including hepatitis B or C); a history of depression or mental illness; a personal or family history of Long QT syndrome; or osteoporosis, or osteopenia (low bone mineral density). Some people taking tenofovir develop a serious condition called lactic acidosis. This may be more likely in women, in people who are overweight or have liver disease, and in people who have taken HIV/AIDS medication for a long time. Talk with your doctor about your risk. HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection. Tell your doctor if you become pregnant during treatment. If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of the medicine on the baby. Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk. This medicine is not approved for use by anyone younger than 12 years old. How should I take this medicine? Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Always take this medicine with food. If a child is using this medicine, tell your doctor if the child has any changes in weight. Doses are based on weight in children, and any changes may affect your child's dose. While using this medicine, you may need frequent blood tests. Your bone density may also need to be tested. If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function for several months after you stop using this medicine. HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor. Store in original container at room temperature away from moisture and heat. What happens if I miss a dose? Take the missed dose as soon as you remember. Be sure to take the medicine with a meal. If you are more than 12 hours late, skip the missed dose. Do not take extra medicine to make up the missed dose. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while taking this medicine? Taking this medicine will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person. If you also take an antacid, take it at least 2 hours before or 4 hours after taking Complera or Odefsey. If you also take a heartburn or GERD medicine (such as Tagamet, Pepcid, Zantac), take it at least 12 hours before or 4 hours after taking Complera or Odefsey. This medicine side effects Get emergency medical help if you have signs of an allergic reaction: hives, blistering skin rash with fever; mouth sores, eye redness; difficulty breathing; swelling of your face, lips, tongue, or throat. Some people develop lactic acidosis while taking HIV medication. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired. Call your doctor at once if you have: confusion, severe depression, unusual thoughts or behavior, suicidal thoughts or actions; increased thirst and urination, loss of appetite, weakness, constipation; kidney problems--little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; liver problems--swelling around your midsection, upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or signs of inflammation in your body--swollen glands, flu symptoms, easy bruising or bleeding, severe tingling or numbness, muscle weakness, upper stomach pain, jaundice (yellowing of the skin or eyes), chest pain, new or worsening cough with fever, trouble breathing; This medicine may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment. Tell your doctor if you have: signs of a new infection--fever, night sweats, swollen glands, diarrhea, weight loss; chest pain (especially when you breathe), dry cough, wheezing; cold sores, sores on your genital or anal area; feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement; trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex. Common side effects may include: headache, dizziness, tiredness; depressed mood, sleep problems (insomnia), strange dreams; rash; nausea, diarrhea; or changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist). This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Side Effects (complete list) Emtricitabine, rilpivirine, and tenofovir dosing information Usual Adult Dose for HIV Infection: At least 35 kg: 1 tablet orally once a day with a meal Comments: -Patients should be tested for HBV infection before starting this drug. -In all patients, estimated CrCl, urine glucose, and urine protein should be assessed before starting emtricitabine/rilpivirine/tenofovir alafenamide and should be monitored during therapy. -Replacement of current regimen with emtricitabine/rilpivirine/tenofovir disoproxil fumarate (DF) may be considered for virologically-suppressed patients if: patients have no history of virologic failure; patients have been stably suppressed (HIV-1 RNA less than 50 copies/mL) for at least 6 months before switching therapy; patients are currently on their first or second antiretroviral regimen before switching therapy; patients have no history of resistance to any of the 3 components. -After replacing therapy in virologically-suppressed patients, additional monitoring of HIV-1 RNA and regimen