Blinatumomab Side Effects
Commonly reported side effects of blinatumomab include: encephalopathy, seizure disorder, febrile neutropenia, opportunistic infection, balance impairment, confusion, cytokine release syndrome, disorientation, headache, impaired consciousness, tremor, fever, hypotension, increased serum alanine aminotransferase, increased serum aspartate aminotransferase, nausea, neutropenia, speech disturbance, and bacteremia. Other side effects include: pneumonia, sepsis, tumor lysis syndrome, and increased serum bilirubin. Continue reading for a comprehensive list of adverse effects.
Applies to blinatumomab: parenteral powder for injection.
Cytokine Release Syndrome
- Cytokine release syndrome, sometimes life-threatening or fatal, reported.1 2
- Interruption or discontinuance of blinatumomab therapy may be necessary.1 (See Cytokine Release Syndrome under Dosage and Administration and also under Cautions.)
- Neurologic toxicities, sometimes severe, life-threatening, or fatal, reported.1 2
- Interruption or discontinuance of blinatumomab therapy may be necessary.1 (See Neurologic Toxicity under Dosage and Administration and also under Cautions.)
FDA approved a REMS for blinatumomab to ensure that the benefits outweigh the risk. However, FDA later rescinded REMS requirements. See the FDA REMS page ([Web]).
Side effects include:
For Healthcare Professionals
Applies to blinatumomab: intravenous powder for injection.
Very common (10% or more): Hypotension (up to 11%)
Very common (10% or more): Nausea (up to 25%), constipation (up to 20%), diarrhea (e.g., colitis, diarrhea, enteritis, and neutropenic colitis) (up to 20%), abdominal pain (up to 15%), vomiting (up to 13%)[Ref]
Common (1% to 10%): Leukopenia, leukocytosis, lymphopenia
Uncommon (0.1% to 1%): Capillary leak syndrome[Ref]
Common (1% to 10%): Hypersensitivity[Ref]
Very common (10% or more): Cytokine release syndrome (up to 11%), various pathogen infections (44%), bacterial infections (19%), fungal infections (15%), viral infections (13%), increased weight (up to 11%)
Common (1% to 10%): Cytokine storm[Ref]
Very common (10% or more): Headache (up to 36%), tremor (e.g., resting tremor and tremor) (up to 20%), dizziness (up to 14%)
Common (1% to 10%): Encephalopathy, paresthesia, aphasia, convulsion, memory impairment, cognitive disorder
Uncommon (0.1% to 1%): Speech disorder[Ref]
Very common (10% or more): Pyrexia (up to 62%), peripheral edema (up to 25%), fatigue (up to 17%), chills (up to 15%), chest pain (up to 11%)
Very common (10% or more): Increased alanine aminotransferase (up to 12%), increased aspartate aminotransferase (up to 11%)[Ref]
Very common (10% or more): Insomnia (up to 15%),
Common (1% to 10%): Confusion, disorientation[Ref]
Very common (10% or more): Cough (up to 19%), dyspnea (e.g., acute respiratory failure, bronchial hyperactivity, bronchospasm, dyspnea, dyspnea exertional, respiratory distress, respiratory failure, wheezing) (up to 15%)
Uncommon (0.1% to 1%): Bronchospasm[Ref]
Frequently asked questions
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More about blinatumomab
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- Reviews (1)
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- Drug class: CD19 monoclonal antibodies
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Related treatment guides
1. Cerner Multum, Inc. UK Summary of Product Characteristics.
2. Pharmaceutical Society of Australia. APPGuide online. Australian prescription products guide online. http://www.appco.com.au/appguide/default.asp 2006.
3. Product Information. Blincyto (blinatumomab). Amgen USA. 2014.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.