CALQUENCE

Acalabrutinib and its active metabolite, ACP-5862, exposures increase proportionally with dose across a dose range of 75 to 250 mg (0.75 to 2.5 times the approved recommended single dosage) in patients with B-cell malignancies. At the recommended dose of 100 mg twice daily, the geometric mean (% coefficient of variation [CV]) daily area under the plasma drug concentration over time curve (AUC 24h ) and maximum plasma concentration (C max ) for acalabrutinib were 1843 (38%) ng

• h/mL and 563 (29%) ...

14.1 Previously Untreated Mantle Cell Lymphoma DOCVARIABLE vault_nd_4d1e0c80-2ff6-409f-bee7-897264eadbff \* MERGEFORMAT ECHO The efficacy of CALQUENCE in patients with previously untreated MCL was evaluated in a randomized, double blind, placebo controlled, multicenter study (ECHO; NCT02972840). The study enrolled 598 patients who were ≥ 65 years of age and who had no intention for transplant. The study excluded patients with total bilirubin > 1.5 × upper limit of normal (ULN), AST or ALT > 2.5 × ULN, or estimated creatinine clearance of ≤ 50 mL/min. Patients were randomized in a 1:1 ratio to ...

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:

• Serious and Opportunistic Infections [see Warnings and Precautions (5.1) ]
• Hemorrhage [see Warnings and Precautions (5.2) ]
• Cytopenias [see Warnings and Precautions (5.3) ]
• Second Primary Malignancies [see Warnings and Precautions (5.4) ]
• Cardiac Arrhythmias [see Warnings and Precautions (5.5) ]
• Hepatotoxicity, including DILI [see Warnings and Precautions (5.6) ] ...

None. None. ( 4 )

• Serious and Opportunistic Infections: Monitor for signs and symptoms of infection and treat promptly. ( 5.1 )
• Hemorrhage: Monitor for bleeding and manage appropriately. ( 5.2 )
• Cytopenias: Monitor complete blood counts regularly. ( 5.3 )
• Second Primary Malignancies: Other malignancies have occurred, including skin cancers and other solid tumors. Advise patients to use sun protection. ( 5.4 )
• Cardiac Arrhythmias: Monitor for symptoms of arrhythmias and manage. ( 5.5 )
• Hepatotoxicity, ...

7 DRUG INTERACTIONS

• Strong CYP3A Inhibitors : Avoid co-administration with CALQUENCE. ( 2.2 , 7 )
• Moderate CYP3A Inhibitors : Reduce the dosage of CALQUENCE. ( 2.2 , 7 )
• Strong CYP3A Inducers : Avoid co-administration with CALQUENCE. If co-administration is unavoidable, increase the dosage of CALQUENCE. ( 2.2 , 7 ) 7.1 Effect of Other Drugs on CALQUENCE Strong CYP3A Inhibitors Clinical Effec...