Truvada for prep is only for people who are at risk of getting hiv1 and weigh at least 77 pounds. Two medications have been approved for use as prep by the fda. Do not prescribe truvada for a prep indication to patients with hiv1 infection or. Highlights of prescribing information recommended dosage. Full prescribing information 1 indications and usage kaletra is indicated in combination with other antiretroviral agents for the treatment of hiv1 infection inadults and pediatric patients 14 days and older. Apr 14, 2019 truvada prep is used together with safersex practices to reduce the risk of becoming infected with hiv. Truvada is also used with other antiviral medicines to treat hiv1 in adults and children 12 years and older. Hematologic toxicity, myopathy, lactic acidosis and severe hepatomegaly with steatosis, and exacerbations of hepatitis b see full prescribing information for complete boxed warning. For additional information, consult the prescribing information for emtriva and viread. See 17 for patient counseling information and fdaapproved patient labeling. Truvada prep is used together with safersex practices to reduce the risk of becoming infected with hiv. Highlights of prescribing information these highlights do not include all the information needed to use isentress safely and effectively.
May 18, 2018 for additional information, consult the prescribing information for emtriva and viread. In hivinfected subjects, addition of tdf to atazanavir 300 mg plus ritonavir 100 mg, resulted in auc and c min values of atazanavir that were 2. What is the most important information you should know about taking truvada. Therefore, adjust the dosing interval of truvada in hiv1 infected adult patients with baseline creatinine clearance 3049 mlmin using. If you are being treated for hiv infection your doctor will prescribe truvada with other. Highlights of prescribing information recommended dose in. For additional information, please consult the prescribing information for emtriva and viread. Full prescribing information pi nourianz istradefylline. Only take truvada as part of a complete prevention strategy because truvada is not always effective in preventing a person from getting infected with hiv1. Most important information about truvada for prep before starting and while taking truvada for prep.
Full prescribing information 1 indications and usage veltassa is indicated for the treatment of hyperkalemia. Truvada is one of several medications that are currently used to treat human immunodeficiency virus hiv and hepatitis b virus infection. Agreement form for initiating truvada for preexposure. It is critical to achieving our goal of virtual elimination of new hiv infections by 2020, victorian minister for health jill hennessy said. National institutes of health nih recommends antiretroviral therapy art for all people with hivaids. The recommended dosage of descovy for treatment of hiv1 is one tablet taken orally once daily with or without food in. In the discover trial of hiv1 uninfected men and transgender women who have sex with men and who are at risk of hiv1 infection receiving descovy or truvada for hiv1 prep, genotyping was performed on participants found to be infected during the trial who had hiv1 rna. Safety information fact sheet for prescribers about truvada. Emtricitabinetenofovir is used both to treat and to prevent hivaids.
Tenofovir dfemtricitabine truvada treatment national hiv. Veltassa should not be used as an emergency treatment for lifethreatening hyperkalemia because of its delayed onset of action see clinical pharmacology 12. Information about truvada to reduce the risk of getting human immunodeficiency virus1 hiv1 infection will include both information directed to prescribers for education, as well as safety risk. Prep plan of action toolkit florida department of health.
Truvada should only be administered to hiv1 infected pediatric patients with body weight greater than or equal to 17 kg and who are able to swallow a whole tablet. Tenofovir alafenamideemtricitabine descovy treatment. Reyataz prescribing information bristolmyers squibb. Truvada emtricitabine and tenofovir disoproxil fumarate tablets, for oral use initial u.
The centers for disease control and prevention cdc recommends the use of emtricitabinetenofovir for preexposure prophylaxis prep for uninfected. It is the use of antiretroviral medication to prevent acquisition of hiv infection. A safe and effective dose of kaletra oral solution in this. Emtricitabinetenofovir, sold under the brand name truvada among others, is a medication. Highlights of prescribing information 3 prs 16 weeks 16 weeks. Important safety information about truvada to reduce the risk of getting hiv1 infection an easytounderstand guide on the most important safety information about truvada for a prep indication prescribing information prescribing information for truvada for a prep indication gilead sciences, inc. Truvada fda prescribing information, side effects and uses. Prep is used by people without hiv who are at risk of being exposed to hiv through sexual contact or injection drug use. You must be hivnegative and an adult to use truvada prep for this purpose. Truvada, innemtricitabinetenofovir disoproxil european. Gp and sexual health physician dr vincent cornelisse believes it is important to consider all. In developed countries, hivinfected mothers are generally recommended to not breastfeed due to slight risk of mothertochildren hiv transmission.
