Source: FDA, National Drug Code (US) Revision Year: 2021
VOCABRIA is indicated in combination with EDURANT (rilpivirine) for short-term treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA less than 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 [see Dosage and Administration (2.1)]:
Consult the prescribing information for CABENUVA (cabotegravir; rilpivirine) extended-release injectable suspension before initiating VOCABRIA to ensure therapy with CABENUVA is appropriate. See full prescribing information for CABENUVA.
Oral lead-in should be used for approximately 1 month (at least 28 days) to assess the tolerability of cabotegravir prior to the initiation of CABENUVA. The recommended oral daily dose is one 30-mg tablet of VOCABRIA in combination with one 25-mg tablet of EDURANT (rilpivirine). The last oral dose should be taken on the same day injections with CABENUVA are started.
Take VOCABRIA once daily with EDURANT at approximately the same time each day with a meal [see Clinical Pharmacology (12.3)].
Because VOCABRIA is indicated in combination with rilpivirine tablets, the prescribing information for EDURANT should also be consulted.
If a patient plans to miss a scheduled injection of CABENUVA (cabotegravir; rilpivirine) extended-release injectable suspensions 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). Take VOCABRIA with EDURANT at approximately the same time each day with a meal. 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. See full prescribing information for CABENUVA to resume monthly injection dosing.
There is no known specific treatment for overdose with VOCABRIA. If overdose occurs, monitor the patient and apply standard supportive treatment as required. As cabotegravir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis.
Store below 30°C (86°F).
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