However, due to Gilead Sciences, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.General Disorders and Administration Site ConditionsPediatric Patients 2 Years and Older with HIV-1 infection[see Adverse Reactions (6.1) and Clinical Studies (14.3)]. Study conducted with ATRIPLA® (EFV/FTC/TDF) coadministered with HARVONI; coadministration with HARVONI also results in comparable increases in tenofovir exposure when TDF is administered as COMPLERA® (FTC/rilpivirine/TDF), or TRUVADA + dolutegravir.i. Based on the results of Tenofovir Disoproxil Fumarate has been evaluated in healthy volunteers in combination with other antiretroviral and potential concomitant drugs. If you notice other effects not listed above, contact your doctor or pharmacist.Call your doctor for medical advice about side effects. Tenofovir displayed antiviral activity in cell culture against HIV-1 clades A, B, C, D, E, F, G, and O (EC50 values ranged from 0.5 μM to 2.2 μM) and strain-specific activity against HIV-2 (EC50 values ranged from 1.6 μM to 5.5 μM).HIV-1 isolates with reduced susceptibility to tenofovir have been selected in cell culture. Table 17 summarizes the HIV-1 RNA response by baseline Tenofovir Disoproxil Fumarate susceptibility.The antiviral activity of tenofovir against HBV was assessed in the HepG2 2.2.15 cell line. In a pre/postnatal development study in rats, TDF was administered orally through lactation at doses up to 600 mg/kg/day; no adverse effects were observed in the offspring at tenofovir exposures of approximately 2.7 times higher than human exposures at the recommended daily dose of Tenofovir Disoproxil FumarateBased on published data, tenofovir has been shown to be present in human breast milk The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1.Because of the potential for: (1) HIV transmission (in HIV-negative infants); (2) developing viral resistance (in HIV-positive infants); and (3) adverse reactions in a breastfed infant similar to those seen in adults, instruct mothers not to breastfeed if they are taking Tenofovir Disoproxil Fumarate for the treatment of HIV-1.The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Tenofovir Disoproxil Fumarate and any potential adverse effects on the breastfed infant from Tenofovir Disoproxil Fumarate or from the underlying maternal condition.In a study of 50 HIV-uninfected, breastfeeding women on a tenofovir-containing regimen initiated between 1 and 24 weeks postpartum (median 13 weeks), tenofovir was undetectable in the plasma of most infants after 7 days of treatment in mothers. Take your next dose at the regular time.
All patients should be tested for HBV infection before or when starting Tenofovir Disoproxil Fumarate and those who are infected with HBV need close medical follow-up for several months after stopping Tenofovir Disoproxil Fumarate to monitor for exacerbations of hepatitis Inform patients that renal impairment, including cases of acute renal failure and Fanconi syndrome, has been reported in association with the use of Tenofovir Disoproxil Fumarate. However, due to Gilead Sciences, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.Table 20 Outcomes of Randomized Treatment at Week 48 and 144 (Trial 903)Table 21 Outcomes of Randomized Treatment at Week 48 and 144 (Trial 934)Table 22 Outcomes of Randomized Treatment (Trial 907)[see Warnings and Precautions (5.5), Adverse Reactions (6.1), and Clinical Pharmacology (12.3)].Table 23 Histological, Virological, Biochemical, and Serological Response at Week 48 (Trials 0102 and 0103)Lamivudine-Resistant Chronic HBV Subjects: Trial 121Chronic HBV and Decompensated Liver Disease Subjects: Trial 0108Pediatric Subjects 12 Years to less than 18 Years of Age with Chronic HBVPediatric use information is approved for Gilead Sciences, Inc.'s VIREAD® (Tenofovir Disoproxil Fumarate) tablets. Do not give Tenofovir Disoproxil Fumarate tablet to other people, even if they have the same condition you have.
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