[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-seo-403331-105":3,"detail-sidebar-cat-0-en-105":81,"doc-detail-403331-en":131},{"code":4,"msg":5,"data":6},0,"ok",{"site_id":7,"language":8,"slug":9,"title":10,"keywords":11,"description":12,"schema_data":13,"social_meta":74,"head_meta":76,"extra_data":78,"updated_unix":80},105,"en","truvada-prescribing-information-highlights","TRUVADA - Prescribing Information - Highlights","","Prescribing information highlights for TRUVADA (emtricitabine and tenofovir disoproxil fumarate) tablets outline boxed warnings on posttreatment acute exacerbation of hepatitis B and the risk of drug resistance in HIV-1 PrEP when early infection is undiagnosed. It summarizes indications for HIV-1 treatment and HIV-1 pre-exposure prophylaxis, key dosing and required baseline monitoring, contraindications based on HIV-1 status, and major warnings covering renal impairment, immune reconstitution, bone mineral density changes, and lactic acidosis risk. Common adverse reactions for both treated HIV-1 patients and PrEP participants are listed.",{"@graph":14,"@context":73},[15,34,56],{"@type":16,"itemListElement":17},"BreadcrumbList",[18,23,27,31],{"item":19,"name":20,"@type":21,"position":22},"https://docshare.wps.com","Home","ListItem",1,{"item":24,"name":25,"@type":21,"position":26},"https://docshare.wps.com/document/","Document",2,{"item":28,"name":29,"@type":21,"position":30},"https://docshare.wps.com/document/healthcare/","Healthcare",3,{"item":32,"name":10,"@type":21,"position":33},"https://docshare.wps.com/document/truvada-prescribing-information-highlights/403331/",4,{"url":32,"name":10,"@type":35,"image":36,"author":41,"headline":10,"publisher":44,"fileFormat":47,"inLanguage":8,"description":12,"dateModified":48,"datePublished":49,"encodingFormat":47,"isAccessibleForFree":50,"interactionStatistic":51},"DigitalDocument",{"url":37,"@type":38,"width":39,"height":40},"https://docshare.wps.com/thumbnails/truvada-prescribing-information-highlights/403331.png","ImageObject",300,407,{"name":42,"@type":43},"Margaret","Person",{"url":19,"name":45,"@type":46},"DocShare","Organization","application/pdf","2026-10-31","2026-09-27",true,{"@type":52,"interactionType":53,"userInteractionCount":55},"InteractionCounter",{"@type":54},"ViewAction",14,{"@type":57,"mainEntity":58},"FAQPage",[59,65,69],{"name":60,"@type":61,"acceptedAnswer":62},"When must hepatitis B status be tested for TRUVADA use?","Question",{"text":63,"@type":64},"Test for hepatitis B virus infection prior to or when initiating TRUVADA. Monitor hepatic function closely in HBV-infected individuals who discontinue TRUVADA.","Answer",{"name":66,"@type":61,"acceptedAnswer":67},"What HIV-1 testing is required for TRUVADA used for HIV-1 PrEP?",{"text":68,"@type":64},"TRUVADA for HIV-1 PrEP must be prescribed only to individuals confirmed to be HIV-negative immediately prior to initiating and at least every 3 months during use. It should not be initiated if signs or symptoms of acute HIV infection are present unless negative status is confirmed.",{"name":70,"@type":61,"acceptedAnswer":71},"What key renal and bone safety precautions apply?",{"text":72,"@type":64},"Assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein on a clinically appropriate schedule; in chronic kidney disease, also assess serum phosphorus. Avoid TRUVADA with concurrent or recent use of nephrotoxic drugs and consider assessment of bone mineral density in individuals with risk