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Brukinsa Dosage

Generic name: ZANUBRUTINIB 80mg
Dosage form: capsule, gelatin coated
Drug class: BTK inhibitors

Medically reviewed by Drugs.com. Last updated on Mar 7, 2022.

Recommended Dosage

‚ÄčThe recommended dosage of BRUKINSA is 160 mg taken orally twice daily or 320 mg taken orally once daily until disease progression or unacceptable toxicity.

BRUKINSA can be taken with or without food. Advise patients to swallow capsules whole with water. Advise patients not to open, break, or chew the capsules. If a dose of BRUKINSA is missed, it should be taken as soon as possible on the same day with a return to the normal schedule the following day.

Dosage Modification for Use in Hepatic Impairment

The recommended dosage of BRUKINSA for patients with severe hepatic impairment is 80 mg orally twice daily [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

Dosage Modifications for Drug Interactions

Recommended dosage modifications of BRUKINSA for drug interactions are provided in Table 1 [see Drug Interactions (7.1)].

Table 1: Dosage Modifications for Use With CYP3A Inhibitors or Inducers
Co-administered Drug Recommended BRUKINSA Dose
Strong CYP3A inhibitor 80 mg once daily
Interrupt dose as recommended for adverse reactions [see Dosage and Administration (2.4)].
Moderate CYP3A inhibitor 80 mg twice daily
Modify dose as recommended for adverse reactions [see Dosage and Administration (2.4)].
Moderate or strong CYP3A inducer Avoid concomitant use.

After discontinuation of a CYP3A inhibitor, resume previous dose of BRUKINSA [see Dosage and Administration (2.1, 2.2) and Drug Interactions (7.1)].

Dosage Modifications for Adverse Reactions

Recommended dosage modifications of BRUKINSA for Grade 3 or higher adverse reactions are provided in Table 2:

Table 2: Recommended Dosage Modification for Adverse Reaction
Event Adverse Reaction Occurrence Dosage Modification
(Starting Dose: 160 mg twice daily or 320 mg once daily)
*
Evaluate the benefit-risk before resuming treatment at the same dose for a Grade 4 non-hematological toxicity.
Evaluate the benefit-risk before resuming treatment at the same dose for Grade 4 non-hematological toxicity.
Hematological toxicities [see Warnings and Precautions (5.3)]
Grade 3 febrile neutropenia

Grade 3 thrombocytopenia with significant bleeding

Grade 4 neutropenia (lasting more than 10 consecutive days)

Grade 4 thrombocytopenia (lasting more than 10 consecutive days)
First Interrupt BRUKINSA
Once toxicity has resolved to Grade 1 or lower or baseline: Resume at 160 mg twice daily or 320 mg once daily.
Second Interrupt BRUKINSA
Once toxicity has resolved to Grade 1 or lower or baseline: Resume at 80 mg twice daily or 160 mg once daily.
Third Interrupt BRUKINSA
Once toxicity has resolved to Grade 1 or lower or baseline: Resume at 80 mg once daily.
Fourth Discontinue BRUKINSA
Non-hematological toxicities [see Warnings and Precautions (5.5) and Adverse Reactions (6.1)]
Grade 3 or 4 non-hematological toxicities * First Interrupt BRUKINSA
Once toxicity has resolved to Grade 1 or lower or baseline: Resume at 160 mg twice daily or 320 mg once daily.
Second Interrupt BRUKINSA
Once toxicity has resolved to Grade 1 or lower or baseline: Resume at 80 mg twice daily or 160 mg once daily.
Third Interrupt BRUKINSA
Once toxicity has resolved to Grade 1 or lower or baseline: Resume at 80 mg once daily.
Fourth Discontinue BRUKINSA

Asymptomatic lymphocytosis should not be regarded as an adverse reaction, and these patients should continue taking BRUKINSA.

Frequently asked questions

Further information

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