There were no serious adverse events.The safety and effectiveness of VIREAD in pediatric patients 2 years to less than 18 years of age is supported by data from two randomized trials. At Week 48, 89% of subjects in the VIREAD treatment group and 90% of subjects in the d4T or AZT treatment group had HIV-1 RNA concentrations <400 copies/mL. Hair loss, or alopecia, is a condition both men and women may experience during their lives as a result of health-related issues, genetics, and medications.. 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.The 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.Tenofovir is primarily eliminated by the kidneys [see In the treatment of chronic hepatitis B, VIREAD should not be administered in combination with HEPSERA (adefovir dipivoxil).Table 12 provides a listing of established or clinically significant drug interactions. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.Before you take VIREAD, tell your healthcare provider about all of your medical conditions, including if you:Some medicines may interact with VIREAD. The mechanism(s) underlying bone toxicity is unknown.Evidence of renal toxicity was noted in 4 animal species. In HIV-1 infected subjects 2 years to less than 18 years of age, bone effects were similar to those observed in adult subjects and suggest increased bone turnover. Advise patients not to discontinue VIREAD without first informing their healthcare provider. Similar trends were observed in chronic HBV-infected pediatric subjects 2 years to less than 18 years of age. These toxicities were noted at exposures (based on AUCs) 2−20 times higher than those observed in humans. You can ask your pharmacist or healthcare provider for information about VIREAD that is written for health professionals. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.The most common side effects in all people taking VIREAD are:In some people with advanced HBV-infection, other common side effects may include:These are not all the possible side effects of VIREAD.Call your doctor for medical advice about side effects. In Trial 144, 89 HBeAg positive (96%) and negative (4%) subjects 2 years to less than 12 years of age were treated with VIREAD 8 mg/kg up to maximum dose of 300 mg or placebo once daily for 48 weeks. oral powder contains the following inactive ingredients: mannitol, You may report side effects to FDA at 1-800-FDA-1088.Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Dosage for pediatric patients 2 years and older weighing between 17 kg and 35 kg and able to swallow an intact tablet is provided in Table 1. Subgroup analyses suggest the lack of difference in virologic response may be attributable to imbalances between treatment arms in baseline viral susceptibility to VIREAD and OBR [see Although changes in HIV-1 RNA in these highly treatment-experienced subjects in Trial 321 were less than anticipated, the pharmacokinetic profile of tenofovir in patients 2 years to less than 18 years of age at the recommended doses was similar to that found to be safe and effective in adult clinical trials [see The effects of VIREAD-associated changes in BMD and biochemical markers on long-term bone health and future fracture risk in HIV-1 pediatric patients 2 years and older are unknown. The high dose in female mice, liver adenomas were increased at exposures ( on... About VIREAD that is written for health professionals provides accurate and independent information on this site is subject to terms! Dogs, the terminal elimination half-life of tenofovir is approximately 17 hours people... 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