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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.

REBLOZYL is not for use as 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.

INDICATIONS (2 of 3)

REBLOZYL® (luspatercept-aamt) is a prescription medicine used to treat anemia (low red blood cells) in adults with myelodysplastic syndromes with ring sideroblasts (MDS-RS) or myelodysplastic/myeloproliferative neoplasms with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T) who need regular RBC transfusions and have not responded well to or cannot receive an erythropoiesis stimulating agent (ESA).

REBLOZYL is not for use as 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.

INDICATIONS (3 of 3)

REBLOZYL® (luspatercept-aamt) is a prescription medicine used to treat anemia (low red blood cells) in adults with beta thalassemia who need regular red blood cell (RBC) transfusions.

REBLOZYL is not for use as 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.

Understanding MDS & Anemia

Learning about the relationship between MDS and anemia may help you better understand the disease.

What is MDS?

Myelodysplastic syndromes (MDS) (my-el-o-dys-plastic sin-dromes) 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.

Icon: Bone marrow

Bone Marrow

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.

The abnormal cells take up space needed for normal bone marrow function. 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).

Icon: Mature red blood cell

Mature
RBC

Icon: Abnormal red blood cell

Abnormal
RBC

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

1.

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

2.

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

3.

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

Icon: 9 out of 10 people who have MDS diagram

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 causes anemia?

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

Watch this short video to see how anemia develops.

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What are the symptoms of anemia?

There are many symptoms of anemia, and it can feel different from person to person. Some symptoms can easily be overlooked and confused with normal signs of aging, which is why it’s helpful to share how you’re feeling with your healthcare team. Speaking up helps them understand what might be causing your symptoms and can be used to create a treatment plan that works best for you.

Some common symptoms of anemia include:

  • Problems with thinking or memory
  • 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
Icon: brain, lungs and heart

Anemia symptoms can get in the way of your daily activities. So it's important to track how you're feeling and proactively speak with your healthcare team about your options.

Untreated anemia can also cause more health problems over time. For example, it may affect how well your brain, heart, and lungs work.

When should I talk to my doctor?

It's important to speak up about any symptoms or daily disruptions you're experiencing.

Feeling empowered starts with knowing what to look for.

Select (+) for more information on how to prepare for talks with your care team:

Make sure your care team knows about any symptoms you're experiencing, which may include:

  • Problems with memory or thinking
  • Feeling tired
  • Weakness
  • Dizziness
  • Chills
  • Lightheadedness
  • Pale or yellowish skin
  • Headaches
  • Shortness of breath
  • Muscle cramps and bone pain
  • Any other symptom that impacts how you feel

Tracking and sharing your symptoms consistently is the best way for your doctor to understand how you're feeling and what options might be right for you.

It's important to track and share everything you're feeling, especially if symptoms get in the way of your daily activities.

For example, if you're feeling tired or unwell and need a break while making the bed, or a nap after getting your mail, it's time to talk to your care team.

Come prepared with a list of all current and past anemia treatments, including details around red blood cell transfusions, if you've received any. This history will help your care team create the right MDS-related anemia management plan for you.

Generally, the main treatment options for MDS-related anemia are:

  • RBC transfusions, which add donated RBCs to your body
  • Erythropoiesis-stimulating agents (ESAs), a type of medicine given intravenously or by injection that may help raise blood cell counts
  • Erythroid maturation agents (EMAs) like REBLOZYL that help your body's RBCs mature, which can also increase your hemoglobin (Hgb) levels and may lower your need for transfusions

Setting goals and sticking to treatment is an important part of setting you up for success. Having goals can help you and your doctor keep track of your progress.

Common treatment goals in MDS-related anemia include:

  • Raise hemoglobin levels
  • Become transfusion independent
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Download our complete Doctor Discussion Guide for more information about navigating conversations with your care team. The guide also includes worksheets and places to take notes to help you get organized.

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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 syndromes 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-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.