EDURANT PACKAGE INSERT PDF

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 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.

Marketing authorisation number s 9. 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. Outcome in the week 96 analysis. The median duration of exposure for patients was 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.

Date of first authorisation: The pharmacokinetics of rilpivirine in paediatric patients less than 12 years of age are under investigation.

Edurant (rilpivirine) Tablets, Package Insert

Renal impairment The pharmacokinetics of rilpivirine have not been studied in patients with renal insufficiency. No dose adjustment of rilpivirine is required in patients with mild or moderate renal impairment. Pregnancy Edurant should be used during pregnancy only if the potential benefit justifies the potential risk. Treatment of overdose with rilpivirine consists of general supportive measures including monitoring of vital signs and ECG QT interval as well as observation of the clinical status of the patient.

Tabulated summary of adverse reactions ADRs reported in adult patients treated with rilpivirine are summarised in Table 2. In rats, there were no drug-related neoplasms.

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Table 3 displays selected baseline disease characteristics of the patients in the rilpivirine and efavirenz arms. The single resistance-associated mutations associated with a loss of susceptibility to rilpivirine were: Edurant should be used during pregnancy only if the potential benefit justifies the potential risk.

Rilpivirine is approximately 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. Unboosted PIs atazanavir, fosamprenavir, indinavir, nelfinavir. Antiviral for systemic use, non-nucleoside reverse transcriptase inhibitors, ATC code: Rilpivirine did not induce chromosomal damage in the in vivo micronucleus test in mice.

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

Store in the original bottle in order to protect from light. The KN substitution did not result in reduced susceptibility to rilpivirine by itself, but the combination of KN and LI resulted in a 7-fold reduced susceptibility to rilpivirine. Show table of contents Hide table of contents 1. In ECHO, randomisation was stratified by screening viral load.

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

Detailed information on this medicinal product is available on the website of the European Medicines Agency http: Lower exposures deurant rilpivirine were observed during pregnancy, therefore viral load should be monitored paciage. No clinically relevant differences in the pharmacokinetics of rilpivirine have been observed between men and women. Qualitative and quantitative composition 3.

However, fatigue, dizziness and somnolence have been reported in some patients taking EDURANT and should be considered when assessing a patient’s ability to drive or operate machinery. The trials were identical in design, with the exception of the background regimen BR.

The terminal elimination half-life of rilpivirine is approximately 45 hours. Percentage of subjects with: There were no new safety findings compared with the known safety profile of rilpivirine in HIV-1 infected adults see sections 4.

ADRs reported in adult patients treated with rilpivirine are summarised in Table 2. No human data on the effect of rilpivirine on fertility are available. Edurant 25 mg tablets. Any inflammatory symptoms should be evaluated and treatment instituted when necessary.

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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.

Dose dependent decreases in rilpivirine plasma concentrations are expected. Reporting suspected adverse reactions after authorisation of the medicinal product is important. For the resistance analysis, a broader definition of virologic failure was used than in the primary efficacy analysis.

Carbamazepine Oxcarbazepine Phenobarbital Phenytoin. Discontinuations due to adverse events were higher in the efavirenz arm at week 96 than the rilpivirine arm. Race Population pharmacokinetic analysis of rilpivirine in HIV infected patients indicated that race had no clinically relevant effect on the exposure to rilpivirine.

Vardenafil Tadalafil Not studied. However, clinical monitoring is recommended as methadone maintenance therapy may need to be adjusted in some patients.

Pregnancy There are limited amount of data less than pregnancy outcomes from the use of rilpivirine in pregnant women see sections 4. 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.

Medicinal products that induce or inhibit CYP3A may thus affect the clearance of rilpivirine see section 5. Eeach film-coated tablet contains 56 mg lactose monohydrate.

Most of these discontinuations occurred in the first 48 weeks of treatment. In the trials, the presence of the mutations V90I and VI, at baseline, did not affect response.

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. In 4 of those 5 subjects, NRTI resistance was observed as well.