Note: Ingredients listed on restricted chemical lists
General Information
Revision date
2015-08-21
Product name
Xermelo
Chemical name
Mixture - contains a phenylalanine derivative
1.2.1 Relevant identified uses
Bulk formulated pharmaceutical mixture/Formulated pharmaceutical product/ of the substance or mixture for research and development; under investigation for use in the treatment mixture and uses of carcinoid syndrome (CS)
Icons in SDS
Company Information
company name
Lexicon Pharmaceuticals
e-mail address of the competent person responsible for the Safety Data Sheet
sds@lexpharma.com
GHS Information
Signal word
None
Section 2
2.1 Classification of the substance or mixture
The classification and labelling listed below is for bulk drug product. …continued Globally Harmonized Mixture not yet fully tested. System [GHS] Other/Supplemental
2.3 Other hazards
US OSHA)
Hazard statements
None required None required
Signal word
None required Caution US Hazard overview Contains telotristat etiprate - a tryptophan hydroxylase inhibitor. Mixture not yet fully tested. Combustible dust. Note This mixture does not meet criteria for classification according to directive 1999/ 45/EC and Regulation EC No 1272/2008 (EU CLP). Nevertheless, it should be regarded as hazardous because it has not yet been full tested and it contains a pharmacologically active ingredient. See Section 16 for full text of EU and GHS classifications.
Precautionary statements
None required
Other hazards
Telotristat etiprate is a tryptophan hydroxylase (serotonin-synthesizing enzyme) inhibitor under investigation for the treatment of CS. Oral doses used in clinical trials have ranged from 500-1,500 mg/day. The most commonly reported adverse effects seen to date were mild to moderate gastrointestinal (GI) effects, fatigue, and taste disturbances.
