Blinatumomab Side Effects

In Summary

Commonly reported side effects of blinatumomab include: convulsions, encephalopathy, febrile neutropenia, opportunistic infection, cytokine release syndrome, confusion, disorientation, equilibrium disturbance, fever, headache, hypotension, impaired consciousness, 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. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to blinatumomab: intravenous powder for solution

In addition to its needed effects, some unwanted effects may be caused by blinatumomab. In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking blinatumomab, check with your doctor or nurse immediately:

• Agitation
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blurred vision
• chest pain
• confusion
• cough or hoarseness
• dizziness
• fever or chills
• headache
• 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
• tightness in the chest
• tingling of the hands or feet
• troubled breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• vomiting

• 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

Minor Side Effects

Some of the side effects that can occur with blinatumomab may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

• 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]

Not all side effects for blinatumomab may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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