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Cabenuva
cabotegravir and rilpivirine
Adult Dosing .
Dosage forms: INJ
HIV infection
- [qmo dosing regimen, cabotegravir component]
- Dose: 600 mg IM x1, then 400 mg IM qmo; Start: on last day of current antiretroviral regimen or oral lead-in tx; Info: for patients with HIV-1 RNA <50 and no known tx failure or resistance to cabotegravir or rilpivirine; give with qmo rilpivirine IM injections; may give injections up to 7 days before or after scheduled dose; see pkg insert for dose recommendations for missed doses or switching to q2mo dosing regimen
- [qmo dosing regimen, rilpivirine component]
- Dose: 900 mg IM x1, then 600 mg IM qmo; Start: on last day of current antiretroviral regimen or oral lead-in tx; Info: for patients with HIV-1 RNA <50 and no known tx failure or resistance to cabotegravir or rilpivirine; give with qmo cabotegravir IM injections; may give injections up to 7 days before or after scheduled dose; see pkg insert for dose recommendations for missed doses or switching to q2mo dosing regimen
- [q2mo dosing regimen, cabotegravir component]
- Dose: 600 mg IM qmo x2 doses, then 600 mg IM q2mo; Start: on last day of current antiretroviral regimen or oral lead-in tx; Info: for patients with HIV-1 RNA <50 and no known tx failure or resistance to cabotegravir or rilpivirine; give with q2mo rilpivirine IM injections; may give injections up to 7 days before or after scheduled dose; see pkg insert for dose recommendations for missed doses or switching to qmo dosing regimens
- [q2mo dosing regimen, rilpivirine component]
- Dose: 900 mg IM qmo x2 doses, then 900 mg IM q2mo; Start: on last day of current antiretroviral regimen or oral lead-in tx; Info: for patients with HIV-1 RNA <50 and no known tx failure or resistance to cabotegravir or rilpivirine; give with q2mo cabotegravir IM injections; may give injections up to 7 days before or after scheduled dose; see pkg insert for dose recommendations for missed doses or switching to qmo dosing regimen
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined, caution advised
- HD/PD: not defined, caution advised
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined
Peds Dosing .
- Dosage forms: INJ
HIV infection
- [qmo dosing regimen, cabotegravir component, 12 yo and older, >35 kg]
- Dose: 600 mg IM x1, then 400 mg IM qmo; Start: on last day of current antiretroviral regimen or oral lead-in tx; Info: for patients with HIV-1 RNA <50 and no known tx failure or resistance to cabotegravir or rilpivirine; give with qmo rilpivirine IM injections; may give injections up to 7 days before or after scheduled dose; see pkg insert for dose recommendations for missed doses or switching to q2mo dosing regimen
- [qmo dosing regimen, rilpivirine component, 12 yo and older, >35 kg]
- Dose: 900 mg IM x1, then 600 mg IM qmo; Start: on last day of current antiretroviral regimen or oral lead-in tx; Info: for patients with HIV-1 RNA <50 and no known tx failure or resistance to cabotegravir or rilpivirine; give with qmo cabotegravir IM injections; may give injections up to 7 days before or after scheduled dose; see pkg insert for dose recommendations for missed doses or switching to q2mo dosing regimen
- [q2mo dosing regimen, cabotegravir component, 12 yo and older, >35 kg]
- Dose: 600 mg IM qmo x2 doses, then 600 mg IM q2mo; Start: on last day of current antiretroviral regimen or oral lead-in tx; Info: for patients with HIV-1 RNA <50 and no known tx failure or resistance to cabotegravir or rilpivirine; give with q2mo rilpivirine IM injections; may give injections up to 7 days before or after scheduled dose; see pkg insert for dose recommendations for missed doses or switching to qmo dosing regimens
- [q2mo dosing regimen, rilpivirine component, 12 yo and older, >35 kg]
- Dose: 900 mg IM qmo x2 doses, then 900 mg IM q2mo; Start: on last day of current antiretroviral regimen or oral lead-in tx; Info: for patients with HIV-1 RNA <50 and no known tx failure or resistance to cabotegravir or rilpivirine; give with q2mo cabotegravir IM injections; may give injections up to 7 days before or after scheduled dose; see pkg insert for dose recommendations for missed doses or switching to qmo dosing regimen
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined, caution advised
- HD/PD: not defined, caution advised
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- avoid: breastfeeding (patients with non-virological suppression throughout 3rd trimester)
- avoid: breastfeeding (patients with non-virological suppression postpartum)
- avoid: breastfeeding (patients with cracked nipple or bleeding nipple)
- avoid: breastfeeding (patients with mastitis)
- caution: depressive disorder
- caution: HIV infection and HBV infection, concurrent
- caution: HIV infection and HCV infection, concurrent
- caution: hepatic disease
- caution: liver transaminases elevated
- caution: CrCl <30
- caution: electrolyte abnormalities
- caution: long QT syndrome, congenital
- caution: QT prolongation
- caution: QT prolongation family history
- caution: torsades de pointes history
- caution: ventricular arrhythmia
- caution: bradycardia
- caution: MI, recent
- caution: CHF
Drug Interactions .
