Blinatumomab Side Effects

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

Applies to blinatumomab: intravenous powder for solution.

Important warnings This medicine can cause some serious health issues

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 blinatumomab

Along with its needed effects, blinatumomab 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 side effects

• 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 blinatumomab

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 side effects

• 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.

General adverse events

The most common adverse reactions occurring in 20% of patients or greater were pyrexia, infusion-related reactions, headache, infections (pathogen unspecified), tremor, nausea, anemia, thrombocytopenia, edema, febrile neutropenia, and chills.^[Ref]

Cardiovascular

• Very common (10% or more): Arrhythmia (up to 14%), hypotension (up to 14%), tachycardia (up to 10.6%)
• Frequency not reported: Hypertension/increased blood pressure, hypotension, flushing/hot flush, capillary leak syndrome

Arrhythmia includes bradycardia, sinus arrhythmia, sinus bradycardia, sinus tachycardia, and ventricular extrasystoles.

Dermatologic

• Very common (10% or more): Rashes such as contact dermatitis, eczema, erythema, and maculopapular rash (up to 16%)

Gastrointestinal

• Very common (10% or more): Diarrhea (up to 19.7%), vomiting (up to 19%), nausea (up to 23.9%), constipation (up to 13.5%), abdominal pain (up to 10.6%)
• Postmarketing reports: Life-threatening or fatal pancreatitis (in combination with dexamethasone)

Hematologic

• Very common (10% or more): Neutropenia (up to 31%), leukopenia (up to 14%), thrombocytopenia (up to 21%), anemia (up to 25%), decreased lymphocyte count (up to 80%), decreased white blood cell count (up to 53%), decreased hemoglobin (up to 29%), decreased neutrophil count (up to 57%), decreased platelet count (up to 47%), febrile neutropenia (up to 20.4%)
• Common (1% to 10%): Leukocytosis
• Uncommon (0.1% to 1%): Lymphadenopathy, hematophagic histiocytosis

Hepatic

• Very common (10% or more): Hypertransaminasemia/elevated liver enzymes (up to 15%), increased ALT (up to 11%)
• Common (1% to 10%): Increased bilirubin, increased AST
• Frequency not reported: Hyperbilirubinemia

Hypersensitivity

• Frequency not reported: Hypersensitivity and reactions related such as anaphylaxis, angioedema, allergic dermatitis, drug eruption, drug hypersensitivity, erythema multiforme, and urticaria

Immunologic

• Very common (10% or more): Infusion-related reactions (up to 77%), decreased immunoglobulins (up to 18%), cytokine release syndrome (up to 14%)
• Common (1% to 10%): Anti-blinatumomab antibodies

Infusion-related reaction includes the term infusion-related reaction and the following events occurring with the first 48 hours of infusion lasting 2 days or less: cytokine release syndrome, eye swelling, hypertension, hypotension, myalgia, periorbital edema, pruritus generalized, pyrexia, and rash.

Decreased immunoglobulins includes decreased immunoglobulin A, immunoglobulin G, immunoglobulin M, hypogammaglobulinemia, and hypoglobulinemia.

Metabolic

• Frequency not reported: Increased alkaline phosphatase, tumor lysis syndrome

Musculoskeletal

• Very common (10% or more): Back pain (up to 12%)
• Frequency not reported: Chest pain (non-cardiac), pain in extremity, bone pain

Nervous system

• Very common (10% or more): Headache (up to 39%), tremor (up to 31%), aphasia (up to 12%), dizziness (up to 10%), encephalopathy (up to 10%)
• Frequency not reported: Immune effector cell-associated neurotoxicity syndrome (ICANS), seizures/generalized tonic-clonic seizures, speech disorder, hypoesthesia, tremor, altered state of consciousness, dizziness, memory impairment, aphasia, cognitive disorder, speech disorder, hypoesthesia, encephalopathy, paresthesia, and cranial nerve disorders

Some neurological adverse effects may represent signs/symptoms of immune effector cell-associated neurotoxicity syndrome (ICANS).

Encephalopathy includes cognitive disorder, depressed level of consciousness, disturbance in attention, lethargy, leukoencephalopathy, memory impairment, somnolence, and toxic encephalopathy.

Tremor includes essential and intention tremors.

Other

• Very common (10% or more): Pyrexia/increased body temperature (up to 91%), infections with unspecified pathogen (up to 39%), chills (up to 28%), increased weight (up to 10%), edema (up to 18%), viral infection (up to 11%), bacterial infection (up to 14%), fungal infections (up to 10%)
• Common (1% to 10%): Sepsis
• Frequency not reported: Peripheral edema, pain, medication error and overdose, hyperthermia, systemic inflammatory response syndrome

Psychiatric

• Very common (10% or more): Insomnia (up to 18%)
• Frequency not reported: Confusional state, disorientation, depression

Respiratory

• Very common (10% or more): Cough (up to 13%)
• Common (1% to 10%): Pneumonia, dyspnea, productive cough, wheezing
• Uncommon (0.1% to 1%): Exertional dyspnea, acute respiratory failure

Frequently asked questions

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Further information

Blinatumomab side effects can vary depending on the individual. 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