Drug Detail:Brukinsa (Zanubrutinib)
Generic Name: ZANUBRUTINIB 80mg
Dosage Form: capsule, gelatin coated
Drug Class: BTK inhibitors
Recommended Dosage
The 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)].
| Coadministered Drug | Recommended BRUKINSA Dosage (Starting Dose: 160 mg twice daily or 320 mg once daily) |
|---|---|
| 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)]. |
| Strong CYP3A inducer | Avoid concomitant use. |
| Moderate CYP3A inducer | Avoid concomitant use. If these inducers cannot be avoided, increase BRUKINSA dose to 320 mg twice daily. |
After discontinuation of a CYP3A inhibitor or moderate CYP3A4 inducer, 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.
| Adverse Reaction | Adverse Reaction Occurrence | Dosage Modification (Starting Dose: 160 mg twice daily or 320 mg once daily) |
|---|---|---|
|
||
| Hematological toxicities [see Warnings and Precautions (5.3)] | ||
| Grade 3 or Grade 4 febrile neutropenia Platelet count decreased to 25,000-50,000/mm3 with significant bleeding Neutrophil count decreased to <500/mm3 (lasting more than 10 consecutive days) Platelet count decreased to <25,000/mm3 (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)] | ||
| Severe or life-threatening 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.
