Small Lymphocytic Lymphoma (SLL) Treatments

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Brand Name

Brukinsa

Generic Name

Zanubrutinib

View Brand Information

FDA approval date: November 14, 2019

Classification: Kinase Inhibitor

Form: Tablet, Capsule

What is Brukinsa (Zanubrutinib)?

BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with: Mantle cell lymphoma who have received at least one prior therapy.

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A Phase 1b/2, Open-Label, Master Protocol Study of BTK-Degrader BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies

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A Phase II Randomized Study Comparing BTK Inhibitors (Ibrutinib Plus Rituximab or Zanubrutinib Alone) vs. BCL-2 Inhibitor (Venetoclax) and Rituximab in Previously Untreated Waldenström's Macroglobulinemia (WM) / Lymphoplasmacytic Lymphoma (LPL)

Who is this study for: Patients with Lymphoplasmacytic Lymphoma, Waldenstrom Macroglobulinemia

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Intervention Type: Biological, Procedure, Drug

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Study Phase: Phase 2

Summary: This phase II trial studies the effects of venetoclax and rituximab in comparison to ibrutinib and rituximab or zanubrutinib in treating patients with previously untreated Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody. It binds to a protein called C...

A Randomized Phase 3 Trial of Continuous vs. Intermittent Maintenance Therapy With Zanubrutinib as Upfront Treatment in Older Patients With Mantle Cell Lymphoma

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Summary: This phase III trial tests whether continuous or intermittent zanubrutinib after achieving a complete remission (CR) with rituximab works in older adult patients with mantle cell lymphoma (MCL) who have not received treatment in the past (previously untreated). Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Zanubrutinib may stop the growt...

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Brand Information

BRUKINSA (zanubrutinib)

1DOSAGE 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.

Tablets: 160 mg, blue, oval, film-coated tablets debossed with "zanu" on one side and functional scoring on the other side.

2CONTRAINDICATIONS

None.

3ADVERSE REACTIONS

The following clinically significant adverse reactions are discussed in more detail in other sections of the labeling:

Hemorrhage
Infections
Cytopenias
Second Primary Malignancies
Cardiac Arrhythmias
Hepatotoxicity, including DILI

3.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data in the WARNINGS AND PRECAUTIONS reflect exposure to BRUKINSA in nine monotherapy and 2 combination clinical trials, administered at 160 mg twice daily in 1608 patients and at 320 mg once daily in 121 patients. Among these 1729 patients, the median duration of exposure was 27.6 months, 78% of patients were exposed for at least 12 months, and 60% of patients were exposed for at least 24 months.

In this pooled safety population, the most common adverse reactions (≥30%), including laboratory abnormalities, were neutrophil count decreased (51%), platelet count decreased (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%).

3.2Postmarketing Experience

The following adverse reactions have been identified during postapproval use of BRUKINSA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hepatobiliary disorder: drug-induced liver injury

4DESCRIPTION

BRUKINSA (zanubrutinib) is a kinase inhibitor. The empirical formula of zanubrutinib is C

The molecular weight of zanubrutinib is 471.55 Daltons.

Zanubrutinib has the following structure:

Each BRUKINSA capsule for oral administration contains 80 mg zanubrutinib and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The capsule shell contains edible black ink, gelatin, and titanium dioxide.

Each BRUKINSA tablet for oral administration contains 160 mg zanubrutinib and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The film coating contains FD&C Blue No. 1, FD&C Blue No. 2, hypromellose, titanium dioxide, and triacetin.

5PATIENT COUNSELING INFORMATION

Advise patients to read the FDA-approved patient labeling (Patient Information).

6PRINCIPAL DISPLAY PANEL - 80 mg Capsule Carton

NDC 72579-011-02

Brukinsa

80 mg

Swallow capsules whole.

120 capsules

PRINCIPAL DISPLAY PANEL - 80 mg Capsule Carton

7PRINCIPAL DISPLAY PANEL - 160 mg Tablet Carton

Rx only

Brukinsa

160 mg

Swallow tablets whole.

60 tablets

PRINCIPAL DISPLAY PANEL - 160 mg Tablet Carton