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.
LUSP
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.
For the treatment of red blood cell (RBC) transfusion-dependent anemia in patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who have ringed sideroblasts, require at least two RBC units over 8 weeks, and have progressed on or are not suitable for an erythropoietin stimulating agent.
(Refer to EAP for full funding criteria.)
luspatercept
Exceptional Access Program
(luspatercept - For the treatment of red-blood cell (RBC) transfusion-dependent anemia associated with Myelodysplastic Syndromes (MDS), according to clinical criteria)
(EAP Website
)
Starting Dose:
| luspatercept | 1 mg /kg | Subcut | Day 1 |
Refer to Section E for dose titration based on response.
REPEAT EVERY 21 DAYS
Until a lack of meaningful response*, progression of MDS to a higher risk category or transformation to AML, or unacceptable toxicity
*Refer to Dose Modification section for details.
Doses should be modified according to the protocol by which the patient is being treated.
Assess hemoglobin (Hgb) prior to each administration. If RBC transfusion occurred prior to dosing, pre-transfusion Hgb must be considered for dosing purposes.
Dose Titration Based on Response:
| Parameter | Action |
| Insufficient Response | |
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After ≥ 2 consecutive doses (6 weeks) at 1 mg/kg:
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Increase* dose to 1.33 mg/kg |
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After ≥ 2 consecutive doses (6 weeks) at 1.33 mg/kg:
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Increase* dose to 1.75 mg/kg |
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No reduction in RBC transfusion burden or no increase from baseline Hgb after > 3 consecutive doses (9 weeks) at 1.75 mg/kg |
Discontinue. |
| Pre-dose Hgb ≥ 115 g/L or Rapid Hgb Rise | |
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Pre-dose Hgb ≥ 115 g/L in the absence of transfusions |
Hold until Hgb is ≤ 110 g/L |
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Increase in Hgb > 20 g/L within 3 weeks in the absence of transfusion and: |
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*Do not increase dose more frequently than q6 weeks (2 doses) or exceed the maximum dose of 1.75 mg/kg or 168 mg.
Dosage with toxicity
| Toxicity | Action |
| Any Grade 2 adverse reaction | Hold until < Grade 1. |
| Grade 3 or 4 hypersensitivity reactions | Discontinue. |
| Grade 3 or 4 leukocytosis (>100,000 WBC/μL) | Hold until ≤ Grade 1. |
| Suspected hematologic malignancy | Hold and investigate; discontinue if confirmed. |
| Other Grade 3 or 4 adverse reactions | Hold until ≤ Grade 1. |
Hepatic Impairment
No dosage adjustments are required for patients with mild to severe hepatic impairment. Pharmacokinetic data are not available for patients with AST or ALT ≥ 3 x ULN.
Renal Impairment
| Approximate Creatinine Clearance* (mL/min) | Luspatercept Dose |
| ≥ 30 | No dosage adjustment required. |
| < 30 | No data; no dosage recommendations. |
*Reported as eGFR in mL/min/1.73 m2.
Dosage in the Elderly
No dosage adjustments are required for patients ≥ 65 years of age.
Refer to luspatercept drug monograph(s) for additional details of adverse effects.
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Common (25-49%) |
Less common (10-24%) |
Uncommon (< 10%), but may be severe or life-threatening |
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Refer to luspatercept drug monograph(s) for additional details.
Administration
- Reconstitute with SWFI and swirl gently to mix. Avoid aggressive shaking.
- Administer by subcutaneous injection into the upper arm, thigh, and/or abdomen.
- Divide doses requiring larger volumes (i.e. > 1.2 mL) into separate injections and administer into separate sites.
- If a dose is missed, administer missed dose as soon as possible and continue dosing with at least 3 weeks between doses.
- Store vials refrigerated at 2-8˚C in original carton to protect from light. Do not freeze.
Contraindications
- Patients who are hypersensitive to this drug or any of its components
Other Warnings/Precautions
- Luspatercept is not a substitute for RBC transfusions in patients who require immediate correction of anemia.
Pregnancy/Lactation
- This regimen is not recommended for use in pregnancy. Adequate contraception should be used by patients and their partners while on treatment and after the last treatment dose. Recommended methods and duration of contraception may differ depending on the treatment. Refer to the drug monograph(s) for more information.
- Breastfeeding is not recommended during treatment and after the last treatment dose. Refer to the drug monograph(s) for recommendations after the last treatment dose (if available).
- Fertility effects: Probable
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
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CBC; Baseline, prior to each dose, and as clinically indicated
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Blood pressure; Baseline, prior to each dose, and as clinically indicated
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Liver function tests; Baseline and as clinically indicated
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Renal function tests; Baseline and as clinically indicated
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Clinical toxicity assessment for hypersensitivity, injection site reactions, infection, and cardiovascular effects; At each visit
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Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
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CADTH Reimbursement Recommendation: Luspatercept (Reblozyl). Canadian Journal of Health Technologies. Dec 2021.
Fenaux P, Platzbecker U, Mufti GJ, et al. Luspatercept in Patients with Lower-Risk Myelodysplastic Syndromes.N Engl J Med 2020;382:140-51. DOI: 10.1056/NEJMoa1908892
Luspatercept drug monograph. Ontario Health (Cancer Care Ontario).
July 2025 Expanded into full regimen monograph
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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