Transcription of US Product Labeling @std Template for PLR
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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)
Th e ventrogluteal site is recommended . Do not administer by any other route or anatomical site. Consider the body mass index (BMI) of the patient to ensure that the needle length is sufficient to reach the gluteus muscle. Longer needle lengths (not included in the dosing kit ) …
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