INDICATIONS (1 of 2)
REBLOZYL® (luspatercept-aamt) is a prescription medicine used to treat anemia (low red blood cells) in adults with myelodysplastic syndromes with ring sideroblasts (MDS-RS) or myelodysplastic/myeloproliferative neoplasms with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T) who need regular RBC transfusions and have not responded well to or cannot receive an erythropoiesis stimulating agent (ESA).
REBLOZYL is not for use as a substitute for RBC transfusions in people who need immediate treatment for anemia.
It is not known if REBLOZYL is safe or effective in children under 18 years of age.
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What are the possible benefits of REBLOZYL?
What are the possible benefits of REBLOZYL?
Starting a medicine is a lot to take in. Knowing how REBLOZYL has impacted other people can help you understand what to expect from treatment.
A clinical study was done to determine the safety and effectiveness of REBLOZYL
The main goal of the study was to stop the need for red blood cell (RBC) transfusions
for at least 8 weeks during the first 24 weeks of treatment.
People in both treatment groups were allowed to receive best supportive care. This included RBC transfusions, as needed.
REBLOZYL helped patients lower their need for RBC transfusions
Percentage of people who had
no rbc transfusions for at least 8 weeks
during the first 24 weeks of treatment
REBLOZYL was studied in:
229 people with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) and MDS/MPN-RS-T
To be in the study, people needed to receive 2 or more RBC transfusions every 8 weeks. They also needed to either:
- Have a poor response to an erythropoiesis-stimulating agent (ESA) treatment
- Be unlikely to respond to an ESA
- This was defined as having serum erythropoietin levels greater
than 200 U/L and not having received an ESA previously
- This was defined as having serum
- Or not be able to handle side effects of an ESA treatment
Patients could not be a part of the study if they had:
- Specific mutations in their DNA (deletion 5q)
- Other blood count disorders
- Ever used a disease-modifying agent for the treatment of
myelodysplastic syndromes (MDS)
Why it’s important to track your transfusions
While on REBLOZYL, you may get to the point where you no longer need transfusions. However, the results can be different depending on the person. This is why it’s so important to talk about your treatment goals with your healthcare team. Together, you can make sure you’re tracking toward the same expectation.
What are the possible side effects of REBLOZYL?
It’s important to know about the possible side effects of REBLOZYL before beginning treatment. Remember: people may react to medicines differently, and that’s expected.
The possible side effects of REBLOZYL are well-known. Be sure to talk with your healthcare team about what to expect when starting treatment with REBLOZYL.
What are the serious side effects of REBLOZYL?
Serious side effect
Serious side effect
A serious side effect is a side effect that can sometimes become life-threatening and can lead to death. They may happen any time during treatment or even after your treatment has ended. You may experience more than one side effect at the same time.
Blood clots (thrombosis/
thromboembolism)
Blood clots (thrombosis/thromboembolism)
Blood clots in the arteries, veins, brain, and lungs have happened in people with beta thalassemia during treatment with REBLOZYL. The risk of blood clots may be higher in people who have had their spleen removed or who take hormone replacement therapy or birth control pills.
Call your healthcare provider or get medical help right away if you have any of these symptoms:
- Chest pain
- Trouble breathing or shortness of breath
- Pain in your leg, with or without swelling
- A cold or pale arm or leg
- Sudden numbness or weakness that is short-term or continues to happen over a long period of time, especially on one side of the body
- Severe headache or confusion
- Sudden trouble with seeing, speaking, balancing, walking, or dizziness
High blood pressure (hypertension)
High blood pressure (hypertension)
REBLOZYL may cause an increase in your blood pressure. Your healthcare provider will check your blood pressure before you receive your REBLOZYL dose. Your healthcare provider may prescribe you medicine to treat high blood pressure or increase the dose of medicine you already take to treat high blood pressure, if you develop high blood pressure during treatment with REBLOZYL.