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. In combination with Vocabria (cabotegravir) for short-term treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine, for use as: oral lead-in to assess the tolerability of rilpivirine prior to administration of Cabenuva (cabotegravir; rilpivirine) extended-release injectable suspensions; or oral therapy for patients who will miss planned injection dosing with Cabenuva.
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. In combination with Vocabria: prior to initiation, consult additional full labelings (Vocabria and Cabenuva) to ensure appropriate therapy. Take with a meal at the same time each day. 25mg once daily in combination with Vocabria (30mg/day) for approx. 1 month (≥28 days). As oral lead-in: the last oral dose should be taken on the same day Cabenuva inj is started. As oral replacement (if planned to miss a scheduled Cabenuva inj by >7days): can replace up to 2 consecutive monthly inj visits. The first oral dose should be taken approx. 1 month after the last Cabenuva inj and continued until the day inj dosing is restarted.
Concomitant carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, systemic dexamethasone (more than 1 dose), St. John's wort. Also: use of Cabenuva with rifabutin is contraindicated; see Cabenuva full labeling.
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.
Generic Drug Availability: