Zanubrutinib 80mg Capsules — Second-Generation BTK Inhibitor for CLL, MCL, WM, MZL, and Follicular Lymphoma
Brukinsa® (Zanubrutinib) — Second-Generation BTK Inhibitor for B-Cell Malignancies
A Sourcing Guide for Hospitals and Haematology Centres
Brukinsa® (Zanubrutinib) is a second-generation Bruton’s tyrosine kinase (BTK) inhibitor indicated, according to its approved prescribing information, for the treatment of adult patients with chronic lymphocytic leukaemia (CLL), small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), Waldenström’s macroglobulinaemia (WM), marginal zone lymphoma (MZL), and follicular lymphoma (FL), depending on the specific approved indication and line of therapy. As with all BTK inhibitor therapies, the decision to prescribe Brukinsa rests entirely with the treating haematologist or oncologist, in accordance with the approved label. This page provides sourcing and procurement information for hospitals and pharmacies, not clinical or treatment guidance.
As both a trusted medicine distributor in Delhi and a licensed pharmaceutical distributor in Delhi, A.K. Pharma supplies genuine Brukinsa (Zanubrutinib) 80mg capsules to hospitals, haematology centres, oncology clinics, and pharmacies across India. Hospitals managing broader B-cell malignancy caseloads can also source companion medicines through A.K. Pharma’s full product range and browse the complete Cancer Medicines category.
Brukinsa contains Zanubrutinib, a small-molecule inhibitor that selectively and covalently binds Bruton’s tyrosine kinase (BTK), a key enzyme in the B-cell receptor signalling pathway.
Second-Generation BTK Inhibition — Design Rationale:
According to published haematology and pharmacology literature, first-generation BTK inhibitors such as Ibrutinib demonstrated significant clinical benefit in B-cell malignancies but also inhibited several off-target kinases, including ITK, TEC, and EGFR, contributing to certain class-associated side effects such as cardiac arrhythmia and bleeding risk. Zanubrutinib was specifically engineered as a second-generation BTK inhibitor with greater selectivity for BTK relative to these off-target kinases, according to the manufacturer’s published pharmacology data, alongside near-complete and sustained BTK occupancy designed to maximise target inhibition throughout the dosing interval.
Zanubrutinib’s Mechanism: By covalently binding BTK, Zanubrutinib blocks downstream B-cell receptor signalling that drives survival, proliferation, and tissue homing of malignant B-cells in CLL, MCL, WM, MZL, and follicular lymphoma, according to the manufacturer’s prescribing information — interrupting the same signalling cascade exploited by other BTK-dependent B-cell malignancies described for related agents such as Nitib (Ibrutinib) and Acabrunat (Acalabrutinib), both also available from A.K. Pharma.
Full prescribing information is available at the FDA label for Zanubrutinib, with additional background on BTK-dependent B-cell malignancies available via the National Cancer Institute and the Leukemia & Lymphoma Society.
ASPEN Trial (Zanubrutinib vs Ibrutinib in Waldenström’s Macroglobulinaemia)
Published in Blood (2020), the ASPEN trial directly compared Zanubrutinib against Ibrutinib in patients with WM, providing head-to-head comparative data between first- and second-generation BTK inhibitors. Findings demonstrated a lower incidence of atrial fibrillation and certain other cardiovascular adverse events with Zanubrutinib, alongside comparable disease response rates, supporting its differentiated tolerability profile.
SEQUOIA Trial (Zanubrutinib in Treatment-Naive CLL/SLL)
Published in the Lancet Oncology (2022), the SEQUOIA trial evaluated Zanubrutinib in previously untreated CLL/SLL patients, demonstrating significantly improved progression-free survival compared to Bendamustine plus Rituximab chemoimmunotherapy, supporting Zanubrutinib’s role as a first-line treatment option.
ALPINE Trial (Zanubrutinib vs Ibrutinib in Relapsed/Refractory CLL/SLL)
Published in the New England Journal of Medicine (2023), the ALPINE trial compared Zanubrutinib against Ibrutinib in relapsed/refractory CLL/SLL patients, demonstrating superior progression-free survival and a lower rate of atrial fibrillation with Zanubrutinib, providing further comparative evidence between the two BTK inhibitors.
MAGNOLIA Trial (Zanubrutinib in Relapsed/Refractory Marginal Zone Lymphoma)
Published in Blood Advances (2021), this trial evaluated Zanubrutinib in patients with previously treated MZL, demonstrating meaningful overall response rates in a population with limited prior treatment options.
For broader clinical guidance on BTK inhibitor selection across B-cell malignancies, the American Society of Hematology (ASH) and NCCN Guidelines publish ongoing treatment recommendations.
Brukinsa is supplied as:
| Presentation | Strength |
|---|---|
| Brukinsa Capsules | 80mg per capsule |
Standard Dosing (per approved prescribing information):
| Regimen | Total Daily Dose |
|---|---|
| Twice-daily dosing | 160mg (2 capsules) twice daily |
| Once-daily dosing | 320mg (4 capsules) once daily |
Dose adjustments apply for hepatic impairment and concomitant use with CYP3A inhibitors or inducers, per the approved label.
Chronic Lymphocytic Leukaemia (CLL) / Small Lymphocytic Lymphoma (SLL):
Mantle Cell Lymphoma (MCL):
Waldenström’s Macroglobulinaemia (WM):
Marginal Zone Lymphoma (MZL):
Follicular Lymphoma (FL):
For detailed indication information refer to MedlinePlus Zanubrutinib and the Lymphoma Research Foundation.
