CABENUVA

Combination product

Pronunciation: ka-boe-TEG-ra-veer and ril-pi-VIR-een (KAB-en-oo-va)

Combination of Cabotegravir and Rilpivirine.

Each component keeps its own pharmacology page; the combination itself adds no new mechanism.

Components (2)

Cabotegravir ballicule — decagon mechanism diagram — Cabotegravir

Rilpivirine ballicule — decagon mechanism diagram — Rilpivirine

FDA label

Read the full label on DailyMed ↗

FDA dosing	Population	Start	Target	Max
HIV-1 infection (complete regimen, replacement) — monthly	Adults & adolescents >=12 yr and >=35 kg, virologically suppressed	Initiation: 600 mg cabotegravir + 900 mg rilpivirine IM	400 mg cabotegravir + 600 mg rilpivirine IM monthly	—
HIV-1 infection — every 2 months	Adults & adolescents >=12 yr and >=35 kg, virologically suppressed	600 mg cabotegravir + 900 mg rilpivirine IM for 2 consecutive months	600 mg cabotegravir + 900 mg rilpivirine IM every 2 months	—

Renal No adjustment for mild/moderate; increased monitoring for adverse effects in severe renal impairment or ESRD

Hepatic No adjustment for mild/moderate (Child-Pugh A/B); effect of severe (Child-Pugh C) unknown

Adhere to the scheduled dosing; residual drug may persist in circulation >=12 months

Instructions

Gluteal intramuscular injection only, administered by a healthcare provider
Optional oral lead-in (oral cabotegravir + rilpivirine) ~1 month to assess tolerability
Give cabotegravir and rilpivirine at separate gluteal sites during the same visit
If discontinued, start an alternative suppressive regimen <=1 month (monthly) or <=2 months (every-2-month) after the last injection

Available strengths

inj 400/600 mg/2 mL
inj 600/900 mg/3 mL

Contraindications

Coadministration with UGT1A1/CYP3A inducers that reduce cabotegravir/rilpivirine levels: carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone (more than single-dose), and St John's wort

Cautions

Hypersensitivity reactions (including SJS/TEN, DRESS)
Post-injection reactions (rilpivirine)
Hepatotoxicity
Depressive disorders
Long-acting residual drug — risk of virologic failure/resistance with missed doses

Adverse reactions

Injection site reactions
Pyrexia
Fatigue
Headache
Musculoskeletal pain
Nausea
Sleep disorders
Dizziness
Rash

Pregnancy Insufficient human data; lower rilpivirine exposures during pregnancy — monitor viral load closely; drug persists >=12 months (consider fetal exposure).

Lactation Rilpivirine present in human milk; cabotegravir present in animal milk; residual exposures may persist >=12 months after last injection.

Cost

CABENUVA

Strength		#/mo	generic $/unit	CostPlus
400/600 mg/2 mL	inj	per unit		not offered
600/900 mg/3 mL	inj	per unit		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. CABENUVA is administered under clinical supervision and dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

Part D rank #679.

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