Truvada emtricitabinetenofovir disoproxil fumarate nucleosidenucleotide analog human immunodeficiency virus1. The package insert lists administration of bicftc taf with dofetilide or rifampin as contraindications due to altering serum concentrations with potential for adverse reactions. Taf is similar to tenofovir disoproxil fumarate tdf, sold separately as viread and a component of stribild, atripla, complera and truvada. Please note the following when using package inserts from this web site. Descovy emtricitabine and tenofovir alafenamide gilead.
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. Biktarvy bictegravirtenofovir alafenamideemtricitabine. 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 3 prs 16 weeks 16. Ftctdf emtricitabinetenofovir disoproxil fumarate truvada these drugs may be available in additional formulations. 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. Emtriva oral solution is a clear, orange to dark orange liquid containing 10 mg of emtricitabine per ml.
Highlights of prescribing information nss are frequent nss. Highlights of prescribing information these highlights do not include all the information needed to use delstrigo safely and effectively. Mepron oral suspension is contraindicated in patients who develop or have a history of. 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. Mepron is a bright yellow, citrusflavored, oral suspension containing 750 mg of atovaquone per 5 ml. Truvada emtricitabinetenofovir df dosing, indications. Dacogen decitabine for injection description e 59 66 57 70. Jan, 2020 these are not all the possible side effects of odefsey.
Emtricitabine was not genotoxic in the reverse mutation bacterial test ames test or mouse lymphoma or mouse micronucleus assays. Among 572 virologically suppressed adults in studies 1844 and 1878, 2 virologic rebound subjects had genotypic and phenotypic data 1. 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. Emtricitabine emtriva treatment national hiv curriculum. Highlights of prescribing information nss are frequent. Virological suppression after use of crushed tenofovir. It has a molecular formula of c 8 h 10 fn 3 o 3 s and a molecular weight of 247. 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. Emtriva is available as capsules or as an oral solution.
Not recommended with atripla, which contains efavirenz, emtricitabine, and tenofovir disoproxil fumarate, unless needed for dose adjustment when. 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. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported. Emtriva, innemtricitabine european medicines agency. Highlights of prescribing information 3 prs 16 weeks 16 weeks. Other antiretroviral agents for the treatment of human immunodeficiency virus hiv1 infection in adults and pediatric patients weighing at least 17 kg.
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. Hiv variants with reduced susceptibility to emtricitabine and tenofovir have been selected for in vitro and have also been isolated from patients. Mepron is supplied in 210ml bottles or 5ml foil pouches. 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. Highlights of prescribing information recommended dosage. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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. Highlights of prescribing information reported cases of. Symtuza darunavir, cobicistat, emtricitabine, and tenofovir. Sep 19, 2019 detailed emtricitabine dosage information for adults and children. Biktarvy bictegravir, emtricitabine, tenofovir alafenamide.
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. Among 572 virologically suppressed adults in studies 1844 and 1878, 2 virologic rebound subjects had. 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. This case suggests adequate drug absorption from crushed tenofoviremtricitabine and dolutegravir tablets and the achievement of rapid virological suppression. 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. Highlights of prescribing information these highlights do not include all the information needed to use sustiva. 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. 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. Emtricitabinetenofovir disoproxil fumarate springerlink. Dailymed descovy emtricitabine and tenofovir alafenamide. Ftc, a synthetic nucleoside analog of cytidine, is an hiv nucleoside analog reverse transcriptase inhibitor hiv nrti.
Each edurant tablet also contains the inactive ingredients croscarmellose sodium, lactose monohydrate, magnesium stearate, polysorbate 20, povidone k30 and silicified microcrystalline cellulose. Descovy is a fixeddose combination containing tenofovir alafenamide, or taf, and emtricitabine. 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. Emtricitabine, rilpivirine hydrochloride, tenofovir. Each hard capsule contains 200 mg of emtricitabine. Additional information is needed to confirm the longterm effectiveness of crushed dolutegravir in adult hivinfected patients and whether the virological response is sustained. In drug combination studies of emtricitabine with nucleoside reverse. The chemical name of ftc is 5fluoro12r,5s2hydroxymethyl1,3oxathiolan5ylcytosine. All patients with hiv1 should be tested for presence of chronic hepatitis b virus hbv before initiating antiretroviral therapy. Rilpivirinetenofovir dfemtricitabine complera treatment. Emtriva emtricitabine is also contained as an ingredient in the following combinations. 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.
