Luspatercept-aamt (lus-PAT-er-sept - aamt)

Treats anemia in patients with blood or bone marrow problems (beta thalassemia, myelodysplastic syndromes, or myelodysplastic/myeloproliferative neoplasms) who need regular blood transfusions.

Brand Name(s):

Reblozyl

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin.
• A nurse or other health provider will give you this medicine.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Call your doctor or pharmacist for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how luspatercept-aamt works. Tell your doctor if you are using birth control pills or hormone replacement medicines.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control during treatment with this medicine and for at least 3 months after the last dose.
• Do not breastfeed while you are using this medicine and for at least 3 months after the last dose.
• Tell your doctor if you have kidney disease, liver disease, high blood pressure, or a history of blood clots or blood problems. Tell your doctor if you also have had surgery to remove your spleen (splenectomy) or if you smoke.
• This medicine may cause the following problems:
  • Increased risk of blood clots (including deep vein thrombosis, ischemic strokes, portal vein thrombosis, pulmonary embolus)
  • High blood pressure
  • Blood problems, including extramedullary hematopoietic masses (EMH)
• Some women who use this medicine have become infertile (unable to have children). Talk to your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision, dizziness, nervousness, headache, slow or fast heartbeat
• Bone pain
• Chest pain, trouble breathing, coughing up blood
• Fever, chills, cough, sore throat, stuffy or runny nose, body aches
• Numbness or weakness in your arm or leg, or on one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Pain or swelling in your lower leg
• Rapid weight gain, swelling in your hands, ankles, or feet
• Severe back pain, numbness, weakness, or problems with movement in the feet, legs, hands, or arms, loss of bowel or urine control
• Unusual tiredness or weakness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, nausea, stomach pain
• Joint or muscle pain

If you notice other side effects that you think are caused by this medicine, tell your doctor

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