ELIGIBLE PATIENTS

WHY IPSS-R

The IPSS-R provides a more accurate prognosis in terms of overall survival and evolution to acute myeloid leukemia compared with the IPSS.2

The IPSS-R accounts for:

  • 5 major prognostic categories, rather than 4 as in the IPSS2
  • Cytogenetic risk groups, marrow blast percentage, and depth of cytopenias (hemoglobin, platelet. and absolute neutrophil count levels)2

The International Prognosis Scoring System-Revised (IPSS-R) helps identify very low- to intermediate-risk patients who may be eligible for Reblozyl.1,2

IPSS-R SCORING SYSTEM
  Risk Score
Prognostic
variable
0.0 0.5 1.0 1.5 2.0 3.0 4.0
Cytogenetics Very good Good Intermediate Poor Very poor
Bone Marrow
blast %
≤2% >2-<5% 5-10% >10%
Hemoglobin, g/dL ≥10 8-<10 <8
Platelets x 109/L ≥100 50-<100 <50
Absolute
neutrophil
count x 109/L
≥0.8 <0.8
Overall
risk score
Very low Low Intermediate High Very high
≤1.5 >1.5-3 >3-4.5 >4.5-6 >6

May be eligible for Reblozyl

Why IPSS-R

The International Prognosis Scoring System-Revised (IPSS-R) helps identify very low- to intermediate-risk patients who may be eligible for Reblozyl.1,2

IPSS-R SCORING SYSTEM
  RISK SCORE
Prognostic
variable
0.0 0.5
Cytogenetics Very good
Bone Marrow
(BM) blast %
≤2%
Hemoglobin,
g/dL
≥10
Platelets
x 109/L
≥100 50-<100
Absolute
neutrophil
count (ANC)
x 109/L
≥0.8 <0.8
Prognostic
variable
1.0 1.5
Cytogenetics Good
BM blast % >2-<5%
Hemoglobin,
g/dL
8-<10 <8
Platelets
x 109/L
<50
ANC x 109/L
Prognostic
variable
2.0 3.0
Cytogenetics Intermediate Poor
BM blast % 5-10% >10%
Hemoglobin,
g/dL
Platelets
x 109/L
ANC x 109/L
Prognostic
variable
4.0
Cytogenetics Very poor
BM blast %
Hemoglobin,
g/dL
Platelets
x 109/L
ANC x 109/L
Overall risk score
Very low Low Intermediate
≤1.5 >1.5-3 >3-4.5
Overall risk score
High Very high
>4.5-6 >6

May be eligible for Reblozyl

About the IPSS-R

The IPSS-R accounts for:

  • 5 major prognostic categories, rather than 4 as in the IPSS2
  • Cytogenetic risk groups, marrow blast percentage, and depth of cytopenias (hemoglobin, platelet. and absolute neutrophil count levels)2

References:

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

2. Greenberg PL, Tuechler H, Schanz J, et al. Revised International Prognostic Scoring System for myelodysplastic syndromes. Blood. 2012;120(12):2454-2465.

3. Arber DA, Orazi A, Haserjan R, et al. The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood. 2016;127(20):2391-2405.

4. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Myelodysplastic Syndromes. NCCN Evidence BlocksTM. V2.2017. © National Comprehensive Cancer Network, Inc. 2016. All rights reserved. Accessed November 25, 2019.

5. Iron staining. In: Bone Marrow Aspiration: Normal Hematopoiesis and Basic Interpretive Procedures [online course]. LabCE. https://www.labce/spg448399_iron_staining_aspx.  Accessed November 19, 2019.

6. Sundberg RD, Broman H. The application of the Prussian blue stain to previously stained films of blood and bone marrow. Blood. 1955;10(2):160-166.

7. Almeida A, Fenaux P, List AF, Platzbecker U, Santini V. Recent advances in the treatment of lower-risk non-del(5q) myelodysplastic syndromes (MDS). Leuk Res. 2017;52:50-57.

8. Germing U, Oliva EN, Hiwase D, Almeida A. Treatment of anemia in transfusion-dependent and non-transfusion-dependent lower-risk MDS: current and emerging strategies. HemaSphere. 2019;3(6):1-9. doi:10.1097/HS9.0000000000000314.

9. Park S, Hamel J-F, Toma A, et al. Outcome of lower-risk patients with myelodysplastic syndromes without 5q deletion after failure of erythropoiesis-stimulating agents. J Clin Oncol. 2017;35(14):1591-1597.

