Emtriva, emtricitabine dosing, indications, interactions. Truvada emtricitabinetenofovir disoproxil fumarate. Descovy emtricitabine and tenofovir alafenamide gilead. Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. These substitutions are included in the us fda list of rilpivirineassociated substitutions as noted in the us package insert. Emtricitabine was not genotoxic in the reverse mutation bacterial test ames test or mouse lymphoma or mouse micronucleus assays. Precertification update for truvada emtricitabine tenofovir disoproxil fumarate and descovy emtricitabine tenofovir alafenamide this notice is to update the previous prep preexposure prophylaxis criteria that went into effect on january 6, 2020. Descovy is indicated in combination with other antiretroviral arv agents for the treatment of hiv1 infection in patients weighing at least 35 kg. Sep 19, 2019 detailed emtricitabine dosage information for adults and children. Prevalence of preexisting resistanceassociated mutations.
Efv, 200 mg of emtricitabine ftc, and 300 mg of tenofovir disoproxil fumarate tdf. Emtricitabine is also marketed in a fixeddose combination with tenofovir disoproxil viread under the brand name truvada, and with tenofovir alafenamide vemlidy under the brand name descovy a fixeddose triple combination of emtricitabine, tenofovir and efavirenz sustiva, marketed by bristolmyers squibb was approved by the u. Highlights of prescribing information these highlights do not include all the information needed to use delstrigo safely and effectively. To learn more about possible side effects of truvada, read the drug label or package insert or talk to your health care provider or pharmacist. Highlights of prescribing information nss are frequent nss. Rilpivirine hydrochloride is practically insoluble in water over a wide ph range. Other antiretroviral agents for the treatment of human immunodeficiency virus hiv1 infection in adults and pediatric patients weighing at least 17 kg. Descovy is a twodrug combination of emtricitabine ftc and tenofovir. Jan, 2020 descovy emtricitabine and tenofovir alafenamide is a fixed dose combination tablet containing emtricitabine ftc and tenofovir alafenamide taf for oral administration. Hiv nucleoside and nucleotide reverse transcriptase inhibitors va class.
Emtriva capsules, containing 200 mg of emtricitabine, are size 1 hard gelatin capsules with a blue cap and white body, printed with 200 mg in black on the cap and gilead and the corporate logo in black on the body. Dacogen decitabine for injection description dacogen decitabine for injection contains decitabine 5aza2deoxycytidine, an analogue of the natural nucleoside 2deoxycytidine. Ftctdf emtricitabinetenofovir disoproxil fumarate truvada these drugs may be available in additional formulations. Truvada emtricitabine and tenofovir disoproxil fumarate tablets, for oral use initial u. You can report side effects to fda at 1800fda1088 18003321088 or online. Jan, 2020 these are not all the possible side effects of odefsey. Rilpivirine hydrochloride is a white to almost white powder. Emtricitabine did not affect fertility in male rats at approximately 140fold or in male and female mice at approximately 60fold higher exposures auc than in humans given the recommended 200 mg daily dose. Emtriva, innemtricitabine european medicines agency. Includes dosages for hiv infection, occupational exposure and nonoccupational exposure.
Among 634 treatmentnaive adults in studies 1489 and 1490, 8 treatmentfailure subjects were tested and no amino acid substitutions emerged that were associated with biktarvy resistance through week 144. Pdf documents can be viewed with the free adobe reader. Recommended mar 2015 2 bioequivalence based on 90% ci. Delstrigo doravirine, lamivudine, and tenofovirdisoproxil fumaratetablets, for oral use initial u. It has a molecular formula of c 8 h 10 fn 3 o 3 s and a molecular weight of 247. Descovy emtricitabine and tenofovir alafenamide is a fixed dose combination tablet containing emtricitabine ftc and tenofovir alafenamide taf for oral administration. Truvada emtricitabinetenofovir df dosing, indications. Rilpivirinetenofovir dfemtricitabine complera treatment. Product monograph page 5 of 43 3 serious warnings and precautions box 4 dosage and administration 4. Each hard capsule contains 200 mg of emtricitabine. In combination with either a ritonavirboosted protease inhibitor or a nonnucleoside reverse transcriptase inhibitor, tdfftc is a preferred choice in recent treatment guidelines on the basis of demonstrated potency in randomized clinical trials, one. Descovy is a fixeddose combination containing tenofovir alafenamide, or taf, and emtricitabine.
