Source: FDA, National Drug Code (US) Revision Year: 2022
BRUKINSA is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
BRUKINSA is indicated for the treatment of adult patients with Waldenström’s macroglobulinemia (WM).
BRUKINSA is indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen.
This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14.3)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
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.
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)].
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)].
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) |
|---|---|---|
| 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 | |
* 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.
Asymptomatic lymphocytosis should not be regarded as an adverse reaction, and these patients should continue taking BRUKINSA.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
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