Improved Selectivity Over First-Generation BTK Inhibitors
Zanubrutinib’s greater kinase selectivity, compared to first-generation agents, is associated with a lower incidence of certain off-target effects, according to comparative trial data from ASPEN and ALPINE.
Demonstrated Superiority Over Ibrutinib in Head-to-Head Trials
The ALPINE trial demonstrated superior progression-free survival and a lower rate of atrial fibrillation compared to Ibrutinib in relapsed/refractory CLL/SLL, providing direct comparative evidence supporting Zanubrutinib’s differentiated profile.
Broad Indication Base Across B-Cell Malignancies
With approvals spanning CLL/SLL, MCL, WM, MZL, and follicular lymphoma, Brukinsa offers haematologists a single BTK inhibitor option across multiple B-cell malignancy types.
Dosing Flexibility
Available as either twice-daily or once-daily dosing regimens, per the approved label, offering scheduling flexibility for patients and prescribers.
Dosing of Brukinsa is determined by the prescribing haematologist or oncologist according to the approved label. General administration information from the manufacturer’s prescribing information includes:
Monitoring (per manufacturer prescribing information):
Full dosing guidelines are available in the manufacturer’s official prescribing information and should always be followed exactly as directed by the treating haematologist or oncologist.
Brukinsa is prescribed by haematologists and oncologists for:
Brukinsa is prescribed by specialists managing B-cell malignancies. A.K. Pharma supplies Brukinsa to hospitals and haematology centres across Delhi and India.
Common side effects reported in clinical trials include decreased neutrophil count, upper respiratory tract infection, haemorrhage/bruising, musculoskeletal pain, decreased platelet count, and diarrhoea.
Serious side effects include:
Haemorrhage: Serious bleeding events have been reported; increased risk in patients on concomitant antiplatelet or anticoagulant therapy, per the approved prescribing information.
Infections: Serious infections, including bacterial, viral, and fungal infections, have been reported; monitoring for signs of infection is recommended throughout treatment.
Cytopenias: Neutropenia, thrombocytopenia, and anaemia have been reported; regular complete blood count monitoring is recommended per the approved label.
Cardiac Arrhythmias: Atrial fibrillation and flutter have been reported, though at a lower rate compared to first-generation BTK inhibitors in comparative trials; cardiac monitoring is recommended, particularly in patients with cardiac risk factors.
Second Primary Malignancies: Including skin cancers, reported with this therapeutic class; dermatological monitoring is recommended.
Full side effect information is available at FDA Zanubrutinib Safety Information.
As a responsible medicine distributor in Delhi, A.K. Pharma stores all oncology and haematology medicines including Brukinsa under manufacturer-recommended conditions ensuring product integrity for every supply.
Brukinsa (Zanubrutinib) is manufactured by BeOne Medicines (formerly BeiGene). Zanubrutinib received its first FDA accelerated approval in November 2019 for mantle cell lymphoma, with subsequent expanded approvals across CLL/SLL, WM, MZL, and follicular lymphoma. A.K. Pharma supplies only genuine Brukinsa sourced from authorised distributors. Learn more about BeOne Medicines’ haematology-oncology portfolio directly from the manufacturer.
Q. What is Brukinsa used for?
Brukinsa (Zanubrutinib) is used to treat chronic lymphocytic leukaemia (CLL), small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), Waldenström’s macroglobulinaemia (WM), marginal zone lymphoma (MZL), and follicular lymphoma, depending on the specific approved indication.
Q. What is the generic name and strength of Brukinsa?
The generic name of Brukinsa is Zanubrutinib, supplied as 80mg capsules, manufactured by BeOne Medicines.
Q. How is Zanubrutinib different from Ibrutinib?
Zanubrutinib is a second-generation BTK inhibitor designed with greater selectivity for BTK relative to off-target kinases compared to first-generation agents like Ibrutinib. Head-to-head trials including ALPINE and ASPEN have demonstrated a lower rate of atrial fibrillation with Zanubrutinib compared to Ibrutinib.
Q. Can Brukinsa be taken once or twice daily?
Yes. Per the approved label, Brukinsa can be dosed as either 160mg twice daily or 320mg once daily, providing scheduling flexibility determined by the prescribing physician.
Q. Is Brukinsa available in India?
Brukinsa can be supplied to hospitals and haematology centres across India through licensed pharmaceutical distributors. Contact A.K. Pharma — medicine distributor in Delhi and pharmaceutical distributor in Delhi — for availability and pricing.
Q. What is the price of Brukinsa in India?
Brukinsa price in India varies by pack size. Contact A.K. Pharma at 011 4172 6999 or WhatsApp +91 9810034827 for current pricing and bulk supply rates.
Q. How to order Brukinsa from A.K. Pharma?
You can request a quote directly from this page, call us at 011 4172 6999, or WhatsApp us at +91 9810034827 with your requirements and we will respond promptly.
Q. Does A.K. Pharma supply Brukinsa in bulk?
Yes. A.K. Pharma supplies Brukinsa in bulk to hospitals and haematology centres across Delhi and India.
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Disclaimer: This page is intended for informational and sourcing/procurement purposes only and does not constitute medical or clinical advice. All treatment decisions, including drug selection and dosing, should be made by a qualified healthcare professional in accordance with the approved prescribing information. A.K. Pharma is a licensed medicine distributor and does not provide clinical guidance.
