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.
FC(PO)+R
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.
Treatment of anti-CD20 antibody-naive previously untreated or second-line relapsed or refractory CLL patients, in whom fludarabine-based therapy is considered appropriate. There is insufficient evidence for the use of maintenance rituximab in CLL patients.
riTUXimab
New Drug Funding Program (Rituximab (Biosimilar IV) and Rituximab SC - Previously Untreated Chronic Lymphocytic Leukemia)
riTUXimab
New Drug Funding Program (Rituximab (Biosimilar IV) and Rituximab SC - Second Line - Chronic Lymphocytic Leukemia)
fludarabine
ODB Limited Use (fludarabine - For the first-line treatment of CLL in combination with rituximab (tablets; with or without cyclophosphamide))
fludarabine
ODB Limited Use (fludarabine - For second-line therapy of patients with CLL who have failed or are intolerant to chlorambucil (tablets))
riTUXimab (subcut)
New Drug Funding Program (Rituximab (Biosimilar IV) and Rituximab SC - Previously Untreated Chronic Lymphocytic Leukemia)
riTUXimab (subcut)
New Drug Funding Program (Rituximab (Biosimilar IV) and Rituximab SC - Second Line - Chronic Lymphocytic Leukemia)
cyclophosphamide
ODB - General Benefit (cyclophosphamide - oral tablets)
Note: Different rituximab products are NOT INTERCHANGEABLE.
Cycle 1: All patients must receive their first dose of rituximab by IV infusion.
| riTUXimab | 375 mg /m² | IV * | Day 1 |
In clinical trials, cycle 1 rituximab was given the day prior to FC | |||
| fludarabine | 25 mg /m² | PO | Days 1 to 5 |
(Outpatient prescription in 10 mg tablets) | |||
| cyclophosphamide | 150 mg /m² | PO | Days 1 to 5 |
(Outpatient prescription in 25 mg or 50 mg tablets) Rituximab IV: | |||
| riTUXimab | 500 mg /m² | IV * | Day 1 |
Rituximab (subcut): | |||
| riTUXimab (subcut) | 1600** mg | Subcut | Day 1 |
PLUS FC(PO) chemotherapy: | |||
| fludarabine | 25 mg /m² | PO | Days 1 to 5 |
(Outpatient prescription in 10 mg tablets) | |||
| cyclophosphamide | 150 mg /m² | PO | Days 1 to 5 |
(Outpatient prescription in 25 mg or 50 mg tablets) | |||
* Consider slower infusion rate or split dosing over days 1-2 (± corticosteroids) for any cycle where high tumour load or WBC > 25 x 109/L.
** Note: Rituximab subcut dosing is higher in CLL compared to other indications. Ensure the proper dose is administered.
REPEAT EVERY 28 DAYS
For a usual total of 6 cycles unless disease progression or unacceptable toxicity occurs
FC(PO): Outpatient prescription for home administration
Assouline S, Buccheri V, Delmer A, et al. Pharmacokinetics, safety, and efficacy of subcutaneous versus intravenous rituximab plus chemotherapy as treatment for chronic lymphocytic leukaemia (SAWYER): a phase 1b, open-label, randomised controlled non-inferiority trial. Lancet Haematol 2016;3(3):e128-38.
Cazin B, Divine M, Leprêtre S, et al. High efficacy with five days schedule of oral fludarabine phosphate and cyclophosphamide in patients with previously untreated chronic lymphocytic leukaemia. Br J Haematol. 2008 Oct;143(1):54-9.
Hallek M, Fischer K, Fingerle-Rowson G, et al. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial. Lancet 2010;376(9747):1164-74.
Hendry L, Bowen A, Matutes E, et aL. Fludarabine, cyclophosphamide and mitoxantrone in relapsed or refractory chronic lymphocytic leukemia and low grade non-Hodgkin's lymphoma. Leuk Lymphoma 2004 May;45(5):945-50.
Hillmen P, Cohen DR, Cocks K, et al. A randomized phase II trial of fludarabine, cyclophosphamide and mitoxantrone (FCM) with or without rituximab in previously treated chronic lymphocytic leukaemia. Br J Haematol. 2011 Mar;152(5):570-8.
Keating MJ, O’Brien S, Albitar M, et al. Early results of a chemoimmunotherapy regimen of fludarabine, cyclophosphamide, and rituximab as initial therapy for chronic lymphocytic leukemia. J Clin Oncol 2005; 23: 4079-88.
Laurenti L, De Padua L, Tarnani M, et al. Comparison between oral and intravenous fludarabine plus cyclophosphamide regime as front-line therapy in patients affected by chronic lymphocytic leukaemia: influence of biological parameters on the clinical outcome. Ann Hematol. 2011 Jan;90(1):59-65.
Robak T, Dmoszynska A, Solal-Celigny P, et al. Rituximab plus fludarabine and cyclophosphamide prolongs progression-free survival compared with fludarabine and cyclophosphamide alone in previously treated chronic lymphocytic leukemia. J Clin Oncol 2010; 28: 1756-65.
Tam CS, O’Brien S, Wierda W, et al. Long-term results of the fludarabine, cyclophosphamide, and rituximab regimen as initial therapy of chronic lymphocytic leukemia. Blood 2008; 112(4): 975-80.
August 2020 Updated NDFP forms and interchangeability information in Drug Regimen section
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.