Cabenuva for treatment of HIV-1 infection in adults and adolescents

Cabenuva is an injectable medication containing extended-release formulations of cabotegravir and rilpivirine used as a complete treatment regimen for HIV-1 infection. It is intended for adults and adolescents aged 12 years and older who weigh at least 35 kg and who have achieved viral suppression on a stable antiretroviral regimen without history of treatment failure or resistance to the components.

Cabenuva is approved for the treatment of HIV-1 infection in adults and adolescents (12 years and older) weighing at least 35 kg. It is used to replace the current antiretroviral regimen in patients who are already virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable regimen and have no known or suspected resistance to cabotegravir or rilpivirine.

cabotegravir; rilpivirine

Cabotegravir is an integrase strand transfer inhibitor (INSTI) that blocks the HIV integrase enzyme, preventing the virus from integrating its genetic material into the host's DNA. Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that inhibits the reverse transcriptase enzyme, which the virus needs to replicate. Together, they reduce viral replication and help maintain viral suppression.

Cabenuva is administered as gluteal intramuscular injections by a healthcare provider and is available as two vials: one containing cabotegravir extended-release suspension and the other rilpivirine extended-release suspension. Injection dosing can be given monthly or every two months.

Optional Oral Lead-In

• One tablet daily: 30 mg VOCABRIA (cabotegravir) and 25 mg EDURANT (rilpivirine) with a meal for at least 28 days to assess tolerability before injections.

Monthly Dosing Schedule

• Initiation: On the last day of oral lead-in or antiretroviral therapy, give a single 600 mg (3 mL) cabotegravir injection and a single 900 mg (3 mL) rilpivirine injection at separate gluteal sites during the same visit.
• Continuation: Starting one month after initiation, give monthly injections of 400 mg (2 mL) cabotegravir and 600 mg (2 mL) rilpivirine at separate gluteal sites.
• Doses may be given up to 7 days before or after the scheduled monthly date.

Every-2-Month Dosing Schedule

• Initiation: Two consecutive monthly injections of 600 mg cabotegravir and 900 mg rilpivirine at separate gluteal sites, initiated on the last day of oral lead-in or antiretroviral therapy.
• Continuation: Every 2 months thereafter, give 600 mg cabotegravir and 900 mg rilpivirine injections at separate gluteal sites.
• Doses may be given up to 7 days before or after the scheduled date.

Dosing Adjustments When Switching Schedules

• Switching from monthly to every-2-month injections requires a 600 mg cabotegravir and 900 mg rilpivirine injection one month after the last monthly injection, then every 2 months.
• Switching from every-2-month to monthly involves a 400 mg cabotegravir and 600 mg rilpivirine injection 2 months after the last every-2-month injection, then monthly thereafter.

Missed Doses

Missed injections should be managed clinically with recommendations depending on the time since the last injection. For planned or unplanned missed doses exceeding 7 days, an oral regimen of daily 30 mg cabotegravir (VOCABRIA) and 25 mg rilpivirine (EDURANT) taken with a meal can be used temporarily until injections resume for up to two months. Longer interruptions require reassessment and possible re-initiation of induction dosing.

Hypersensitivity reactions: Serious allergic reactions may occur. Monitor patients closely, especially during oral lead-in dosing if used, and discontinue immediately if signs of hypersensitivity develop.

Adherence: Strict adherence to the injection schedule is critical to maintain viral suppression and prevent resistance. Missed or late injections increase risk of viral rebound and resistance.

Common side effects include injection site reactions such as pain, swelling, redness, or nodules. Other side effects may include headache, fever, fatigue, nausea, and rash. Serious adverse reactions such as hypersensitivity must be promptly addressed.

Patients transitioning to or from CABENUVA may continue using oral cabotegravir and rilpivirine (VOCABRIA and EDURANT). Drug interactions are not detailed in the label excerpt but care should be taken with agents affecting cabotegravir or rilpivirine metabolism.

Store CABENUVA refrigerated between 2°C to 8°C (36°F to 46°F). Before use, remove from the refrigerator and allow vials to reach room temperature for at least 15 minutes. After removal, vials may be kept at room temperature for up to 6 hours; do not refrigerate again. Discard if not used within 6 hours. Filled syringes should be administered within 2 hours and not refrigerated.