General Information
Version
1.1.0
Revision date
2016-07-11
Product name
Dinutuximab (for injection)
Product name
Dinutuximab (for injection)
Identification on the label/Trade name
Unituxin
Product Synonyms
For dinutuximab: Immunoglobulin G1, anti-(ganglioside GD2) (human-Mus musculus monoclonal ch14.18 heavy chain) disulfide with human-Mus musculus monoclonal ch14.18 light chain, dimer; Chimeric monoclonal antibody ch14.18; Chimeric MOAB 14.18; Human/murine anti-GD2 monoclonal antibody; Chimeric anti-GD2; Chimeric mAb 14.18
Chemical name
Mixture - contains a monoclonal antibody
CAS No.
1363687-32-4
1.2.1 Relevant identified uses
Bulk formulated pharmaceutical mixture/Formulated pharmaceutical product/ of the substance or mixture packaged in final form for patient use mixture and uses
Emergency telephone
+1 (800) 424-9300, +1 (703) 527-3887
Icons in SDS
Company Information
company name
1040 Spring Street
e-mail address of the competent person responsible for the Safety Data Sheet
druginformation@unither.com
GHS Information
Signal word
None required
Section 2
SECTION 2: Hazards identification
2.1 Classification of the substance or mixture
substance or mixture Globally Harmonized Not classified System [GHS]
Hazard statements
None required None required
Signal word
None required
Precautionary statements
None required
2.3 Other hazards
Dinutuximab is a chimeric (mouse - human) monoclonal antibody used in combination therapy for treatment of pediatric patients with neuroblastoma. It causes death of melanoma and neuroblastoma cells through both antibody- dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity. The most commonly reported adverse effects observed with dinutuximab use included 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. Note This mixture does not meet criteria for classification under GHS as implemented
