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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Exposure to ppackage was generally lower in HIV-1 infected patients than in healthy subjects. After oral administration, the maximum plasma concentration of rilpivirine is generally achieved within hours. Renal elimination of rilpivirine is negligible. General disorders and administration site conditions.

Edurant 25 mg tablets

Lansoprazole Rabeprazole Pantoprazole Esomeprazole Not studied. Antiviral for systemic use, non-nucleoside reverse transcriptase inhibitors, ATC code: Rilpivirine was well tolerated during pregnancy and postpartum.

No human data on the effect of rilpivirine on fertility eduranr available. This interaction study has been performed with a dose higher than the recommended dose for rilpivirine assessing the maximal effect on the co-administered medicinal product.

Cardiovascular 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. Tabulated summary of adverse reactions ADRs reported in adult patients treated with rilpivirine are summarised in Table 2.

Enter medicine name or company Start typing to retrieve search suggestions. There were no patients who discontinued treatment due inxert ADRs.

No clinically relevant packagf interactions are expected. Where possible, alternatives such as azithromycin should be considered. Rilpivirine was evaluated for carcinogenic potential by oral gavage administration to mice and rats up to weeks. This analysis included 36 patients who had completed at least 48 weeks of treatment or discontinued earlier.

Lower exposures of rilpivirine were observed during pregnancy, therefore viral load should be monitored closely. Marketing authorisation number s 9. 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. 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.

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A strict dosing schedule, with intake of H 2- receptor antagonists at least 12 hours before or at least 4 hours after rilpivirine should be used.

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

NNRTIs delavirdine, efavirenz, etravirine, nevirapine. Rilpivirine should not be used in combination with systemic dexamethasone except as a single dose as co-administration may result in loss of therapeutic effect of rilpivirine see section 4. Edurxnt observed hepatocellular findings in mice may be rodent-specific. In patients with severe renal impairment or end-stage renal disease, rilpivirine should be used with caution.

In patients co-infected with hepatitis B or C virus receiving rilpivirine, the incidence of hepatic enzyme elevation was higher than in patients receiving rilpivirine who were not co-infected. Dose dependent decreases in rilpivirine plasma concentrations are expected. While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.

If the patient misses a dose of EDURANT within 12 hours of the time it is usually taken, the patient must take the medicine with a meal edurqnt soon as possible and resume the normal dosing schedule.

Edurant (rilpivirine) Tablets, Package Insert

Each film-coated tablet contains rilpivirine hydrochloride equivalent to 25 mg rilpivirine. 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.

Repeated dose toxicity Liver toxicity associated with liver enzyme induction was observed in rodents. There was no impact of body weight on rilpivirine pharmacokinetics in paediatric subjects in trial C 33 to 93 kgsimilar to what was observed in adults.

Reproductive toxicology studies Studies in animals have shown no evidence of relevant embryonic or foetal toxicity or an effect on reproductive function.

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Packsge vitro experiments indicate that rilpivirine primarily undergoes oxidative metabolism mediated by the cytochrome P CYP 3A system. There are limited amount of data less than pregnancy packwge from the use of rilpivirine in pregnant women see sections 4.

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 packafe the exposure of medicinal products metabolised by CYP enzymes.

Qualitative and quantitative composition 3. Dexamethasone systemic, except for single dose use. 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. Medicinal products that induce or inhibit CYP3A may thus affect the clearance of rilpivirine see section 5. Other Antiviral Agents Ribavirin Not studied.

Population pharmacokinetic analysis of rilpivirine in HIV infected patients indicated that race had no clinically relevant effect on the exposure to rilpivirine. The most frequent serious treatment-related ADRs were reported in 7 1. Rilpivirine inhibits P-glycoprotein in vitro IC 50 is 9. Rilpivirine did not induce chromosomal damage in the in vivo micronucleus test in mice.

However, clinical monitoring is recommended as insfrt maintenance therapy may need to be adjusted in some patients.

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

Renal impairment The pharmacokinetics of rilpivirine have not been studied in patients with renal insufficiency. The greater risk of virologic failure for patients in the rilpivirine arm was observed in the first 48 weeks of these trials see section 5.

HIV PIs — with co-administration of low dose ritonavir. The list of rilpivirine resistance-associated mutations presented in section pacjage.