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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)

MDS and anemia:
How they work and what you can do

Learning about the relationship between myelodysplastic syndromes (MDS) (my-el-odys-plastic sin-dromes) and anemia may help you better understand your disease.

What is MDS?

MDS is a group of disorders in which the bone marrow fails to make enough healthy red blood cells (RBCs), white blood cells (WBCs), or platelets (PLTs). MDS is considered a blood cancer. Bone marrow is the soft tissue found in the center of most bones and is the main place where blood cells are made.

What causes MDS?

MDS may be caused by changes to DNA called mutations. These mutations change the way the cells grow and function. With MDS, newly formed blood cells become abnormal and do not grow (mature) correctly. These abnormal blood cells do not enter your bloodstream to do their jobs. They pile up in the bone marrow instead.

Mature red blood cell

Mature
Red Blood Cell (RBC)

Abnormal red blood cell

Abnormal
RBC

Bone marrow

Bone Marrow

The abnormal blood cells take space your bone marrow needs to function normally. This can lead to your body making too few mature blood cells.

The pile-up in the bone marrow keeps immature RBCs from growing into mature RBCs. With fewer mature blood cells in your body, you can develop anemia (low RBCs). You can also develop other low blood counts (cytopenias).

Bone marrow

Bone Marrow

What are the 3 different types of low blood cell counts (cytopenias)?

The 3 types of low blood counts include:

Anemia: low red blood counts. Red blood cells help deliver oxygen to your body.

Neutropenia: low white blood counts. White blood cells are important in fighting infection in the body

Thrombocytopenia: low platelet counts. Platelets help control bleeding inside your body and on your skin.

Anemia is the most common type of low blood count in people with lower-risk MDS. In fact, anemia occurs in up to 9 out of 10 people who have MDS.

What is anemia?

Anemia is a type of low blood count that happens when you don’t have enough working red blood cells (RBCs). People with anemia can have low hematocrit, low levels of hemoglobin, or sometimes both.

What causes anemia?

For people with MDS, anemia is caused by having too few healthy, working RBCs. Working RBCs have a molecule called hemoglobin that carries oxygen to the organs in your body.

Low hemoglobin levels mean lower oxygen levels. With less oxygen, you may feel tired, weak, forgetful, or unable to finish daily tasks.

Low hemoglobin levels mean lower oxygen levels. With less oxygen, you may feel tired, weak, forgetful, or unable to finish daily tasks.

To make it simpler, think of your bloodstream as a mail system:

  • Think of your RBCs as the mail carriers. They deliver important boxes (hemoglobin) full of mail (oxygen) to various parts of your body.
  • Think of your bone marrow as the post office where your RBC mail carriers get their training.
  • In MDS, that training is not very good, and your post office (bone marrow) has too few trained (mature) RBC mail carriers. Instead, the post office is overstaffed with mail carriers in training (immature RBCs) that aren’t ready to go out and deliver boxes (hemoglobin) of mail (oxygen).
  • Anemia happens when there are not enough trained (mature) RBC mail carriers out there delivering oxygen packages. Anemia leaves some parts of your body waiting for oxygen packages that never arrive.

If your healthcare team is monitoring you for anemia, they may tell you that your blood cell count is low. This may seem alarming at first, but there are treatment options to help you manage the symptoms. Your healthcare team will help you identify what type of low blood count you are experiencing and next steps to take.

What can anemia feel like?

What can anemia feel like?

There are many symptoms of anemia, and it can feel different from person to person. Sharing what you’re feeling with your healthcare team can help them understand what might be causing your symptoms. These conversations can also help you understand if what you’re feeling comes from anemia or aging.

Some common symptoms of anemia include:

  • Problems with memory or thinking
  • Feeling tired
  • Feeling weak
  • Dizziness
  • Lightheadedness
  • Headaches

Other symptoms can include:

  • Chills or cold hands and feet
  • Irregular heart rate
  • Chest pain
  • Pale or yellowish skin
  • Shortness of breath
  • Muscle cramps, bone pains and body aches

Some of the most common symptoms of anemia are often overlooked. It can be hard to know the cause of symptoms like exhaustion, weakness, dizziness, and body aches. That’s why tracking and talking about these symptoms with your healthcare team is so important.

Living with anemia symptoms can be frustrating and discouraging. These symptoms can get in the way of your daily activities.

It’s important for your healthcare team to manage and treat your anemia. Symptoms from untreated anemia may impact your daily routine. Untreated anemia can also cause more health problems over time. For example, it may affect how well your brain, heart, and lungs work.

Want to learn about some of your MDS
and MDS-related anemia treatment options?

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

When should I speak up about my anemia?

