EDURANT PACKAGE INSERT PDF

Drug information on Rilpivirine Tablet (film coated) for health care professionals. Edurant (rilpivirine) Tablets, Package Insert. EDURANT is a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside reverse. For patients concomitantly receiving rifabutin, the EDURANT dose should be increased to 50 mg .. The interaction between rilpivirine and the medicinal product was evaluated in a clinical study. See package leaflet for further information.

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Rilpivirine was evaluated for carcinogenic potential by oral gavage administration to mice and rats up to weeks.

Edurant (rilpivirine) Tablets, Package Insert

In ECHO, randomisation was stratified by screening viral load. For the resistance analysis, a broader definition of virologic failure was used than in the primary efficacy analysis. NNRTIs delavirdine, efavirenz, etravirine, nevirapine.

Medicinal products that are affected by the use of rilpivirine Rilpivirine at a dose of 25 mg once daily is not likely to have a clinically relevant effect on the exposure of medicinal products metabolised by CYP enzymes.

Detailed information on this medicinal product is available on the website of the European Medicines Agency http: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.

The 36 subjects had a median age of ADRs reported in adult patients treated with insery are summarised edurabt Table 2. In dogs, cholestasis-like effects were noted.

In the week 48 pooled resistance analysis from the Phase III trials, 62 of a total of 72 virologic failures in the rilpivirine arm had resistance data at baseline and time of failure.

The greater risk of virologic failure inseft patients in the rilpivirine arm was observed in the first 48 weeks of these trials see section 5. No dose adjustment is required. Lower exposures of rilpivirine were observed when rilpivirine 25 mg once daily was taken during pregnancy. Biotransformation In vitro experiments indicate that rilpivirine primarily undergoes oxidative metabolism mediated by the cytochrome P CYP 3A system.

Edurant (rilpivirine) Tablets, Package Insert | DAIDS Regulatory Support Center (RSC)

In the phase 3 studies, lower rilpivirine exposure, similar to that seen during pregnancy, has been associated with an increased risk of virological failure, therefore viral load should be monitored closely see sections 4.

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The EK substitution emerged most frequently during rilpivirine treatment, commonly in combination edurnat the MI substitution. White to off-white, round, biconvex, film-coated tablet with a diameter of 6. No dose adjustment is needed for patients with mild or moderate renal impairment.

If a patient vomits more than 4 hours after taking the medicine, the patient does not need to take another dose of EDURANT until the next regularly scheduled dose. Edurant 25 mg tablets.

It is not known whether rilpivirine is excreted in human milk. In vitro experiments indicate that rilpivirine primarily undergoes oxidative metabolism mediated by the cytochrome P CYP 3A system. Immune reactivation syndrome In HIV infected patients with severe immune deficiency at the time of initiation of CART, an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions or aggravation of symptoms.

Race Population pharmacokinetic analysis of rilpivirine in HIV infected patients indicated that race had no clinically relevant effect on the exposure to rilpivirine.

Carbamazepine Oxcarbazepine Phenobarbital Phenytoin. Fertility Inaert human data on the effect of rilpivirine on fertility are available. Human experience of overdose with rilpivirine is limited. By packags to browse the site you are agreeing to our policy on the use of cookies. Back to top Janssen-Cilag Ltd contact details. There were no new safety findings compared with the known safety profile of rilpivirine in HIV-1 infected adults see sections 4.

Last updated on eMC: Virologic failure and development of resistance EDURANT has not been evaluated in patients with previous ibsert failure to any other antiretroviral therapy. There were no safety concerns identified in the week analyses. Steady-state administration of rilpivirine 75 mg once daily and mg once daily resulted in a mean C max approximately 2.

However, it may not be completely excluded that rilpivirine can increase the exposure to other medicines transported by P-glycoprotein that are more sensitive to intestinal P-gp inhibition, e. Only adolescents deemed likely to have good adherence to antiretroviral therapy should be treated with rilpivirine, as suboptimal adherence can lead to development of resistance and the loss of future treatment options.

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Medicinal products by therapeutic areas.

Other NRTIs abacavir, emtricitabine, lamivudine, stavudine and zidovudine. The distribution of rilpivirine into compartments other eurant plasma e.

Findings in adolescents 12 to less than 18 years of age in trial C were generally in line with these data for details see section 5.

Hypersensitivity to the active substance or to any of the excipients listed eudrant section 6. Liver toxicity associated with liver enzyme induction was observed in rodents. A risk for increases in dabigatran plasma concentrations cannot be excluded.

Resistance outcome by background NRTI regimen used. At supra-therapeutic doses 75 and mg once dailyrilpivirine has been associated with prolongation of the QTc interval of the electrocardiogram ECG see sections 4. Pregnancy Lower exposures of rilpivirine were observed during pregnancy, therefore viral load should be monitored closely.

Treatment with rilpivirine resulted in an early small increase of mean serum creatinine levels which remained stable over time and is not considered clinically relevant see section 4. Eduranr and quantitative composition 3. In the week 96 pooled resistance analysis, lower rates of virologic failure were observed in the second 48 weeks than in the first 48 weeks of treatment. Effects imsert electrocardiogram The effect of rilpivirine at the recommended dose of 25 mg once daily on the QTcF interval was evaluated in a randomised, placebo and active moxifloxacin mg once daily controlled crossover study in 60 healthy adults, with 13 measurements over 24 hours at steady-state.

Studies in animals have shown no evidence of relevant embryonic or foetal toxicity or an effect on reproductive function. Rilpivirine must not be used in combination with rifampicin as co-administration is likely to result in loss of therapeutic effect of rilpivirine see section 4. Continue typing to refine.