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# FDA Oks Change to Cabenuva Start-up Regimen
- URL: https://www.fdaweb.com/fda-oks-change-to-cabenuva-start-up-regimen/
- Published: 2022-03-24T12:00:00.000Z
- Updated: 2026-09-14T17:37:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151449

FDA has approved a label update for Janssen’s Cabenuva (cabotegravir and rilpivirine) to give healthcare professionals and HIV patients the option to start its monthly or every-two-month injectable treatment without the need for an oral lead-in phase of daily Cabenuva tablets for one month. A company [statement](https://www.prnewswire.com/news-releases/us-fda-approves-streamlined-process-for-initiating-hiv-therapy-with-cabenuva-cabotegravir-and-rilpivirine-the-first-and-only-complete-long-acting-injectable-hiv-treatment-301510323.html?ref=fdaweb.com) says clinical data demonstrated the regimen displays a similar safety and effectiveness profile both with and without an oral lead-in period.