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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Liver toxicity associated with liver enzyme induction was observed in rodents.

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

The EK substitution emerged most frequently during rilpivirine treatment, commonly in combination with the MI substitution. 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. 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.

Company contact details Janssen-Cilag Ltd. No human data on the effect eedurant rilpivirine on fertility are available. 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 packwge 4.

Fluconazole Itraconazole Posaconazole Voriconazole Pxckage studied. To view the changes to packagr medicine you must sign up and log in. 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.

Eeach film-coated tablet contains isert mg lactose monohydrate. There were no new safety findings compared with the known safety profile inserg rilpivirine in HIV-1 infected lackage see sections 4. There are limited amount of data less than pregnancy outcomes from the use of rilpivirine in pregnant women see sections 4. Healthcare professionals are asked to report any suspected adverse reactions via:. Continue typing to refine.

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No clinically relevant drug-drug interaction is expected. There was no impact of body weight on rilpivirine pharmacokinetics in paediatric subjects in trial C 33 to 93 isnertsimilar to what was observed in adults.

In a clinical study, rilpivirine did not significantly affect the pharmacokinetics of digoxin. The proportion of virological failures was Last updated on eMC: Table 3 displays selected baseline disease characteristics of the patients in the rilpivirine and efavirenz arms. St John’s wort Hypericum perforatum. Other Antiviral Agents Ribavirin Not studied.

Patients in the control arm received efavirenz mg once daily in addition to a BR in both parts of the study. Population pharmacokinetic analysis in HIV infected patients showed that rilpivirine pharmacokinetics are not different across the age range 18 to 78 years evaluated, with only 3 subjects aged 65 years or older.

Rilpivirine must not be used in combination with proton pump inhibitors as co-administration is likely to result in loss of therapeutic effect of pacjage see section 4.

Each film-coated tablet contains rilpivirine hydrochloride equivalent to 25 mg rilpivirine. No clinically relevant effects on fertility were seen in animal studies see section 5.

Edurant 25 mg tablets

Marketing authorisation holder 8. Within each insrt grouping, ADRs are presented in order of decreasing frequency. It is recommended that the film-coated tablet be swallowed whole with water and not be chewed or crushed. The median duration of exposure for patients in the rilpivirine arm and efavirenz arm was However, it may not be excluded that the pharmacologically active, unbound, rilpivirine exposure is significantly increased in moderate hepatic impairment.

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Lansoprazole Rabeprazole Pantoprazole Esomeprazole. The pharmacokinetics of rilpivirine have not been studied in patients edurannt renal insufficiency. The combination of rilpivirine and dabigatran etexilate should be used with caution. Lansoprazole Rabeprazole Pantoprazole Esomeprazole Not studied.

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. Elimination The terminal elimination half-life of rilpivirine is approximately 45 hours.

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

Most ADRs occurred in the first 48 weeks of treatment. 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. Where possible, alternatives such as azithromycin should be considered. Renal impairment The pharmacokinetics of rilpivirine have not been studied in patients with renal insufficiency.

Store in the original bottle in order to protect from light. White to off-white, round, biconvex, film-coated tablet with a diameter of 6. Resistance was defined as the emergence of any resistance-associated mutation at failure. Established and theoretical interactions with selected antiretrovirals and non-antiretroviral medicinal products are inaert in table 1.

Hypersensitivity to the active substance or to any of the excipients listed in section 6. This site uses cookies. Lower exposures of rilpivirine were observed when rilpivirine 25 mg once daily was taken during pregnancy. In vitro experiments indicate that rilpivirine primarily undergoes oxidative metabolism mediated by the cytochrome P CYP 3A system.