• Relapsed or refractory high-risk neuroblastoma in the bone or bone marrow in patients who have demonstrated a partial response, minor response, or stable disease to prior therapy (in combination with granulocyte-macrophage colony-stimulating factor [GM-CSF]).

Contraindicated in:

• Severe hypersensitivity
• Uncontrolled hypertension
• OB: Pregnancy (may cause fetal harm)
• Lactation: Lactation.

Use Cautiously in:

• Women of reproductive potential
• Pedi: Children <1 yr (safety and effectiveness not established).

CV: hypertension, peripheral edema, tachycardia.

Derm: ↑ sweating, erythema multiforme, urticaria.

EENT: blurred vision, impaired vision, mydriasis, photophobia, rhinorrhea, unequal pupils.

Endo: hyperglycemia, hypoglycemia.

F and E: hypocalcemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia.

GI: ↑ liver enzymes, constipation, diarrhea, hypoalbuminemia, nausea, vomiting.

GU: urinary retention.

Hemat: anemia, lymphocytopenia, neutropenia, thrombocytopenia.

Local: injection site reaction.

Metab: ↓ appetite, ↓ weight.

Neuro: anxiety, fatigue, headache, irritability, neuropathic pain, peripheral neuropathy, sedation, POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME (PRES), transverse myelitis.

Resp: cough.
Misc: fever, infusion reactions, (INCLUDING ANAPHYLAXIS)HYPERSENSITIVITY REACTIONS .

Drug-Drug:

• None reported.

• Solution for injection: 4 mg/mL;

• IV (Adults): 3 mg/kg/day (max = 150 mg/day) on Days 1, 3, and 5 of each treatment cycle. Repeat treatment cycle every 4 wk until complete response or partial response, then repeat treatment cycle every 4 wk for 5 cycles. Subsequent treatment cycles may be repeated every 8 wk. Discontinue treatment if disease progression or unacceptable toxicity occurs.

Danyelza

• Acts as a glycolipid disialoganglioside (GD2)-binding monoclonal antibody that binds to specific cells in the CNS and peripheral nerves, inducing cell lysis through antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity.

• Decreased progression of neuroblastoma.

Therapeutic Classification: antineoplastics, n/a

Pharmacologic Classification: monoclonal antibodies

Absorption: IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism/Excretion: Metabolized into small peptides.

Half-life: 8.2 days.

(plasma concentrations)

• Explain purpose of naxitamab to patient. Advise patient to read Patient Information before starting therapy and periodically during therapy in case of changes.
• Advise patient to notify health care professional immediately if signs and symptoms of infusion related reactions (swelling of face, eyes, lips, mouth, or tongue; itching; redness on face [flushing]; rash; hives; trouble breathing; cough; wheezing; noisy high-pitched breathing; feeling faint or dizziness [low blood pressure]) occur.
• Advise patient to notify health care professional if signs and symptoms of severe pain (severe pain in abdomen, bones, neck, legs, arms); inflammation of spinal cord (weakness in legs or arms; bladder and bowel problems; pain in back, legs, or abdomen; numbness; tingling; burning sensation); PRES (severe headache; vision changes; changes in mental status [confusion, disorientation, decreased alertness], difficulty speaking; weakness in arms or legs; seizures); numbness, tingling, or burning sensation in the arms or legs; nervous system problems of the eye (unequal pupil size, blurred vision, trouble focusing your eyes, dilated pupils, decreased ability to see, sensitivity to light) or problems urinating or emptying your bladder occur.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking Rx, OTC, or herbal products.
• May cause fetal harm. Advise female of reproductive potential to use effective contraception and avoid breastfeeding during and for 2 mo after last dose of naxitamab.

nax-IT-a-mab