Note: This document contains side effect information about naxitamab. Some dosage forms listed on this page may not apply to the brand name Danyelza.
Applies to naxitamab: intravenous solution.
Warning
Intravenous route (Solution)
Warning: Serious Infusion-related Reactions and NeurotoxicitySerious Infusion-related Reactions: Naxitamab-gqgk can cause serious infusion reactions, including cardiac arrest, anaphylaxis, hypotension, bronchospasm, and stridor. Premedicate prior to each naxitamab-gqgk infusion as recommended. Reduce the rate, interrupt infusion, or permanently discontinue naxitamab-gqgk based on severity.Neurotoxicity: Naxitamab-gqgk can cause severe neurotoxicity, including severe neuropathic pain, transverse myelitis, and reversible posterior leukoencephalopathy syndrome (RPLS). Premedicate to treat neuropathic pain as recommended. Permanently discontinue naxitamab-gqgk based on the adverse reaction and severity.
Serious side effects of Danyelza
Along with its needed effects, naxitamab (the active ingredient contained in Danyelza) 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 naxitamab:
More common
- Back pain, sudden and severe
- bigger, dilated, or enlarged pupils (black part of eye)
- blurred vision
- bone pain
- burning, numbness, tingling, or painful sensations
- change in color vision
- chest tightness
- confusion
- decrease in frequency of urination
- decrease in urine volume
- difficulty in passing urine
- difficulty seeing at night
- dizziness
- drowsiness
- fever
- flushing
- headache
- increased sensitivity of the eyes to light
- muscle weakness, sudden and progressing
- nausea and vomiting
- nervousness
- painful urination
- pounding in the ears
- seizures
- slow or fast heartbeat
- stomach pain
- swelling
- trouble breathing
- unsteadiness or awkwardness
- unusual tiredness or weakness
- weakness in the arms, hands, legs, or feet
Less common
- Constipation
- diarrhea
Other side effects of Danyelza
Some side effects of naxitamab 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
- Blistering, peeling, loosening of the skin
- chills
- cough
- decreased appetite
- fast heartbeat
- flushing, redness of the skin
- increased sweating
- itching
- joint or muscle pain
- red, irritated eyes
- runny nose
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness
- unusually warm skin
For Healthcare Professionals
Applies to naxitamab: intravenous solution.
Hematologic
Very common (10% or more): Lymphocytes decreased (74%), platelet count decreased (65%), neutrophils decreased (61%), hemoglobin decreased (48%)[Ref]
Hypersensitivity
Very common (10% or more): Anaphylactic reaction (12%)[Ref]
Immunologic
Very common (10% or more): Influenza (12%)[Ref]
Local
Very common (10% or more): Infusion related reactions (e.g., hypotension, bronchospasm, flushing, wheezing, stridor, urticaria, dyspnea, pyrexia, infusion-related reaction, face edema, edema mouth, tongue edema, lip edema, respiratory tract edema, chills, hypoxia, pruritus, rash) (all Grades: 100%; Grade 3 or 4: 68%)[Ref]
Ocular
Very common (10% or more): Neurological disorders of the eye (e.g., unequal pupils, blurred vision, mydriasis) (24%)[Ref]
Metabolic
Very common (10% or more): Anorexia (53%), weight loss (12%)[Ref]
Psychiatric
Very common (10% or more): Anxiety (26%), irritability (25%)[Ref]
Respiratory
Very common (10% or more): Cough (60%), cough (57%), rhinorrhea (24%), breath sounds abnormal (15%), rhinovirus infection (12%), enterovirus infection (13%), upper respiratory tract infection (12%)[Ref]
Other
Very common (10% or more): Pain (e.g., pain, abdominal pain, pain in extremity, bone pain, neck pain, back pain, musculoskeletal pain) (all Grades: 100%; Grade 3 or 4: 72%), fatigue/asthenia (28%), pyrexia not occurring on the day of infusion or the day following an infusion (28%), contusion (15%)[Ref]
General
The most common adverse reactions were infusion-related reaction, pain, tachycardia, vomiting, cough, nausea, diarrhea, decreased appetite, hypertension, fatigue, erythema multiforme, peripheral neuropathy, urticaria, pyrexia, headache, injection site reaction, edema, anxiety, localized edema, and irritability. The most common Grade 3 or 4 laboratory abnormalities (5% or greater) were decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased platelet count, decreased potassium, increased alanine aminotransferase, decreased glucose, decreased calcium, decreased albumin, decreased sodium, and decreased phosphate.[Ref]
Nervous system
Very common (10% or more): Peripheral neuropathy (e.g., peripheral sensory neuropathy, paresthesia, neuralgia) (32%), headache (28%), depressed level of consciousness (24%), lethargy (14%)
Postmarketing reports: Transverse myelitis[Ref]
Cardiovascular
Very common (10% or more): Tachycardia/sinus tachycardia (84%), hypertension (all Grades: 44%; Grade 3 or 4: 4%), localized edema (25%)
Common (1% to 10%): Peripheral edema[Ref]
Dermatologic
Very common (10% or more): Erythema multiforme (33%), urticaria not occurring on the day of infusion or the day following an infusion (32%), hyperhidrosis (17%), erythema (11%)[Ref]
Gastrointestinal
Very common (10% or more): Vomiting (all Grades: 60%; Grade 3 or 4: 4%), diarrhea (all Grades: 56%; Grade 3 or 4: 8%), nausea (56%), constipation (15%), oropharyngeal pain (15%)[Ref]
