Dinutuximab (1 brand name, 1 dosage form, 1 route)
Available dosage forms: INJECTABLE.
Routes of administration: INTRAVENOUS.
Brand Names
- UNITUXIN
Indications and Usage
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 [see Clinical Studies (14)].
Dosage and Administration
Verify that patients have adequate hematologic, respiratory, hepatic, and renal function prior to initiating each course of Unituxin [see Clinical Studies (14)]. Administer required premedication and hydration prior to initiation of each Unituxin infusion [see Dosage and Administration (2.2)].
Contraindications
Unituxin is contraindicated in patients with a history of anaphylaxis to dinutuximab.
Adverse Reactions
The following adverse reactions are discussed in greater detail in other sections of the labeling: Serious Infusion Reactions [see Boxed Warning and Warnings and Precautions (5.1)] Neurotoxicity, including Pain, Peripheral Neuropathy, Neurological Disorders of the Eye, Prolonged Urinary Retention, Transverse Myelitis, and Reversible Posterior Leukoencephalopathy Syndrome [see Boxed Warning and Warnings and Precautions (5.2)] Capillary Leak Syndrome [see Warnings and Precautions (5.3)] Hypotension [see Warnings and Precautions (5.4)] Infection [see Warnings and Precautions (5.5)] Bone Marrow Suppression [see Warnings and Precautions (5.6)] Electrolyte Abnormalities [see Warnings and Precautions (5.7)] Atypical Hemolytic Uremic Syndrome [see Warnings and Precautions (5.8)] Embryo-Fetal Toxicity [see Warnings and Precautions (5.9)]
Drug Interactions
No drug-drug interaction studies have been conducted with dinutuximab.
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).