Note: Ingredients listed on restricted chemical lists
EC/CAS
232-674-9/9004-34-6
Name of the chemical
cellulose
Concentration
20-30%
General Information
Version
1.1.0
Revision date
2017-03-30
Product name
Orkambi
Product Synonyms
VX-809/VX-770 Fixed-dose Tablets For VX-809 Lumacaftor; VRT-826809; VRT-0826809; 3-[6-({[1-(2,2-difluoro- 1,3-benzodioxol-5-yl)cyclopropyl]carbonyl}amino)-3-methylpyridin-2-yl]benzoic acid For VX-770 Ivacaftor; 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
WHMIS 2015 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. Please consult the prescribing/packaging information. The classification and labeling listed below is for bulk drug product Globally Harmonized System [GHS] Not classified
Hazard statements
None required None required
Signal word
None required
Precautionary statements
None required
2.3 Other hazards
Orkambi® Tablets contains fixed amounts of VX-770 and VX-809. VX-809 partially restores expression of the CF transmembrane conductance regulator (CFTR) protein, whereas VX-770 improves CFTR functions. Commonly observed adverse effects reported in healthy volunteers given high doses were diarrhea and fatigue. In studies with CF patients, mild to moderate effects including cough, throat pain, difficulty breathing, and increased blood pressure were reported. Menstrual abnormalities have also been reported. Note This mixture does not meet criteria for classification under GHS as implemented
2.1 Classification of the substance or mixture
Drugs in the finished state and intended for the final user are not subject to substance or mixture
