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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Autoimmune disorders such as Graves’ disease and autoimmune hepatitis have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment see section 4.

Edurant 25 mg tablets

For the full list of excipients, see section 6. In HIV infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy CARTan inflammatory reaction to asymptomatic or residual opportunistic infections may arise. Pregnancy Lower exposures of rilpivirine were observed during pregnancy, therefore viral load should be monitored closely.

Rilpivirine must not be used in combination with proton pump inhibitors as co-administration is likely to result in loss of therapeutic effect of rilpivirine see section 4. There were no safety concerns identified in the week analyses. This observation was the same in the efavirenz arm. 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.

There are limited amount of data less than pregnancy outcomes from the use of rilpivirine in pregnant women see sections 4. In patients with severe renal impairment or end-stage renal disease, the combination of rilpivirine with a strong CYP3A inhibitor e.

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. HIV PIs — with co-administration of low dose ritonavir. Carbamazepine Oxcarbazepine Phenobarbital Phenytoin.

The proportion of virological failures was Administration of activated charcoal may be used to aid in removal of unabsorbed active substance. Pregnancy and Postpartum The exposure to total rilpivirine after intake of rilpivirine 25 mg once daily as part of an antiretroviral regimen was lower during pregnancy similar for the 2nd and 3rd trimester compared with postpartum see table 6. No mother to child transmission occurred in all 10 infants born to the mothers who completed the trial and for whom the HIV status was available.

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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. Increased exposure of rilpivirine is expected.

Lower exposures of rilpivirine were observed during pregnancy, therefore viral load should be monitored closely. ADRs reported in adult patients treated with rilpivirine are summarised in Table 2.

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

Significant decreases in rilpivirine plasma concentrations are pxckage. Race Population pharmacokinetic analysis of rilpivirine in Eduarnt infected patients indicated that race had no clinically relevant effect on the exposure to rilpivirine. If a patient misses a dose of EDURANT by more than 12 hours, the patient should not take the ;ackage dose, but resume the usual dosing schedule.

The exposures at the embryo-foetal No Observed Adverse Effects Levels NOAELs in rats and rabbits were respectively 15 and 70 times higher than the exposure in humans at the recommended dose of 25 mg once daily.

Discontinuations due to adverse events were higher in the efavirenz arm at week 96 than the rilpivirine arm. Lansoprazole Rabeprazole Pantoprazole Esomeprazole. The combination of rilpivirine and antacids should be used with particular caution.

Therapy should be initiated by a physician experienced in the management of HIV infection. Rilpivirine is primarily metabolised and eliminated by the liver. 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.

Edurant 25 mg tablets – Summary of Product Characteristics (SmPC) – (eMC)

Dose dependent decreases in rilpivirine plasma concentrations are expected. A risk for increases in dabigatran plasma concentrations cannot be excluded. After oral administration, the maximum plasma concentration of rilpivirine is generally achieved within hours. Effects on 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.

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There is limited information available on the potential for a pharmacodynamic interaction between rilpivirine and medicinal products that prolong the QTc interval of the ECG. Percentage of subjects with: Alternatives should be considered, particularly for long-term use. Elimination The terminal elimination half-life of rilpivirine is approximately 45 hours.

Rilpivirine was well tolerated during pregnancy and postpartum.

Rilpivirine was evaluated for carcinogenic potential by oral gavage administration to mice and rats up to weeks. By continuing to browse the eurant you are agreeing to our policy on the use of cookies. Hepatic impairment Rilpivirine is primarily metabolised and eliminated by the liver.

Medicinal products that induce or inhibit CYP3A may thus affect the clearance of rilpivirine see section 5. No dose adjustment is required. Table 3 displays selected baseline disease characteristics of the patients in the rilpivirine and efavirenz arms. Vardenafil Tadalafil Not studied.

Edurant (rilpivirine) Tablets, Package Insert

Autoimmune disorders such as Graves’ disease and autoimmune hepatitis have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment see section 4. Virologic failure and development of resistance EDURANT has not been evaluated paxkage patients with previous virologic failure to any other antiretroviral therapy.

Alternatively, switching to another ART regimen could be considered see sections 4. Other Antiviral Agents Ribavirin Not studied. Excipient with paclage effect: The virologic response was generally preserved throughout the study: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. In the open label part of the trial, patients originally randomised to one of the three doses of rilpivirine were all treated with rilpivirine 25 mg once daily in addition to a BR, once the dose for the Phase III studies was selected.

However, it may not be eduant excluded that nisert can increase the exposure to other medicines transported by P-glycoprotein that are more sensitive to intestinal P-gp inhibition, e. Show table of contents Hide table of contents 1.