Emtricitabine commonly called ftc, systematic name 2,3dideoxy5fluoro3thiacytidine, with trade name emtriva formerly coviracil, is a nucleoside reversetranscriptase inhibitor nrti for the prevention and treatment of hiv infection in adults and children. Truvada is a twodrug fixed dose combination product containing emtricitabine ftc and tenofovir disoproxil fumarate tdf. Biktarvy bictegravirtenofovir alafenamideemtricitabine. Highlights of prescribing information recommended dosage in. Dacogen decitabine for injection description e 59 66 57 70.
Severe acute exacerbations of hepatitis b have been reported in patients who are coinfected with hiv1 and hbv and have discontinued products containing emtricitabine ftc andor tenofovir disoproxil fumarate tdf, and may occur with. Data sources include ibm watson micromedex updated 10 apr 2020, cerner multum updated 6. Mepron is a bright yellow, citrusflavored, oral suspension containing 750 mg of atovaquone per 5 ml. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including emtricitabine, a component of symtuza, and tenofovir disoproxil fumarate tdf, another prodrug of tenofovir, alone or in combination with other. Posttreatment acute exacerbation of hepatitis b and risk of drug resistance with use of truvada for hiv1 preexposure prophylaxis prep in. Mepron oral suspension is contraindicated in patients who develop or have a history of. See full prescribing information for complete boxed warning. Symtuza darunavir, cobicistat, emtricitabine, and tenofovir.
Highlights of prescribing information recommended dosage. Hiv variants with reduced susceptibility to emtricitabine and tenofovir have been selected for in vitro and have also been. Among 572 virologically suppressed adults in studies 1844 and 1878, 2 virologic rebound subjects had genotypic and phenotypic data 1. Emtricitabinetenofovir disoproxil glenmark 200 mg245 mg filmcoated tablets. Taf is similar to tenofovir disoproxil fumarate tdf, sold separately as viread and a component of stribild, atripla, complera and truvada. The drug labels and other drugspecific information on this website represent the most recent drug listing information that companies have provided to, or which is obtainable by, the division of aids, niaid, nih daids, and are made available here in support of daidsfunded andor sponsored clinical trials, both. Each edurant tablet also contains the inactive ingredients croscarmellose sodium, lactose monohydrate, magnesium stearate, polysorbate 20, povidone k30 and silicified microcrystalline cellulose. Epivirhbv tablets and oral solution contain a lower lamivudine dose than the lamivudine dose used to treat hiv1 infection with epivir tablets and oral solution or with lamivudinecontaining antiretroviral fixeddose combination. Precertification update for truvada emtricitabinetenofovir disoproxil fumarate and descovy emtricitabinetenofovir alafenamide this notice is to update the previous prep preexposure prophylaxis criteria that went into effect on january 6, 2020. The recommended dosage of atripla in adults and pediatric patients weighing at least 40 kg is one tablet once daily taken orally on an empty stomach.
In drug combination studies of emtricitabine with nucleoside reverse. Package insert pi table daids regulatory support center rsc. Highlights of prescribing information nss are frequent. Hiv variants with reduced susceptibility to emtricitabine and tenofovir have been selected for in vitro and have also been isolated from patients. Jun 29, 2017 emtricitabine and tenofovir disoproxil fumarate used for prep must only be prescribed to individuals confirmed to be hivnegative immediately prior to initial use and periodically during use. Highlights of prescribing information these highlights do not include all the information needed to use sustiva. The nucleoside analogue reverse transcriptase inhibitor rti emtricitabine and the nucleotide analogue rti tenofovir disoproxil fumarate tenofovir df have each shown antiviral activity against a number of hiv clinical isolates and cell lines. Emtricitabine emtriva treatment national hiv curriculum. Truvada emtricitabine tenofovir disoproxil fumarate tablets, for oral use. Data sources include ibm watson micromedex updated 10 apr 2020, cerner multum updated 6 apr 2020, wolters kluwer updated. Mepron is supplied in 210ml bottles or 5ml foil pouches. Atripla is a prescription medicine that contains efavirenz, emtricitabine, and tenofovir. Aug 01, 2016 this case suggests adequate drug absorption from crushed tenofoviremtricitabine and dolutegravir tablets and the achievement of rapid virological suppression.
