Medically reviewed by Drugs.com. Last updated on Aug 6, 2020.
Generic name: ZANUBRUTINIB 80mg
Dosage form: capsule, gelatin coated
The recommended dose 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
Dosage Modifications for Drug Interactions
Recommended dose modifications of BRUKINSA for drug interactions are provided in Table 1 [see Drug Interactions (7.1)].
|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.|
Dosage Modifications for Adverse Reactions
Recommended dose modifications of BRUKINSA for Grade 3 or higher adverse reactions are provided in Table 2:
|Event||Adverse Reaction Occurrence||Dose Modification|
|(Starting Dose: 160 mg twice daily or 320 mg once daily)|
|Grade 3 or higher non-hematological toxicities
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)
|Once toxicity has resolved to recovery to Grade 1 or lower or baseline: Resume at 160 mg twice daily or 320 mg once daily|
|Once toxicity has resolved to recovery to Grade 1 or lower or baseline: Resume at 80 mg twice daily or 160 mg once daily|
|Once toxicity has resolved to recovery to Grade 1 or lower or baseline: Resume at 80 mg once daily|
Asymptomatic lymphocytosis should not be regarded as an adverse reaction, and these patients should continue taking BRUKINSA.
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