Indications for: VOCABRIA
In combination with Edurant (rilpivirine) for short-term treatment of HIV-1 infection in adults 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, for use as: oral lead-in to assess the tolerability of cabotegravir prior to administration of Cabenuva (cabotegravir; rilpivirine) ext-rel inj susp; or oral therapy for patients who will miss planned inj dosing with Cabenuva. To reduce the risk of sexually acquired HIV-1 infection in at-risk adults and adolescents for pre-exposure prophylaxis (PrEP), may be used as: oral lead-in to assess the tolerability of cabotegravir prior to administration of Apretude (cabotegravir ext-rel inj susp); or oral therapy for patients who will miss planned inj dosing with Apretude.
Prior to initiation, consult additional full labelings (Edurant, Cabenuva, and Apretude) to ensure appropriate therapy. Take with a meal at the same time each day. HIV-1 treatment: 30mg once daily in combination with Edurant (25mg/day) for approx. 1 month (≥28 days). As oral lead-in: the last oral dose should be taken on the same day Cabenuva inj is started. As oral replacement (if planned to miss a scheduled Cabenuva inj by >7days): can replace up to 2 consecutive monthly inj visits. The first oral dose should be taken approx. 1 month after the last Cabenuva inj and continue until the day inj dosing is restarted. HIV-1 PrEP: ≥12yrs (≥35kg): prior to initiation, and with each subsequent Apretude inj, must have a negative HIV-1 test. 30mg once daily for approx. 1 month (≥28 days). As oral lead-in: the last oral dose should be taken on the same day Apretude inj is started or within 3 days. As oral replacement (if planned to miss a scheduled Apretude inj by >7 days): can replace one every 2-month inj visit. The first oral dose should be taken approx. 2 months after the last Apretude inj and continue until the day inj dosing is restarted or within 3 days.
HIV-1 treatment, HIV-1 PrEP (<12yrs or <35kg): not established.
HIV-1 treatment: in combination with rilpivirine, see Edurant full labeling for additional contraindications. Also: use of Cabenuva with rifabutin is contraindicated; see Cabenuva full labeling. HIV-1 PrEP: unknown or positive HIV-1 status. Both: concomitant carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine.
Prior to initiating for HIV-1 treatment, review Edurant full labeling for risks associated with rilpivirine treatment. Prior to initiating for HIV-1 PrEP, counsel individuals on the use of other prevention measures (eg, condom use, knowledge of partner(s)’ HIV-1 status, regular testing for STIs); reassess risk of HIV-1 acquisition and test before each Apretude inj to confirm HIV-1 negative status. Discontinue immediately if hypersensitivity reactions develop. Underlying liver disease or marked elevation in transaminases. Monitor liver function; discontinue if hepatotoxicity is suspected. Promptly evaluate if depressive symptoms occur. Severe hepatic impairment. ESRD (CrCl <15mL/min). Elderly. Pregnancy. Nursing mothers: not recommended.
HIV-1 integrase strand transfer inhibitor (INSTI).
See Contraindications. Concomitant other antiretrovirals: not recommended. Antagonized by polyvalent cation-containing products (eg, aluminum or magnesium hydroxide, calcium carbonate); separate dosing by at least 2hrs before or 4hrs after cabotegravir.
Headache, nausea, abnormal dreams, anxiety, insomnia; also for HIV-1 PrEP: diarrhea, dizziness, upper respiratory tract infection, somnolence, fatigue, vomiting, abdominal pain; hepatotoxicity, depressive disorders.
Generic Drug Availability: