The degree of renal impairment was defined according to baseline creatinine clearance (CrCl) (normal renal function when CrCl > 80 mL/min; mild impairment with CrCl = 50-79 mL/min; moderate impairment with CrCl = 30-49 mL/min and severe impairment with CrCl = 10-29 mL/min). The increased exposure of tenofovir could potentiate adverse reactions associated with tenofovir disoproxil, including renal disorders. Efficacy was strongly correlated with adherence as assessed by detection of plasma or intracellular drug levels and was higher among substudy participants who received active adherence counselling and as show in Table 10.The safety and efficacy of emtricitabine/tenofovir disoproxil in children under the age of 12 years have not been established.Treatment of HIV-1 infection in the paediatric populationThere are no clinical studies conducted with emtricitabine/tenofovir disoproxil in the paediatric population with HIV-1 infection. If you do not, the amount of HIV virus in your blood may increase and the virus may develop resistance to this medication. Emtricitabine is primarily excreted by the kidneys with complete recovery of the dose achieved in urine (approximately 86%) and faeces (approximately 14%). Interaction studies have only been performed in adults. "�T�%_!�+� �8n The mean (%CV) tenofovir CGenotoxicity studies revealed positive results in the Oral carcinogenicity studies in rats and mice only revealed a low incidence of duodenal tumours at an extremely high dose in mice. If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered. 4 0 obj <>stream When missing data were excluded, 91% of patients in the tenofovir disoproxil treatment group and 94% of patients in the stavudine or zidovudine treatment group had HIV 1 RNA concentrations < 400 copies/mL at week 48. Total body bone gain was less in the tenofovir disoproxil treatment group compared to the stavudine or zidovudine treatment group. endstream x�+� � | Mylan-Emtricitabine/Tenofovir Disoproxil should be used in the treatment of HIV-1 infected patients only in combination with other antiretroviral agents. • The M184V/I mutation developed in 2/19 (10.5%) isolates analysed from patients in the emtricitabine/tenofovir disoproxil/efavirenz group and in 10/29 (34.5%) isolates analysed from the lamivudine/zidovudine/efavirenz group (p-value < 0.05, Fisher's Exact test comparing the emtricitabine+tenofovir disoproxil group to the lamivudine/zidovudine group among all patients). down the sink or in the toilet) or in household garbage. x�S�*�*T0T0 A=KKK30;9WA?
This means that it is converted into tenofovir in the body. "�X�%_!�+� �&l H� Please refer to the Summary of Product Characteristics for these medicinal products. 3 0 obj <>stream BMD Z scores declined by 0.012 for lumbar spine and by 0.338 for total body in the 64 subjects who were treated with tenofovir disoproxil for 96 weeks. endstream If you miss a dose, take it as soon as possible and continue with your regular schedule. The increased exposure of tenofovir could potentiate tenofovir associated adverse events, including renal disorders. (90 mg/400 mg q.d.) 7 0 obj <>stream x�S�*�*T0T0 A=KKK30;9WA? There have been reports of mitochondrial dysfunction in HIV negative infants exposed In HIV infected patients with severe immune deficiency at the time of institution of CART, an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms. endstream Tenofovir is primarily excreted by the kidney by both filtration and an active tubular transport system with approximately 70-80% of the dose excreted unchanged in urine following intravenous administration. 14 0 obj <>stream Renal function should be closely monitored (see section 4.4).Concomitant administration of sofosbuvir/velpatasvir and efavirenz is expected to decrease plasma concentrations of velpatasvir. Interactions between emtricitabine/tenofovir disoproxil or its individual component(s) and other medicinal products are listed in Table 2 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, twice daily as “b.i.d.” and once daily as “q.d.”). x�S�*�*T0T0 A=KKK30;9WA? The increased exposure of tenofovir could potentiate adverse reactions associated with tenofovir disoproxil, including renal disorders.
4.5 Interaction with other medicinal products and other forms of interaction6.6 Special precautions for disposal and other handling9. endstream Precautions to prevent transmission of HIV by infected individuals should be taken in accordance with national guidelines.
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