BRUKINSA

BRUKINSA- zanubrutinib capsule
BEIGENE USA, INC.

1 INDICATIONS AND USAGE

1.1 Mantle Cell Lymphoma

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.

1.2 Waldenström’s Macroglobulinemia

BRUKINSA is indicated for the treatment of adult patients with Waldenström’s macroglobulinemia (WM).

1.3 Marginal Zone Lymphoma

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.

2 DOSAGE AND ADMINISTRATION

2.1 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.

2.2 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)].

2.3 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 dailyInterrupt dose as recommended for adverse reactions [see Dosage and Administration (2.4)].
Moderate CYP3A inhibitor 80 mg twice dailyModify 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)].

2.4 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 neutropeniaGrade 3 thrombocytopenia with significant bleedingGrade 4 neutropenia (lasting more than 10 consecutive days)Grade 4 thrombocytopenia (lasting more than 10 consecutive days) First Interrupt BRUKINSAOnce toxicity has resolved to Grade 1 or lower or baseline: Resume at 160 mg twice daily or 320 mg once daily.
Second Interrupt BRUKINSAOnce toxicity has resolved to Grade 1 or lower or baseline: Resume at 80 mg twice daily or 160 mg once daily.
Third Interrupt BRUKINSAOnce 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 BRUKINSAOnce toxicity has resolved to Grade 1 or lower or baseline: Resume at 160 mg twice daily or 320 mg once daily .
Second Interrupt BRUKINSAOnce toxicity has resolved to Grade 1 or lower or baseline: Resume at 80 mg twice daily or 160 mg once daily.
Third Interrupt BRUKINSAOnce 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.

3 DOSAGE FORMS AND STRENGTHS

Capsules: Each 80 mg capsule is a size 0, white to off-white opaque capsule marked with “ZANU 80” in black ink.

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

5.1 Hemorrhage

Fatal and serious hemorrhagic events have occurred in patients with hematological malignancies treated with BRUKINSA monotherapy. Grade 3 or higher hemorrhage including intracranial and gastrointestinal hemorrhage, hematuria and hemothorax have been reported in 3.4% of patients treated with BRUKINSA monotherapy. Hemorrhage events of any grade, excluding purpura and petechiae, occurred in 35% of patients.

Bleeding events have occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Co-administration of BRUKINSA with antiplatelet or anticoagulant medications may further increase the risk of hemorrhage.

Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA if intracranial hemorrhage of any grade occurs. Consider the benefit-risk of withholding BRUKINSA for 3-7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.