ELIGIBLE PATIENTS

Eligibility

Consider Reblozyl for adult patients with transfusion-dependent anemia associated with β-thalassemia1

Is Reblozyl right for your patients with β-thalassemia?

Please consult the full EU Summary of Product Characteristics (EU SmPC) and the EU Abbreviated Prescribing Information (EU API) before prescribing.

β-thalassemia patients who meet the following criteria
may be candidates for Reblozyl1

are ≥18 years of age

any genotype, including β0β0

RBC transfusion dependence (with or without iron chelation therapy)

Eligible Patients

Consider Reblozyl for adult patients with transfusion-dependent anemia associated with β-thalassemia1

Is Reblozyl right for your patients with β-thalassemia?

β-thalassemia patients who meet the following criteria may be candidates for Reblozyl1

are ≥18 years of age

any genotype, including β0β0

RBC transfusion dependence

(with or without iron chelation therapy)

Reference:  

1. Reblozyl® (luspatercept) Summary of Product Characteristics (SmPC). Celgene 2020.

CONTRAINDICATIONS

Pregnancy

Treatment with Reblozyl should not be started if the woman is pregnant. There are no data from the use of Reblozyl in pregnant women. Studies in animals have shown reproductive toxicity. Reblozyl is contraindicated during pregnancy. If a patient becomes pregnant, Reblozyl should be discontinued.

Women of childbearing potential should use effective contraception during treatment with Reblozyl and for at least 3 months after the last dose. Prior to starting treatment with Reblozyl, a pregnancy test should be performed for women of childbearing age.

Contraindications of Reblozyl1

Contraindication Of Reblozyl In MDS Is Pregnancy

Pregnancy

Hypersensitivity

to the active substance or to any of the excipients

Contraindications

Contraindications of Reblozyl1

Contraindication Of Reblozyl In MDS Is Pregnancy

Pregnancy

Hypersensitivity

to the active substance or to any of the excipients

Pregnancy
Treatment with Reblozyl should not be started if the woman is pregnant. There are no data from the use of Reblozyl in pregnant women. Women of childbearing potential should use effective contraception during treatment with Reblozyl and for at least 3 months after the last dose. Prior to starting treatment with Reblozyl, a pregnancy test should be performed for women of childbearing potential. Reblozyl is contraindicated during pregnancy. If a patient becomes pregnant, Reblozyl should be discontinued.1

Reference:  

1. Reblozyl® (luspatercept) Summary of Product Characteristics (SmPC). Celgene 2020.

Special warnings & precautions

Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.1

Thromboembolic events
In patients with β-thalassemia, thromboembolic events (TEEs) were reported in 3.6% (8/223) of patients treated with Reblozyl in a controlled clinical study. Reported TEEs included deep vein thrombosis, portal vein thrombosis, pulmonary emboli, and ischemic stroke. All patients with TEEs were splenectomized and had at least one other risk factor for developing TEE (eg, history of thrombocytosis or concomitant use of hormone replacement therapy). The occurrence of TEE was not correlated with elevated hemoglobin (Hb) levels. The potential benefit of treatment with Reblozyl in β-thalassemia should be weighed against the potential risk of TEEs in patients with a splenectomy and other risk factors for developing TEE. Thromboprophylaxis according to current clinical guidelines should be considered in patients with β-thalassemia at higher risk.1

Increased blood pressure
In controlled clinical studies in MDS and β-thalassemia, patients treated with Reblozyl had an average increase in systolic and diastolic blood pressure of 5 mm Hg from baseline not observed in patients receiving placebo. Blood pressure should be monitored prior to each Reblozyl administration. In the case of persistent hypertension or exacerbations of pre-existing hypertension, patients should be treated for hypertension as per current clinical guidelines.1

Sodium content
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say it is essentially “sodium-free.”1

To Improve The Traceability of Biological Medicinal Products, Record the Name and Batch Number of Reblozyl

Traceability

Record the name and batch number of Reblozyl in the patient’s file1

Thromboembolic events (TEEs)

The potential benefit of treatment with Reblozyl should be weighed against the potential risk of TEEs in β-thalassemia patients with a splenectomy and other risk factors for developing TEE1

Monitor Blood Pressure Prior To Administering Reblozyl

Increased blood pressure

Monitor blood pressure prior to administering Reblozyl1

Reblozyl Is Essentially “Sodium-Free”

Sodium content

Reblozyl is essentially “sodium-free”1

Special warnings & precautions

To Improve The Traceability of Biological Medicinal Products, Record the Name and Batch Number of Reblozyl

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.1

Thromboembolic events

In patients with β-thalassemia, thromboembolic events (TEEs) were reported in 3.6% (8/223) of patients treated with Reblozyl in a controlled clinical study. Reported TEEs included deep vein thrombosis, portal vein thrombosis, pulmonary emboli, and ischemic stroke. All patients with TEEs were splenectomized and had at least one other risk factor for developing TEE (e.g. history of thrombocytosis or concomitant use of hormone replacement therapy). The occurrence of TEE was not correlated with elevated hemoglobin (Hb) levels. The potential benefit of treatment with Reblozyl in β-thalassemia should be weighed against the potential risk of TEEs in patients with a splenectomy and other risk factors for developing TEE. Thromboprophylaxis according to current clinical guidelines should be considered in patients with β-thalassemia at higher risk.1

Monitor Blood Pressure Prior To Administering Reblozyl

Increased blood pressure

In controlled clinical studies in MDS and β-thalassemia, patients treated with Reblozyl had an average increase in systolic and diastolic blood pressure of 5 mm Hg from baseline not observed in patients receiving placebo. Blood pressure should be monitored prior to each Reblozyl administration. In the case of persistent hypertension or exacerbations of pre-existing hypertension, patients should be treated for hypertension as per current clinical guidelines.1

Reblozyl Is Essentially “Sodium-Free”

Sodium content

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say it is essentially “sodium-free.”1

Reference:  

1. Reblozyl® (luspatercept) Summary of Product Characteristics (SmPC). Celgene 2020.

 

This site is not intended for US or UK healthcare professionals.

The product has received European Medicines Agency approval. The registration status and approved product labels of Reblozyl may vary from country to country. The information on this website is not country-specific and may not be applicable to your country. For more information, please refer to your local Prescribing Information.
IMPORTANT: The information on this website is based on the European Summary of Product Characteristics (EU SmPC).
This site is not intended for US or UK healthcare professionals. View the US site.
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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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
EU Summary of Product Characteristics.