What is the most important information I should know about tenofovir? What should I discuss with my healthcare provider before taking tenofovir?

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1 1 of 6 6/10/2016 4:33 PM Generic Name: tenofovir (ten OF oh vir) Brand Name: Viread What is tenofovir? Tenofovir is an antiviral medicine that prevents human immunodeficiency virus (HIV) or hepatitis B from multiplying in your body. Tenofovir is used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). Tenofovir is not a cure for HIV or AIDS. Tenofovir is also used to treat chronic hepatitis B. Tenofovir may also be used for purposes not listed in this medication guide. What is the most important information I should know about tenofovir? Do not take tenofovir together with adefovir (Hepsera), or with combination medicines that contain tenofovir (Atripla, Complera, Genvoya, Odefsey, Stribild, or Truvada). 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. Tenofovir can also cause severe or life-threatening effects on your liver. Call your doctor at once if you have: nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). What should I discuss with my healthcare provider before taking tenofovir? You should not take tenofovir if you are allergic to it. Do not take tenofovir together with adefovir (Hepsera), or with combination medicines that contain tenofovir (Atripla, Complera, Genvoya, Odefsey, Stribild, or Truvada). Tenofovir should not be given to a child with HIV who is younger than 2 years old. Tenofovir should not be used to treat hepatitis B in a child younger than 12 years old. To make sure tenofovir is safe for you, tell your doctor if you have: liver disease (especially hepatitis B if you also have HIV); kidney disease; or 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.

2 2 of 6 6/10/2016 4:33 PM This medication is not expected to be harmful to an unborn baby, but 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. 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 tenofovir on the baby. Tenofovir can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using tenofovir to treat hepatitis B. 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. How should I take tenofovir? Before you start treatment with tenofovir, your doctor may perform tests to make sure you do not have HIV (if you are being treated for hepatitis B) or hepatitis B (if you are being treated for HIV). Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions. Tenofovir tablets may be taken with or without food. Take the medicine at the same time each day. Tenofovir oral powder should be taken with food. Mix the powder with soft food such as applesauce, yogurt, or baby food. Do not mix tenofovir oral powder with liquid. If a child is taking this medication, tell your doctor if the child has any changes in weight. Tenofovir doses are based on weight in children. While using tenofovir, you may need frequent blood tests. Your liver and kidney function may also need to be checked. Use tenofovir regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. 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 at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use. 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 tenofovir. Visit your doctor regularly. What happens if I miss a dose? Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled 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

3 3 of 6 6/10/2016 4:33 PM What should I avoid while taking tenofovir? Avoid drinking alcohol. It may increase your risk of liver damage. 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. Tenofovir side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Early symptoms of lactic acidosis may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms: 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: sore throat, flu symptoms, easy bruising or unusual bleeding; kidney problems--little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; or liver problems--nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Tenofovir 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 with tenofovir. Tell your doctor if you have: signs of a new infection--fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss; chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath; cold sores, sores on your genital or anal area; rapid heart rate, 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: nausea, vomiting, diarrhea; fever, pain, weakness; headache, dizziness; depressed mood; sleep problems (insomnia); itching or rash; 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 FDA-1088.

4 4 of 6 6/10/2016 4:33 PM See also: Side effects (in more detail) Tenofovir dosing information Usual Adult Dose for HIV Infection: 300 mg orally once a day Approved indication: In combination with other antiretroviral agents, for the treatment of HIV-1 infection Usual Adult Dose for Chronic Hepatitis B: 300 mg orally once a day Duration of therapy: The optimum duration is not known. Usual Adult Dose for Occupational Exposure: (Not approved by FDA) US Public Health Service working group recommendations: 300 mg orally once a day Duration of therapy: 28 days, if tolerated -Tenofovir plus emtricitabine plus raltegravir is recommended as the preferred regimen for HIV postexposure prophylaxis; tenofovir is also recommended as a component in various alternative regimens. -Prophylaxis should be started as soon as possible, preferably within hours after exposure. -The optimal duration of prophylaxis is unknown and may differ based on the institution's protocol. -The most current therapeutic guidelines should be consulted for more information. Usual Adult Dose for Nonoccupational Exposure: (Not approved by FDA) CDC recommendations: 300 mg orally once a day Duration of therapy: 28 days -Tenofovir should be used in combination with efavirenz plus (emtricitabine or lamivudine). -Prophylaxis should be started as soon as possible, within 72 hours of exposure. Usual Pediatric Dose for HIV Infection: 2 to less than 12 years: 8 mg/kg orally once a day Maximum dose: 300 mg per dose Dosage based on body weight for pediatric patients 2 years or older: Using oral powder: 10 to less than 12 kg: 80 mg (2 scoops of powder) orally once a day 12 to less than 14 kg: 100 mg (2.5 scoops of powder) orally once a day 14 to less than 17 kg: 120 mg (3 scoops of powder) orally once a day 17 to less than 19 kg: 140 mg (3.5 scoops of powder) orally once a day 19 to less than 22 kg: 160 mg (4 scoops of powder) orally once a day

5 5 of 6 6/10/2016 4:33 PM 22 to less than 24 kg: 180 mg (4.5 scoops of powder) orally once a day 24 to less than 27 kg: 200 mg (5 scoops of powder) orally once a day 27 to less than 29 kg: 220 mg (5.5 scoops of powder) orally once a day 29 to less than 32 kg: 240 mg (6 scoops of powder) orally once a day 32 to less than 34 kg: 260 mg (6.5 scoops of powder) orally once a day 34 to less than 35 kg: 280 mg (7 scoops of powder) orally once a day 35 kg or greater: 300 mg (7.5 scoops of powder) orally once a day Using tablets: 17 to less than 22 kg: 150 mg orally once a day 22 to less than 28 kg: 200 mg orally once a day 28 to less than 35 kg: 250 mg orally once a day 35 kg or greater: 300 mg orally once a day -Weight should be monitored periodically and the tenofovir dose should be adjusted accordingly. -Safety and efficacy for treatment of HIV-1 have not been established in patients younger than 2 years. 12 years or older (35 kg or more): 300 mg orally once a day Approved indication: In combination with other antiretroviral agents, for the treatment of HIV-1 infection Usual Pediatric Dose for Chronic Hepatitis B: 12 years or older (35 kg or more): 300 mg orally once a day Duration of therapy: The optimum duration is not known. -Safety and efficacy for treatment of chronic HBV have not been established in patients younger than 12 years or less than 35 kg. What other drugs will affect tenofovir? Tenofovir 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). Tell your doctor about all your current medicines and any you start or stop using, especially: atazanavir (Reyataz); darunavir (Prezista); didanosine (Videx); ledipasvir and sofosbuvir (Harvoni); or lopinavir and ritonavir (Kaletra). This list is not complete. Other drugs may interact with tenofovir, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Where can I get more information?

6 6 of 6 6/10/2016 4:33 PM Your pharmacist can provide more information about 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 Cerner Multum, Inc. Version: Revision Date: , 2:50:36 PM.

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