Danyelza Side Effects

Generic name: naxitamab

Medically reviewed by Drugs.com. Last updated on Sep 24, 2023.

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

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]