dinutuximab

REMS

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]) .

Contraind./Precautions ⬆ ⬇

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;

Adv. Reactions/Side Effects ⬆ ⬇

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

Interactions ⬆ ⬇

Drug-drug:

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

Availability ⬆ ⬇

Solution for injection: 3.5 mg/mL

Route/Dosage ⬆ ⬇

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

US Brand Names ⬆ ⬇

Action ⬆ ⬇

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).

Therapeutic effects:

Decreased progression of neuroblastoma.

Classifications ⬆ ⬇

Therapeutic Classification: antineoplastics

Pharmacologic Classification: monoclonal antibodies

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: 10 days.

Time/Action Profile ⬆ ⬇

(event-free survival probability)

ROUTE	ONSET	PEAK	DURATION
IV	6 mo	2 yr	unknown

Patient/Family Teaching ⬆ ⬇

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.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

66302- United Therapeutics Corporation
- 66302-014- Unituxin
  - 66302-014-01- 1 VIAL, SINGLE-DOSE in 1 BOX (66302-014-01) / 5 mL in 1 VIAL, SINGLE-DOSE

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Indications ⬇