Drug Formulary information is intended for use by healthcare professionals. It is not intended to be medical advice. Some of the information, including information about funding for cancer drugs, does not apply to all patients. Cancer treatment plans are unique to each patient. If you are a patient, please speak with your healthcare team to understand how this information applies to you.
IBRU+RITU
Regimen is considered appropriate as part of the standard care of patients; meaningfully improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR). Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.
This Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph. Full regimen monographs will be published for each ST-QBP regimen as they are developed.
For the treatment of patients with previously treated refractory or relapsed Waldenström’s macroglobulinemia (WM).
(Refer to the NDFP eligibility form for detailed funding criteria.)
iBRUtinib
Exceptional Access Program
(iBRUtinib - In Combination with Rituximab for Previously Treated Waldenstrӧms Macroglobulinemia)
(EAP Website)
riTUXimab
New Drug Funding Program
(Rituximab (Biosimilar IV) and Rituximab SC - In Combination with Ibrutinib for Previously Treated Waldenstrӧms Macroglobulinemia)
(NDFP Website
)
riTUXimab (subcut)
New Drug Funding Program
(Rituximab (Biosimilar IV) and Rituximab SC - In Combination with Ibrutinib for Previously Treated Waldenstrӧms Macroglobulinemia)
(NDFP Website
)
Note: Different rituximab products are not interchangeable.
Rituximab IV and subcutaneous formulations are not interchangeable. The dosing and concentrations of these products are different. Refer to Safety Considerations for the Implementation of Subcutaneous Rituximab Formulation.
Cycle 1: All patients must receive their first dose of rituximab by IV infusion.
| iBRUtinib | 420 mg | PO | Days 1 to 28 |
| riTUXimab | 375 mg /m² | IV | Day 1 |
|
Rituximab IV: |
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| riTUXimab | 375 mg /m² | IV | Day 8, 15, 22 |
|
The subcutaneous formulation must only be given at the second or subsequent doses, and only after at least 1 full rituximab IV dose. |
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| riTUXimab (subcut) | 1400 mg | Subcut | Day 8, 15, 22 |
|
Cycle 2 to 4: |
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| iBRUtinib | 420 mg | PO | Days 1 to 28 |
|
Cycle 5: |
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| iBRUtinib | 420 mg | PO | Days 1 to 28 |
|
Rituximab IV: |
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| riTUXimab | 375 mg /m² | IV | Day 1, 8, 15, 22 |
|
Rituximab (subcut): |
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| riTUXimab (subcut) | 1400 mg | Subcut | Day 1, 8, 15, 22 |
|
Cycle 6 and onwards: |
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| iBRUtinib | 420 mg | PO | Days 1 to 28 |
CYCLES REPEAT EVERY 28 DAYS
iBRUtinib: Until disease progression or unacceptable toxicity occurs
riTUXimab IV/subcut: Weekly dosing during cycles 1 and 5 (up to a maximum of 8 doses), unless disease progression or unacceptable toxicity occurs
Minimal
- Also refer to CCO Antiemetic Recommendations.
Screen for hepatitis B virus in all cancer patients starting systemic treatment. Refer to the hepatitis B virus screening and management guideline.
Other Supportive Care:
- Patients at risk of tumour lysis syndrome should have appropriate prophylaxis and be monitored closely.
- Consider prophylaxis for patients at an increased risk for opportunistic infections.
Pre-medication (prophylaxis for infusion/administration reactions)
Administer at least 30 minutes prior to rituximab:
- Oral antipyretic (e.g. acetaminophen)
- H1-receptor antagonist (e.g. diphenhydramine)
- Corticosteroid (e.g. methylprednisolone 80 mg IV) in patients with high bulk disease or pulmonary involvement if no corticosteroids are already being given as part of the chemotherapy regimen.
- In patients receiving subcut rituximab who experienced adverse effects with pre-medications, the omission of pre-medications can be considered.
Also refer to the CCO guideline for detailed description of Management of Cancer Medication-Related Infusion Reactions.
CADTH Reimbursement Recommendation: Ibrutinib (Imbruvica). Canadian Journal of Health Technologies. January 2024.
Dimopoulos MA, Tedeschi A, Trotman J, et al. Phase 3 Trial of Ibrutinib plus Rituximab in Waldenström's Macroglobulinemia. N Engl J Med. 2018 Jun 21;378(25):2399-2410.
Ibrutinib drug monograph. Ontario Health (Cancer Care Ontario).
Rituximab drug monograph. Ontario Health (Cancer Care Ontario).
Rituximab (subcut) drug monograph. Ontario Health (Cancer Care Ontario).
April 2025 new ST-QBP regimen
Regimen Abstracts
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. Such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph. Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Regimen Monographs
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.