- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations of zanubrutinib.
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
Risk factors for cardiovascular disorder
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.
Lower respiratory tract infection
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: July 2022
Summary of Product Characteristics: Brukinsa 80 mg hard capsules. BeiGene UK Ltd. Revised December 2021.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.