tolerability recommended to assess potential virologic failure or rebound. Use: As a complete regimen for the treatment of HIV-1 infection: -Emtricitabine/rilpivirine/tenofovir alafenamide: As initial therapy in patients with no antiretroviral treatment history and with HIV-1 RNA up to 100,000 copies/mL, or to replace a stable antiretroviral regimen in patients who are virologically-suppressed (HIV-1 RNA less than 50 copies/mL) for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components -Emtricitabine/rilpivirine/tenofovir DF: In patients with no antiretroviral treatment history and with HIV-1 RNA up to 100,000 copies/mL at the start of therapy, and in certain virologically-suppressed (HIV-1 RNA less than 50 copies/mL) patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen Usual Pediatric Dose for HIV Infection: 12 years or older and at least 35 kg: 1 tablet orally once a day with a meal Comments: -Patients should be tested for HBV infection before starting this drug. -In all patients, estimated CrCl, urine glucose, and urine protein should be assessed before starting emtricitabine/rilpivirine/tenofovir alafenamide and should be monitored during therapy. -Replacement of current regimen with emtricitabine/rilpivirine/tenofovir DF may be considered for virologically-suppressed patients if: patients have no history of virologic failure; patients have been stably suppressed (HIV-1 RNA less than 50 copies/mL) for at least 6 months before switching therapy; patients are currently on their first or second antiretroviral regimen before switching therapy; patients have no history of resistance to any of the 3 components. -After replacing therapy in virologically-suppressed patients, additional monitoring of HIV-1 RNA and regimen tolerability recommended to assess potential virologic failure or rebound. Use: As a complete regimen for the treatment of HIV-1 infection: -Emtricitabine/rilpivirine/tenofovir alafenamide: As initial therapy in patients with no antiretroviral treatment history and with HIV-1 RNA up to 100,000 copies/mL, or to replace a stable antiretroviral regimen in patients who are virologically-suppressed (HIV-1 RNA less than 50 copies/mL) for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components -Emtricitabine/rilpivirine/tenofovir DF: In patients with no antiretroviral treatment history and with HIV-1 RNA up to 100,000 copies/mL at the start of therapy, and in certain virologically-suppressed (HIV-1 RNA less than 50 copies/mL) patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen What other drugs will affect emtricitabine, rilpivirine, and tenofovir? This medicine can harm your kidneys. This effect is increased when you also use certain other medicines, including: antivirals, chemotherapy, injected antibiotics, medicine for bowel disorders, medicine to prevent organ transplant rejection, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve). Many drugs can interact with emtricitabine, rilpivirine, and tenofovir, and some drugs should not be used together. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with emtricitabine, rilpivirine, and tenofovir. Give a list of all your medicines to any healthcare provider who treats you. Next Side Effects Print this page Add to My Med List More about emtricitabine/rilpivirine/tenofovir Side Effects During Pregnancy Dosage Information Drug Interactions Support Group 57 Reviews Add your own review/rating Drug class: antiviral combinations Consumer resources Emtricitabine, Rilpivirine, and Tenofovir Disoproxil Fumarate Emtricitabine, rilpivirine, and tenofovir (Advanced Reading) Other brands: Complera Professional resources Emtricitabine, Rilpivirine, and Tenofovir Disoproxil Fumarate (Wolters Kluwer) Related treatment guides HIV Infection Where can I get more information? Your pharmacist can provide more information about emtricitabine, rilpivirine, and tenofovir. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist. Copyright 1996-2012 Cerner Multum, Inc. Version: 3.07. Date modified: December 03, 2017 Last reviewed: July 11, 2017} Drug Status Rx Availability Prescription only B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class Antiviral combinations Related Drugs HIV Infection Truvada , Atripla , Norvir , Viread , Isentress , Prezista , Stribild , lamivudine , abacavir , tenofovir , Epzicom , Reyataz , ritonavir , Complera , darunavir , emtricitabine , Kaletra , Intelence , Sustiva , Epivir , efavirenz , nevirapine , atazanavir , raltegravir , Selzentry , More... Emtricitabine / rilpivirine / tenofovir Rating 57 User Reviews 8.4 /10 57 User Reviews 8.4 Rate it! Help and Support Looking for answers? Ask a question or go join the emtricitabine / rilpivirine / tenofovir support group to connect with others who have similar interests.} } extensive
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