regimen-monograph

OFAT

Intent

Palliative

Regimen Category

Evidence-Informed

Drugs Used

oFAtumumab

QBP Type

Compassionate

A - Regimen Name

OFAT Regimen

Ofatumumab

Disease Site

Hematologic - Leukemia - Chronic Lymphocytic (CLL)

Intent

Palliative

Regimen Category

Evidence-Informed :

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.

Rationale and Uses

Treatment of chronic lymphocytic leukemia (CLL) that is refractory to fludarabine and alemtuzumab.

B - Drug Regimen

oFAtumumab

(This drug is not publicly funded. Universal compassionate access program is available. )

Week	Infusion Number	Dose
1	1	300 mg
2	2	2000 mg
3-8	3-8	2000 mg weekly
12	9	2000 mg
16, 20 and 24	10-12	2000 mg q 4 weeks

C - Cycle Frequency

REPEAT WEEKLY

For a usual total of 8 weekly infusions FOLLOWED BY

REPEAT EVERY 28 DAYS

For a usual total of 4 monthly infusions (q 4 weeks) unless disease progression or unacceptable toxicity occurs

D - Premedication and Supportive Measures

Antiemetic Regimen:

Minimal

Premedications (give 30 - 120 minutes prior):

acetaminophen 1000 mg
oral or IV antihistamine (cetirizine 10 mg or equivalent)
IV corticosteroid (prednisolone 100mg or equivalent)

Refer to section H for infusion rates.

Week	Infusion Number	Steroid Premedication with each infusion
1	1	Full dose*
2	2	Full dose*
3-8	3-8	Decreased in each cycle if no prior Grade 3/4 infusion reaction
12	9	Full dose*
16, 20 and 24	10-12	50mg to 100mg prednisolone (or equivalent) if no Grade 3/4 infusion reaction with infusion 9

*prednisolone 100mg or equivalent

E - Dose Modifications

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

Toxicity	Dosing*
GI obstruction	Hold; investigate and manage appropriately
Viral hepatitis or other serious infections	Discontinue
PML	Discontinue and refer to neurologist for diagnosis and treatment
Serious or life-threatening arrhythmias or other cardiac events	Discontinue
Infusion reactions (IR) Grade 1-2	Hold; restart at half the infusion rate (but not slower than 12 mL/hr) when patient is stable (may increase rate to tolerance, but do not exceed doubling rate every 30 min)
Toxicity (continued)	Dosing*
IR Grade 3	Hold until stable; restart at 12 mL/hr when patient is stable (may increase rate to tolerance, but do not exceed doubling rate every 30 mins) Discontinue if anaphylaxis
IR Grade 4	Discontinue
* missed or delayed doses may be administered later at MD discretion

Hepatic Impairment

Information not available. Elimination of ofatumumab is not restricted to hepatic tissue therefore hepatic impairment is unlikely to require dosage modification^.

Renal Impairment

No data available in severe renal impairment (CrCl < 30 mL/min). Baseline CrCl did not have a clinically relevant effect on pharmacokinetics.

CrCl (ml/min)	Dose
> 30	No adjustment needed
≤ 30	No data. Use with extreme caution or avoid.

Dosage in the Elderly

No dosage adjustment necessary. Patients aged 65 and older receiving ofatumumab in combination with chlorambucil experienced more serious adverse events, including myelosuppression and infections.

Dosage based on gender:

Females had higher Cmax and AUC values in pharmacokinetic studies. No dose adjustment recommended.

F - Adverse Effects

Refer to ofatumumab drug monograph(s) for additional details of adverse effects

Less Common (10-24%)	Uncommon (< 10%), but may be severe or life-threatening
Rash (may be severe) Diarrhea Fatigue Nausea, vomiting Fluid retention Immunosuppression (including atypical infections such as PML) Myelosuppression +/- infection, bleeding Cough, dyspnea Musculoskeletal pain	Hypersensitivity reactions, including cytokine release syndrome Arrhythmia Tumour lysis syndrome Arterial and venous thromboembolism Hemolysis GI obstruction Secondary malignancy Increased LFTs

G - Interactions

Refer to ofatumumab drug monograph(s) for additional details

Caution with drugs that cause immunosuppression; monitor patient closely and avoid this combination if possible

H - Drug Administration and Special Precautions

Refer to ofatumumab drug monograph(s) for additional details

Administration:

Ofatumumab should be administered only as an IV infusion with supplied in-line filter set. Do not administer as an IV push or bolus.
Compatible with sodium chloride 0.9%. It should not be mixed with other IV solutions or medications. Flush the line before and after ofatumumab administration with sodium chloride 0.9%.
Store diluted solution at 2° to 8°C

Refractory CLL:

Infusion rate:

Infusion Time (min)	Infusions 1 and 2 (mL/hour)	Infusions 3 to 12 (mL/hour)
0 - 30	12	25
31 - 60	25	50
61 - 90	50	100
91 - 120	100	200
>120	200	400

Contraindications:

Patients who have a hypersensitivity to this drug or any of its components
Patients with known PML or a history of PML
Patients with active hepatitis
Avoid the use of live vaccines

Precautions:

Consider risk vs. benefit of inactivated vaccines
Use with extreme caution in patients who are hepatitis B or C positive
Patients with history of cardiovascular disease should be monitored closely during and after infusions
Monitor patients with a history of decreased lung function closely during ofatumumab infusion

Pregnancy/lactation:

Ofatumumab is not recommended for use in pregnancy. Adequate contraception (methods that result in < 1% pregnancy rate) should be used by both sexes during treatment, and for at least 6 months after the last dose.
Breastfeeding is not recommended

I - Recommended Clinical Monitoring

Recommended Clinical Monitoring

CBC; Baseline and before each dose and as clinically indicated during treatment, and after treatment completion
Cardiac tests for all patients with cardiac risk factors; Baseline and periodic
Hepatitis B screening prior to treatment for all patients. Monitor for signs and symptoms of hepatitis B during treatment. Seropositive patients should see hepatologist and be closely monitored for several months after the last infusion.;
LFTs; Baseline and regular
Clinical toxicity assessment for infusion reactions (including cytokine release syndrome), cardiac events (especially in patients with cardiac risk factors), infection, bleeding, neurotoxicity, respiratory, GI and skin toxicities; At each visit
Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version

J - Administrative Information

Approximate Patient Visit

7 hours initial 4.5 hours subsequent

Pharmacy Workload (average time per visit)

27.587 minutes

Nursing Workload (average time per visit)

74.833 minutes

K - References

Ofatumumab drug monograph, Cancer Care Ontario.

Wierda WG, Kipps TJ, Mayer J, et al. Ofatumumab as single-agent CD20 immunotherapy in fludarabine-refractory chronic lymphocytic leukemia. J Clin Oncol 2010;28(10):1749–55.

January 2018 Added compassionate supply info to drug

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 27, 2026

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