See full prescribing information for complete boxed warning. Delstrigo doravirine, lamivudine, and tenofovirdisoproxil fumaratetablets, for oral use initial u. Emtricitabine, rilpivirine, tenofovir waiver request of in vivo testing. Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide for initial treatment of hiv1 infection.
Rilpivirine hydrochloride is a white to almost white powder. Truvada emtricitabine and tenofovir disoproxil fumarate tablets, for oral use initial u. Tenofovir emtricitabine tdfftc represents one of the more recent fixeddose combinations. These tables are not intended to compare the indications or clinical efficacy and safety of the listed products. Includes dosages for hiv infection, occupational exposure and nonoccupational exposure. Descovy emtricitabine and tenofovir alafenamide is a fixed dose combination tablet containing emtricitabine ftc and tenofovir alafenamide taf for oral administration. 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. Package insert pi table daids regulatory support center rsc. 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. Highlights of prescribing information recommended dosage in. Stribild elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate tablets, for oral use drug information pdf dosing. Pharmacokinetics of emtricitabine have not been studied with hepatic impairment.
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. Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Aug 01, 2016 this case suggests adequate drug absorption from crushed tenofoviremtricitabine and dolutegravir tablets and the achievement of rapid virological suppression. Data sources include ibm watson micromedex updated 10 apr 2020, cerner multum updated 6. 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. Patients coinfected with hiv1 and hbv who discontinue symtuza should be closely monitored with both clinical and laboratory followup for.
Recommended mar 2015 2 bioequivalence based on 90% ci. 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. Highlights of prescribing information dosage adjustment with. Pdf documents can be viewed with the free adobe reader.
All patients should be tested for the presence of chronic hepatitis b virus hbv before or when initiating. Antiretroviral treatmentnaive adults with a screening hiv1 rna at least 5000 copiesml and a cd4 cell count more than 50 cells. Tenofoviremtricitabine tdfftc represents one of the more recent fixeddose combinations. Atripla is a prescription medicine that contains efavirenz, emtricitabine, and tenofovir. Prevalence of preexisting resistanceassociated mutations. Descovy emtricitabine and tenofovir alafenamide tablets, for oral use initial u. Efv, 200 mg of emtricitabine ftc, and 300 mg of tenofovir disoproxil fumarate tdf. Truvada is a twodrug fixed dose combination product containing emtricitabine ftc and tenofovir disoproxil fumarate tdf. Patients coinfected with hiv1 and hbv who discontinue symtuza should be closely monitored with both clinical and laboratory followup for at least several months after stopping treatment. Descovy is a twodrug combination of emtricitabine ftc and tenofovir. Prevalence of preexisting resistanceassociated mutations to. Product monograph page 5 of 43 3 serious warnings and precautions box 4 dosage and administration 4. Hiv nucleoside and nucleotide reverse transcriptase inhibitors va class.
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. Truvada emtricitabine tenofovir disoproxil fumarate tablets, for oral use. Dacogen decitabine for injection description dacogen decitabine for injection contains decitabine 5aza2deoxycytidine, an analogue of the natural nucleoside 2deoxycytidine. Emtricitabinetenofovir disoproxil glenmark 200 mg245 mg filmcoated tablets. These are not all the possible side effects of truvada. Posttreatment acute exacerbation of hepatitis b and risk of drug resistance with use of truvada for hiv1 preexposure prophylaxis prep in. Emtriva, emtricitabine dosing, indications, interactions. 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. Gilead sciences 1 highlights of prescribing information these highlights do not include all the information needed to use descovy safely and effectively. 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. Hiv variants with reduced susceptibility to emtricitabine and tenofovir have been selected for in vitro and have also been. 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.
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