Dinutuximab Side Effects

Medically reviewed by Drugs.com. Last updated on Apr 28, 2024.

Applies to dinutuximab: intravenous solution.

Important warnings This medicine can cause some serious health issues

Intravenous route (solution)

Serious and possibly life-threatening infusion reactions have been reported in 26% of patients receiving treatment with dinutuximab.

Administer prehydration and premedication prior to each infusion and monitor patients for signs and symptoms of infusion reactions during treatment and for at least 4 hours after the infusion is completed.

If severe infusion reactions occur during treatment, immediately stop the infusion.

Permanently discontinue use if anaphylaxis occurs.

Dinutuximab causes serious neurologic adverse reactions including severe neuropathic pain in most patients, as well as peripheral neuropathy (eg, peripheral sensory neuropathy, severe motor neuropathy).

Not all cases of neuropathy were resolved during clinical trials.

Administer IV opioids prior to, during, and for 2 hours after completion of treatment.

Discontinue use if severe unresponsive pain, severe sensory neuropathy, or moderate to severe peripheral motor neuropathy occur.

Serious side effects of dinutuximab

Along with its needed effects, dinutuximab 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 dinutuximab:

More common side effects

• black, tarry, stools
• bleeding gums
• blood in the urine or stools
• blurred vision
• chills
• cloudy urine
• coma
• confusion
• convulsions
• cough or hoarseness
• decrease or increase in the amount of urine
• difficult or labored breathing
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• fainting or lightheadedness
• fast or irregular heartbeat
• fever
• headache
• hives or welts, itching, or skin rash
• increased thirst
• irregular heartbeat
• loss of appetite
• lower back or side pain
• muscle pain or cramps
• nausea or vomiting
• noisy breathing
• numbness or tingling in the hands, feet, or lips
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• redness of the skin
• sore throat
• stomach pain
• sweating
• swelling of the face, hands, ankles, feet, or lower legs
• tightness in the chest
• troubled breathing with exertion
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness

Less common side effects

• back pain
• bigger, dilated, or enlarged pupils (black part of the eye)
• burning, numbness, tingling, or painful sensations
• change in color vision
• change in the ability to see colors, especially blue or yellow
• chest pain
• difficulty seeing at night
• drooping upper eyelids
• increased sensitivity of the eyes to sunlight
• muscle or joint pain
• nerve pain
• pain in the arms or legs
• unsteadiness or awkwardness
• weakness in the arms, hands, legs, or feet

Incidence not known

• yellow eyes or skin

Other side effects of dinutuximab

Some side effects of dinutuximab 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

• diarrhea

For healthcare professionals

Applies to dinutuximab: intravenous solution.

General adverse events

The most common adverse drug reactions (25% or more) are pain, pyrexia, thrombocytopenia, lymphopenia, infusion reactions, hypotension, hyponatremia, increased alanine aminotransferase, anemia, vomiting, diarrhea, hypokalemia, capillary leak syndrome, neutropenia, urticaria, hypoalbuminemia, increased aspartate aminotransferase, and hypocalcemia.

Dermatologic

• Very common (10% or more): Urticaria (37%)^[Ref]

Gastrointestinal

• Very common (10% or more): Pain (85%) (e.g., gingival pain, proctalgia, oropharyngeal pain, abdominal pain, abdominal pain upper), vomiting (46%), diarrhea (43%), nausea (10%)^[Ref]

Genitourinary

• Very common (10% or more): Pain (85%) (e.g., bladder pain), proteinuria (16%)^[Ref]

Hematologic

• Very common (10% or more): Thrombocytopenia (66%), lymphopenia (62%), anemia (51%), neutropenia (39%)^[Ref]

Hepatic

• Very common (10% or more): Increased alanine aminotransferase (56%), increased aspartate aminotransferase (28%)^[Ref]

Hypersensitivity

• Very common (10% or more): Infusion reactions (66%)^[Ref]

Immunologic

• Very common (10% or more): Patients developing anti-drug antibodies to dinutuximab (18%), sepsis (18%), device related infection (16%)^[Ref]

Local

• Very common (10% or more): Infusion related pain (85%)^[Ref]

Metabolic

• Very common (10% or more): Hyponatremia (58%), hypokalemia (43%), hypoalbuminemia (33%), hypocalcemia (27%), hypophosphatemia (20%), hyperglycemia (16%), hypertriglyceridemia (16%), decreased appetite (up to 15%), hypomagnesemia (12%), increased weight (10%)^[Ref]

Musculoskeletal

• Very common (10% or more): Pain (85%) (e.g., arthralgia, back pain, bone pain, chest pain, facial pain, musculoskeletal chest pain, myalgia, nick pain, pain in extremity)^[Ref]

Nervous system

• Very common (10% or more): Peripheral neuropathy (13%)^[Ref]

Ocular

• Frequency not reported: Blurred vision, photophobia, mydriasis, fixed or unequal pupils, optic nerve disorder, eyelid ptosis, papilledema, loss of vision^[Ref]

Other

• Very common (10% or more): Pain (85%) (e.g., abdominal pain, abdominal pain upper, arthralgia, back pain, bladder pain, bone pain, chest pain, facial pain, gingival pain, musculoskeletal chest pain, myalgia, neck pain, neuralgia, oropharyngeal pain, pain in extremity, proctalgia), pyrexia (72%), edema (17%)^[Ref]

Renal

• Very common (10% or more): Increased serum creatinine (15%)^[Ref]

Respiratory

• Very common (10% or more): Hypoxia (24%)^[Ref]

Cardiovascular

• Very common (10% or more): Hypotension (60%), capillary leak syndrome (40%), hemorrhage (17%) (including gastrointestinal hemorrhage, hematochezia, rectal hemorrhage, hematemesis, upper GI hemorrhage, hematuria, hemorrhage urinary tract, renal hemorrhage, epistaxis, respiratory tract hemorrhage, disseminated intravascular coagulation, catheter site hemorrhage, hematoma), hypertension (14%), tachycardia (19%) (e.g., tachycardia, sinus tachycardia)^[Ref]

Further information

Dinutuximab 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.

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