Reblozyl®▼ website is only intended for healthcare professionals in Belgium and Luxembourg.

Reblozyl® (luspatercept) has received European Medicines Agency approval. The registration status and approved product labels of Reblozyl® may vary from country to country.

IMPORTANT: The information on this website is based on the EU Summary of Product Characteristics (SmPC). View the SmPC: in English, in French, in Dutch.

The information provided on this website is intended for use by a healthcare professional qualified to prescribe and supply medications, thus requiring specific scientific knowledge and training to interpret it correctly.

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If you have any other queries, please contact us via email at medicalaffairs.belgium@bms.com.

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See Section 4.8 in the EU Summary of Product Characteristics for more information. Before prescribing Reblozyl®, please refer to the SmPC.

For your adult patients with
MDS- or β-thalassemia–associated anemia

With Reblozyl®▼ —the first and only erythroid maturation agent—you can reduce or even eliminate patients’ red blood cell (RBC) transfusion dependence.1-3

Reblozyl® is reimbursed in Belgium as of August 1st 2021 for the treatment of adult patients:

  • with transfusion-dependent anemia due to very low, low or intermediate-risk (IPSS-R) myelodysplastic syndrome (MDS) with ring sideroblasts, who had an unsatisfactory response to or are ineligible to erythropoietin-based therapy
  • with transfusion-dependent anemia associated with β-thalassemia.

The request has to be submitted via eHealth.

The maximum reimbursed posology is 1,75 mg/kg every 21 days for MDS and 1,25mg/kg every 21 days for beta-thalassemia.


Reblozyl® treatment will stop being reimbursed if:

  • there is no reduction of the transfusion burden after 9 weeks (3 cycles) at the maximum dose level, if the lack of response cannot be explained otherwise (bleeding, surgical intervention, other concomitant disease) or,
  • anytime in case of unacceptable toxicities.4

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Before prescribing Reblozyl®, please refer to the SmPC. View the EU SmPC in English, SmPC in French, SmPC in Dutch.

References:

1. Reblozyl® (luspatercept) [Summary of Product Characteristics (SmPC)]. Bristol Myers Squibb Pharma EEIG, Dublin, Ireland.
SmPC in English, SmPC in French, SmPC in Dutch.

2. Suragani RN, Cadena SM, Cawley SM, et al. Transforming growth factor-β superfamily ligand trap ACE-536 corrects anemia by promoting late-stage erythropoiesis. Nat Med. 2014;20(4):408-414.

3. Attie KM, Allison MJ, McClure T, et al. A phase 1 study of ACE-536, a regulator of erythroid differentiation, in healthy volunteers. Am J Hematol. 2014;89(7):766-770.

4. Institut national d'assurance maladie-invalidité (INAMI). https://ondpanon.riziv.fgov.be/SSPWebApplicationPublic/fr/Public/ProductSearch. Accessed December 2021.

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