Indications for: VOCABRIA
In combination with Edurant (rilpivirine) for short-term treatment of HIV-1 infection in patients 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 patients 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 (≥12yrs [≥35kg]): As oral lead-in: 30mg once daily in combination with Edurant (25mg/day) for approx. 1 month (≥28 days). The last oral dose should be taken on the same day Cabenuva inj is started. As oral replacement (if planned to miss a scheduled monthly Cabenuva inj by >7 days): can take daily up to 2 months to replace missed inj visits. The first oral dose should be taken 1 month (±7 days) after the last Cabenuva inj and continue until the day inj dosing is restarted; (if planned to miss a scheduled every-2-month Cabenuva inj by >7 days): can take daily up to 2 months to replace 1 missed every-2-month inj. The first oral dose should be taken approx. 2 months after the last Cabenuva inj and continue until the day inj dosing is restarted. For oral therapy with Vocabria/Edurant of durations >2 months, use alternative oral regimen. HIV-1 PrEP (≥35kg): prior to initiation, and with each subsequent Apretude inj, must have a confirmed negative HIV-1 test. As oral lead-in: 30mg once daily for approx. 1 month (≥28 days). Following oral lead-in, initiate Apretude inj on the last day of oral lead-in or within 3 days. As oral replacement (if planned to miss a scheduled Apretude inj by >7 days): can take daily to replace 1 every 2-month inj visit. The first oral dose should be taken approx. 2 months after the last Apretude inj; restart Apretude inj on the day oral dosing completes or within 3 days.
<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.
UGT1A1, UGT1A9 (minor).
Fecal (59%), renal (27%). Half-life: 41 hours.
Generic Drug Availability: