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Indications

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INDICATIONS (2 of 2)

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.

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Hypothetical patient with anemia in beta thalassemia (BT) Hypothetical patient with anemia in beta thalassemia (BT)

Beta (β) thalassemia (BAY-tah THAL-a-SEE-mee-ah) (BT) and anemia

Learning about the relationship between BT and anemia may be helpful to better understand your disease.

What is BT?

BT is a rare blood disorder that is inherited. That means it passes down from parent to child through their genes. BT is a disorder that can lead to anemia and often requires lifelong, ongoing care.

What causes BT?

Our bodies make blood cells in the bone marrow, a soft tissue that is found in the center of most bones.

Erythropoiesis [ih-rith-roh-poi-ee-sis] is the process of immature blood cells maturing into healthy red blood cells (RBCs). When something goes wrong with this process and it doesn’t work, it is called ineffective erythropoiesis (IE).

IE can cause many different symptoms in people living with BT, including:

Anemia (low RBC count)

Higher chance of developing blood clots

Abnormalities in your bones

In many people with BT, beta globin proteins are not formed correctly

The bodies of people with BT may not make hemoglobin (Hgb) correctly. Hgb is an important part of an RBC, a type of blood cell, that carries oxygen through your body. Normal, healthy Hgb includes 2 sets of alpha globin and beta (β) globin. While these proteins are different, both are considered building blocks of Hgb. If your body doesn’t make enough of either one of the proteins, RBCs do not form the right way. That means they cannot carry the oxygen your organs need to stay healthy. This could result in anemia (low RBCs), which may be severe enough to require red blood cell (RBC) transfusions.

Many people with BT rely on RBC transfusions

What it means to have BT may vary from person to person. Because people with BT can’t make enough working RBCs, they may need RBC transfusions regularly to manage their anemia. Transfusions add new, working RBCs to your body from a donor. They temporarily replace RBCs and help increase Hgb, but do not help your body produce more.

RBCs are rich in iron, so repeated transfusions may result in iron collecting abnormally in organs like your heart, liver, spleen, or endocrine glands. This buildup can prevent these organs from working properly, so a treatment called a “chelating agent” is often used to remove this excess iron.

Some types of BT may require RBC transfusions. These include:

BT intermedia

BT intermedia

People with this type of BT have anemia symptoms that can range from mild to severe. Many people eventually require regular RBC transfusions.

BT major (Cooley’s anemia)

BT major (Cooley’s anemia)

People with this type of BT start showing anemia symptoms as a baby. They need regular RBC transfusions and ongoing medical care.

Based on the severity of a person’s transfusion burden, they may refer to their BT as being either transfusion dependent or non-transfusion dependent.

How is BT treated?

Living with BT and its symptoms can be challenging. The symptoms you experience may be mild, or they may impact your ability to complete the tasks of daily living. There are options available to help you manage this. Your doctor will decide the right treatment option for you.

Treatments might include:

  • RBC transfusions: Many people with BT need RBC transfusions. RBC transfusions add donated RBCs to your body. They can improve your anemia in the short term
    • RBC transfusions are usually given in a healthcare setting (such as a hospital or clinic)
  • Chelation therapy: This treatment helps remove extra iron from your blood
  • Stem cell transplant: A process where you receive healthy blood stem cells from a donor to replace your abnormal cells. Stem cells are a unique kind of cell that can turn into any other kind of cell. In your bone marrow, stem cells are used to make all of your blood cells
Hypothetical doctor discussing REBLOZYL® (luspatercept-aamt) treatment with patient and caregiver

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:
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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-RS or MDS/MPN-RS-T who need regular RBC transfusions and have not responded well to or cannot receive another type of medicine called an erythropoiesis stimulating agent (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 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?

The most common side effects of REBLOZYL include:

  • feeling tired
  • muscle or bone pain
  • dizziness
  • diarrhea
  • stomach (abdominal) pain
  • allergic reactions
  • headache
  • joint pain (arthralgia)
  • nausea
  • cough
  • trouble breathing

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 accompanying Full Prescribing Information and Medication Guide for REBLOZYL. Talk to your healthcare team for more information about this medication.