If you’re feeling any anemia symptoms more often, it’s important to speak up honestly with your healthcare team. Speaking up will give your healthcare team a better idea of your current health, and help them discuss with you any changes that may be needed in your treatment.

If you’re changing your daily routines because you’re not feeling good, bring it up with your healthcare team. For example, if you’re feeling tired or unwell enough that you need a break while making the bed, or a nap after getting your mail, it’s time to talk to your healthcare team.

It may not feel important to give your healthcare team an update on how you’re feeling and how that’s impacting your daily life, but tracking and sharing your symptoms is one of the best ways to help your healthcare team help you.

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

Tips for talking to your healthcare team

Important Facts About
REBLOZYL®

(luspatercept-aamt)

This is a summary of important information that you need to know about REBLOZYL. Your healthcare team can work with you to help answer any questions you may have about this medication. Keep this information in a safe place so you can refer to it before and during your treatment.

Look out for the following icons as you read:
Talk to your healthcare team
Call a healthcare provider right away
Helpful information to remember

What is REBLOZYL?

REBLOZYL is a prescription medicine for injection, and is used to treat anemia (low red blood cells) in adults with:

β (beta) thalassemia who need regular red blood cell (RBC) transfusions.

MDS who may need regular RBC transfusions and have never received another type of medicine called an erythropoiesis stimulating agent (ESA).

MDS: myelodysplastic syndromes

MDS-RS or MDS/MPN-RS-T who need 2 or more RBC units over 8 weeks and have not responded well to an ESA.

MDS-RS: myelodysplastic syndromes with ring sideroblasts

MDS/MPN-RS-T: myelodysplastic or myeloproliferative neoplasms with ring sideroblasts and thrombocytosis

REBLOZYL is not 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.

What should I discuss with my healthcare team before starting treatment?

Talk to your healthcare team about all of your health problems and risk factors, including if you:

  • have or have had blood clots
  • take hormone replacement therapy or birth control pills (oral contraceptives)
  • have had your spleen removed (splenectomy)
  • smoke
  • have or have had high blood pressure (hypertension)
  • have a history of extramedullary hematopoietic (EMH) masses
  • have or have had enlarged spleen or liver

Talk to your healthcare team about all the medicines you are taking, including:

  • prescription medicines
  • over-the-counter medicines
  • vitamins
  • herbal supplements

These are not all the topics you should discuss with your healthcare team. Ask your healthcare team about anything you may be unsure about before starting treatment.

What should I discuss with my healthcare team about pregnancy, birth control, and breastfeeding?

Talk to your healthcare team if:

  • You are pregnant or plan to become pregnant — REBLOZYL may harm your unborn baby

    If you are able to become pregnant, your healthcare team should do a pregnancy test before you start receiving REBLOZYL. You should use an effective method of birth control during treatment and for at least 3 months after your last dose of REBLOZYL. Talk to your healthcare team about birth control methods that you can use with REBLOZYL.

    • Call your healthcare provider right away if you become pregnant or think you are pregnant during treatment with REBLOZYL.

    REBLOZYL may affect your ability to become pregnant. Talk to your healthcare team if fertility problems are a concern for you.

  • You are breastfeeding or plan to breastfeed

    Do not breastfeed during treatment and for 3 months after the last dose of REBLOZYL. It is not known if REBLOZYL passes into your breast milk. Talk to your healthcare team about the best way to feed your baby during this time.

What are the serious side effects of REBLOZYL?

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 β-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) — 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?

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.

Talk to your healthcare team for more information about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-10881-800-FDA-1088.

How will I receive REBLOZYL?

REBLOZYL is given as a subcutaneous injection (under your skin) in the upper arm, thigh, or stomach by your healthcare provider. The recommended starting dose of REBLOZYL is 1 mg/kg, once every 3 weeks. Work with your healthcare team to determine the right treatment plan for you.

REBLOZYL is a type of medicine called an erythroid maturation agent (EMA), and comes in single-dose vials that need to be prepared for injection by a healthcare professional.

Active ingredients: luspatercept-aamt

Inactive ingredients: citric acid monohydrate, polysorbate 80, sucrose, and tri-sodium citrate dihydrate

Before each REBLOZYL injection, your healthcare provider will do a blood test to check your hemoglobin and review your transfusion record to see how your anemia is responding to REBLOZYL. Your healthcare provider may adjust your dose or stop treatment depending on how you respond to REBLOZYL.

What if I delayed or missed a dose?

Call your healthcare provider as soon as possible to reschedule your next appointment if you delayed or missed a dose. Your healthcare provider will give your dose of REBLOZYL as soon as possible. Your treatment with REBLOZYL will continue as prescribed, with at least 3 weeks between doses.

For more information, please see Full Prescribing Information and Medication Guide for REBLOZYL. Talk to your healthcare team for more information about this medication.

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