10. Santini V. Treatment of low-risk myelodysplastic syndromes. Hematology Ann Soc Educ Program. 2016;2016(1):462-469.

11. Fenaux P, Santini V, Spiriti, MAA, et al. A phase 3 randomized, placebo-controlled study assessing the efficacy and safety of epoetin-α in anemic patients with low-risk MDS. Leukemia. 2018;32(12):2648-2658.

12. Howe RB, Porwit-MacDonald A, Wanat R, Tehranchi R, Hellström-Lindberg E. The WHO classification of MDS does make a difference. Blood. 2004;103(9):3265-3270.

13. Cheson B, Greenberg PL, Bennett JM, et al. Clinical application and proposal for modification of the International Working Group (IWG) response criteria in myelodysplasia. Blood. 2006;108(2):419-425.

14. Goldberg SL, Chen E, Corral M, et al. Incidence and clinical complications of myelodysplastic syndromes among United States Medicare beneficiaries. J Clin Oncol. 2010;28(17):2847-2852.

15. Malcovati L, Porta MG, Pascutto C, et al. Prognostic factors and life expectancy in myelodysplastic syndrome classified according to WHO criteria: a basis for clinical decision making. J Clin Oncol. 2005;23(30):7594-7603.

DETERMINING RS STATUS

Staining for RS and checking for SF3B1 mutations are needed to accurately classify MDS using WHO 2016 criteria.3
  • Staining for RS should be done routinely on initial evaluation4
  • RS are identified through Perls’ staining, which can be easily performed, even on samples that have been previously stored5,6  

Determining ring sideroblast (RS) status is essential for accurate classification of MDS subtypes and patient eligibility for Reblozyl

Using the WHO 2016 criteria, patients with RS can be identified if a bone marrow aspirate shows3:

≥15% RS

with or without a confirmed SF3B1 mutation

OR
≥5% RS

with a confirmed SF3B1 mutation

Determining RS status

Determining ring sideroblast (RS) status is essential for accurate classification of MDS subtypes and patient eligibility for Reblozyl

Using the WHO 2016 criteria, patients with RS can be identified if a bone marrow aspirate shows3:

≥15% RS

with or without a confirmed SF3B1 mutation

OR
≥5% RS

with a confirmed SF3B1 mutation

Staining for RS and checking for SF3B1 mutations

Staining for RS and checking for SF3B1 mutations are needed to accurately classify MDS using WHO 2016 criteria.3

  • Staining for RS should be done routinely on initial evaluation4
  • RS are identified through Perls’ staining, which can be easily performed, even on samples that have been previously stored5,6

References:

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

2. Greenberg PL, Tuechler H, Schanz J, et al. Revised International Prognostic Scoring System for myelodysplastic syndromes. Blood. 2012;120(12):2454-2465.

3. Arber DA, Orazi A, Haserjan R, et al. The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood. 2016;127(20):2391-2405.

4. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Myelodysplastic Syndromes. NCCN Evidence BlocksTM. V2.2017. © National Comprehensive Cancer Network, Inc. 2016. All rights reserved. Accessed November 25, 2019.

5. Iron staining. In: Bone Marrow Aspiration: Normal Hematopoiesis and Basic Interpretive Procedures [online course]. LabCE. https://www.labce/spg448399_iron_staining_aspx.  Accessed November 19, 2019.

6. Sundberg RD, Broman H. The application of the Prussian blue stain to previously stained films of blood and bone marrow. Blood. 1955;10(2):160-166.

7. Almeida A, Fenaux P, List AF, Platzbecker U, Santini V. Recent advances in the treatment of lower-risk non-del(5q) myelodysplastic syndromes (MDS). Leuk Res. 2017;52:50-57.

8. Germing U, Oliva EN, Hiwase D, Almeida A. Treatment of anemia in transfusion-dependent and non-transfusion-dependent lower-risk MDS: current and emerging strategies. HemaSphere. 2019;3(6):1-9. doi:10.1097/HS9.0000000000000314.

9. Park S, Hamel J-F, Toma A, et al. Outcome of lower-risk patients with myelodysplastic syndromes without 5q deletion after failure of erythropoiesis-stimulating agents. J Clin Oncol. 2017;35(14):1591-1597.

10. Santini V. Treatment of low-risk myelodysplastic syndromes. Hematology Ann Soc Educ Program. 2016;2016(1):462-469.

11. Fenaux P, Santini V, Spiriti, MAA, et al. A phase 3 randomized, placebo-controlled study assessing the efficacy and safety of epoetin-α in anemic patients with low-risk MDS. Leukemia. 2018;32(12):2648-2658.

12. Howe RB, Porwit-MacDonald A, Wanat R, Tehranchi R, Hellström-Lindberg E. The WHO classification of MDS does make a difference. Blood. 2004;103(9):3265-3270.

