Transcription of CALQUENCE PRESCRIBING INFORMATION
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CALQUENCE PRESCRIBING INFORMATION
US-33441 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the INFORMATION needed to use CALQUENCE safely and effectively. See full PRESCRIBING INFORMATION for (acalabrutinib) capsules, for oral use Initial Approval: 2017-------------------------------- RECENT MAJOR CHANGES ---------------------------------Indicat ions and Usage ( ) 11/2019 Dosage and Administration ( ) 11/2019--------------------------------- INDICATIONS AND USAGE ---------------------------------CALQUEN CE is a kinase inhibitor indicated for the treatment of adult patients with: Mantle cell lymphoma (MCL) who have received at least one prior therapy.
7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.3 Females and Males of Reproductive Potential 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Hepatic Impairment 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 14.1 Mantle Cell Lymphoma 16 HOW SUPPLIED/STORAGE AND HANDLING
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