Blincyto Side Effects
Generic name: blinatumomab
Note: This document contains side effect information about blinatumomab. Some dosage forms listed on this page may not apply to the brand name Blincyto.
Applies to blinatumomab: intravenous powder for solution.
Warning
Intravenous route (Powder for Solution)
Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving blinatumomab; interrupt or discontinue blinatumomab and treat with corticosteroids as recommended. Neurological toxicities, which may be severe, life-threatening, or fatal, occurred in patients receiving blinatumomab. Interrupt or discontinue blinatumomab as recommended.
Serious side effects of Blincyto
Along with its needed effects, blinatumomab (the active ingredient contained in Blincyto) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking blinatumomab:
More common
- Agitation
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blurred vision
- chest pain or tightness
- chills
- confusion
- cough
- dizziness
- fever
- headache
- hoarseness
- irritability
- lower back or side pain
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- rapid, shallow breathing
- seeing, hearing, or feeling things that are not there
- seizures
- sore throat
- stiff neck
- tingling of the hands or feet
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- vomiting
Incidence not known
- Cloudy urine
- darkened urine
- discouragement
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- extremely high fever or body temperature
- eye pain
- feeling sad or empty
- general feeling of illness
- irritability
- lack or loss of strength
- loss of interest or pleasure
- mood or mental changes
- pains in the stomach, side, or abdomen, possibly radiating to the back
- persistent bleeding or oozing from puncture sites, mouth, or nose
- pounding in the ears
- problems with speech or speaking
- rash
- slow or fast heartbeat
- stomach pain
- sweating
- swelling of the hands, ankles, feet, or lower legs
- trouble sleeping
- ulcers, sores, or white spots in the mouth
- yellow eyes or skin
Other side effects of Blincyto
Some side effects of blinatumomab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Bone, joint, or muscle pain
- change in urination
- decreased appetite
- diarrhea
- difficulty having a bowel movement
- dry mouth
- increased hunger or thirst
- irregular heartbeat
- muscle pain or cramps
- pain in the arms or legs
- shakiness in the legs, arms, hands, or feet
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
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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.