13. Cheson B, Greenberg PL, Bennett JM, et al. Clinical application and proposal for modification of the International Working Group (IWG) response criteria in myelodysplasia. Blood. 2006;108(2):419-425.

14. Goldberg SL, Chen E, Corral M, et al. Incidence and clinical complications of myelodysplastic syndromes among United States Medicare beneficiaries. J Clin Oncol. 2010;28(17):2847-2852.

15. Malcovati L, Porta MG, Pascutto C, et al. Prognostic factors and life expectancy in myelodysplastic syndrome classified according to WHO criteria: a basis for clinical decision making. J Clin Oncol. 2005;23(30):7594-7603.

ESA RESPONSE STATUS

There is an unmet clinical need for patients who have an unsatisfactory response to, or are ineligible for, an erythropoiesis-stimulating agent (ESA)7-8

Patients with elevated endogenous erythropoietin (EPO) levels who are RBC transfusion dependent are less likely to respond to ESAs.9-10

  • Selection criteria for ESAs include endogenous EPO levels of <500 mU/mL but, in an ESA registration trial, no patients with endogenous EPO levels of ≥200 mU/mL had a response8,10,11 

Primary ESA resistance is more frequent among patients with MDS-RS vs MDS without RS, while durable responses are less frequent9,12

  • According to IWG 2006 Criteria for Hematological Improvement, an adequate response includes a hemoglobin increase by at least 1.5 g/dL or a reduction in RBC transfusions by at least 4 transfusions in 8 weeks13
  • An effect must persist at least 8 weeks to be considered a response13
Many Patients With MDS Are Unresponsive To, Or Lose Response To ESAs
PAY CLOSE ATTENTION TO ESA RESPONSE
IN PATIENTS WITH MDS
  • ESAs are used widely and are most effective in patients with low RBC transfusion requirements, a low serum EPO level, and lower-risk MDS per the IPSS-R9,10 
  • Many patients are unresponsive to, or lose response to, ESAs9
  • Once ESAs fail, many patients rely on RBC transfusions, which are associated with reduced overall survival and burdensome complications7,9,14,15
  • Patients, therefore, need an effective treatment option that could reduce dependence on RBC transfusions10

ESA response status

There is an unmet clinical need for patients who have an unsatisfactory response to or are ineligible for erythropoiesis-stimulating agents” (ESAs)7-8

Many Patients With MDS Are Unresponsive To, Or Lose Response To ESAs
  • Patients with elevated endogenous erythropoietin (EPO) levels who are RBC transfusion dependent are less likely to respond to ESAs.9-10
    • Selection criteria for ESAs include endogenous EPO levels of <500 mU/mL but, in an ESA registration trial, no patients with endogenous EPO levels of ≥200 mU/mL had a response8,10,11
  • Primary ESA resistance is more frequent among patients with MDS-RS vs MDS without RS, while durable responses are less frequent9,12
    • According to IWG 2006 Criteria for Hematological Improvement, an adequate response includes a hemoglobin increase by at least 1.5 g/dL or a reduction in RBC transfusions by at least 4 transfusions in 8 weeks13
    • An effect must persist at least 8 weeks to be considered a response13

PAY CLOSE ATTENTION TO ESA RESPONSE IN PATIENTS WITH MDS

  • ESAs are used widely and are most effective in patients with low RBC transfusion requirements, a low serum EPO level, and lower-risk MDS per the IPSS-R9,10 
  • Many patients are unresponsive to, or lose response to, ESAs9
  • Once ESAs fail, many patients rely on RBC transfusions, which are associated with reduced overall survival and burdensome complications7,9,14,15
  • Patients, therefore, need an effective treatment option that reduces dependence on RBC transfusions10

References:

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

2. Greenberg PL, Tuechler H, Schanz J, et al. Revised International Prognostic Scoring System for myelodysplastic syndromes. Blood. 2012;120(12):2454-2465.

3. Arber DA, Orazi A, Haserjan R, et al. The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood. 2016;127(20):2391-2405.

4. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Myelodysplastic Syndromes. NCCN Evidence BlocksTM. V2.2017. © National Comprehensive Cancer Network, Inc. 2016. All rights reserved. Accessed November 25, 2019.

5. Iron staining. In: Bone Marrow Aspiration: Normal Hematopoiesis and Basic Interpretive Procedures [online course]. LabCE. https://www.labce/spg448399_iron_staining_aspx.  Accessed November 19, 2019.

