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.
FLUD(PO)
(including Waldenstrom’s Macroglobulinemia)
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.
Second-line therapy for previously treated patients with stage III-IV low-grade lymphoma (including Waldenstrom’s Macroglobulinemia)
| fludarabine | 40 mg /m²/day | PO | Days 1 to 5 |
| (This drug is not currently publicly funded for this regimen and intent) | |||
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(Outpatient prescription available in 10mg tablets)
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REPEAT EVERY 28 DAYS
For a total of 6 cycles, or 2 cycles beyond maximum response in the absence of disease progression or unacceptable toxicity
Minimal
Other Supportive Care:
- Allopurinol and hydration to reduce the risk of tumour lysis syndrome are recommended.
- Consider prophylaxis for PCP (cotrimoxazole) as per local guidelines.
- Use irradiated blood products to ↓ risk of GVHD.
Doses should be modified according to the protocol by which the patient is being treated. The following recommendations are in use at some centres.
Dosage with toxicity
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Toxicity / Grade
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Action
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Dose next cycle
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Platelet < 100 x 109/L and/or ANC < 1.5 x 109/L
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Hold until recovery
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↓ 25%
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Febrile neutropenia, thrombocytopenic bleeding
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Hold until recovery
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↓ 25%
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Grade 3 non-hematologic toxicity
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Hold until recovery
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↓ 25%
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Grade 4 non-hematologic toxicity OR
Any grade neurotoxicity, hemolysis OR
Suspected/proven pneumonitis/fibrosis
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Discontinue
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Discontinue
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Hepatic Impairment
No data available; use with caution.
Renal Impairment
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Creatinine Clearance
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% usual dose
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30 - 70 mL/min
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REDUCE to 50%
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< 30 mL/min
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DISCONTINUE
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| Most Common Side Effects | Less Common Side Effects, but may be Severe or Life Threatening |
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Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.
Recommended Clinical Monitoring
- Clinical toxicity assessment (including fever or infection, hemolysis, dehydration, pulmonary, GI, CNS).
- CBC before each cycle. Interim counts should be done in first cycle and repeated if dose modification necessary.
- Baseline and regular liver and renal function tests
- Creatinine clearance if > 70 yrs or renal dysfunction suspected
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Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
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Boogaerts MA, Van Hoof A, Catovsky D, et al. Activity of Oral Fludarabine Phosphate in Previously Treated Chronic Lymphocytic Leukemia J Clin Oncol,2001; 19(22): 4252-4258
Fludarabine drug monograph, Cancer Care Ontario.
Klasa R, Meyer R, Shustik C, et al. Randomized phase III study of fludarabine phosphate versus cyclophosphamide, vincristine, and prednisone in patients with recurrent low-grade non-Hodgkin's lymphoma previously treated with an alkylating agent or alkylator-containing regimen. J Clin Oncol. 2002 Dec 15;20(24):4649-54.
Tobinai K, Watanabe T, Ogura M, et al. Phase II study of oral fludarabine phosphate in relapsed indolent b-cell non-hodgkin’s lymphoma. JCO 2006; 24: 174-80.
October 2017 added not publicly funded to drug 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.