Brukinsa Dosage
Generic name: ZANUBRUTINIB 80mg
Dosage form: capsule, gelatin coated
Drug class: BTK inhibitors
Medically reviewed by Drugs.com. Last updated on Jul 30, 2025.
Recommended Dosage
The recommended dosage of BRUKINSA for monotherapy or in combination with obinutuzumab is 160 mg taken orally twice daily or 320 mg taken orally once daily until disease progression or unacceptable toxicity.
Capsule Administration Instructions
- Administer BRUKINSA capsules with or without food. Advise patients to swallow capsules whole with water and not to open, break, or chew capsules.
Dosage Modification for Use in Hepatic Impairment
The recommended dosage of BRUKINSA for patients with severe hepatic impairment (Child-Pugh class C) is 80 mg orally twice daily; no dosage modification is recommended for patients with mild or moderate hepatic impairment (Child-Pugh class A or B).
Dosage Modifications for Drug Interactions
Recommended dosage modifications of BRUKINSA for drug interactions are provided in Table 1.
| Coadministered Drug | Recommended BRUKINSA Dosage (Starting Dose: 160 mg twice daily or 320 mg once daily) |
|---|---|
| Clarithromycin 250 mg twice daily* | 80 mg twice daily† |
| Clarithromycin 500 mg twice daily | 80 mg once daily† |
| Posaconazole suspension 100 mg once daily | 80 mg twice daily† |
| Posaconazole suspension dosage higher than 100 mg once daily Posaconazole delayed-release tablets 300 mg once daily Posaconazole intravenous 300 mg once daily |
80 mg once daily† |
| Other strong CYP3A inhibitor | 80 mg once daily† |
| Moderate CYP3A inhibitor | 80 mg twice daily† |
| 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 CYP3A inducer, resume previous dose of BRUKINSA.
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 | ||
| 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 | |
| Nonhematological toxicities | ||
| Severe or life-threatening nonhematological 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 in CLL and MCL should not be regarded as an adverse reaction, and these patients should continue taking BRUKINSA.
Refer to the obinutuzumab prescribing information for management of obinutuzumab toxicities.
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