Cabotegravir (2 brand names, 1 dosage form, 1 route)
Available dosage forms: SUSPENSION, EXTENDED RELEASE.
Routes of administration: INTRAMUSCULAR.
Brand Names
- APRETUDE
- CABENUVA KIT
Indications and Usage
CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg 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 [see Microbiology (12.4), Clinical Studies (14.1)].
Contraindications
CABENUVA is contraindicated in patients: •with previous hypersensitivity reaction to cabotegravir or rilpivirine [see Warnings and Precautions (5.1)]. •receiving the following coadministered drugs for which significant decreases in cabotegravir and/or rilpivirine plasma concentrations may occur due to uridine diphosphate glucuronosyltransferase (UGT)1A1 and/or cytochrome P450 (CYP)3A enzyme induction, which may result in loss of virologic response [see Drug Interactions (7), Clinical Pharmacology (12.3)]: oAnticonvulsants: Carbamazepine, oxcarbazepine, phenobarbital, phenytoin oAntimycobacterials: Rifabutin, rifampin, rifapentine oGlucocorticoid (systemic): Dexamethasone (more than a single-dose treatment) oHerbal product: St John’s wort (Hypericum perforatum)
Adverse Reactions
The following adverse reactions are described below and in other sections of the labeling: •Hypersensitivity reactions [see Warnings and Precautions (5.1)] •Post-injection reactions [see Warnings and Precautions (5.2)] •Hepatotoxicity [see Warnings and Precautions (5.3)] •Depressive disorders [see Warnings and Precautions (5.4)]
Mechanism of Action
CABENUVA contains 2 long-acting HIV-1 antiretroviral drugs, cabotegravir and rilpivirine [see Microbiology (12.4)].
Overdosage
There is no known specific treatment for overdose with cabotegravir or rilpivirine. If overdose occurs, monitor the patient and apply standard supportive treatment as required, including monitoring of vital signs and ECG (QT interval) as well as observation of the clinical status of the patient. As both cabotegravir and rilpivirine are highly bound to plasma proteins, it is unlikely that either would be significantly removed by dialysis. Consider the prolonged exposure to cabotegravir and rilpivirine (components of CABENUVA) following an injection when assessing treatment needs and recovery [see Warnings and Precautions (5.6)].