These are not all the possible side effects of truvada. Emtricitabine is the enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5position. Severe acute exacerbations of hepatitis b have been reported in patients who are coinfected with hiv1 and hbv and have discontinued products containing emtricitabine ftc andor tenofovir disoproxil fumarate tdf, and may occur with discontinuation of biktarvy. Antiretroviral treatmentnaive adults with a screening hiv1 rna at least 5000 copiesml and a cd4 cell count more than 50 cells. To learn more about possible side effects of odefsey, read the drug label or package insert or talk to your health care provider or pharmacist. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Precertification update for truvada emtricitabinetenofovir disoproxil fumarate and descovy emtricitabinetenofovir alafenamide effective january 6, 2020, precertification clinical criteria will change for the following medications when indicated for preexposure prophylaxis prep. All patients with hiv1 should be tested for presence of chronic hepatitis b virus hbv before initiating antiretroviral therapy. Dailymed descovy emtricitabine and tenofovir alafenamide. Prevalence of preexisting resistanceassociated mutations to. Highlights of prescribing information reported cases of.
Yestake bictarvy fasting 2 hours before antacids containing almgca1take bictarvy with food simultaneously with cafe supplements1. This case suggests adequate drug absorption from crushed tenofoviremtricitabine and dolutegravir tablets and the achievement of rapid virological suppression. Highlights of prescribing information 3 prs 16 weeks 16 weeks. Among 572 virologically suppressed adults in studies 1844 and 1878, 2 virologic rebound subjects had. Not recommended with atripla, which contains efavirenz, emtricitabine, and tenofovir disoproxil fumarate, unless needed for dose adjustment when.
Tenofoviremtricitabine tdfftc represents one of the more recent fixeddose combinations. The chemical name of ftc is 5fluoro12r,5s2hydroxymethyl1,3oxathiolan5ylcytosine. The package insert lists administration of bicftc taf with dofetilide or rifampin as contraindications due to altering serum concentrations with potential for adverse reactions. Dosing at bedtime may improve the tolerability of nervous system symptoms see clinical pharmacology 12. Additional information is needed to confirm the longterm effectiveness of crushed dolutegravir in adult hivinfected patients and whether the virological response is sustained. Patients coinfected with hiv1 and hbv who discontinue symtuza should be closely monitored with both clinical and laboratory followup for. Sep 17, 2012 the nucleoside analogue reverse transcriptase inhibitor rti emtricitabine and the nucleotide analogue rti tenofovir disoproxil fumarate tenofovir df have each shown antiviral activity against a number of hiv clinical isolates and cell lines. Highlights of prescribing information 3 prs 16 weeks 16. Emtricitabinetenofovir disoproxil fumarate springerlink.
Highlights of prescribing information dosage adjustment with. Stribild elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate tablets, for oral use drug information pdf dosing. All patients should be tested for the presence of chronic hepatitis b virus hbv before or when initiating. Pharmacokinetics of emtricitabine have not been studied with hepatic impairment. Emtricitabine and tenofovir disoproxil fumarate used for prep must only be prescribed to individuals confirmed to be hivnegative immediately prior to initial use and periodically during use. Descovy emtricitabine and tenofovir alafenamide tablets, for oral use initial u. Virological suppression after use of crushed tenofovir.
Biktarvy bictegravir, emtricitabine, tenofovir alafenamide. Emtricitabine inhibits the activity of hiv1 reverse transcriptase by competing with the natural substrate deoxycytidine 5triphosphate and by being incorporated into nascent viral dna, resulting in chain. Truvada emtricitabinetenofovir disoproxil fumarate nucleosidenucleotide analog human immunodeficiency virus1. These tables are not intended to compare the indications or clinical efficacy and safety of the listed products. Gilead sciences 1 highlights of prescribing information these highlights do not include all the information needed to use descovy safely and effectively. Drugresistant hiv1 variants have been identified with the use of emtricitabine and tenofovir disoproxil fumarate for prep following undetected acute hiv. Precertification update for truvada emtricitabinetenofovir.
Ftc, a synthetic nucleoside analog of cytidine, is an hiv nucleoside analog reverse transcriptase inhibitor hiv nrti. For initial treatment in antiretroviralnaive pediatric patients, experts state that emtricitabine and zidovudine is a preferred dual nrti option for use with a recommended pi, nnrti, or insti in neonates, infants, and children dec 14, 2018 emtricitabine is a white to offwhite powder with a solubility of approximately 112 mgml in water at 25 c. The drug labels and other drugspecific information on this website represent the most recent drug listing information that companies have provided to, or which is obtainable by, the division of aids, niaid, nih daids, and are made available here in support of daidsfunded andor sponsored clinical. Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide for initial treatment of hiv1 infection. Please note the following when using package inserts from this web site.
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