factors.","https://schema.org",{"og:url":32,"og:type":75,"og:title":10,"og:site_name":45,"og:description":12},"article",{"robots":77,"canonical":32},"index,follow",{"doc_id":79,"site_id":7},403331,1790672037,{"code":4,"msg":82,"data":83},"success",[84,88,92,96,101,106,110,115,120,123,127],{"id":22,"doc_module":4,"doc_module_name":25,"category_name":85,"show_sort_weight":86,"slug":87},"Story & Novel",90,"story-novel",{"id":26,"doc_module":4,"doc_module_name":25,"category_name":89,"show_sort_weight":90,"slug":91},"Literature",80,"literature",{"id":33,"doc_module":4,"doc_module_name":25,"category_name":93,"show_sort_weight":94,"slug":95},"Exam",70,"exam",{"id":97,"doc_module":4,"doc_module_name":25,"category_name":98,"show_sort_weight":99,"slug":100},5,"Comic",60,"comic",{"id":102,"doc_module":4,"doc_module_name":25,"category_name":103,"show_sort_weight":104,"slug":105},6,"Technology",50,"technology",{"id":107,"doc_module":4,"doc_module_name":25,"category_name":29,"show_sort_weight":108,"slug":109},7,40,"healthcare",{"id":111,"doc_module":4,"doc_module_name":25,"category_name":112,"show_sort_weight":113,"slug":114},8,"Research & Report",30,"research-report",{"id":116,"doc_module":4,"doc_module_name":25,"category_name":117,"show_sort_weight":118,"slug":119},9,"Religion & Spirituality",20,"religion-spirituality",{"id":118,"doc_module":4,"doc_module_name":25,"category_name":121,"show_sort_weight":118,"slug":122},"World Cup","world-cup",{"id":124,"doc_module":4,"doc_module_name":25,"category_name":125,"show_sort_weight":124,"slug":126},10,"Lifestyle","lifestyle",{"id":128,"doc_module":4,"doc_module_name":25,"category_name":129,"show_sort_weight":97,"slug":130},19,"General","general",{"code":4,"msg":82,"data":132},{"doc_id":79,"user_id":133,"nickname":42,"user_avatar":134,"doc_module":4,"category_id":107,"category_name":29,"doc_title":10,"doc_description":12,"doc_content":135,"file_id":136,"file_url":137,"file_type":138,"file_size":139,"view_count":55,"is_deleted":4,"is_public":22,"is_downloadable":22,"audit_status":22,"page_count":140,"language":141,"language_code":8,"site_id":7,"html_lang":8,"table_of_contents":142,"faqs":143,"seo_title":144,"seo_description":12,"update_tm":145,"read_time":146,"preview_page_count":4},137451207643,"https://ap-avatar.wpscdn.com/davatar_3d24733baf745e90a7e4bdd5f77d97b2","HIGHLIGHTS OF PRESCRIBING INFORMATION  \nThese highlights do not include all the information needed to use TRUVADA safely and effectively. See full prescribing information for TRUVADA.  \nTRUVADA® (emtricitabine and tenofovir disoproxil fumarate) tablets, for oral use  \nInitial U.S. Approval: 2004  \nWARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B and RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION See full prescribing information for complete boxed warning.  \n• Severe acute exacerbations of hepatitis B (HBV) have been reported in HBV-infected individuals who have discontinued TRUVADA. Hepatic function should be monitored closely in these individuals who discontinue TRUVADA. If appropriate anti-hepatitis B therapy may be warranted. (5.1)  \n• TRUVADA used for HIV-1 PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and at least every 3 months during use. Drugresistant HIV-1 variants have been identified with the use of TRUVADA for HIV-1 PrEP following undetected acute HIV-1 infection. Do not initiate TRUVADA for HIV-1 PrEP if signs or symptoms of acute HIV infection are present unless negative infection status is confirmed. (5.2)  \n-------------------------------INDICATIONS AND USAGE-------------------------  \nHIV-1 Treatment (1 . 1)  \nTRUVADA is a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated:  \n• in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg.  \nHIV-1 PrEP (1 .2):  \n• TRUVADA is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating TRUVADA for HIV-1 PrEP.  \n------------------------DOSAGE AND ADMINISTRATION----------------------  \n• Testing: Prior to or when initiating TRUVADA test for hepatitis B virus infection. Prior to initiation and during use of TRUVADA, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all individuals. In individuals with chronic kidney disease, also assess serum phosphorus. (2 . 1)  \n• HIV-1 Screening: Screen all individuals for HIV-1 infection immediately prior to initiating TRUVADA for HIV-1 PrEP and at least once every 3 months while taking TRUVADA, and upon diagnosis of any other sexually transmitted infections (STIs) . (2 .2)  \nTreatment of HIV-1 Infection  \n• Recommended dosage in adults and pediatric patients weighing at least 35 kg: One TRUVADA tablet (containing 200 mg of FTC and 300 mg of TDF) once daily taken orally with or without food. (2 .3)  \n• Recommended dosage in pediatric patients weighing at least 17 kg: One TRUVADA low-strength tablet (100 mg/150 mg, 133 mg/200 mg, or 167 mg/250 mg based on body weight) once daily taken orally with or without food. (2 .4)  \n• Recommended dosage in renally impaired HIV-1 infected adult patients:  \no Creatinine clearance (CrCl) 30−49 mL/min: 1 tablet every 48 hours. (2 .6)  \no CrCl below 30 mL/min or hemodialysis: TRUVADA is not recommended. (2 .6)  \nHIV-1 Pre-Exposure Prophylaxis (PrEP)  \n• Recommended dosage in HIV-1 uninfected adults and adolescents weighing at least 35 kg: One TRUVADA tablet (containing 200 mg  \n• of FTC and 300 mg of TDF) once daily taken orally with or without food. (2 .5)  \n• Recommended dosage in renally impaired HIV-uninfected individuals: TRUVADA is not recommended in HIV-uninfected individuals if CrCl is below 60 mL/min. (2 .6)  \n-----------------------DOSAGE FORMS AND STRENGTHS--------------------  \nTablets: 200 mg/300 mg, 167 mg/250 mg, 133 mg/200 mg, and 100 mg/150 mg of emtricitabine and tenofovir disoproxil fumarate,","cbCaianuxrCMOo9w","https://ap.wps.com/l/cbCaianuxrCMOo9w","pdf",584320,38,"English","# WARNING\n## Posttreatment acute exacerbation of hepatitis B and drug resistance risk with PrEP\n# INDICATIONS AND USAGE\n## HIV-1 treatment\n## HIV-1 PrEP\n# DOSAGE AND ADMINISTRATION\n## Testing and HIV-1 screening\n## Dosing for treatment\n## Dosing for PrEP\n# DOSAGE FORMS AND STRENGTHS\n# CONTRAINDICATIONS\n# WARNINGS AND PRECAUTIONS\n## Renal impairment\n## Immune reconstitution syndrome\n## Bone mineral density decreases\n## Lactic acidosis and hepatotoxicity\n# ADVERSE REACTIONS","[{\"question\":\"When must hepatitis B status be tested for TRUVADA use?\",\"answer\":\"Test for hepatitis B virus infection prior to or when initiating TRUVADA. Monitor hepatic function closely in HBV-infected individuals who discontinue TRUVADA.\"},{\"question\":\"What HIV-1 testing is required for TRUVADA used for HIV-1 PrEP?\",\"answer\":\"TRUVADA for HIV-1 PrEP must be prescribed only to individuals confirmed to be HIV-negative immediately prior to initiating and at least every 3 months during use. It should not be initiated if signs or symptoms of acute HIV infection are present unless negative status is confirmed.\"},{\"question\":\"What key renal and bone safety precautions apply?\",\"answer\":\"Assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein on a clinically appropriate schedule; in chronic kidney disease, also assess serum phosphorus. Avoid TRUVADA with concurrent or recent use of nephrotoxic drugs and consider assessment of bone mineral density in individuals with risk factors.\"}]","TRUVADA - Prescribing Information - Highlights | PDF",1790538915,96]