Dinutuximab

What it is and how it works

Mechanism of Action Dinutuximab binds to the glycolipid GD2. This glycolipid is expressed on neuroblastoma cells and on normal cells of neuroectodermal origin, including the central nervous system and peripheral nerves. Dinutuximab binds to cell surface GD2 and induces cell lysis of GD2-expressing cells through antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).

Mechanism class: Glycolipid Disialoganglioside-directed Antibody Interactions

Indications

Unituxin (dinutuximab) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy . Unituxin is a GD2-binding monoclonal antibody indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy.

Dosage and administration (summary)

Verify that patients have adequate hematologic, respiratory, hepatic, and renal function prior to initiating each course of Unituxin . Administer required premedication and hydration prior to initiation of each Unituxin infusion . 17.5 mg/m 2 /day as a diluted intravenous infusion over 10 to 20 hours for 4 consecutive days for up to 5 cycles. ( 2.1 , 2.4 ) Recommended Dose The recommended dose of Unituxin is 17.5 mg/m 2 /day administered as an intravenous infusion over 10 to 20 hours for 4 consecutive days for a maximum of 5 cycles (Table 1 and Table 2) . Initiate at an infusion rate of 0.875 mg/m 2 /hour for 30 minutes.

Contraindications

Unituxin is contraindicated in patients with a history of anaphylaxis to dinutuximab. History of anaphylaxis to dinutuximab.

Warnings and precautions

Neurological Disorders of the Eye: Interrupt Unituxin for dilated pupil with sluggish light reflex or other visual disturbances and permanently discontinue Unituxin for recurrent eye disorders or loss of vision. Prolonged Urinary Retention and Transverse Myelitis: Permanently discontinue Unituxin and institute supportive care. Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Permanently discontinue Unituxin and institute supportive care for signs and symptoms of RPLS.

Pregnancy

Pregnancy Risk Summary Based on its mechanism of action, Unituxin may cause fetal harm when administered to a pregnant woman . There are no studies in pregnant women and no reproductive studies in animals to inform the drug-associated risk.

Storage and supply

Store Unituxin vials under refrigeration at 2°C to 8°C (36°F to 46°F) in the outer carton to protect from light until time of use. Do not freeze or shake the vial.

Source: Dinutuximab (Unituxin) — US FDA prescribing information, 2026-07-06, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.