Brukinsa (Zanubrutinib) – CLL | DengYueMed

Brukinsa Application Scope

Brukinsa is an oral, selective Bruton’s tyrosine kinase (BTK) inhibitor used to treat several B-cell malignancies, including CLL/SLL, MCL, WM, MZL, and FL.

Characteristics

• Ingredients: Zanubrutinib

• Properties: Small oral capsule; BTK inhibitor targeting B-cell receptor signaling

• Packaging Specification: Capsules, 80 mg gelatin‑coated, white/off‑white, marked “ZANU 80”

• Storage: Store at controlled room temperature; Refer to packaging for precise conditions

• Expiry Date: Refer to the printed label on each pack

• Executive Standard: Follows FDA and EMA product monographs

• Approval Number:

  • FDA approval for MCL Nov 2019

  • Expanded indications approved in January 2023 for CLL/SLL

• Date of Revision: US prescribing info updated Jan 2025; Canadian monograph revised Feb 17, 2022

• Manufacturer: BeiGene (BeiGene Switzerland GmbH, Basel)

Guidelines for the Use of Brukinsa

• Dosage and Administration:

  • 160 mg orally twice daily or 320 mg once daily until disease progression/toxicity

  • Take with or without food; swallow capsules whole with water

  • If missed, take same day; resume usual schedule next day

  • For severe hepatic impairment (Child‑Pugh C): 80 mg twice daily

• Adverse Reactions:

  • Common (≥30 %):

    • decreased neutrophils, thrombocytopenia

    • upper respiratory infection, bleeding, musculoskeletal pain

  • Serious risks:

    • hemorrhage, infections, cytopenias, cardiac arrhythmias

    • liver injury, second primary malignancies, embryo‑fetal toxicity

• Contraindications: Known allergy to zanubrutinib or any capsule excipients

• Precautions:

  • Monitor blood counts, liver function, signs of bleeding/infection/arrhythmia

  • Avoid use around surgery; assess bleeding risk when on anticoagulants

  • Use contraception during and after treatment (women ≥1 week; men ≥3 months)

  • Avoid breastfeeding while taking and for 2 weeks after the last dose

Brukinsa Interactions

• Drug Interactions:

  • Metabolized by CYP3A. Strong/moderate inhibitors require dose reduction

  • Strong/moderate inducers should be avoided, or the dosage increased to 320 mg BID

  • Anticoagulants/antiplatelet agents may increase bleeding risk

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.