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Indications

Full Prescribing Information

Patient Information

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Patient Information

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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.

What’s possible when switching to REBLOZYL?

If you have tried an ESA (erythropoiesis-stimulating agent), such as epoetin alfa, to help reduce your need for red blood cell (RBC) transfusions, but the results are less than you had hoped for, it might be time to consider a change.

Second-line treatment results for REBLOZYL

In a clinical study done to determine the safety and effectiveness of REBLOZYL for people who tried an ESA as their first treatment, REBLOZYL helped lower the need for RBC transfusions.

The main goal of the study was to stop the need for RBC transfusions for at least 8 weeks during the first 24 weeks of treatment.

Icon: IV for blood transfusion

Transfusion
independence

With REBLOZYL NEARLY 3X AS MANY PEOPLE HAD NO RBC TRANSFUSIONS for at least 8 weeks compared to placebo

Infographic: REBLOZYL® (luspatercept-aamt) clinical study

The study was designed to assess people who
did not respond well to an ESA:

Infographic: REBLOZYL® (luspatercept-aamt) clinical study Infographic: REBLOZYL® (luspatercept-aamt) clinical study

To be in the study, people needed to receive 2 or more RBC transfusions every 8 weeks. They also needed to either:

  • Have received 2 or more RBC transfusions every 8 weeks
  • They also needed to either:
    • Have a poor response to an ESA treatment
    • Be unlikely to respond to an ESA - Defined as having a blood test that shows high levels (>200 U/L) of a protein called erythropoietin and not having received an ESA previously
    • Or not being able to handle the side effects of an ESA treatment

People could not be a part of the study if they had:

  • Specific mutations in their DNA (deletion 5q)
  • Other blood count disorders
  • Received treatment for their underlying MDS

What are the possible side effects of REBLOZYL?

It’s important to know about the possible side effects of REBLOZYL before beginning treatment. Remember: people may react to medicines differently, and that’s expected.

The possible side effects of REBLOZYL are well-known. Be sure to talk with your healthcare team about what to expect when starting treatment with REBLOZYL.

What are the serious side effects of REBLOZYL?

Icon: warning triangle with exclamation point

Serious side effect

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.

Icon: blood clot in artery

Blood clots (thrombosis/thromboembolism)

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 hormonereplacement 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)
Photo of a hypothetical patient wearing a dark blue dress shirt and glasses, sitting in a doctor's office and talking to a healthcare professional
Icon: blood pressure cuff

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.

What are the most common side effects of REBLOZYL?

The most common side effects are the side effects that were the most frequently reported by patients in the study. You may experience more than one side effect at the same time.

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. For more information about side effects, please see the REBLOZYL Patient Information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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.