General Information
Revision date
2021-02-19
Product name
TRODELVY
Product Synonyms
hRS7-CL2A-SN-38; IMMU-132
Chemical name
Mixture - contains an antibody-drug conjugate (ADC)
CAS No.
1491917-83-9
1.2.1 Relevant identified uses
Formulated pharmaceutical product/mixture packaged in final form for patient use; being investigated for the treatment of cancer
Emergency telephone
+1 (800) 424-9300, +1 (703) 527-3887
Icons in SDS
Company Information
company name
Gilead Sciences, Inc
e-mail address of the competent person responsible for the Safety Data Sheet
sdscoordinator@gilead.com
GHS Information
Signal word
Danger
Hazard Codes
Hazard statements (CLP)
H341, H360Df, H373
Hazard statements
Code
Statements
H341
Suspected of causing genetic defects
Section 2
SECTION 2: Hazards identification
1272/2008 Classification of the substance or mixture The classification and labeling listed below is for bulk drug product Germ cell mutagenicity Category 2 Suspected of causing genetic defects Reproductive toxicity Category 1B May damage the unborn child. Suspected of damaging fertility Specific target organ toxicity (repeated exposure) Category 2 May cause damage to organs (gastrointestinal tract, bone marrow) through prolonged or repeated exposure
Signal word
Danger
Hazard statements
H341 - Suspected of causing genetic defects H360Df - May damage the unborn child. Suspected of damaging fertility. H373 - May cause damage to organs (gastrointestinal tract, bone marrow) through prolonged or repeated exposure
Precautionary statements
P201 - Obtain special instructions before use. P260 - Do not breathe dust/fume/gas/mist/vapors/spray. P280 - Wear protective gloves. P308+P313 - If exposed or concerned: Get medical advice/attention. P314 - Get medical advice/attention if you feel unwell. P405 - Store locked up. P501 - Dispose of contents/container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
2.3 Other hazards
Trodelvy™ is an antibody drug conjugate (ADC), comprised of an antibody (hRS7), linker (CL2A), and payload (SN-38). In clinical studies, following intravenous administration, the most frequent treatment-related adverse events by system organ class were gastrointestinal disorders, blood and lymphatic system disorders, general disorders and administration site conditions, skin and subcutaneous tissue disorders, and metabolism and nutrition disorders. Note This mixture is classified as hazardous under GHS as implemented by Regulation EC No
2.1 Classification of the substance or mixture
The classification and labeling listed below is for bulk drug product. Germ cell mutagenicity Category 2 Suspected of causing genetic defects Reproductive toxicity Category 1B May damage the unborn child. Suspected of damaging fertility. Specific target organ toxicity (repeated exposure) Category 2 May cause damage to organs (gastrointestinal tract, bone marrow) through prolonged or repeated exposure
