Blinatumomab Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jan 21, 2025.

Applies to blinatumomab: intravenous powder for solution.

Precautions

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests are needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before receiving this medicine. Use an effective form of birth control during treatment and for at least 48 hours after your treatment ends to keep from getting pregnant. If you think you have become pregnant while receiving this medicine, tell your doctor right away.

This medicine may cause cytokine release syndrome (CRS) and infusion reactions. These may be life-threatening and require immediate attention. Tell your doctor right away if you or your child have a fever, chills, headache, nausea, lightheadedness, dizziness, fainting, skin rash, trouble breathing, or tiredness or weakness.

Check with your doctor right away if you or your child have seizures, loss of balance, loss of consciousness, confusion, disorientation, difficulty with speaking, or slurred speech.

This medicine can temporarily lower the number of white blood cells in your blood, which increases your chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you or your child are getting an infection or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may cause a serious reaction, called tumor lysis syndrome (TLS). Your doctor may give you a medicine to help prevent this. Call your doctor right away if you or your child have a change in how much or how often you urinate, muscle or joint pain, rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.

Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you or your child have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

This medicine may make you dizzy, confused, or less alert than you are normally. Do not drive or do anything else that could be dangerous until you or your child know how this medicine affects you.

While you are being treated with blinatumomab, do not have any immunizations (vaccinations) without your doctor's approval. Live virus vaccinations should not be given for at least 2 weeks before start of treatment, during treatment, and until recovery following the last cycle of this medicine.

This medicine may contain benzyl alcohol which may cause serious reactions (eg, gasping syndrome) to newborn or premature infants. Talk to your doctor if you have concerns.

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:

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:

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

See also:

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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer