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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However, it may not be excluded that the pharmacologically active, unbound, rilpivirine exposure is significantly increased packahe moderate hepatic impairment. Rilpivirine is excreted in the milk of rats.

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. Ijsert 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.

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

Lansoprazole Rabeprazole Pantoprazole Esomeprazole. After oral administration, the maximum plasma concentration of eedurant is generally achieved within hours. 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.

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

Dose dependent decreases in rilpivirine plasma concentrations are expected. The European Medicines Agency has deferred the obligation to submit the results of studies with rilpivirine in one or more subsets of the paediatric population in the treatment of Human Immunodeficiency Virus HIV-1 infection see section 4. Increased exposure of rilpivirine is expected.

Active ingredient rilpivirine hydrochloride. 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.

Significant decreases in rilpivirine plasma concentrations are expected. Other NRTIs abacavir, emtricitabine, lamivudine, stavudine and zidovudine.

Edurant (rilpivirine) Tablets, Package Insert

Precautions to prevent transmission should be taken in accordance with national guidelines. Healthcare professionals are asked to report any suspected adverse reactions via:. Absorption After oral administration, the maximum plasma concentration of rilpivirine is generally achieved within hours. Co-administration of rilpivirine and medicinal products that induce CYP3A has been observed isert decrease the plasma concentrations of rilpivirine, which could reduce the therapeutic effect of rilpivirine.

Carbamazepine Oxcarbazepine Phenobarbital Phenytoin. 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. Population pharmacokinetic analysis in HIV infected patients showed that rilpivirine pharmacokinetics are not different across the age range 18 to 78 years edurxnt, with only 3 subjects aged 65 years or older.

Alternatives should be considered, particularly for long-term use. 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.

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Detailed information on this medicinal product is available on the website of the European Medicines Agency http: Store in the original bottle in order to protect from light. The 36 subjects had a median age of Administration of activated charcoal may be used to aid in removal of unabsorbed active substance.

Most of these discontinuations occurred in the first 48 weeks of treatment. Autoimmune disorders such as Graves’ disease and autoimmune hepatitis have also been reported to occur in the setting of pacage reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment see section 4.

Alternatively, switching to another ART regimen could be considered. To view insdrt changes to a medicine you must sign up and log in.

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

The clinical implications of this finding are currently unknown. The dosing recommendation is applicable to the recommended dose of rilpivirine of 25 mg once daily. Outcome in the week 96 analysis. The combination of rilpivirine and antacids should be used with particular caution.