Vocabria Generic Name & Formulations
Legal Class
Rx
General Description
Cabotegravir 30mg; tabs.
Pharmacological Class
HIV-1 integrase strand transfer inhibitor (INSTI).
How Supplied
Tabs—30
Manufacturer
Generic Availability
NO
Mechanism of Action
Cabotegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle.
Vocabria Indications
Indications
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.
Vocabria Dosage and Administration
Adult
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.
Children
<12yrs or <35kg: not established.
Vocabria Contraindications
Contraindications
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.
Vocabria Boxed Warnings
Not Applicable
Vocabria Warnings/Precautions
Warnings/Precautions
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.
Vocabria Pharmacokinetics
Absorption
Median Tmax: 3 hours.
Distribution
Plasma protein bound: >99.8%.
Elimination
Fecal (59%), renal (27%). Half-life: 41 hours.
Vocabria Interactions
Interactions
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.
Vocabria Adverse Reactions
Adverse Reactions
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.
Vocabria Clinical Trials
See Literature
Vocabria Note
Not Applicable
Vocabria Patient Counseling
See Literature
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