REBLOZYL® (luspatercept-aamt) logo
Now approved for earlier treatment of MDS-related anemia badge

INDICATIONS (1 of 3)

REBLOZYL® (luspatercept-aamt) is a prescription medicine used to treat anemia (low red blood cells) without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions.

It is not known if REBLOZYL is safe or effective in children under 18 years of age.

Now approved for earlier treatment of MDS-related anemia badge

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Hypothetical patient with anemia in myelodysplastic syndromes with ring sideroblasts (MDS-RS)
Hypothetical patient with anemia in myelodysplastic syndromes with ring sideroblasts (MDS-RS)

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

153 patients received 1 REBLOZYL injection every 3 weeks; 58 of them achieved the main goal of the study

76 patients received 1 placebo injection every 3 weeks; 10 of them achieved the main goal of the study

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
  • Or not be able to handle side effects of an ESA treatment

Patients could not be a part of the study if they had:

Hypothetical patient with anemia in myelodysplastic syndromes with ring sideroblasts (MDS-RS)
Hypothetical patient with anemia in myelodysplastic syndromes with ring sideroblasts (MDS-RS)

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 problems with vision, speech, or balance (such as trouble speaking, difficulty 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.

What are the most common side effects of REBLOZYL?

Most common side effects

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:

  • tiredness
  • headache
  • back, joint, muscle, or bone pain
  • joint pain
  • dizziness
  • nausea
  • diarrhea
  • cough
  • stomach (abdominal) pain
  • trouble breathing
  • swelling of your hands, legs, or feet
  • high blood pressure
  • allergic reactions

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 FDA at 1-800-FDA-1088.

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 FDA at 1-800-FDA-1088.

Stay connected to the
support you need

Your REBLOZYL Connection is an educational program designed to help you understand your treatment with REBLOZYL, and provide resources that allow you to be more active role with your care.