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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Edurant 25 mg tablets
A risk for increases in dabigatran plasma concentrations cannot be excluded. Most ADRs were Grade 1 or 2. 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.
Each film-coated tablet contains rilpivirine hydrochloride equivalent to 25 mg rilpivirine. The median duration of exposure for patients in the rilpivirine arm and efavirenz arm was Alternatives should be considered, particularly for long-term use. Population pharmacokinetic analysis of rilpivirine in HIV infected patients indicated that race had no clinically relevant effect on the exposure to rilpivirine.
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. Last updated on eMC: Rilpivirine is primarily metabolised and eliminated by the liver.
Steady-state administration of rilpivirine 75 mg once daily and mg once daily resulted in a mean C max approximately 2. At the lowest tested doses in the carcinogenicity studies, the systemic exposures based on AUC to rilpivirine were fold mice and 3-fold ratsrelative to those observed in humans at the recommended dose 25 mg once daily.
The incidence of virologic failure was higher in the rilpivirine arm than the efavirenz arm at week 96; however, most of the virologic failures occurred within the first 48 weeks of treatment.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity see section 5. However, edurantt may not be completely excluded that rilpivirine can increase insertt exposure to other medicines transported pacjage P-glycoprotein that are more sensitive to intestinal P-gp inhibition, e.
No dose adjustments are required when initiating co-administration of methadone with rilpivirine. Reporting suspected adverse reactions after authorisation of the medicinal product is important.
In patients with severe renal impairment or end-stage renal disease, rilpivirine should be used with caution. Treatment of overdose with rilpivirine consists of general eduarnt measures including monitoring of vital signs and ECG QT interval as well as observation of the clinical status of the patient.
Rilpivirine should not be used in combination with systemic dexamethasone efurant as a single dose as co-administration may result in loss of therapeutic effect of rilpivirine see section 4. From the week 48 to the week 96 analysis, 24 3.
Administration of activated charcoal may be used to aid in removal of unabsorbed active substance. The trials were identical in design, with the exception of the background regimen BR. In a clinical study, rilpivirine did not significantly affect the pharmacokinetics of digoxin. To bookmark a medicine you must sign up and log in.
Edurant 25 mg tablets – Summary of Product Characteristics (SmPC) – (eMC)
Eduurant was evaluated for carcinogenic potential by oral gavage administration to mice and rats up to weeks. 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.
Throughout co-administration of rilpivirine with rifabutin, the rilpivirine dose should be increased from 25 mg once daily to 50 mg once daily. 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.
Fluconazole Itraconazole Posaconazole Voriconazole Not studied. No clinically relevant effects on fertility were seen in animal studies see section 5. White to off-white, round, biconvex, film-coated tablet with a diameter of 6. Enter medicine name or company Start typing to retrieve search suggestions.
Edurant (rilpivirine) Tablets, Package Insert
Vardenafil Tadalafil Not studied. HIV PIs — without co-administration of low dose ritonavir. Percentage of patients with the following background regimens: Lansoprazole Rabeprazole Pantoprazole Esomeprazole Not studied. Most ADRs occurred in the first 48 weeks of treatment. Table 3 displays selected baseline disease characteristics of the patients in the rilpivirine and efavirenz arms. Exposure to rilpivirine was generally lower in HIV-1 infected patients than in healthy subjects.
Human experience of overdose with rilpivirine is limited. Continue typing to refine. The combination of rilpivirine and dabigatran etexilate should be used with caution.
Alternatively, switching to another ART regimen could be considered see sections 4. As rilpivirine is highly bound to plasma proteins, it is unlikely that it will be significantly removed by haemodialysis or peritoneal dialysis see section 4. The most common mutations were the same in the week 48 and week 96 analyses.
Percentage of subjects with: Edurrant the resistance analysis, a broader definition of virologic failure was iinsert than in the primary efficacy analysis. Findings in adolescents 12 to insfrt than 18 years of age in trial C were generally in line with these data for details see section 5. 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.
Healthcare professionals are asked to report any suspected adverse reactions via:.