REBLOZYL® (luspatercept-aamt) logo

A clinical study was done to determine the safety
and effectiveness of REBLOZYL

The main goal of the study was to see if REBLOZYL could lower the number of transfusions needed by at least one-third during a set 12-week period compared to placebo.* People in both treatment groups were allowed to receive best supportive care. This included red blood cell (RBC) transfusions, iron-chelating agents, use of antibiotic, antiviral and antifungal therapy or nutritional support, as needed.

*Set 12-week period was weeks 13–24.

IV for blood transfusion
IV for blood transfusion

Percentage of people who

reduced the need For Transfusions by at least a third

over 12 weeks of treatment

Infographic: REBLOZYL® (luspatercept-aamt) clinical study
Infographic: REBLOZYL® (luspatercept-aamt) clinical study

which means that

4x greater percentage of patients receiving REBLOZYL reduced their transfusion burden vs placebo

REBLOZYL may mean fewer transfusions for you

While on REBLOZYL, you may lower the number of transfusions needed, which can look different from person to 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.

Example patient: What this might look like

Icon: 6 IV's for blood transfusion

For example, if a patient needed 6 RBC units every 12 weeks before starting REBLOZYL…

Icon: 4 IV's for blood transfusion

…this patient may only need 4 (or less) RBC units during weeks 13 to 24 after starting REBLOZYL

REBLOZYL was studied in:

Infographic: REBLOZYL® (luspatercept-aamt) clinical study
Infographic: REBLOZYL® (luspatercept-aamt) clinical study

Everyone in the study regularly received 6 to 20 units of packed RBCs and had not been transfusion-free for more than 35 days within 24 weeks before the study started

Patients could not be a part of the study if they were under 18 or 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-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

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 in the arteries, veins, brain, and lungs have happened in people with BT 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)

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.

Extramedullary Hematopoietic (EMH) Masses 

EMH masses have happened in people with beta thalassemia during treatment with REBLOZYL. You may have a higher risk for developing EMH masses if you have a history of EMH masses, have had your spleen removed, have or have had enlarged spleen or liver, or have low hemoglobin levels. Your healthcare provider will monitor you before you start and during treatment with REBLOZYL. Call your healthcare provider or get medical help right away if you get any of these symptoms:

  • Severe pain in the back
  • Numbness or weakness or loss of voluntary movement in feet, legs, hands or arms
  • Loss of bowel and bladder control

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.