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Convenient at-home dosing taken once or twice daily1

The recommended total daily dose of BRUKINSA is 320 mg1

Treatment with BRUKINSA should be continued until disease progression or unacceptable toxicity1

Can be taken concomitantly with PPIs or H2RAs1

Can be taken with or without a meal, even with fatty food1

Should be swallowed whole with water, and should not be crushed or chewed1

  • No restrictions for co-administration with PPIs or H2RAs1
  • No dose modification for patients aged ≥65 years, or with mild-to-moderate impairment of kidney function or liver function1
  • For 3 to 7 days pre- and post-surgery, consider the benefit-risk of withholding BRUKINSA depending upon the type of surgery and the risk of bleeding1
  • Dose reductions can be achieved by splitting the tablet in half along the score line1
  • The recommended daily dose of BRUKINSA is 320 mg; dose modifications should only be considered when clinically indicated per the label1

Special populations1

Population Dose adjustment
Elderly (≥65 years) None

Renal impairment*

Mild to moderate
(CrCl ≥30 mL/min)

Severe/dialysis
(CrCl <30 mL/min)

 

None


Monitor for adverse reactions

Hepatic impairment†

Mild (Child-Pugh class A)

Moderate (Child-Pugh class B)

Severe (Child-Pugh class C)

 

None

None

80 mg twice daily (one half-tablet AM, one half-tablet PM)‡

  • *Estimated by Cockcroft–Gault.1
  • †Based on Child–Pugh score.1
  • ‡The safety of BRUKINSA has not been evaluated in patients with severe hepatic impairment. Monitor these patients closely for adverse events of BRUKINSA.1

CYP3A inhibitors or inducers1

Co-administration with CYP3A inhibitors Co-administration with CYP3A inducers
Mild inhibitors:
Monitor patients closely for toxicity and follow dose modification guidance as needed
Mild inducers: May be used with caution
Moderate inhibitors:
160 mg once daily or 80 mg twice daily
Moderate inducers: Avoid concomitant use
Strong inhibitors:
80 mg once daily
Strong inducers: Avoid concomitant use

Recommended dose modification for Grade ≥3 adverse reactions1

  • Dose reduction across studies (N=1,550): 5%1
  • Treatment discontinuation across studies (N=1,550): 5%1

The safety profile is based on pooled data from 1,550 patients with B-cell malignancies treated with BRUKINSA in clinical studies with a median duration of exposure of 34.41 months1

Pooled data: treatment-emergent adverse reactions in ≥10% of patients with B-cell malignancies (N=1,550)*1

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  • *Grades were evaluated based on the NCI-CTCAE version 4.031
  • †<1% of patients with Grade 3 or higher adverse reactions.1
  • ‡Includes multiple adverse reaction terms.1
  • Includes events with fatal outcome(s).1