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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Marketing authorisation number s 9. There were no patients who discontinued treatment due to ADRs. Show table of contents Hide table of contents 1.
Edurant (rilpivirine) Tablets, Package Insert
There is limited information available on the potential for a pharmacodynamic interaction between rilpivirine and inssrt products that prolong the QTc interval of the ECG. Only H 2- receptor antagonists that can be dosed once daily should be used. Store in the original bottle in order to protect from light. Fluconazole Itraconazole Posaconazole Voriconazole Not studied.
Dexamethasone systemic, except for single dose use.
For the resistance analysis, a broader definition of virologic failure inserr used than in the primary efficacy analysis. 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.
Edurant 25 mg tablets – Summary of Product Characteristics (SmPC) – (eMC)
Antacids should only be administered either at least 2 hours before or at least 4 hours after rilpivirine. However, it may not be excluded that the pharmacologically active, unbound, rilpivirine exposure is significantly increased in moderate hepatic impairment. Each carton contains one bottle of 30 tablets. Missed dose 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 as soon as possible and resume the normal dosing schedule.
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. From the week 96 pooled resistance analysis, the resistance outcome for patients with protocol defined virological failure, and paired genotypes baseline and failure is shown in table 5. For those patients failing therapy with rilpivirine and who developed resistance to rilpivirine, cross-resistance to other approved NNRTIs etravirine, efavirenz, nevirapine was generally seen.
HIV PIs — with co-administration of low dose ritonavir. In this analysis, the resistance-associated mutations RAMs associated with NNRTI resistance that developed in at least 2 rilpivirine virologic failures were: Renal elimination of rilpivirine is negligible.
Company contact details Janssen-Cilag Ltd. From the week 48 to the week 96 analysis, 24 3. No dose adjustments are required when initiating co-administration of methadone with rilpivirine.
Renal impairment The pharmacokinetics of rilpivirine have fdurant been studied in patients with renal insufficiency. The observed hepatocellular findings in mice may be rodent-specific. Percentage of subjects with: This information is intended for use by health professionals.
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 ihsert healthy adults, with 13 measurements over 24 hours at steady-state.
Dose dependent decreases in rilpivirine plasma concentrations are expected. Edurqnt of rilpivirine with medicinal products that increase gastric pH may result in decreased plasma concentrations of rilpivirine which could potentially reduce the therapeutic effect of EDURANT.
All other drug-drug interactions shown are predicted. Rilpivirine must not be used in combination with rifampicin as co-administration is likely to result in loss eudrant therapeutic effect of rilpivirine see section 4. Rilpivirine must not be used in combination with products containing St John’s wort as co-administration may result in loss of therapeutic effect of rilpivirine see section 4.
There was no teratogenicity with rilpivirine in rats and rabbits. Elimination The terminal elimination half-life of rilpivirine is approximately 45 hours. 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. Similar efficacy for rilpivirine was seen in each trial demonstrating non-inferiority to efavirenz.
After oral administration, the maximum plasma concentration of rilpivirine is generally achieved within hours. Most ADRs were Grade 1 or 2.
Edurant 25 mg tablets
Pregnancy Edurant should be used during pregnancy only if the potential benefit justifies the potential risk. Excipient with known effect: The single resistance-associated mutations associated with a loss of susceptibility to rilpivirine were: No dose adjustment is required. Lower exposures of rilpivirine were observed when rilpivirine 25 mg once daily was taken during pregnancy.
Table 3 displays selected baseline disease characteristics of the patients in the rilpivirine and efavirenz arms.