Finding a path forward for myelodysplastic syndromes associated anemia

(BPT) - Dave and his wife, Diana, envisioned a tranquil retirement amidst sprawling pines and open spaces, trading city life for a remote, overgrown property in East Texas. Their dream: to transform the land into a "little Eden," complete with a workshop where Dave could pursue his passion for woodwork, crafting tables and turning bowls. But as they poured their energy into clearing the land over the years, a subtle yet unsettling shift began.

"I noticed that I needed to stop and rest more often as work began on the house, which I just attributed to getting older," says Dave. "But it seemed like my physical capabilities reduced a little bit quicker than I expected."

What he initially dismissed as signs of aging slowly escalated. Annual blood work revealed minor abnormalities, placing Dave on a cautious watchlist with his primary care doctor. The true alarm sounded when he was turned away from a local blood drive due to low hemoglobin levels. This prompted another doctor's visit, a new round of blood tests, and ultimately, a referral to an oncologist.

Dave remembered feeling anxious after the initial consultation. It took months for a definite answer to emerge, as his blood counts continued their troubling decline. Finally, a bone marrow biopsy delivered a definitive diagnosis: Myelodysplastic syndromes (MDS)-related anemia.

MDS is a group of disorders in which the bone marrow fails to make enough healthy red blood cells (RBCs), white blood cells (WBCs) or platelets.¹ The resulting low red blood cells cause anemia, leading to common symptoms such as feeling tired, weak and dizzy. These symptoms are often overlooked, frequently mistaken for normal signs of aging and many can get in the way of daily activities.^1,2 Left untreated, anemia can worsen over time, potentially affecting vital organs like the brain, heart and lungs.³

Dave remembers his diagnosis feeling like a "curveball," threatening not only his health but also the shared dream he had with his wife, Diana, of building their ideal home. Despite the shock, this shared adversity strengthened Dave and Diana's bond, and they were determined to navigate their new reality together.

Dave discussed his treatment options with his oncologist. While some people may require RBC transfusions, they weren't the required initial approach for his specific case yet. Healthcare providers may recommend treating anemia with RBC transfusions based on symptom severity and hemoglobin levels.¹ His oncologist recommended Reblozyl (luspatercept-aamt), a prescription medicine for injection used to treat adults with anemia associated with MDS, and together they decided to move forward with the treatment.

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REBLOZYL (luspatercept-aamt) is a prescription medicine for injection, and is used to treat anemia (low red blood cells) in adults with⁴:

• MDS who may need regular RBC transfusions and have never received an erythropoiesis-stimulating agent (ESA).

It is not known if REBLOZYL is safe or effective in children under 18 years of age. REBLOZYL is not for use as a substitute for RBC transfusions in people who need immediate treatment for anemia.

REBLOZYL may cause serious side effects, including blood clots (also known as thrombosis or thromboembolism) and high blood pressure (also known as hypertension). 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, and allergic reactions. Please see additional Important Safety Information for REBLOZYL below and at www.REBLOZYL.com.

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Dave says he experienced a noticeable difference early in his treatment. He reported lower gastrointestinal side effects, though he acknowledges that each person's experience can vary. Now, Dave and Diana are getting back to planning for their future.

Dave offers poignant advice to others facing similar health circumstances: "Don't just sit there and listen to a one-way conversation. Ask your doctor questions so that you can make decisions about your own treatment. Autonomy is empowering and may change the way you look at the path forward." For more information, visit www.reblozyl.com.

What is REBLOZYL^® (luspatercept-aamt)?

REBLOZYL is a prescription medicine used to treat anemia (low red blood cells) in adults with:

• myelodysplastic syndromes who may need regular red blood cell transfusions (RBC transfusions) and have never received an erythropoiesis stimulating agent (ESA).
• myelodysplastic syndromes with ring sideroblasts (MDS-RS) or myelodysplastic/myeloproliferative neoplasms with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T) who need 2 or more RBC units over 8 weeks and have not responded well to 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
• 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)
• 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.
  For 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
• 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

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.

Please see accompanying US Full Prescribing Information and Patient Information for REBLOZYL.

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