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INDICATIONS (1 of 2)

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.

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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)

Resources for people with myelodysplastic syndromes (MDS)

Resources for
people with
myelodysplastic
syndromes (MDS)

Helpful resources to download

These resources are available to help you navigate starting and staying with REBLOZYL.

REBLOZYL® (luspatercept-aamt) patient brochure

Patient
Brochure

Download
REBLOZYL® (luspatercept-aamt) doctor discussion guide

Doctor
Discussion Guide

Download
REBLOZYL® (luspatercept-aamt) treatment journal tracker

Treatment
Tracker

Download
MDS education brochure

MDS Education
Brochure

Download
Spanish brochure

Spanish
Brochure

Download

Websites to explore for more information about MDS

The following organizations provide disease education, additional support, and expert opinions. This list of independent organizations is provided as an additional resource for obtaining information related to MDS. This list does not indicate endorsement by Bristol Myers Squibb of an organization or its communications.

MDS Glossary

Anemia: Low red blood cell (RBC) count

Blood cells: Blood cells begin as stem cells in the bone marrow. Stem cells grow and mature into different types of cells: red blood cells, white blood cells, and platelets. After the cells have matured in the bone marrow, the red blood cells, white blood cells, and platelets enter the bloodstream

Blood pressure: The force of circulating blood on the walls of blood vessels

Bone marrow: The soft interior of the bones where new blood cells are created

Chemotherapy: A type of treatment that kills or stops the growth of abnormal cells in the body. It is often used to treat cancer

Cytopenia: Lower than normal number of blood cells

DNA: The information inside your cells that is responsible for how you look and behave

Erythroid cells: An immature red blood cell

Erythroid maturation agent (EMA): Treatment that helps red blood cells to mature

Erythropoiesis-stimulating agent (ESA): A manufactured erythropoietin given to people to help with anemia

Erythropoietin: A natural growth hormone produced by the kidneys that tells the body to make more immature red blood cells

Hemoglobin (Hgb): Oxygen-carrying protein found in red blood cells

Hormone: A chemical made by your body that travels in the bloodstream to send messages throughout your body

Immunomodulator: A type of medicine that changes part of the immune system

Immunosuppressive therapy: A type of treatment that decreases the body’s immune response

Immunotherapy: A type of treatment that modifies your immune system to help the body fight cancer

Kilogram (kg): A unit for measuring your weight. One kg is 2.2 pounds

Lower-risk: A lower chance of your MDS progressing to a more serious condition

Milligram (mg): A unit for measuring weight

mg/kg: The dose of your medication based on your body weight

Mutation: An abnormal change within a gene

MDS/MPN-RS-T: Abbreviation for myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis. It is a rare form of MDS in which there are a high number of platelets in the blood and the immature red blood cells contain ring sideroblasts

Myelodysplastic syndromes (MDS): MDS are a group of disorders in which the bone marrow does not make enough healthy blood cells

Myelodysplastic syndromes with ring sideroblasts (MDS-RS): A type of MDS where a certain number of immature red blood cells in your bone marrow are ring sideroblasts

Neutropenia: Lower than normal amount of neutrophils, a type of white blood cell

Placebo: An inactive substance that looks the same as, and is given the same way as, an active drug or treatment being tested

Platelets: A type of blood cell that helps with clotting

Red blood cells (RBCs): Blood cells that carry oxygen from the lungs to all cells in the body

Red blood cell transfusion: A process that adds red blood cells into the bloodstream

Ring sideroblasts (RS): Cells containing rings of iron deposits

Risk level: Your risk level is a score given by your healthcare team. Your risk level helps them understand the chances of your MDS progressing to a more serious condition. Risk level scores can range from “very low” to “very high”

Serum: The clear liquid part of the blood that remains after blood cells and clotting proteins have been removed

SF3B1: Splicing Factor 3B Subunit 1 (SF3B1) is a gene that can have mutations as part of your MDS. This mutation can be tested for as a part of your MDS diagnosis

Stem cell: All immature cells before they mature and develop a specific role

Stem cell transplant: A type of treatment that replaces your abnormal cells with healthy stem cells from a donor

Symptom: A physical or mental sign of a condition or disease

Thrombocytopenia: Lower than normal number of platelets in the blood

Transfusions: Procedures that add parts of blood or whole blood into the bloodstream

Transfusion burden: How often you need to have red blood cell (RBC) transfusions

White blood cells (WBCs): Blood cells that help the body fight infection as part of the body’s immune system

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.