CABENUVA- cabotegravir and rilpivirine
ViiV Healthcare Company
CABENUVA is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per 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 Clinical Studies (14.1)].
CABENUVA must be administered by a healthcare professional. Prior to starting CABENUVA, healthcare professionals should carefully select patients who agree to the required monthly injection dosing schedule and counsel patients about the importance of adherence to scheduled dosing visits to help maintain viral suppression and reduce the risk of viral rebound and potential development of resistance with missed doses [see Warnings and Precautions (5.6)].
Oral lead-in should be used for approximately 1 month (at least 28 days) prior to the initiation of CABENUVA to assess the tolerability of cabotegravir and rilpivirine. The recommended oral lead-in daily dose is one 30-mg tablet of VOCABRIA (cabotegravir) and one 25-mg tablet of EDURANT (rilpivirine). See Table 1 for recommended oral lead-in and intramuscular injection dosing schedule for CABENUVA [Dosage and Administration (2.3)].
Initiation Injections (CABENUVA 600-mg/900-mg Kit)
Initiate injections on the last day of oral lead-in. CABENUVA contains cabotegravir and rilpivirine extended-release injectable suspensions. The recommended initial injection doses of CABENUVA in adults are a single 600-mg (3-mL) gluteal intramuscular injection of cabotegravir and a single 900-mg (3-mL) gluteal intramuscular injection of rilpivirine. Administer cabotegravir and rilpivirine at separate gluteal injection sites (on opposite sides or 2 cm apart) during the same visit [see Dosage and Administration (2.5)]. Continuation injections should be initiated a month after the initiation injections.
Continuation Injections (CABENUVA 400-mg/600-mg Kit)
After the initiation injections, the recommended monthly continuation injection doses of CABENUVA in adults are a single 400-mg (2-mL) gluteal intramuscular injection of cabotegravir and a single 600‑mg (2-mL) gluteal intramuscular injection of rilpivirine at each visit. Administer cabotegravir and rilpivirine at separate gluteal injection sites (on opposite sides or 2 cm apart) during the same visit [see Dosage and Administration (2.5)]. Patients may be given CABENUVA up to 7 days before or after the date the patient is scheduled to receive monthly injections.
(at Least 28 Days)
Intramuscular (Gluteal) Initiation Injections
Intramuscular (Gluteal) Continuation Injections
At Month 2 (On the Last Day of Oral Lead-In Dosing)
Month 3 Onwards
30 mg once daily with a meal
600 mg (3 mL)
400 mg (2 mL)
25 mg once daily with a meal
900 mg (3 mL)
600 mg (2 mL)
Adherence to the monthly injection dosing schedule is strongly recommended. Patients who miss a scheduled injection visit should be clinically reassessed to ensure resumption of therapy remains appropriate. Refer to Table 2 for dosing recommendations after missed injections.
Planned Missed Injections (Oral Dosing to Replace Up to 2 Consecutive Monthly Injections)
If a patient plans to miss a scheduled injection visit by more than 7 days, take daily oral therapy to replace up to 2 consecutive monthly injection visits. The recommended oral daily dose is one 30-mg tablet of VOCABRIA (cabotegravir) and one 25-mg tablet of EDURANT (rilpivirine). The first dose of oral therapy should be taken approximately 1 month after the last injection dose of CABENUVA and continued until the day injection dosing is restarted. Refer to Table 2 for injection dosing recommendations.
Unplanned Missed Injections
If monthly injections are missed or delayed by more than 7 days and oral therapy has not been taken in the interim, clinically reassess the patient to determine if resumption of injection dosing remains appropriate [see Warnings and Precautions (5.6)]. If injection dosing will be continued, see Table 2 for dosing recommendations.
Time Since Last Injection
Less than or equal to 2 months
Resume with 400-mg (2-mL) cabotegravir and 600-mg (2-mL) rilpivirine intramuscular monthly injections as soon as possible.
Greater than 2 months
Re-initiate the patient with 600-mg (3-mL) cabotegravir and 900-mg (3‑mL) rilpivirine intramuscular injections then continue to follow the 400‑mg (2‑mL) cabotegravir and 600-mg (2-mL) rilpivirine intramuscular monthly injection dosing schedule.
- a Refer to oral dosing recommendations if a patient plans to miss a scheduled injection visit.
Refer to the Instructions for Use for complete administration instructions with illustrations.
A complete dose requires 2 injections: one injection of cabotegravir and one injection of rilpivirine [see Dosage and Administration (2.3)].
Cabotegravir and rilpivirine are suspensions for gluteal intramuscular injection that do not need further dilution or reconstitution.
Administer each injection at separate gluteal injection sites (on opposite sides or 2 cm apart) during the same visit. The ventrogluteal site is recommended. Do not administer by any other route or anatomical site. Consider the body mass index (BMI) of the patient to ensure that the needle length is sufficient to reach the gluteus muscle. Longer needle lengths (not included in the dosing kit) may be required for patients with higher BMI (example: greater than 30 kg/m2) to ensure that injections are administered intramuscularly as opposed to subcutaneously. The administration order of cabotegravir and rilpivirine injections is not important.
Before preparing the injections, remove CABENUVA from the refrigerator and wait at least 15 minutes to allow the medicines to come to room temperature. The vials may remain in the carton at room temperature for up to 6 hours. If not used within 6 hours, the medication must be discarded.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The cabotegravir vial has a brown tint to the glass which may limit visual inspection. Discard CABENUVA if either medicine exhibits particulate matter or discoloration.
Shake each vial of CABENUVA vigorously so that the suspensions look uniform before injecting. Small air bubbles are expected and acceptable.
Once the suspensions have been drawn into the respective syringes, the injections should be administered as soon as possible, but may remain in the syringes for up to 2 hours. If 2 hours are exceeded, the medication, syringes, and needles must be discarded [see How Supplied/Storage and Handling (16)].
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