Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Dinutuximab
Drug ID BADD_D00685
Description Dinutuximab is an IgG1 monoclonal human/mouse chimeric antibody against GD2, a disialoganglioside expressed on tumors of neuroectodermal origin, including human neuroblastoma and melanoma, with highly restricted expression on normal tissues. It is composed of the variable heavy- and light-chain regions of the murine anti-GD2 mAb 14.18 and the constant regions of human IgG1 heavy-chain and kappa light-chain. By binding to GD2, dinutiximab induces antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity of tumor cells thereby leading to apoptosis and inhibiting proliferation of the tumour. It 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. Despite a high clinical response seen after first-line treatment, the complete eradication of neuroblastoma is rarely achieved and the majority of patients with advanced disease suffer a relapse. Current strategies for treatment include immunotherapy with drugs such as dinutuximab to target surviving neuroblastoma cells and to prevent relapse.
Indications and Usage 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. Despite a high clinical response seen after first-line treatment, the complete eradication of neuroblastoma is rarely achieved and the majority of patients with advanced disease suffer a relapse. Current strategies for treatment include immunotherapy with drugs such as dinutuximab to target surviving neuroblastoma cells and to prevent relapse.
Marketing Status approved; investigational
ATC Code L01FX06
DrugBank ID DB09077
KEGG ID D10559
MeSH ID C112746
PubChem ID Not Available
TTD Drug ID Not Available
NDC Product Code 66302-014
UNII 7SQY4ZUD30
Synonyms dinutuximab | dinutuximab beta | APN-311 | APN311 | unituxin | ch14.18 | MAb ch14.18 | CH-14.18-UTC | CH-14.18 | monoclonal antibody ch14.18 | ch14.18 monoclonal antibody | CH14.18-UTC
Chemical Information
Molecular Formula Not Available
CAS Registry Number 1363687-32-4
SMILES Not Available
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Infusion related reaction08.01.03.002; 10.01.01.017; 12.02.05.009--
Protein urine present13.13.02.006---
Haemorrhage24.07.01.002---
Haemorrhage urinary tract20.02.03.005; 24.07.01.007---
Antibody test13.06.03.009---
Decreased appetite08.01.09.028; 14.03.01.005--
Immunology test13.06.03.007---
Device related infection08.07.01.005; 11.01.08.018--
Oropharyngeal pain07.05.05.004; 22.12.03.016--
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