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Zanubrutinib oral


Oral formulations of zanubrutinib.

Drugs List

  • BRUKINSA 80mg capsules
  • zanubrutinib 80mg capsules
  • Therapeutic Indications


    Waldenstrom's macroglobulinaemia

    Monotherapy for the treatment of Waldenstrom's macroglobulinaemia (WM) who have received at least one prior therapy or in first line treatment for patients unsuitable for chemo-immunotherapy in adult patients.



    320mg once daily, or 160mg twice daily.

    Patients with Hepatic Impairment

    Severe hepatic impairment: 80mg twice daily

    Additional Dosage Information

    Dose modifications for adverse reactions
    Greater than or equal to grade 3 non-haematological toxicities, Grade 3 febrile neutropenia, Grade 3 thrombocytopenia with significant bleeding, Grade 4 neutropenia (lasting longer than 10 consecutive days) or Grade 4 thrombocytopenia (lasting longer than 10 consecutive days)
    First occurrence: Interrupt treatment with zanubrutinib. Once toxicity has resolved to lower than or equal to grade 1 or baseline, resume treatment at 320mg once daily or 160mg twice daily.
    Second occurrence: Interrupt treatment with zanubrutinib. Once toxicity has resolved to lower than or equal to grade 1 or baseline, resume treatment at 160mg once daily or 80mg twice daily.
    Third occurrence: Interrupt treatment with zanubrutinib. Once toxicity has resolved to lower than or equal to grade 1 or baseline, resume treatment at 80mg once daily.
    Fourth occurrence: Discontinue treatment with zanubrutinib.

    Dose modifications for co-administration with medicinal products
    Co-administration with strong CYP3A inhibitor: 80mg once daily
    Co-administration with moderate CYP3A inhibitor: 80mg twice daily


    Children under 18 years

    Precautions and Warnings

    Acute infection
    Risk factors for cardiovascular disorder
    Renal dialysis
    Severe hepatic impairment
    Severe renal impairment

    Consider anti-infective prophylaxis in immunocompromised patients
    Reduce dose in patients with severe hepatic impairment
    Advise ability to drive/operate machinery may be affected by side effects
    Before initiating screen all patients for hepatitis B infection
    Treatment to be initiated and supervised by a specialist
    Consult local policy on the safe use of oral anti-cancer drugs
    Staff: Not to be handled by pregnant staff
    Monitor blood counts regularly
    Monitor for atrial fibrillation
    Monitor for bleeding during treatment
    Monitor hepatic function in patients with severe hepatic impairment
    Monitor patient constantly for signs of new infection
    Monitor patients for development of second primary malignancies
    Monitor patients receiving concurrent anticoagulants
    Monitor patients receiving concurrent antiplatelets
    Monitor patients with severe renal impairment for adverse effects
    Reactivation of hepatitis B may occur in chronic carriers
    Suspend treatment and reduce dose if febrile neutropenia occurs
    Suspend treatment and reduce dose if grade 4 neutropenia occurs
    Suspend treatment and/or reduce dose if grade 4 thrombocytopenia
    Suspend treatment and/or reduce dose in grade 3 non-haematological toxicity
    Suspend treatment/reduce dose for grade 3 thrombocytopenia with bleeding
    Advise patient not to take St John's wort concurrently
    Advise patient to avoid grapefruit products
    Advise patient to avoid Seville (sour) orange products
    Female: Contraception required during and for 1 month after treatment
    Female: Use barrier contraception during and for 1 month after treatment
    Advise patient on appropriate sun protection methods

    Fatal haemorrhagic events have been reported in patients treated with zanubrutinib. Zanubrutinib may increase the risk of haemorrhagic events in patients receiving antiplatelet or anticoagulant treatment. Patients should have complete blood counts monitored and should be monitored for signs of bleeding. Warfarin or other vitamin K antagonists should not be administered concomitantly with zanubrutinib.

    Fatal and non-fatal infections in patients treated with zanubrutinib have occurred. Hepatitis B virus reactivation has occurred in patients, therefore, before treatment with zanubrutinib is initiated, the patient's HBV status should be established. In patients who test positive for HBV or have positive hepatitis B serology, consultation with a liver disease specialist is recommended prior to initiating treatment. Patients should be monitored and managed to prevent hepatitis B reactivation. Prophylaxis should be considered for those at increased risk of infections. Patients should be monitored for infections and be treated accordingly.

    Pregnancy and Lactation


    Zanubrutinib is contraindicated during pregnancy.

    The manufacturer recommends that zanubrutinib should not be used during pregnancy. There are no data of the use of zanubrutinib in pregnant women, and animal studies have shown reproductive toxicity.


    Zanubrutinib is contraindicated during breastfeeding.

    The manufacturer recommends that breastfeeding should be discontinued during zanubrutinib treatment. There are no clinical data of use in pregnant women and it is unknown whether zanubrutinib or its metabolites are excreted in human milk. Therefore a risk to the breastfed infant cannot be excluded.

    Side Effects

    Atrial fibrillation
    Back pain
    Gastro-intestinal haemorrhage
    Lower respiratory tract infection
    Musculoskeletal pain
    Reactivation of hepatitis B
    Upper respiratory tract infection
    Urinary tract infections


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: July 2022

    Reference Sources

    Summary of Product Characteristics: Brukinsa 80 mg hard capsules. BeiGene UK Ltd. Revised December 2021.

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