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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Outcome in the week 48 analysis. The median duration of exposure for patients was ADRs reported in adult patients treated with rilpivirine are summarised in Table 2. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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. 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.

Reproductive toxicology studies Studies in animals have shown no evidence of relevant embryonic or foetal toxicity or an effect on reproductive function. Where possible, alternatives such as azithromycin should be considered.

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 on the exposure of medicinal products metabolised by CYP enzymes.

The distribution of rilpivirine into compartments other than plasma e. Therapy should be initiated by a physician experienced in the management of HIV infection. Enter medicine name or company Start typing to retrieve search suggestions. The EK substitution emerged most frequently during rilpivirine treatment, commonly in combination with the MI substitution. After oral administration, the maximum plasma concentration of rilpivirine is generally achieved within hours.

Dose dependent decreases in rilpivirine plasma concentrations are expected. Rilpivirine was well tolerated during pregnancy and postpartum. Population pharmacokinetic analysis of rilpivirine in HIV infected patients indicated that race had no clinically relevant effect on the exposure to rilpivirine. Hepatic impairment Rilpivirine is primarily metabolised and eliminated by the liver. No data are available.

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No clinically relevant drug-drug interactions are expected. Virologic failure and development of resistance EDURANT has not been evaluated in patients with previous virologic failure to any other antiretroviral therapy.

Co-administration of rilpivirine and medicinal products that induce CYP3A has been observed to decrease the plasma concentrations of rilpivirine, which could reduce the therapeutic effect of rilpivirine. Date of revision of the text. White to off-white, round, biconvex, film-coated tablet with a diameter of 6. In the trials, the presence of the mutations V90I and VI, at baseline, did not affect response. Treatment with rilpivirine resulted in an early small increase of mean serum creatinine levels which remained stable over time and is not considered clinically relevant see section 4.

Gender No clinically relevant differences in the pharmacokinetics of rilpivirine have been observed between men and women. NNRTIs delavirdine, efavirenz, etravirine, nevirapine. Concomitant use of rilpivirine with ritonavir-boosted PIs causes an increase in the inaert concentrations of rilpivirine, but no dose adjustment is required. In vitro experiments indicate that rilpivirine primarily undergoes oxidative metabolism mediated by the cytochrome P CYP 3A system.

Exposure to rilpivirine was generally lower in HIV-1 infected patients than in healthy subjects. Typically, such reactions have been observed within the first weeks or inwert of initiation of CART.

Edurant 25 mg tablets

The virologic response was generally preserved throughout the study: No clinically relevant effects on fertility were seen in animal studies see section 5. Rilpivirine did not induce chromosomal damage in the in packagf micronucleus test in mice. If a patient misses a dose of EDURANT by more pacoage 12 hours, the patient should not take the missed dose, but resume the usual dosing schedule. 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.

All other drug-drug interactions shown are predicted. By continuing to browse the site you are agreeing to our policy on the use of cookies. The combination of rilpivirine and antacids should be used with particular caution. Carcinogenesis and mutagenesis Rilpivirine was evaluated for carcinogenic potential by oral gavage administration to mice and rats up to weeks.

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Healthcare professionals are asked to report any suspected adverse reactions via:.

Rilpivirine at a dose of 25 mg once daily is not likely pac,age have a clinically relevant effect on the exposure of medicinal products metabolised by CYP enzymes. 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.

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

Active ingredient rilpivirine hydrochloride. Most of these discontinuations occurred in the first 48 weeks of treatment.

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 inser see table 6. Repeated dose toxicity Liver toxicity associated with liver enzyme induction was observed in rodents. Breast-feeding It is not known whether rilpivirine is excreted in human milk. In a study of healthy subjects, supratherapeutic doses of rilpivirine 75 mg once daily and mg once daily have oackage shown to prolong the QTc interval of the ECG see section 5.

The terminal elimination half-life of rilpivirine is approximately 45 hours. In ECHO, randomisation was stratified by screening viral load. Race Population pharmacokinetic analysis of rilpivirine in HIV infected patients indicated that race had no clinically relevant effect on the exposure to rilpivirine.

Last updated on eMC: To bookmark a medicine you must sign up and log in. At the recommended dose of 25 mg once daily, no dose adjustment is required when rilpivirine is co-administered with ketoconazole.