6. Sundberg RD, Broman H. The application of the Prussian blue stain to previously stained films of blood and bone marrow. Blood. 1955;10(2):160-166.

7. Almeida A, Fenaux P, List AF, Platzbecker U, Santini V. Recent advances in the treatment of lower-risk non-del(5q) myelodysplastic syndromes (MDS). Leuk Res. 2017;52:50-57.

8. Germing U, Oliva EN, Hiwase D, Almeida A. Treatment of anemia in transfusion-dependent and non-transfusion-dependent lower-risk MDS: current and emerging strategies. HemaSphere. 2019;3(6):1-9. doi:10.1097/HS9.0000000000000314.

9. Park S, Hamel J-F, Toma A, et al. Outcome of lower-risk patients with myelodysplastic syndromes without 5q deletion after failure of erythropoiesis-stimulating agents. J Clin Oncol. 2017;35(14):1591-1597.

10. Santini V. Treatment of low-risk myelodysplastic syndromes. Hematology Ann Soc Educ Program. 2016;2016(1):462-469.

11. Fenaux P, Santini V, Spiriti, MAA, et al. A phase 3 randomized, placebo-controlled study assessing the efficacy and safety of epoetin-α in anemic patients with low-risk MDS. Leukemia. 2018;32(12):2648-2658.

12. Howe RB, Porwit-MacDonald A, Wanat R, Tehranchi R, Hellström-Lindberg E. The WHO classification of MDS does make a difference. Blood. 2004;103(9):3265-3270.

13. Cheson B, Greenberg PL, Bennett JM, et al. Clinical application and proposal for modification of the International Working Group (IWG) response criteria in myelodysplasia. Blood. 2006;108(2):419-425.

14. Goldberg SL, Chen E, Corral M, et al. Incidence and clinical complications of myelodysplastic syndromes among United States Medicare beneficiaries. J Clin Oncol. 2010;28(17):2847-2852.

15. Malcovati L, Porta MG, Pascutto C, et al. Prognostic factors and life expectancy in myelodysplastic syndrome classified according to WHO criteria: a basis for clinical decision making. J Clin Oncol. 2005;23(30):7594-7603.

CONTRAINDICATIONS
OF REBLOZYL

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. 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. If a patient becomes pregnant, Reblozyl should be discontinued.

Contraindications1

Contraindication Of Reblozyl In MDS Is Pregnancy

Pregnancy

Contraindication Of Reblozyl In MDS Is Hypersensitivity To The Active Substance Or Any Of The Excipients

Hypersensitivity

to the active substance or to any of the excipients

Contraindications

Contraindications of Reblozyl1

Contraindication Of Reblozyl In MDS Is Pregnancy

Pregnancy

Contraindication Of Reblozyl In MDS Is Hypersensitivity To The Active Substance Or Any Of The Excipients

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 is no data from the use of Reblozyl in pregnant women. Studies in animals have shown reproductive toxicity. 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. If a patient becomes pregnant, Reblozyl should be discontinued.1

References:

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

2. Greenberg PL, Tuechler H, Schanz J, et al. Revised International Prognostic Scoring System for myelodysplastic syndromes. Blood. 2012;120(12):2454-2465.

3. Arber DA, Orazi A, Haserjan R, et al. The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood. 2016;127(20):2391-2405.

4. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Myelodysplastic Syndromes. NCCN Evidence BlocksTM. V2.2017. © National Comprehensive Cancer Network, Inc. 2016. All rights reserved. Accessed November 25, 2019.

5. Iron staining. In: Bone Marrow Aspiration: Normal Hematopoiesis and Basic Interpretive Procedures [online course]. LabCE. https://www.labce/spg448399_iron_staining_aspx.  Accessed November 19, 2019.

6. Sundberg RD, Broman H. The application of the Prussian blue stain to previously stained films of blood and bone marrow. Blood. 1955;10(2):160-166.

7. Almeida A, Fenaux P, List AF, Platzbecker U, Santini V. Recent advances in the treatment of lower-risk non-del(5q) myelodysplastic syndromes (MDS). Leuk Res. 2017;52:50-57.

8. Germing U, Oliva EN, Hiwase D, Almeida A. Treatment of anemia in transfusion-dependent and non-transfusion-dependent lower-risk MDS: current and emerging strategies. HemaSphere. 2019;3(6):1-9. doi:10.1097/HS9.0000000000000314.

9. Park S, Hamel J-F, Toma A, et al. Outcome of lower-risk patients with myelodysplastic syndromes without 5q deletion after failure of erythropoiesis-stimulating agents. J Clin Oncol. 2017;35(14):1591-1597.

