• High-risk neuroblastoma in patients who have had at least a partial response to previous first-line multiagent, multimodality therapy (in combination with granulocyte-macrophage colony-stimulating factor [GM-CSF], interleukin-2 [IL-2], and 13-cis-retinoic acid [RA]).

Contraindicated in:

• Previous anaphylactic reaction to dinutuximab
• OB: Pregnancy (may cause fetal harm)
• Lactation: Lactation.

Use Cautiously in:

• Renal or hepatic impairment
• Rep: Women of reproductive potential

CV: capillary leak syndrome, hypotension, tachycardia.

Derm: urticaria.

EENT: neurologic disorders of the eye.

F and E: hypocalcemia, hypokalemia, hyponatremia.

GI: ↓ appetite, ↑ liver enzymes, diarrhea, vomiting.

GU: proteinuria, urinary retention.

Hemat: anemia, lymphopenia, neutropenia, thrombocytopenia, ATYPICAL HEMOLYTIC UREMIC SYNDROME.

Metab: ↑ weight, hyperglycemia, hypertriglyceridemia, hypoalbuminemia.

Neuro: neuropathic pain , reverse posterior leukoencephalopathy syndrome (rpls) , peripheral neuropathy, transverse myelitis.

Resp: hypoxia.

Misc: pain, INFUSION-RELATED REACTIONS.

Drug-Drug:

• ↑ risk of myelosuppression with other myelosuppressants, antineoplastics and radiation therapy.

• Solution for injection: 3.5 mg/mL;

• IV (Children): 17.5 mg/m² once daily for 4 consecutive days for up to 5 cycles.

Unituxin

• 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 (ADCC) and complement-dependent cytotoxicity (CDC).

• Decreased progression of neuroblastoma.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: monoclonal antibodies

Absorption: IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-life: 10 days.

(event-free survival probability)

• Explain purpose of dinutuximab to patient and caregivers.
• Advise patient to notify health care professional if signs and symptoms of infusion reaction (facial or lip swelling, urticaria, difficulty breathing, lightheadedness or dizziness occurring during or within 24 hours after infusion), capillary leak syndrome, hypotension, infection, or hemolytic uremic syndrome occur.
• Inform patient and caregiver of risk of pain and peripheral neuropathy. Advise patient to notify health care professional if pain, numbness, tingling, burning, or weakness occur.
• Advise patient to notify health care professional if signs and symptoms of neurological eye disorder (blurred vision, photophobia, ptosis, diplopia, unequal pupil size) occur.
• Rep: May cause fetal harm. Caution females of reproductive potential to use effective contraception during and for at least 2 mo following therapy. Advise patient to avoid breastfeeding during therapy.

di-noo-TUX-i-mab

NDC Code^*

• 66302- United Therapeutics Corp.
  • 66302-014- Unituxin
    • 66302-014-01- 1 VIAL, SINGLE-USE in 1 BOX (66302-014-01) > 5 mL in 1 VIAL, SINGLE-USE