Your blood carries oxygen to all of the cells in your body. When there are problems with red blood cells, you can feel weak and tired and may have to take medicines or receive blood transfusions to manage this.
Reblozyl (REB-low-zil) was approved in 2019 and is the first erythroid maturation agent (EMA) that helps to mature red blood cells in people with anemia (low red blood cells) caused by certain blood disorders.
How Does It Work?
Reblozyl is used to treat anemia in adults with the following:
- People with beta-thalassemia who need regular blood transfusions
- People with myelodysplastic syndromes (MDS), also known as bone marrow failure, who may need regular blood transfusions and have never received a medicine called erythropoiesis-stimulating agent (ESA)
- People with specific types of MDS who need blood transfusions and have used an ESA medicine that has not worked for them
Beta-thalassemia is a condition where your body does not make enough hemoglobin, a protein that your blood cells use to carry oxygen. This can make it more difficult for oxygen to get delivered to your body.
Myelodysplastic syndromes (MDS) are a type of cancer where your bone marrow does not make enough healthy blood cells. It can happen if there is a mutation in your DNA, which can change the way your cells grow and function. The bone marrow makes blood cells for your body including red blood cells, which carry oxygen, white blood cells, which fight infections, and platelets, which help your blood to clot. An erythropoiesis-stimulating agent (ESA) is a medicine that tells your body to make more red blood cells.
Beta-thalassemia and MDS can cause anemia. Reblozyl is approved to treat anemia if you have either of these conditions. Reblozyl increases the number of red blood cells by allowing immature red blood cells to mature. This allows the quality of red blood cells to improve and increases the amount of hemoglobin in the blood, allowing your blood to carry more oxygen. Because of this, Reblozyl may help lower the amount of blood transfusions you may need. Reblozyl is not a substitute for blood transfusions.
How Do I Receive It?
Reblozyl is given by a health care provider as an injection once every 3 weeks in your upper arm, thigh, or stomach. It is given at your health care provider’s office. If you miss your dose of Reblozyl, call your health care provider right away. Try to keep all appointments with your health care provider to receive Reblozyl. It may be helpful to write down your symptoms in a notebook or on your phone so that you and your health care provider can discuss how Reblozyl is working for you. The amount of Reblozyl you receive will depend on how much you weigh and how you respond to the medicine.
How Was It Studied?
One study was conducted in people with beta-thalassemia that required regular blood transfusions. People received either Reblozyl or a placebo containing no medicine. The study looked to see the percentage of people who had a reduction in the number of blood transfusions they needed (by 33% or more) plus a reduction in the amount of blood needed for the transfusion from week 13 through week 24. The median age in the study was 30 years old and included White people (54.2%), Asian people (34.8%), Black people (0.3%), and those classified as “Other,” (7.7%) including those classified as Hispanic or Latino (2.1%).
Two studies were conducted on people with MDS. The first study looked at people with anemia due to MDS who had never received an erythropoiesis-stimulating agent (ESA) and were receiving blood transfusions. People received either Reblozyl or epoetin alfa, which is an ESA. The study looked to see the percentage of people who did not need blood transfusions for at least 12 weeks and had an increase in hemoglobin by 1.5 g/dL. The median age in the study was 74 and included White people (79%), Asian people (12%), Black people (1%), and those classified as “Unknown,” (8%) including those classified as Hispanic or Latino (6%).
The second study looked at people with anemia and MDS where an ESA medicine was not effective and were receiving regular blood transfusions. People received either Reblozyl or a placebo. The study looked at the percentage of people who did not need blood transfusions for 8 weeks or longer. The median age in the study was 71 and included White people (69%), Black people (0.4%), and those classified as “Other,” (0.9%) including those classified as Hispanic or Latino (3.1%).
What Benefits Were Seen?
Beta-thalassemia. People in the Reblozyl group had a greater percentage of people (21.4%) who needed fewer blood transfusions and a lower amount of blood needed during those transfusions compared to placebo (4.5%).
Myelodysplastic syndromes. In people who had never received an ESA, Reblozyl had a greater percentage of people (59%) who did not need a blood transfusion and had an increase in hemoglobin compared to epoetin alfa (31%).
In people who had received ESA in the past and had used an ESA medicine that was not effective, more people in the Reblozyl group (38%) did not need a blood transfusion for 8 weeks compared to placebo (13%).
These three clinical studies showed that Reblozyl lowered the severity of anemia and the number of blood transfusions needed in people with beta-thalassemia or MDS.
How Long Does It Take to Work?
Reblozyl may take a few weeks to work to lower your need to have blood transfusions due to your anemia. Your health care provider will monitor you while you are receiving Reblozyl. Your health care provider may adjust your dose or stop treatment with Reblozyl depending on how you respond to the medicine.
What Are the Side Effects and How Can I Manage Them?
The most common side effects seen with Reblozyl are:
- Tiredness
- Headache
- Muscle or joint pain
- Dizziness/feeling off-balance
- Nausea
- Diarrhea
- Cough
- Stomach pain
- Shortness of breath
- COVID-19 infection
- Fluid retention
- High blood pressure
- Allergic reaction
Receiving Reblozyl can cause tiredness, dizziness, or cause you to feel off-balance. It is important not to drive or operate heavy machinery until you know how Reblozyl affects you.
Headaches as well as muscle or joint pain can happen while taking Reblozyl. Taking over-the-counter medicines such as Tylenol or ibuprofen can help. Call your health care provider if these symptoms do not go away or get worse.
Reblozyl can cause nausea, diarrhea, and stomach pain. Eating smaller, more frequent meals may help alongside eating bland foods such as bread, plain crackers, and rice. It is also important to stay hydrated and to drink plenty of water. Your health care provider may tell you to keep certain over-the-counter medicines on hand in case of these side effects. Call your health care provider if your symptoms do not improve or get worse.
You can develop a cough from receiving Reblozyl. Call your health care provider if this becomes bothersome.
Receiving Reblozyl can cause an allergic reaction and shortness of breath. Talk to your health care provider about the symptoms of an allergic reaction. Your health care provider may monitor you immediately after receiving Reblozyl. Call your health care provider right away or go to the nearest emergency room if you have symptoms of an allergic reaction.
Reblozyl can increase your risk of developing COVID-19. These symptoms may include fever, cough, chills, and body aches. If you test positive for COVID-19, call your health care provider. Make sure you isolate yourself from others and wear a mask when out in public to prevent spreading the infections to others.
Reblozyl can cause your body to hold fluid, which can lead to swelling. Call your health care provider if you experience this. Your health care provider may give you medicine to help with this.
Reblozyl can also cause high blood pressure. There are techniques that you can implement to help control your blood pressure. This includes exercising regularly and following the DASH diet, which includes fruits, vegetables, and low-fat or nonfat dairy products. It also limits alcohol, smoking, trans and saturated fats, and sodium. Call your health care provider if you notice your blood pressure increasing and go to the emergency room if the top number (systolic) of your blood pressure is over 180 or if the bottom number (diastolic) of your blood pressure is over 120.
What Types of Drug Interactions Can Happen?
Taking hormone replacement therapy, which can be used for menopause, or birth control with Reblozyl can increase your risk of developing blood clots. Tell your health care provider about all the medicines you are taking including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Is There a Cost-Savings Program?
The manufacturer has a program that can provide information about financial support options for Reblozyl. If you have beta-thalassemia, you can find out more at www.reblozyl.com/beta-thalassemia/resources/financial-assistance. If you have MDS, you can find out more at www.reblozyl.com/mds/resources/financial-assistance. You can also call 800-861-0048.