10. Santini V. Treatment of low-risk myelodysplastic syndromes. Hematology Ann Soc Educ Program. 2016;2016(1):462-469.

11. Fenaux P, Santini V, Spiriti, MAA, et al. A phase 3 randomized, placebo-controlled study assessing the efficacy and safety of epoetin-α in anemic patients with low-risk MDS. Leukemia. 2018;32(12):2648-2658.

12. Howe RB, Porwit-MacDonald A, Wanat R, Tehranchi R, Hellström-Lindberg E. The WHO classification of MDS does make a difference. Blood. 2004;103(9):3265-3270.

13. Cheson B, Greenberg PL, Bennett JM, et al. Clinical application and proposal for modification of the International Working Group (IWG) response criteria in myelodysplasia. Blood. 2006;108(2):419-425.

14. Goldberg SL, Chen E, Corral M, et al. Incidence and clinical complications of myelodysplastic syndromes among United States Medicare beneficiaries. J Clin Oncol. 2010;28(17):2847-2852.

15. Malcovati L, Porta MG, Pascutto C, et al. Prognostic factors and life expectancy in myelodysplastic syndrome classified according to WHO criteria: a basis for clinical decision making. J Clin Oncol. 2005;23(30):7594-7603.

Special warnings and 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 Reblozyl1

The Occurrence Of Thromboembolic Events Was Not Correlated With Elevated Hemoglobin Levels In Reblozyl

Thromboembolic events

The occurrence of TEE was not correlated with elevated hemoglobin levels1

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

The Occurrence Of Thromboembolic Events Was Not Correlated With Elevated Hemoglobin Levels In Reblozyl

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

References:

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

2. Greenberg PL, Tuechler H, Schanz J, et al. Revised International Prognostic Scoring System for myelodysplastic syndromes. Blood. 2012;120(12):2454-2465.

3. Arber DA, Orazi A, Haserjan R, et al. The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood. 2016;127(20):2391-2405.

4. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Myelodysplastic Syndromes. NCCN Evidence BlocksTM. V2.2017. © National Comprehensive Cancer Network, Inc. 2016. All rights reserved. Accessed November 25, 2019.

5. Iron staining. In: Bone Marrow Aspiration: Normal Hematopoiesis and Basic Interpretive Procedures [online course]. LabCE. https://www.labce/spg448399_iron_staining_aspx.  Accessed November 19, 2019.

6. Sundberg RD, Broman H. The application of the Prussian blue stain to previously stained films of blood and bone marrow. Blood. 1955;10(2):160-166.

7. Almeida A, Fenaux P, List AF, Platzbecker U, Santini V. Recent advances in the treatment of lower-risk non-del(5q) myelodysplastic syndromes (MDS). Leuk Res. 2017;52:50-57.

8. Germing U, Oliva EN, Hiwase D, Almeida A. Treatment of anemia in transfusion-dependent and non-transfusion-dependent lower-risk MDS: current and emerging strategies. HemaSphere. 2019;3(6):1-9. doi:10.1097/HS9.0000000000000314.

9. Park S, Hamel J-F, Toma A, et al. Outcome of lower-risk patients with myelodysplastic syndromes without 5q deletion after failure of erythropoiesis-stimulating agents. J Clin Oncol. 2017;35(14):1591-1597.

10. Santini V. Treatment of low-risk myelodysplastic syndromes. Hematology Ann Soc Educ Program. 2016;2016(1):462-469.

11. Fenaux P, Santini V, Spiriti, MAA, et al. A phase 3 randomized, placebo-controlled study assessing the efficacy and safety of epoetin-α in anemic patients with low-risk MDS. Leukemia. 2018;32(12):2648-2658.

12. Howe RB, Porwit-MacDonald A, Wanat R, Tehranchi R, Hellström-Lindberg E. The WHO classification of MDS does make a difference. Blood. 2004;103(9):3265-3270.

13. Cheson B, Greenberg PL, Bennett JM, et al. Clinical application and proposal for modification of the International Working Group (IWG) response criteria in myelodysplasia. Blood. 2006;108(2):419-425.

14. Goldberg SL, Chen E, Corral M, et al. Incidence and clinical complications of myelodysplastic syndromes among United States Medicare beneficiaries. J Clin Oncol. 2010;28(17):2847-2852.

15. Malcovati L, Porta MG, Pascutto C, et al. Prognostic factors and life expectancy in myelodysplastic syndrome classified according to WHO criteria: a basis for clinical decision making. J Clin Oncol. 2005;23(30):7594-7603.

 

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.
I am a European Healthcare Professional (UK excluded)
I am NOT a European Healthcare Professional
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.