Indications for CABENUVA:
As a complete regimen for HIV-1 infection in adults to replace the current antiretroviral regimen in those 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.
Must be administered by a healthcare professional. Give each IM inj at separate gluteal inj sites (on opposite sides or 2cm apart) during same visit; preferably ventrogluteal site. Do not administer by any other route or anatomical site. Prior to initiation, assess tolerability using oral lead-in (with Vocabria and Edurant) for approx. 1 month (≥28 days). At Month 2 (on last day of oral lead-in): initiate injections at 600mg/900mg once; Month 3 onwards: continue at 400mg/600mg injections once monthly (may be given up to 7 days before or after the scheduled date to receive monthly injections). Missed injections: see full labeling.
Concomitant carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone (more than 1 dose), St. John's wort.
Discontinue immediately if hypersensitivity reactions develop. Monitor for post-inj reactions; treat appropriately if occur. Underlying liver disease or marked elevation in transaminases. Monitor liver function; discontinue if hepatotoxicity is suspected. Promptly evaluate if depressive symptoms occur. Long-acting properties: residual drug concentrations may remain ≥12months. Switch to an alternative regimen if virologic failure is suspected. Severe hepatic impairment. Severe renal impairment or ESRD: monitor. Elderly. Pregnancy: monitor. Nursing mothers: not recommended.
HIV-1 integrase strand transfer inhibitor (INSTI) + non-nucleoside reverse transcriptase inhibitor.
See Contraindications. Concomitant other antiretroviral drugs: not recommended. Cabotegravir: antagonized by strong UGT1A1 or 1A9 inducers. Rilpivirine: antagonized by CYP3A inducers or may be potentiated by CYP3A inhibitors. Concomitant drugs with a known risk for torsade de pointes (eg, azithromycin, clarithromycin, erythromycin); caution; consider alternatives. Concomitant methadone; monitor; may need dose adjustment.
Inj site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, rash; hepatotoxicity, depressive disorders.
Generic Drug Availability:
Kit—1 (1 vial of cabotegravir + 1 vial of rilpivirine) w. supplies