Note: Ingredients listed on restricted chemical lists
General Information
Revision date
2013-05-22
Product name
Cometriq
Product Synonyms
XL184, EXEL-7184, EXEL-02977184, BMS-907351
Chemical name
Quinoline
1.2.1 Relevant identified uses
Cabozantinib malate drug product is approved for the treatment of patients with progressive, metastatic medullary thyroid cancer
Emergency telephone
and Canada
Icons in SDS
Company Information
company name
Exelixis, Inc
e-mail address of the competent person responsible for the Safety Data Sheet
SDS@exelixis.com
GHS Information
Signal word
Danger
Hazard Codes
Hazard statements (CLP)
H360F, H373
Hazard statements
Code
Statements
H360F
May damage fertility
Section 2
2.1 Classification of the substance or mixture
Regulation (EC) Reproductive Toxicity - Category 1B. Target organ systemic toxicity (repeat 1272/2008 [GHS] exposure) - Category 2. Mixture not yet fully tested Directive 67/548/EEC or T - R60 (Repr. Cat 2), R48/22. Mixture not yet fully tested 1999/45/EC
Hazard pictograms
SECTION 2 - HAZARDS IDENTIFICATION …continued
Signal word
Danger Warning US Hazard overview If capsules are crushed or broken, may cause adverse reproductive effects and kidney damage (based on animal data). Product/mixture not yet fully tested. Note This mixture should be considered hazardous according to Directive 67/548/EEC, Regulation (EC) No 1272/2008 (EU CLP) and applicable US regulations. The pharmacological, toxicological, and ecological properties of this mixture have not been fully characterized. See Section 16 for full text of EU and GHS classifications. The GHS classifications are based on Regulation (EC) 1272/2008.
CLP CLASSIFICATION
H360F - May damage fertility. H373 - May cause damage to kidneys through
Hazard statements
prolonged or repeated exposure. CLP/GHS precautionary P201 - Obtain special instructions before use. P202 - Do not handle until all safety precautions have been read and understood. P260 - Do not breathe dust. P281 - Use personal protective equipment as required. 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 location in accordance with local/regional/national/international regulations.
2.3 Other hazards
The most commonly reported adverse drug reactions (≥25%) are: diarrhea, stomatitis, palmar-plantar erythrodysesthesia syndrome (PPES), decreased weight, decreased appetite, nausea, fatigue, oral pain, hair color changes, dysgeusia (distortion in sense of taste), hypertension, abdominal pain, and constipation.
