Dinutuximab

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.

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).

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.

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

Boxed warning (serious infusion reactions and neurotoxicity warning: serious infusion reactions and neurotoxicity): Infusion Reactions: Life-threatening infusion adverse reactions occur with Unituxin. Administer required prehydration and premedication. Immediately interrupt for severe infusion reactions and permanently discontinue for anaphylaxis. Neurotoxicity: Unituxin causes severe neuropathic pain. 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.

The following adverse reactions are discussed in greater detail in other sections of the labeling: Serious Infusion Reactions Neurotoxicity, including Pain, Peripheral Neuropathy, Neurological Disorders of the Eye, Prolonged Urinary Retention, Transverse Myelitis, and Reversible Posterior Leukoencephalopathy Syndrome Capillary Leak Syndrome Hypotension Infection Bone Marrow Suppression Electrolyte Abnormalities Atypical Hemolytic Uremic Syndrome Embryo-Fetal Toxicity The most common adverse drug reactions (≥25%) are pain, pyrexia, thrombocytopenia, lymphopenia, infusion reactions, hypotension, hyponatremia, increased alanine aminotransferase, anemia, vomiting, diarrhea, hypokalemia, capillary leak syndrome, neutropenia, urticaria, hypoalbuminemia, increased aspartate aminotransferase, and hypocalcemia.

No drug-drug interaction studies have been conducted with dinutuximab.

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.