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DOSING

ONCE- OR TWICE-DAILY DOSING1

The only BTKi that can be dosed either ONCE or TWICE daily1

Administration1

  • Can be taken with or without food. Can be taken with a high-fat meal – BRUKINSA drug concentration (AUC) is not affected
  • Advise patients to swallow capsules whole with water—do not open, dissolve, or chew capsules
  • BRUKINSA must not be taken with grapefruit juice, grapefruit, and/or Seville oranges
  • If a dose of BRUKINSA is missed, it can be taken as soon as possible with a return to the normal schedule the following day

BRUKINSA should be taken until disease progression or unacceptable toxicity.

  • AUC=area under the concentration-time curve.

RECOMMENDED DOSE ADJUSTMENTS1

CYP Coadministered drug Recommended dose
Inhibition Strong CYP3A inhibitor (e.g., posaconazole, voriconazole, ketoconazole, itraconazole, clarithromycin, lopinavir, ritonavir, telaprevir) 80 mg once daily
Interrupt dose as recommended for adverse reactions
Moderate CYP3A inhibitor (e.g., erythromycin, ciprofloxacin, diltiazem, dronedarone, fluconazole, verapamil, aprepitant) 80 mg twice daily
Modify dose as recommended for adverse reactions
Induction Strong CYP3A inducer (e.g., carbamazepine, phenytoin, rifampin) Avoid concomitant use; consider alternative agents with less CYP3A induction
Moderate CYP3A inducer (e.g., bosentan, efavirenz, etravirine, modafinil, nafcillin) Avoid concomitant use. If concomitant use cannot be avoided, increase BRUKINSA dose to 320 mg twice daily. Monitor closely for toxicity.

No dose adjustment is recommended in patients with mild to moderate renal or hepatic impairment.

Straightforward Dose Modification for ≥Grade 3 Adverse Reactions (ARs)1

Recommended dose modification for ≥Grade 3 ARs

  • Grade ≥3: non-hematological toxicities
  • Grade 3: febrile neutropenia/thrombocytopenia with significant bleeding
  • Grade 4: neutropenia*/thrombocytopenia*
Starting Dose 1st Occurrence 2nd Occurrence 3rd Occurrence 4th Occurrence
Start at
320 mg†
total dose 		Interrupt BRUKINSA Interrupt BRUKINSA Interrupt BRUKINSA Discontinue
Resume BRUKINSA once toxicity has resolved to
≤Grade 1
or baseline 		Resume BRUKINSA once toxicity has resolved to
≤Grade 1
or baseline 		Resume BRUKINSA once toxicity has resolved to
≤Grade 1
or baseline
No dose reduction.
320 mg†
total dose 		Reduce to
160 mg
total dose 		Reduce to
80 mg
total dose
  • * Lasting >10 consecutive days.
  • † 160 mg BID or 320 mg OD.
  • ARs=adverse reactions; BID=twice a day; OD=once daily.

Pooled treatment-emergent adverse reactions in ≥10% of patients with hematologic malignancies* (N=1,550)5

Treatment-Emergent Adverse Reactions BRUKINSA (N=1,550)
All Grades (%) Grade ≥3 (%)
Upper respiratory tract infection† 37.1 2.2
Bruising† 30.4 0.5
Neutropenia† 27.5 18.5
Haemorrhage/hematoma† 27.4 3.0
Musculoskeletal pain† 27.0 1.8
Rash† 25.0 0.7
Diarrhea 18.8 1.5
Cough† 18.6 0.1
Pneumonia† 17.9 9.4
Fatigue† 16.2 1.2
Thrombocytopenia† 15.9 5.7
Anemia† 14.1 5.2
Hypertension† 13.0 6.5
Constipation 12.3 0.3
Urinary tract infection† 11.6 1.7
Dizziness† 10.7 0.3
  • * Chronic lymphocytic leukemia, small lymphocytic lymphoma, Waldenström’s macroglobulinemia, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma, hairy cell leukemia, diffuse large B-cell lymphoma, and Richter’s transformation.
  • † Indicates grouped term that includes multiple preferred terms.

Pooled selected treatment-emergent adverse events of special interest in patients with hematologic malignancies* (N=1,550)5

Treatment-emergent adverse events All Grades (%) Grade ≥3 (%)
Arthralgia 12.8 0.3
Myalgia 3.9 0.3
Atrial fibrillation 2.9 0.8
Atrial flutter 0.3 0.0

Of the 1,550 patients treated with BRUKINSA, 3.0% discontinued therapy and 5.2% experienced a dose reduction due to adverse reactions.1

BRUKINSA Ordering Information

BRUKINSA is supplied through Sentrex Health Solutions
For product ordering information, please call 1-833-234-4366 
or email info@mybeigene.ca

Download BRUKINSA wholesaler
Contact Information

 Patient Support

Designed to provide appropriate information and assistance to BRUKINSA patients, including:

Reimbursement/payment support

  • Dedicated case managers to support insurance verification, bridge, and/or co-pay for patients to gain access to BRUKINSA

Education and support

  • Dedicated nurse case managers for practices, patients, and caregivers
  • Helps provide information about their disease and treatment with BRUKINSA
  • Specialty pharmacists who speak to patients with every refill

Connections to third-party advocacy organizations

  • Assists patients and caregivers with practical help through connections to advocacy groups and local/national free resources such as:
    • Education and events
    • Support group information

Enroll in myBeiGene

Call myBeiGene (8:00 am to 8:00 pm)

1-833-234-4366

Fax Enrollment Form to 1-833-567-0696

DOWNLOAD
ENROLLMENT FORM

THE BEIGENE SAMPLE PROGRAM

BeiGene provides you with samples of BRUKINSA (zanubrutinib) for your patients

Receive a sample in 2 easy steps

  1. Click “Request Sample” below or request a sample form from your Regional Manager.
  2. Complete the form and submit.
Receive the sample(s) in approximately two business days, shipped directly to your office.
Request Sample
Each sample request for BRUKINSA is fulfilled with up to two 120-count bottle(s), each bottle allocated for one patient.
Your BeiGene Regional Manager will provide you with patient materials to accompany the sample(s).
Upon enrollment into the myBeiGene® Patient Support Program, a BRUKINSA Patient Starter Kit will be provided.

These are prescription drug samples provided in accordance with Food and Drug Regulations.
It is unlawful to sell, trade, barter, return for credit, utilize to seek reimbursement, or bill patients for samples.

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IMPORTANT SAFETY INFORMATION

INDICATIONS AND CLINICAL USE:

BRUKINSA (zanubrutinib) is indicated:

  • for the treatment of adult patients with Waldenström’s macroglobulinemia (WM).
  • for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
  • for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy.
  • for the treatment of adult patients with chronic lymphocytic leukemia (CLL).
  • in combination with obinutuzumab for the treatment of adult patients with relapsed or refractory grade 1, 2, or 3a follicular lymphoma (FL) who have received at least 2 prior systemic therapies.

CONTRAINDICATIONS:

BRUKINSA is contraindicated in patients who are hypersensitive to zanubrutinib or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

Most Serious Warnings and Precautions:

OTHER RELEVANT WARNINGS AND PRECAUTIONS:

For more information:

Please consult the BRUKINSA Product Monograph for important information relating to adverse reactions, drug interactions, and dosing information, which have not been discussed in this piece. The Product Monograph is also available by calling 1-877-828-5598.