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Blinatumomab Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jan 31, 2023.

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

    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 However, FDA later rescinded REMS requirements.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]

Frequently asked questions

References

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.

Further information

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.

Medical Disclaimer