Note: This document contains side effect information about dinutuximab. Some dosage forms listed on this page may not apply to the brand name Unituxin.
Summary
Common side effects of Unituxin 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.
Warning
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 Unituxin
Along with its needed effects, dinutuximab (the active ingredient contained in Unituxin) 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 Unituxin
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 (the active ingredient contained in Unituxin) (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.
