Summary
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.
Warning
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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 Toxicity
- 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.)
REMS:
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 However, FDA later rescinded REMS requirements.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:
Pyrexia, infection, headache, peripheral edema, febrile neutropenia, nausea, hypokalemia, rash, constipation, diarrhea, tremor.
For Healthcare Professionals
Applies to blinatumomab: intravenous powder for injection.
Cardiovascular
Very common (10% or more): Hypotension (up to 11%)
Common (1% to 10%): Hypertension, tachycardia[Ref]
Dermatologic
Very common (10% or more): Rash (e.g., erythema, rash, erythematous rash, generalized rash, macular rash, maculopapular rash, papular rash, vesicular rash)[Ref]
Gastrointestinal
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]
Hematologic
Very common (10% or more): Febrile neutropenia (up to 25%), anemia (up to 18%), neutropenia (up to 16%), thrombocytopenia (up to 11%)
Common (1% to 10%): Leukopenia, leukocytosis, lymphopenia
Uncommon (0.1% to 1%): Capillary leak syndrome[Ref]
Hypersensitivity
Common (1% to 10%): Hypersensitivity[Ref]
Immunologic
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%): Pneumonia, sepsis, decreased immunoglobulins, increased blood bilirubin, increased gammaglutamyl-transferase, increased liver enzymes[Ref]
Local
Common (1% to 10%): Cytokine storm[Ref]
Metabolic
Very common (10% or more): Hypokalemia (up to 23%), hypomagnesemia (up to 12%), hyperglycemia (up to 11%), decreased appetite (up to 10%)
Common (1% to 10%): Hypophosphatemia, tumor lysis syndrome, hypoalbuminemia[Ref]
Musculoskeletal
Very common (10% or more): Back pain (14%), pain in extremity (up to 12%), bone pain (11%), arthralgia (10%)[Ref]
Nervous system
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]
Other
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%)
INVESTIGATIONS:
Very common (10% or more): Increased alanine aminotransferase (up to 12%), increased aspartate aminotransferase (up to 11%)[Ref]
Psychiatric
Very common (10% or more): Insomnia (up to 15%),
Common (1% to 10%): Confusion, disorientation[Ref]
Respiratory
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]
