Data are not available to recommend a dose adjustment of didanosine for adult or pediatric patients weighing less than 60 kg. However, due to Gilead Sciences, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.Severe Acute Exacerbation of Hepatitis B in Patients Infected with HBV[see Warnings and Precautions (5.7) and Drug Interactions (7)].What is the most important information I should know about Tenofovir Disoproxil Fumarate tablets?If you have HBV infection and take Tenofovir Disoproxil Fumarate your HBV may get worse (flare- up) if you stop takingFor more information about side effects, see "What are the possible side effects of Tenofovir Disoproxil Fumarate? The proportion of subjects with HBV DNA concentrations below 400 copies/mL (69 IU/mL) at Week 96 was similar between the Tenofovir Disoproxil Fumarate monotherapy and the comparator arms.Across the combined chronic hepatitis B treatment trials, the number of subjects with adefovir-resistance associated substitutions at baseline was too small to establish efficacy in this subgroup.Trial 0108 was a small randomized, double-blind, active-controlled trial evaluating the safety of Tenofovir Disoproxil Fumarate compared to other antiviral drugs in subjects with chronic hepatitis B and decompensated liver disease through 48 weeks.Forty-five adult subjects (37 males and 8 females) were randomized to the Tenofovir Disoproxil Fumarate treatment arm. Subjects received didanosine enteric-coated capsules. Because postmarketing reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.hepatic steatosis, hepatitis, increased liver enzymes (most commonly AST, ALT gamma GT)rhabdomyolysis, osteomalacia (manifested as bone pain and which may contribute to fractures), muscular weakness, myopathyacute renal failure, renal failure, acute tubular necrosis, Fanconi syndrome, proximal renal tubulopathy, interstitial nephritis (including acute cases), nephrogenic diabetes insipidus, renal insufficiency, increased creatinine, proteinuria, polyuriaThe following adverse reactions, listed under the body system headings above, may occur as a consequence of proximal renal tubulopathy: rhabdomyolysis, osteomalacia, hypokalemia, muscular weakness, myopathy, hypophosphatemia.FTC and tenofovir are primarily excreted by the kidneys by a combination of glomerular filtration and active tubular secretion Table 7 provides a listing of established or clinically significant drug interactions.
There were no apparent differences between the subset of subjects who had liver biopsy data at Week 240 and those subjects remaining on open-label Tenofovir Disoproxil Fumarate without biopsy data that would be expected to affect histological outcomes at Week 240. Find out what health conditions may be a health risk when taken with Tenofovir Disoproxil Fumarate Oral Indicates that a drug-drug interaction trial was conducted.There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to emtricitabine and tenofovir disoproxil fumarate during pregnancy. Consider the potential for drug interactions prior to and during therapy with Tenofovir Disoproxil Fumarate; review concomitant medications during therapy with Tenofovir Disoproxil Fumarate; and monitor for adverse reactions associated with the concomitant drugs.The following adverse reactions are discussed in other sections of the labeling:More than 12,000 subjects have been treated with Tenofovir Disoproxil Fumarate alone or in combination with other antiretroviral medicinal products for periods of 28 days to 215 weeks in clinical trials and expanded access programs. In rats and dogs, the bone toxicity manifested as reduced bone mineral density. The EC50 (50% effective concentration) values for tenofovir were in the range of 0.04 μM to 8.5 μM. However, a small (6%) but statistically significant reduction in metabolism of CYP1A substrate was observed. Subjects were followed for a median of 71 weeks and 87 weeks, respectively. The EC Cumulative Tenofovir Disoproxil Fumarate genotypic resistance has been evaluated annually for up to 384 weeks in Trailss 0102, 0103, 0106 ,0108, and 0121 HBV isolates from these subjects who remained viremic showed treatment-emergent substitutions (Table 18); however, no specific substitutions occurred at a sufficient frequency to be associated with resistance to Tenofovir Disoproxil Fumarate (genotypic and phenotypic analyses).f Of the 18 subjects with treatment-emergent amino acid substitutions during Trials 0102 and 0103, 5 subjects had substitutions at conserved sites and 13 subjects had substitutions only at polymorphic sites, and 8 subjects had only transient substitutions that were not detected at the last time point on Tenofovir Disoproxil Fumarate.Cross-resistance has been observed between HBV NrtIs.In cell based assays, HBV strains expressing the rtV173L, rtL180M, and rtM204I/V substitutions associated with resistance to lamivudine and telbivudine showed a susceptibility to tenofovir ranging from 0.7- to 3.4-fold that of wild type virus.
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