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
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 Reblozyl3
Determining RS status
Determining ring sideroblast (RS) status is essential for accurate classification of MDS subtypes and patient eligibility for Reblozyl3
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
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
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
- 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
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
Pregnancy
Hypersensitivity
to the active substance or to any of the excipients
Please consult the full EU Summary of Product Characteristics (EU SmPC) and the EU Abbreviated Prescribing Information before prescribing
Contraindications
Contraindications of Reblozyl1
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 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
Please consult the full EU Summary of Product Characteristics (EU SmPC) and the EU Abbreviated Prescribing Information before prescribing
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
Traceability
Record the name and batch number of Reblozyl1
Thromboembolic events
The occurrence of TEE was not correlated with elevated hemoglobin levels1
Increased blood pressure
Monitor blood pressure prior to administering Reblozyl1
Sodium content
Reblozyl is essentially “sodium-free”1
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 (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
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