First-line treatment results for REBLOZYL
In a clinical study that compared REBLOZYL and epoetin alfa, an erythropoiesis-stimulating agent (ESA), REBLOZYL worked better for more people than epoetin alfa did. In this study, 356 people with very low- to intermediate-risk MDS who had not been treated with an ESA and required regular red blood cell (RBC) transfusions were randomized to receive REBLOZYL (178) or epoetin alfa (178). People received 1 REBLOZYL injection every 3 weeks or 1 injection of an ESA every week over 24 weeks. Dose increases and best supportive care that included RBC transfusions were allowed.
With REBLOZYL NEARLY 2X AS MANY PEOPLE RESPONDED compared to an ESA
Another goal of the study was to see how well REBLOZYL and epoetin alfa could eliminate the need for RBC transfusions for at least 12 weeks.
With REBLOZYL 2/3 OF PEOPLE HAD NO RBC TRANSFUSIONS for at least 12 weeks
This clinical study set out to determine how likely it was for participants to be transfusion-free for at least 12 weeks. This study didn’t set out to compare the most common length of time of transfusion independence.
These were not the only goals and evaluations of the study.
To be included in the study, people needed to:
People could not be a part of the study if they had:
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-studied. 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
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 (sometimes called thrombosis or 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 hormonereplacement therapy or birth control pills.
Call your healthcare provider or get medical help right away if you have any of these symptoms:
High blood pressure (sometimes called 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.
What are the most common side effects of REBLOZYL?
The most common side effects are the side effects that were the most frequently reported by patients in the study. You may experience more than one side effect at the same time.
The most common side effects of REBLOZYL include:
These are not all of the possible side effects. For more information about side effects, please see the REBLOZYL Patient Information.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.