Transcription of XOFLUZA Prescribing Information - Genentech
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XOFLUZA Prescribing Information - Genentech
HIGHLIGHTS OF Prescribing Information Refer to the Full Prescribing Information for Information on recommended These highlights do not include all the Information needed to use dosage of XOFLUZA oral suspension in adults and adolescents (12 years of XOFLUZA safely and effectively. See full Prescribing Information for age and older). ( ). XOFLUZA . Refer to the Full Prescribing Information for additional Information on XOFLUZA (baloxavir marboxil) tablets, for oral use preparation of XOFLUZA for oral suspension for oral or enteral use. ( ). XOFLUZA (baloxavir marboxil) for oral suspension Initial Approval: 2018 ---------------------DOSAGE FORMS AND STRENGTHS---------------------- Tablets: 40 mg and 80 mg. (3). -----------------------------RECENT MAJOR CHANGES------------------------- For oral suspension: 40 mg/20 mL when constituted for final concentration Indications and Usage of 2 mg/mL. (3). Post-Exposure Prophylaxis of Influenza ( ) 11/2020. Dosage and Administration ( , , ) 3/2021 -------------------------------CONTRAIND ICATIONS------------------------------ XOFLUZA is contraindicated in patients with a history of hypersensitivity to -----------------------------INDICATIONS AND USAGE-------------------------- baloxavir marboxil or any of its ingredients.
Hypersensitivitysuch as anaphylaxis, angioedema,urticaria,and erythema multiforme: Initiate appropriate treatment if an allergic-like reaction occurs or is suspected. (5.1) Risk of bacterial infection:Serious bacterial infections may begin with influenza-like symptoms or may coexist with, or occur as,a complication of influenza.
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