Viral infections:
Indications for: CABENUVA
As a complete regimen for HIV-1 infection to replace the current antiretroviral regimen in patients 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.
Adult Dosage:
Must be administered by a healthcare provider. 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. ≥12yrs (≥35kg): Prior to initiation, may consider giving oral lead-in dosing (with Vocabria and Edurant) for approx. 1 month (≥28 days) to assess tolerability or may proceed directly to Cabenuva inj without use of an oral lead-in. Select appropriate inj dosing option. Monthly dosing: initiate single injections of 600mg/900mg (on the last day of current antiretroviral therapy or oral lead-in, if used), then continue single injections of 400mg/600mg once monthly onwards. Or, every 2-month dosing: initiate single injections of 600mg/900mg (on the last day of current antiretroviral therapy or oral lead-in, if used) consecutively 1 month apart for 2 months (Months 1 and 2), and then continue every 2 months onwards (starting at Month 4). Both regimens: may give injections up to 7 days before or after the scheduled date to receive monthly or every 2-month injections. Switching from monthly to every 2-month injections, every 2-month to monthly injections, missed injections: see full labeling.
Children Dosage:
<12yrs or <35kg: not established.
CABENUVA Contraindications:
Concomitant carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone (more than 1 dose), St. John's wort.
CABENUVA Warnings/Precautions:
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.
CABENUVA Classification:
HIV-1 integrase strand transfer inhibitor (INSTI) + non-nucleoside reverse transcriptase inhibitor.
CABENUVA Interactions:
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.
Adverse Reactions:
Inj site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, rash; hepatotoxicity, depressive disorders.
Drug Elimination:
Cabotegravir: fecal (59%), renal (27%); rilpivirine: fecal (85%), renal (6%). Half-life: 5.6–11.5 weeks (cabotegravir); 13–28 weeks (rilpivirine).
Generic Drug Availability:
NO
How Supplied:
Kit—1 (1 vial of cabotegravir + 1 vial of rilpivirine) w. supplies
