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regimen-monograph
RITU
A - Regimen Name
RITU Regimen
riTUXimab
Disease Site
Hematologic - Leukemia - Hairy Cell
Intent
Palliative
Regimen Category
Emergent :
Regimens that may eventually be ‘evidenced informed’, but are still undergoing review. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.
Rationale and Uses
Treatment for refractory Hairy Cell Leukemia.*
*Refer to NDFP form for funding details. Not a Health Canada Indication. Data available from phase II studies.
Supplementary Public Funding
riTUXimab
New Drug Funding Program (Rituximab - Single Agent - Indolent Lymphoma)
riTUXimab
New Drug Funding Program (Rituximab in Combination with Chemotherapy - Indolent B-cell Lymphoma)
riTUXimab
New Drug Funding Program (Rituximab - Retreatment - Indolent Lymphoma) (in combination with chemotherapy)
riTUXimab
New Drug Funding Program (Rituximab - Maintenance Treatment - Lymphoma)
B - Drug Regimen
| riTUXimab
(Round to nearest 10 mg) |
375 mg /m² | IV | |
|
See Section H - "Drug Administration and Special Precautions".
|
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C - Cycle Frequency
Induction:
WEEKLY x 4 DOSES
WEEKLY x 4 DOSES
Maintenance (If patient responds to induction therapy):
Q 12 WEEKS, to be started within 6 months of last dose of induction therapy, for maximum two years of maintenance treatment, unless disease progression or unacceptable toxicity. (Refer to NDFP form for funding details; however, no specific trials have been conducted.)
D - Premedication and Supportive Measures
Antiemetic Regimen:
Minimal (Infusion related events)
Other Supportive Care:
- Premedication:
- Acetaminophen 650mg PO
- Diphenhydramine 50mg PO/IV
Other:
- For chemotherapy combinations that do not contain steroids, consider pre-medication with corticosteroids (i.e. methylprednisolone 80 mg IV), especially in patients with high bulk disease or pulmonary involvement
- If high volume disease consider prophylaxis for tumour lysis
E - Dose Modifications
Screen patients for hepatitis B prior to starting treatment; if antigen positive/active, do not start treatment. Seropositive patients should be assessed by a hepatologist and be followed closely.
Doses should be modified according to the protocol by which the patient is being treated. The following recommendations have been adapted from clinical trials or product monographs and could be considered.
Since transient hypotension may occur during rituximab infusion, consideration should be given to withhold antihypertensive medication 12 hours prior to and throughout the rituximab infusion.
Dosage with toxicity
|
Toxicity
|
Rituximab Dose / Infusion Rate
|
|
Myelosuppression
|
No adjustment required.
|
|
Grade 1-2 Infusion-related
|
|
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≥ Grade 3 Infusion-related or pulmonary
|
|
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Other grade 3 toxicity
|
Delay infusion until ≤ grade 2
|
|
Discontinue
|
Missed or delayed doses may be administered at a later time point, based on physician’s discretion. |
|
Hepatic Impairment
No adjustment required; stop if evidence of hepatitis.
Renal Impairment
No adjustment required.
F - Adverse Effects
Refer to riTUXimab drug monograph(s) for additional details of adverse effects
| Most Common Side Effects | Less Common Side Effects, but may be |
|
|
H - Drug Administration and Special Precautions
Refer to riTUXimab drug monograph(s) for additional details
- First infusion: initial rate of 50 mg/h, then escalate rate in 50 mg/h increments every 30 minutes, to a maximum of 400 mg/h.
- If first infusion well-tolerated, start subsequent infusions at 100 mg/hr, then escalate rate in 100 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr as tolerated
- Published data suggest that a 90 minute infusion (20% of the dose in the first 30 min then the remaining 80% over 60 min) can be used for second and subsequent infusions if no reaction occurred with the first infusion.
- Consider a slower infusion rate for patients with high bulk disease who are at a higher risk of tumour lysis syndrome and infusion related reactions.
I - Recommended Clinical Monitoring
Recommended Clinical Monitoring
- CBC; baseline and regular
- Hepatitis B screening prior to treatment; seropositive patients should see hepatologist and be closely monitored for up to 12 months after the last infusion
- LFTs; baseline and regular
- Renal functions tests; baseline and regular
- Clinical assessment of hypersensitivity reactions, tumour lysis syndrome, hypotension, infection, bleeding, GI, pulmonary, skin, CNS, cardiovascular side effects; regular
- Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
Suggested Clinical Monitoring
- Monitor closely for cardiovascular symptoms for patients who have cardiac conditions or recurrent cardiac events with rituximab
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J - Administrative Information
Approximate Patient Visit
3 to 5 hours
Pharmacy Workload (average time per visit)
20.946 minutes
Nursing Workload (average time per visit)
69.167 minutes
K - References
Hagberg H, Lundholm L. Rituximab, a chimaeric anti-CD20 monoclonal antibody, in the treatment of hairy cell leukaemia. Br J Haematol 2001;115:609–11.
Lauria F, Lenoci M, Annino L, Raspadori D, Marotta G, Bocchia M, et al. Efficacy of anti-CD20 monoclonal antibody, in the treatment of hairy cell leukemia. Haematologica 2001;86:1046-50.
Nieva J, Bethel K, Saven A, et al.: Phase II study of rituximab in the treatment of cladribine-failed patients with hairy cell leukemia. Blood 2003;102(3):810-3.
Salar A, Casao D, Cervera M, et al. Rapid infusion of rituximab with or without steroid-containing chemotherapy: 1-yr experience in a single institution. Eur J Haematol 2006: 77: 338–340.
Sehn LH, Donaldson J, Filewich A, et al. Rapid infusion rituximab in combination with corticosteroid-containing chemotherapy or as maintenance therapy is well tolerated and can safely be delivered in the community setting. Blood 2007;109(10):4171-3.
Thomas DA, O`Brien S, Bueso-Ramos C, Faderl S, Keating MJ, Giles FJ, et al. Rituximab in relapsed or refractory hairy cell leukaemia. Blood 2003;102:3906-11.
Zenhäusern R, Simcock M, Gratwohl A, et al. Rituximab in patients with hairy cell leukemia relapsing after treatment with 2-chlorodeoxyadenosine (SAKK 31/98). Haematologica 2008;93(9):1426-8.
October 2017 Modified monitoring section
M - Disclaimer
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.
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Last Updated: July 21, 2026
