Transcription of US Product Labeling @std Template for PLR
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US Product Labeling @std Template for PLR
1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CABENUVA saf ely an d ef f ectively. S ee f ull p rescrib in g in f ormation f or CABENUVA. CABENUVA (cabotegravir exten d ed-release in jectab le su sp en sion; rilpivirin e exten d ed-release in jectab le su sp en sion), co-packaged f or intramuscular use Initial Approval: 2021 -------------------------------- RECENT MAJOR CHANGES------------------------------ Dosage and Administration ( , , , , , , ) 1/2022 Warnings and Precautions, Post-Injection Reactions ( ) 1/2022 Warnings and Precautions, Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions ( ) 1/2022 Warnings and Precautions, Long-Acting Properties and Potential Associated Risks with CABENUVA ( ) 1/2022 -------------------------------- INDICATIONS AND USAGE ------------------------------ CABENUVA, a 2- drug co-packaged Product of cabotegravir, an HIV-1 integrase strand transfer inhibitor (INSTI), and rilpivirine, an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI)
Cabotegravir extendedrelease injectable suspension and - rilpivirine extended-release injectable suspension, co-packaged as follows: (3) ... help maintain viral suppression and reduce the risk of viral rebound and potential development of resistance with missed doses [see Warnings a nd Precautions (5. 6)].
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