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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)

Understanding treatments for
MDS and anemia

Understanding treatments for MDS and anemia

After you've been diagnosed with myelodysplastic syndromes (MDS) and MDS-related anemia, you may be wondering, “What now?” Thinking about the road ahead can be overwhelming, but having a better idea of what your treatment options are might help you navigate the road ahead.

There are a number of different treatment options for MDS-related anemia, and because every person is unique, there’s no one-size-fits-all approach. You can talk to your healthcare team about finding a treatment plan that fits your individual needs.

What can I expect on my treatment journey?

As you start exploring treatment options for your MDS-related anemia, here are some questions you can ask your healthcare team to help you understand what to expect:

  • How will MDS-related anemia affect my future?
  • What might my symptoms mean?
  • What are the pros and cons of each treatment?
  • What are the common side effects of these treatments?
  • How will we know if a treatment is working?
  • How might my treatment change in the future?
  • How might not getting treatment impact my symptoms?
  • How often should I have appointments with you?
  • Are there any other doctors I should see in addition to you?
Hypothetical patient with anemia in myelodysplastic syndromes with ring sideroblasts (MDS-RS) speaking to healthcare professional

You are your own best advocate. Ask questions to make sure you understand your treatment plan and listen carefully to what your healthcare team has to say. The resources and advice they share can help you on your treatment journey.

How will my treatment journey start?

At the start of your journey, and possibly at other points along the way, you and your healthcare team may use the watch-and-wait method.

Watch-and-wait method

Watch-and-wait means working with your healthcare team to monitor your symptoms and bloodwork for any changes.

What to know about watch-and-wait:

  • You can expect to occasionally meet with your healthcare team
  • Track and share any new or changing symptoms with them to help your healthcare team know how this approach is working
  • Undergo blood testing a few times a year to help your healthcare team know if your MDS and your anemia are getting better, staying the same, or getting worse
  • If your healthcare team thinks your MDS or your anemia is getting worse, you’ll work together to determine what can be treated and what your treatment options may be
Hypothetical patient with anemia in myelodysplastic syndromes with ring sideroblasts (MDS-RS)

What are some common MDS treatments?

Depending on your risk score and the severity of your symptoms, your healthcare team may suggest treatments to help manage your MDS.

Before using these treatments, your healthcare team must decide that they are right for you. These treatments are available if you are in the low- to very-high-risk score range. Examples include:

  • Chemotherapy: A type of medicine that destroys cancer cells. It works by killing abnormal cells. It can also affect normal cells. There are many different types of chemotherapy drugs
  • Immunotherapy: A type of medicine that fights cancer cells by using your immune system
    • Immunosuppressive therapy: A medicine that lowers your immune system response and stops it from attacking your bone marrow
    • Immunomodulator: A medicine that adjusts different parts of your immune system. This type of therapy boosts the immune system and also helps kill abnormal cells
  • Stem cell transplant: A process where you receive healthy blood stem cells from a donor to replace your abnormal cells

MDS advocacy groups offer more information on treatment options for MDS

Explore MDS Resources

What are some common treatments for MDS-related anemia?

It’s important to know your options when it comes to treating your MDS-related anemia. The right treatment option for you will depend on how anemia affects you, what treatments you’ve tried before, and what your body responds well to. Examples include:

Red Blood Cell (RBC) transfusions

RBC transfusions add donated RBCs to your body.

What to know about RBC transfusions:

  • Your healthcare provider may recommend treating your anemia with RBC transfusions based on how severe your symptoms are and the amount of hemoglobin (Hgb) in your blood. The amount of Hgb in your blood is sometimes called your “blood count” or “Hgb level”
  • How often you’ll need RBC transfusions will depend on your symptoms and your blood count. Your healthcare team can tell you if RBC transfusions are right for you and give you a better idea of how frequently you might need transfusions

How RBC transfusions may affect your anemia:

  • RBC transfusions help with anemia by giving your body a fresh batch of mature, working RBCs with Hgb to carry the oxygen your cells need
  • You may feel relief from some of your anemia symptoms after a transfusion. This relief will likely wear off as time passes between transfusions
Hypothetical doctor

What to expect over time with RBC transfusions:

  • The number of RBC transfusions you receive may change over time, depending on how long it takes for your symptoms to worsen and for your Hgb to drop after each transfusion
  • As time passes, many people may need RBC transfusions more often
  • When used over time, RBC transfusions can cause problems such as iron overload. Iron overload happens because the transfused RBCs contain iron that your body can’t get rid of on its own, causing iron to build up. Iron overload can damage organs like the heart and the liver. It is treatable, but make sure to discuss this with your healthcare team so you can monitor for it together

Keeping track of important transfusion details like dates, RBC units, and Hgb levels and sharing them with your healthcare team will help them, help you.

Learn more about REBLOZYL

Erythropoiesis-stimulating agent (ESA)

ESAs are man-made hormone (sometimes called “growth factors”) given by injection that may help raise blood cell counts. A few examples of ESAs are Aranesp® (darbepoetin alfa), Epogen® (epoetin alfa), and Procrit® (epoetin alfa).

What to know about ESAs:

  • Many patients start ESA injections as part of an anemia treatment plan that also includes some RBC transfusions
  • If you and your healthcare team decide to include an ESA in your treatment plan, you may receive injections every 1 to 3 weeks

How ESAs may affect your anemia:

  • ESAs work to treat anemia by raising blood cell counts
  • ESAs may help your body produce more immature RBCs, possibly helping with your anemia and decreasing the number of transfusions you need

What to expect over time with ESAs:

  • ESAs work well for some of the people who receive them, but their effect can wear off over time
  • Depending on how your body is responding, your healthcare team may change your dose or even stop ESAs so you can try another treatment

What you can do:

After 6 to 8 weeks of receiving an ESA, talk to your healthcare team about how you’re responding to treatment. The majority of people taking ESAs don’t respond to them. Tracking and sharing your symptoms, test results, and any transfusion information with your healthcare team is going to help understand if you might need to take a different treatment approach. You can talk about:

  • Any changes in your symptoms
  • Any changes in the number of transfusions you need
  • Any changes in your Hgb levels

Erythroid maturation agents (EMAs)

An EMA is a treatment that helps your body’s RBCs mature, which may lower or end your need for transfusions.

What to know about EMAs:

  • Many patients who receive EMAs have used or are currently using other anemia treatments, like RBC transfusions
  • EMAs are given as injections by a healthcare provider once every 3 weeks

What you can do:

You can track and share your symptoms, test results, and any transfusion information with your healthcare team. When you track and share this information, your healthcare team can better understand how the EMA is working for you. Talk to your healthcare team about:

  • Any changes in your symptoms
  • Any changes in the number of transfusions you need
  • Any changes in your Hgb levels

Talk to your healthcare team and ask if REBLOZYL is right for you.

Learn more about REBLOZYL

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.

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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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