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. ( ) This indication is approved under accelerated approval based on overall response rate.
Table 1: Recommended Dose Modifications for Use with CYP3A Inhibitors or Inducers CYP3A Co-administered Drug Recommended CALQUENCE use Inhibition Strong CYP3A inhibitor Avoid concomitant use. If these inhibitors will be used short-term (such as anti-infectives for up to seven days), interrupt CALQUENCE. Moderate CYP3A inhibitor 100 mg once daily.
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