Overview
cabotegravir
HIV integrase inhibitor
- UGT1A1 substrate
- UGT1A9 substrate
- OAT1 inhibitor
- OAT3 inhibitor
- affected by altered fat absorption
- binds to polyvalent cations
- interferes w/ gene therapy
rilpivirine
NNRTI
- CYP3A4 substrate
- affected by altered fat absorption
- gastric pH sensitive
- interferes w/ gene therapy
- prolongs QT interval (conditional)
Contraindicated
Avoid/Use Alternative
Monitor/Modify Tx
Caution Advised
Adverse Reactions .
Serious Reactions
- hypersensitivity reaction
- Stevens-Johnson syndrome
- toxic epidermal necrolysis
- drug reaction with eosinophilia and systemic symptoms
- immune reconstitution syndrome
- autoimmune disorder
- skin reaction, severe
- hepatotoxicity
- depression
- suicidality
Common Reactions
- injection site reaction
- fever
- fatigue
- headache
- musculoskeletal pain
- nausea
- sleep disorders
- dizziness
- rash
- ALT or AST elevated
- CPK elevated
- hyperlipasemia
- anxiety
- hypercholesterolemia
- Cr elevated
- hyperbilirubinemia
- depression
- abdominal pain
- hypertriglyceridemia
- weight gain
- somnolence (peds patients)
- vomiting (peds patients)
Safety/Monitoring .
Monitoring Parameters
LFTs at baseline, 4-8wk after tx start or change, then q6-12mo
Pregnancy/Lactation .
Pregnancy
Clinical Summary
cabotegravir: weigh risk/benefit during pregnancy; monitor HIV-1 RNA q1-2mo during pregnancy; inadequate human data available, though risk of congenital neural tube defects low based on human data with dolutegravir; possible risk of decr. fetal birth weight, stillbirth, and neonatal death based on conflicting animal data at 28x recommended human dose
rilpivirine: weigh risk/benefit during pregnancy; monitor HIV-1 RNA q1-2mo during pregnancy; no human data available with extended-release INJ form, though no known risk of fetal harm based on limited human data and animal data at 15x and 70x recommended human dose with PO form; possible risk of lower exposure during pregnancy, though not clinically relevant if virologically suppressed based on human data with PO form
Pregnancy Registry
enroll patients in Antiretroviral Pregnancy Registry at 1-800-258-4263; additional info at www.apregistry.com
Lactation
Clinical Summary
weigh risk/benefit if virologically suppressed throughout 3rd trimester and at delivery, otherwise avoid breastfeeding; avoid breastfeeding if mastitis or nipples cracked or bleeding; give infant antiretroviral prophylaxis; risk of postnatal HIV transmission if non-virologically suppressed based on human data; risk of postnatal HIV transmission low if virologically suppressed based on human data; no human data available with cabotegravir to assess risk of infant harm; inadequate human data available with rilpivirine, though possible risk of infant harm based on drug excretion into milk; no human data available to assess effects on milk production
Pharmacology .
Metabolism: for cabotegravir: liver primarily; CYP450: none; UGT: 1A1 (primary), 1A9 substrate; for rilpivirine: liver; CYP450: 3A substrate
Excretion: for cabotegravir: feces 59% (47% unchanged), urine 27% (none unchanged); Half-life: 5.6-11.5wk; for rilpivirine: feces 85% (26% unchanged), urine 6% (<1% unchanged); Half-life: 13-28wk
Subclass: HIV: Integrase Strand Transfer Inhibitors (INSTIs) ; HIV: Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs)
Mechanism of Action
for cabotegravir: inhibits HIV integrase, preventing viral DNA insertion into host cell DNA; for rilpivirine: inhibits reverse transcriptase and incorporates into viral DNA, resulting in DNA chain termination
Formulary .
No Formulary Selected
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