Note: Ingredients listed on restricted chemical lists
EC/CAS
209-150-3
Name of the chemical
Aluminium, zinc, magnesium and calcium stearates
Concentration
1-3%
General Information
Revision date
2019-09-26
Product name
Kalydeco
Product Synonyms
Ivacaftor; VX-770; VRT-813077; N-(2,4-di-tert-butyl-5-hydroxyphenyl)-4-oxo- Ivacaftor; VX-770; VRT-813077; N-(2,4-di-tert-butyl-5-hydroxyphenyl)-4-oxo- 1,4-dihydroquinoline-3-carboxamide
Chemical name
Mixture
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; indicated for the treatment of Cystic mixture and uses Fibrosis (CF)
Emergency telephone
+1 (617) 341-6100
Icons in SDS
Company Information
company name
Vertex Pharmaceuticals Incorporated
e-mail address of the competent person responsible for the Safety Data Sheet
SDS@vrtx.com
GHS Information
Signal word
None required
Section 2
SECTION 2: Hazards identification
2.1 Classification of the substance or mixture
Drugs in the finished state and intended for the final user are not subject to labeling in the US, EU or Canada. Consult prescribing/packaging information. The classification and labeling listed below is for bulk drug product. Globally Harmonized System [GHS] Not classified SECTION 2 - HAZARDS IDENTIFICATION …continued
Hazard statements
None required None required
Signal word
None required
Precautionary statements
None required
2.3 Other hazards
Kalydeco® Pediatric oral granules contain VX-770, which improves CFTR functions. The most common adverse effects noted in patients with CF were headache, mouth/throat pain, upper respiratory tract infection, nasal congestion, gastrointestinal disturbances, and rash. Dizziness may also occur at very high doses. Note This mixture is classified as hazardous under GHS as implemented by Regulation EC No
