Dr. Caroline Behler and Tracey Iraca: November 6, 2020

Thousands of Americans Are Dependent on Blood Transfusions for Anemia Related to Myelodysplastic Syndromes (MDS), But a Treatment Option May Help

First Therapy for MDS in 10 years is Now Available1

 

In the U.S., as many as 170,000 people are living with a group of bone marrow disorders called myelodysplastic syndromes (MDS), in which the body does not produce enough healthy blood cells.2

 

Low blood cell counts in people with MDS are responsible for common symptoms of the disease, including anemia and infections.2 People with MDS-related anemia often require regular blood transfusions to increase the number of healthy red blood cells in circulation.3

 

On October 20, 2020, leading up to MDS World Awareness Day on October 25, Dr. Caroline Behler of Pacific Hematology Oncology Associates, will be available to share more about a  treatment option approved by the U.S. Food and Drug Administration (FDA) that may help reduce and eliminate frequent blood transfusions on adults living with MDS.Reblozyl® (luspatercept-aamt) (REB-loh-zil) is the first  treatment in ten years to treat patients with this condition.1 Dr. Behler and Tracey Iraca, executive director at the MDS Foundation, together, will be available to discuss the challenges of managing the symptoms associated with a bone marrow cancer, like MDS, and where to find resources and support.

 

Dr. Caroline Behler is an oncologist at the Pacific Hematology Oncology Associates and the California Pacific Medical Center with a clinical focus on malignant hematology and expertise in benign hematology and a wide range of solid tumors. Dr. Behler, who enjoys teaching and mentoring, recently became the Program Director for the Center’s new Hematology/Oncology Fellowship Program. Previously, Dr. Behler served as faculty at the UCSF Hematology and BMT clinic as well as the Chief of Malignant Hematology at the San Francisco V.A. Medical Center.

 

 

Tracey Iraca joined the MDS Foundation in 2004 as a part-time Patient Coordinator, assisting with patient education programs. Now, as executive director, Tracey oversees all daily business activities, including finances, staffing and staff projects. She works with the MDSF Board of Directors on strategic planning for meeting the ongoing needs of MDS patients and healthcare professionals. Tracey manages the corporate grants program and is responsible for all corporate relations and business development. She serves as liaison to the Foundation’s International Nurse Leadership Board, International Working Group for Prognosis in MDS (IWG-PM) and MDS/MPN International Working Group (MDS/MPN IWG).

 

Reblozyl® (luspatercept-aamt), is the first and only erythroid maturation agent (EMA), for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).1 Reblozyl (luspatercept-aamt), is an injection, for subcutaneous use. The recommended starting dose is 1 mg/kg once every 3 weeks by subcutaneous injection for patients with anemia of MDS-RS or MDS/MPN-RS-T. 4

 

REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require

immediate correction of anemia.

 

For more information about Reblozyl, please see Important Safety Information below and visit reblozyl.com or reblozylpro.com.

 

 

Produced for: Bristol Myers Squibb

 

For more information about Reblozyl, please see Important Safety Information below.

Reblozyl (luspatercept-aamt), is an injection, for subcutaneous use. The recommended starting dose is 1 mg/kg once every 3 weeks by subcutaneous injection. Reblozyl 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. 5

 

IMPORTANT SAFETY INFORMATION

 

WHAT IS REBLOZYL® (luspatercept-aamt)?

REBLOZYL 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.

 

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
    • Headache
    • Muscle or bone pain
    • Joint pain (arthralgia)
    • Dizziness
    • Nausea
    • Diarrhea
    • Cough
    • Stomach (abdominal)
    • Pain
    • Trouble breathing
    • Allergic reactions 

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.

 

Please see accompanying full Prescribing Information for REBLOZYL

References

1.    U.S. Food and Drug Administration (FDA) Approves Reblozyl® (luspatercept-aamt), the First and Only Erythroid Maturation Agent, to Treat Anemia in Adults with Lower-Risk Myelodysplastic Syndromes (MDS). Available at: https://news.bms.com/press-release/corporatefinancial-news/us-food-and-drug-administration-fda-approves-reblozyl-luspater. Accessed August 2020.

2.    MDS Foundation. What is MDS? Available at: https://www.mds-foundation.org/what-is-mds/. Accessed July 2020.

3.    American Cancer Society. Supportive Therapy for Myelodysplastic Syndromes. Available at https://www.cancer.org/cancer/myelodysplastic-syndrome/treating/supportive-therapy.html. Accessed July 2020.

4.    Reblozyl (luspatercept-aamt) Prescribing Information. U.S. Product Information. Available at: https://media.celgene.com/content/uploads/reblozyl-pi.pdf. Accessed July 2020.

5.    Reblozyl.com. Patient Information. Available at: https://media2.celgene.com/content/uploads/reblozyl-patient-info.pdf. Accessed September 2020.  

 

 

Produced for: Bristol Myers Squibb

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