Note: This document contains side effect information about luspatercept. Some dosage forms listed on this page may not apply to the brand name Reblozyl.
Applies to luspatercept: subcutaneous powder for injection.
Warning
Before using luspatercept tell your doctor about all your medical conditions or allergies, all medicines you use, and if you are pregnant or breastfeeding.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Tell your caregivers right away if you have:
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severe headache, blurred vision, pounding in your neck or ears;
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signs of a stroke--sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, balance problems;
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signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
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signs of a blood clot deep in the body--swelling, warmth, or redness in an arm or leg.
Your luspatercept (the active ingredient contained in Reblozyl) injections may be delayed or permanently discontinued if you have certain side effects.
Common side effects may include:
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stomach pain, diarrhea;
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headache, dizziness;
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feeling tired;
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cough; or
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bone pain, joint pain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to luspatercept: subcutaneous powder for injection.
Hepatic
Very common (10% or more): Total bilirubin 2 or more times the upper limit of normal (ULN) (64%), alanine aminotransferase 3 or more times ULN (12%), aspartate aminotransferase 3 or more times ULN (11%)
Common (1% to 10%): Alkaline phosphatase 2 or more times ULN, direct bilirubin 2 or more times ULN[Ref]
Cardiovascular
Common (1% to 10%): Hypertension, deep vein thrombosis[Ref]
Nervous system
Very common (10% or more): Headache (26%), dizziness (11%)
Common (1% to 10%): Cerebrovascular accident[Ref]
Musculoskeletal
Very common (10% or more): Bone pain (20%), arthralgia (19%)[Ref]
Gastrointestinal
Very common (10% or more): Abdominal pain (14%), diarrhea (12%)
Common (1% to 10%): Nausea[Ref]
Metabolic
Common (1% to 10%): Hyperuricemia[Ref]
Respiratory
Very common (10% or more): Cough (14%)[Ref]
Immunologic
Common (1% to 10%): Influenza, viral upper respiratory infection[Ref]
Other
Very common (10% or more): Fatigue (14%)
Frequency not reported: Death (due to unconfirmed acute myelogenous leukemia)[Ref]
