rilpivirine

Detailed Prescribing Information

May 2011

No dose adjustment of EDURANT is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. EDURANT has not been studied in patients with severe hepatic impairment (Child-Pugh Class C)

No dose adjustment is required in patients with mild or moderate renal impairment.  However, in patients with severe renal impairment or end-stage renal disease, rilpivirine should be used with caution and with increased monitoring for adverse effects, as rilpivirine concentrations may be increased due to alteration of drug absorption, distribution, and metabolism secondary to renal dysfunction. As rilpivirine is highly bound to plasma proteins, it is unlikely that it will be significantly removed by hemodialysis or peritoneal dialysis

anticonvulsants: carbemazepine, oxycarbazepine, phenobarbital, phenytoin

antimycobacterials: rifabutin, rifampin, rifapentine

proton pump inhibitors: esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole

glucocorticoid: dexamethasone (more than a single dose)    

St John's wort (Hypericum perforatum)

Depression including depressed mood, depression, dysphoria, major depression, altered mood, negative thought, suicide attempt, suicidal ideation

3% incidence of rash, usually mild and NONPROGRESSIVE with continued treatment

In supratherapeutic doses, rilpivirine can prolong the QTc interval.

No change in boosted or unboosted protease inhibitor concentrations

Decrease in ketoconazole concentrations - possible decrease in levels for fluconazole, itraconazole, posaconazole, voriconazole

No change in macrolide concentrations including clarithromycin, erythromycin, troleandomycin

Decrease in methadone concentrations

Antacids taken with and H2-blockers taken 2 hours before rilpivirine decrease serum concentrations of rilpivirine - AVOID

Antacids taken at least 2 hours before or at least 4 hours after rilpivirine did not significantly change serum concentrations.