Summary

Commonly reported side effects of dinutuximab include: capillary leak syndrome, sepsis, severe hypokalemia, severe hypotension, severe infusion related reaction, severe thrombocytopenia, SIADH, infusion related reaction, hypotension, peripheral neuropathy, urticaria, abdominal pain, anemia, back pain, eye disease, fever, hypertension, hypocalcemia, hypokalemia, hyponatremia, limb pain, musculoskeletal chest pain, neuralgia, neutropenia, pain, and bacteremia. Other side effects include: febrile neutropenia, and peripheral sensory neuropathy. Continue reading for a comprehensive list of adverse effects.

Applies to dinutuximab: intravenous solution.

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

• 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

• 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

• Diarrhea

For Healthcare Professionals

Applies to dinutuximab: intravenous solution.

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]

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]

General

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.