• Indications

    INDICATIONS

    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 transfusion 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.

    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.

  • Full Prescribing Information
  • Patient Information
  • Healthcare Professional Site
  • BMS Access Support®
Register to Learn More E-mail E-mail

This website is best viewed
using the horizontal display
on your tablet device.

This website is best viewed
using the vertical display on
your mobile device.

What important questions should I ask my healthcare team when receiving REBLOZYL?

One of the best ways to learn about your treatment with REBLOZYL is to talk to your healthcare team. Speaking with your healthcare provider or healthcare team can help make you feel more informed and comfortable. Below are some questions that you may want to ask.

  • Why am I being prescribed REBLOZYL?
  • What are the most important things I need to know about REBLOZYL?
  • Where and how do I receive REBLOZYL?
  • What should I expect while receiving REBLOZYL?
  • What are the most common side effects? And what should I do if I experience one?
  • Are there things that I should not do while receiving REBLOZYL?
  • How and where will my hemoglobin levels be tested prior to dosing?
  • How often should I come in for follow-up visits while receiving REBLOZYL?
  • How long will it take for REBLOZYL to start working? How will I know if it’s working?
  • What dose of REBLOZYL will I be receiving?
  • What if I miss a dose of REBLOZYL?
  • Will my dose of REBLOZYL stay the same?
  • Are there any medications I can’t take while I’m receiving REBLOZYL?
  • How will REBLOZYL affect the course of my disease?
  • What are the pros and cons of receiving REBLOZYL?

Resources for people with β-thalassemia

The following organizations provide disease education, additional support, and expert opinions. Inclusion on this list does not indicate endorsement by Bristol-Myers Squibb Company of an organization or its communications.

Cooley’s Anemia Foundation

212-279-8090

https://www.thalassemia.org

Thalassaemia International Federation (TIF)

+357 22 319129

https://thalassaemia.org.cy/about

The Centers for Disease Control and Prevention

https://www.cdc.gov/ncbddd/thalassemia/index.html

BMS Access Support® Can Provide Patient
Access and Reimbursement Assistance

Bristol Myers Squibb is committed to helping patients gain access to their prescribed BMS medications. That’s why we offer BMS Access Support. BMS Access Support provides resources to help patients understand their insurance coverage. In addition, we can share information on sources of financial support, including co-pay assistance for eligible commercially insured patients.

How BMS Access Support May Help

Find out how BMS can work with patients and their healthcare
providers to help access a prescribed BMS medication.

Financial Support Options

There may be programs and services that could help with the
cost of treatment. Learn about what options are available.

Additional Resources

We provide videos, tools, and other resources that may help
with your access and reimbursement needs.

Have Questions About Our Program or
Possible Financial Support?

If you have questions about coverage for a prescribed BMS medication, BMS Access Support may be able to help. Patients and their healthcare provider can complete an enrollment form to learn about programs that may be of assistance. Visit our website or contact BMS Access Support to learn more.

Call Bristol Myers Squibb Access Support at
1-800-861-0048, 8 AM to 8 PM ET, Monday–Friday

Visit

The accurate completion of reimbursement- or coverage-related documentation is the responsibility of the healthcare provider and the patient. Bristol Myers Squibb and its agents make no guarantee regarding reimbursement for any service or item.

Glossary

Anemia: Low red blood cell count

Beta globin: A protein building block of hemoglobin

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

Chelating agent: A chemical compound used to remove toxic metals from the body

Erythroid cell: An immature red blood cell

Erythroid maturation agent: Treatment that helps young cells become mature cells

Erythropoiesis: The formation of red blood cells in blood-forming tissue within the bone marrow

Erythropoiesis-stimulating agent: A manufactured growth hormone that helps the body produce more immature red blood cells

Hemoglobin: Oxygen-carrying protein found in red blood cells

Hydroxyurea: A type of medicine used to treat certain cancers

Immunosuppressant: An agent that decreases the body’s immune response

Ineffective erythropoiesis: The inability of oxygen-carrying red blood cells to leave the bone marrow

Ischemic stroke: The most common type of stroke, caused by a blood clot that blocks a blood vessel in the brain

Median: A statistics term. The middle of a range of numbers

Mutation: An abnormal change within a gene

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

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

Subcutaneous: Under the skin

Thromboembolic event: Formation of a clot in a vein or artery that breaks loose and is carried by the blood to block a blood vessel

Thrombosis: Formation of a blood clot

Uric acid: A chemical created when the body breaks down certain substances made by the body and found in some foods and drinks, and is removed from the body by the kidneys. Too much uric acid in your body can cause you to become sick

IMPORTANT SAFETY
INFORMATION

Before receiving REBLOZYL, tell your healthcare provider about all of your medical conditions, including if you:

  • have or have had blood clots
  • have or have had high blood pressure (hypertension)
  • take hormone replacement therapy or birth control pills (oral contraceptives)
  • have had your spleen removed (splenectomy)
  • smoke
  • are pregnant or plan to become pregnant. REBLOZYL may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with REBLOZYL.

    Females who are able to become pregnant:

    • Your healthcare provider should do a pregnancy test before you start treatment with REBLOZYL.
    • You should use effective birth control (contraception) during treatment with REBLOZYL and for at least 3 months after the last dose.
  • are breastfeeding or plan to breastfeed. It is not known if REBLOZYL passes into your breast milk.
    • Do not breastfeed during treatment with REBLOZYL and for 3 months after the last dose. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements

What are the possible side effects of REBLOZYL?

REBLOZYL may cause serious side effects, including:

  • Blood clots. Blood clots in the arteries, veins, brain, and lungs have happened in people with beta 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 (oral contraceptives). 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 are both short-term or continue 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. 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.

The most common side effects of REBLOZYL include:

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

REBLOZYL may cause fertility problems in females. This could affect your ability to become pregnant. Talk to your healthcare provider if this is a concern for you.

These are not all of the possible side effects of REBLOZYL. Call your doctor for medical advice about side effects. You are encouraged to report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

WHAT IS REBLOZYL® (luspatercept-aamt)?

REBLOZYL 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.
  • 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.

Please see full Prescribing Information and Patient Information for REBLOZYL.

TO REPORT SUSPECTED ADVERSE REACTIONS OR EMBRYO-FETAL EXPOSURE: CONTACT BRISTOL MYERS SQUIBB AT
1-888-423-5436 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.

Bristol Myers Squibb is committed to transparency. For information on the list price of REBLOZYL as well as information regarding average out-of-pocket costs and assistance programs, please visit our pricing information page.

This website is intended for U.S. residents
18 years of age or older.

© 2022 Bristol-Myers Squibb Company. All rights reserved.
REBLOZYL is a trademark of Celgene Corporation, a Bristol-Myers Squibb Company.
Access Support® is a registered trademark of
Bristol-Myers Squibb Company.
REBLOZYL is licensed from Acceleron Pharmaceuticals, Inc.
2007-US-2200051 02/22