Indications for EDURANT:
In combination with other antiretroviral agents for HIV-1 infection in antiretroviral treatment-naïve patients with HIV-1 RNA ≤100,000 copies/mL at start of therapy.
Adults and Children:
<12yrs or <35kg: not established. Take with a meal. ≥12yrs (≥35kg): 25mg once daily. Pregnancy (already on prior stable dose and with HIV-1 RNA <50 copies/mL): 25mg once daily; monitor viral load. Concomitant rifabutin: 50mg once daily; decrease to 25mg once daily when rifabutin is stopped.
Concomitant carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, systemic dexamethasone (more than a single dose), St. John's wort.
Prolongation of QTc interval with supratherapeutic doses. Promptly evaluate if depressive symptoms occur. Monitor liver enzymes prior to initiation and during therapy in patients with underlying hepatitis B or C, or marked elevations in transaminases; consider monitoring LFTs in patients without pre-existing hepatic dysfunction or other risks. Discontinue immediately if severe skin or hypersensitivity reactions develop. Severe renal impairment or ESRD: monitor. Pregnancy. Nursing mothers: not recommended.
Non-nucleoside reverse transcriptase inhibitor.
Concomitant NNRTIs (eg, delavirdine): not recommended. Concomitant drugs with a known risk for torsades de pointes: consider alternatives to rilpivirine. Antagonized by CYP3A inducers (see Contraindications). May be potentiated by CYP3A inhibitors (eg, azole antifungals [monitor for breakthrough fungal infections], clarithromycin, erythromycin, telithromycin [consider azithromycin use]). Concomitant methadone; monitor. Separate didanosine, antacids (by at least 2hrs before or at least 4hrs after) and H2-receptor antagonists (by at least 12hrs before or 4hrs after rilpivirine); drugs that increase gastric pH may result in decreased plasma concentrations.
Depressive disorders, insomnia, headache, rash; hepatotoxicity, fat redistribution, immune reconstitution syndrome.
To register pregnant patients to the Antiretroviral Pregnancy Registry, call (800) 258–4263.
Hepatic (CYP3A4); 99.7% protein bound.
Fecal (primarily), renal.