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Danyelza Generic Name & Formulations
Legal Class
Rx
General Description
Naxitamab-gqgk 4mg/mL; per vial; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
GD2-binding monoclonal antibody.
How Supplied
Single-dose vial (10mL)—1
Manufacturer
Generic Availability
NO
Danyelza Indications
Indications
In combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy.
Danyelza Dosage and Administration
Adults and Children
<1yr: not established. Premedicate with an antihistamine, acetaminophen, an H2 antagonist, antiemetic, and/or corticosteroid prior to or during infusions, as appropriate: see full labeling. First infusion (Cycle 1, Day 1): give by IV infusion over 60mins. Subsequent infusions: give by IV over 30–60mins, as tolerated. ≥1yr: 3mg/kg/day (max 150mg/day) on Days 1, 3, and 5 of each 4-week cycle until complete or partial response, followed by 5 additional cycles every 4 weeks; subsequent cycles may be repeated every 8 weeks. Days -4 to 0: administer GM-CSF 250mcg/m2/day by SC inj starting 5 days prior to Danyelza infusion; Days 1 to 5: administer GM-CSF 500mcg/m2/day by SC inj at least 1hr prior to Danyelza infusion on Days 1, 3, and 5. Discontinue Danyelza and GM-CSF for disease progression or unacceptable toxicity. Other supportive treatments and dosage modifications: see full labeling.
Danyelza Contraindications
Not Applicable
Danyelza Boxed Warnings
Boxed Warning
Serious infusion-related reactions. Neurotoxicity.
Danyelza Warnings/Precautions
Warnings/Precautions
Have resuscitative medications and equipment available. Risk of serious infusion-related reactions. Monitor closely during and for at least 2 hours after completion of each infusion; reduce infusion rate, interrupt, or permanently discontinue based on severity; treat appropriately. Risk of severe neurotoxicity. Permanently discontinue if Grade 3 neuropathic pain unresponsive to maximum supportive measures, all Grades of RPLS, all Grades of transverse myelitis, Grade ≥2 motor neuropathy, Grade 3/4 sensory neuropathy, neurological eye disorders (subtotal or total vision loss), prolonged urinary retention following discontinuation of opioids develop. Uncontrolled hypertension: do not initiate. Monitor BP during and at least daily on Days 1–8 of each cycle; evaluate for complications (including RPLS); interrupt infusion, resume at a reduced rate, or permanently discontinue based on the severity. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 2 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 months after the last dose).
Danyelza Pharmacokinetics
See Literature
Danyelza Interactions
Danyelza Adverse Reactions
Adverse Reactions
Infusion-related reaction, pain, tachycardia, vomiting, cough, nausea, diarrhea, decreased appetite, hypertension, fatigue, erythema multiforme, peripheral neuropathy, urticaria, pyrexia, headache, inj site reaction, edema, anxiety, localized edema, irritability, Grade 3 or 4 laboratory abnormalities (decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased platelet count, decreased potassium, increased ALT, decreased glucose, decreased calcium, decreased albumin, decreased sodium, decreased phosphate).
Danyelza Clinical Trials
See Literature
Danyelza Note
Not Applicable
Danyelza Patient Counseling
See Literature
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