By being open to prescribing the drug and carefully screening and counseling patients, physicians can help ensure truvadas safe and appropriate use, says general internist and pediatrician henry ng, md, mph. Truvada emtricitabinetenofovir disoproxil fumarate tablets, for oral use initial u. Dailymed truvada emtricitabine and tenofovir disoproxil. Truvada medication information sheet for patients brand name. Please see the full prescribing information with medication guide. Use truvada for prep together with safer sex practices. Initiatingreauthorizing truvada for preexposure prophylaxis. Descovy is a twodrug fixed dose combination product containing 200 mg of emtricitabine ftc and 25 mg of tenofovir alafenamide taf. The truvada emtricitabinetenofovir disoproxil fumarate tablet label was recently updated to expand the indication to include pediatric patients weighing at least 12 kilograms and the addition of the following strength tablets 100150 mg, 3200 mg and 167250 mg. Learn about prep preventing new hiv infections clinicians.
Guidelines for the use of antiretroviral agents in adults and adolescents with hiv pdf. Highlights of prescribing information these highlights do not include all the information needed to use truvada safely and effectively. My personal health information includes information that i provide on my application for the program and. Do not use truvada for prep in uninfected individuals with crcl pdf created august 25, 2019, 4.
Of truvada for prep in undiagnosed hiv1 infection see full prescribing information for complete boxed warning. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Genotypic or phenotypic testing andor treatment history should guide the use of kaletra. Do not use truvada for prep in uninfected individuals with crcl truvada for prep should only be used in individuals confirmed to be hivnegative immediately prior to initiation, at least every 3 months while taking truvada, and upon an sti diagnosis. Important safety information about truvada for a preexposure. The national hiv curriculum is an aids education and training center aetc program supported by the health resources and services administration hrsa of the u. Truvada should only be administered to hiv1 infected pediatric patients with body weight greater than or equal to 17 kg and who are able to swallow a tablet. Important safety information about truvada to reduce the risk of getting human immunodeficiency virus1 hiv1 infection 8. Important safety information about truvada for a preexposure prophylaxis prep indication for uninfected individuals. For more information about the rems program for truvada for a prep indication, please log on to you may also obtain additional information and educational materials about the use of truvada.
Tenofovir dfemtricitabine truvada treatment national. Highlights of prescribing information recommended dosage in. See full prescribing information for complete boxed warning. Consult the full prescribing information prior to and during treatment for potentialdrug interactions. The pharmacokinetic data for tenofovir and ftc following administration of truvada in hiv1 uninfected adolescents weighing 35 kg and above are not available. Safety information fact sheet for prescribers about. Combivir lamivudine and zidovudine tablets, for oral use initial u. In hivinfected patients, addition of tenofovir df to atazanavir 300 mg plus ritonavir. Refer to the emtriva and viread prescribing information for pharmacokinetic information on the individual products in pediatric patients. Prtruvada emtricitabinetenofovir disoproxil fumarate. Tenofovir df viread treatment national hiv curriculum.
The pharmacokinetic data for tenofovir and ftc following administration of truvada in hiv1 uninfected adolescents weighing 35 kg. Truvada for prep preexposure prophylaxis is a prescription medicine that can help reduce the risk of getting hiv1 through sex, when taken every day and used together with safer sex practices. Truvada emtricitabine and tenofovir disoproxil fumarate tablets, for oral use. A brief guide for providers updated april 2016 daily emtricitabinetenofovir truvada is safe and effective for reducing the risk of hiv acquisition in sexually active men and women and injection drug users when used consistently. You must stay hivnegative to keep taking truvada for prep.
Hivprep agreement form university of california, berkeley. Despite these misgivings, truvada reduces the likelihood of hiv infection in sexually active highrisk populations. Hiv1 resistance substitutions may emerge in individuals with undetected hiv1 infection who are taking only truvada. With the hivprevention drug prep now available on the pbs, gp and sexual health physician dr vincent cornelisse talk to newsgp about how gps and patients can increase their knowledge of what has been described as a gamechanging medication. Oct 06, 2014 despite these misgivings, truvada reduces the likelihood of hiv infection in sexually active highrisk populations. For more information about truvada and its indication for prep, please see the full prescribing information and medication guide.
Important safety information about truvada for a pre. A rems goes beyond a drugs written prescribing information and can include a medication guide, communication plan. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including viread, a component of truvada. When prescribing truvada for prep, healthcare providers must. See full prescribing information for complete boxed. Posttreatment acute exacerbation of hepatitis b and risk of drug resistance with use of truvada for hiv1 preexposure prophylaxis prep in. Kaletra oral solution should not be used in preterm neonates in the immediate postnatal period because of possible toxicities. Truvada emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg is a prescription medicine used with other hiv1 medicines to treat hiv1 infection in people who weigh at least 35 kg 77 pounds. Prep is a game changer when it comes to hiv prevention. The availability of preexposure prophylaxis prep on the pharmaceutical benefits scheme pbs represents a breakthrough in ending the transmission of hiv in australia.
636 470 463 1142 569 1339 1484 1287 327 625 544 635 556 57 1087 1074 924 1108 867 1015 1514 550 88 1266 84 158 201 1077 117 1188 1425 1358