Bone and connective tissue cancer:

Indications for: DANYELZA

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.

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.

Boxed Warning:

Serious infusion-related reactions. Neurotoxicity.

DANYELZA 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 Classification:

GD2-binding monoclonal antibody.

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).

Generic Drug Availability:


How Supplied:

Single-dose vial (10mL)—1