General Information
Version
2.2
Revision date
2019-04-12
Product name
ISIS 766720 Liquid Drug Product
Product name
ISIS 766720 Liquid Drug Product
Identification on the label/Trade name
Not applicable
Product Synonyms
IONIS-GHR-LRx, GalNAc Conjugated Liquid Drug Product, Ligand Conjugated
Chemical name
GalNAc conjugated 2"-O-methoxyethyl modified phosphorothioate
1.2.1 Relevant identified uses
Bulk formulated pharmaceutical mixture designed to treat Acromegaly of the substance or mixture and uses
Emergency telephone
1-(800) 424-9300
Icons in SDS
Company Information
company name
Ionis Pharmaceuticals Inc
e-mail address of the competent person responsible for the Safety Data Sheet
SDS@ionisph.com
GHS Information
Signal word
None required
Section 2
SECTION 2: Hazards identification
2.1 Classification of the substance or mixture
substance or mixture Globally Harmonized Mixture not yet fully tested System [GHS]
Hazard pictograms
None required
Signal word
None required
Hazard statements
None required SECTION 2 - HAZARDS IDENTIFICATION …continued
Precautionary statements
None required
2.3 Other hazards
Mixture contains oligonucleotides, which are molecules composed of approximately 16 to 20 covalently linked naturally-occurring nucleotides on a phosphodiester and/or phosphorothioate backbone. Based on their intended diagnostic or therapeutic use, engineered oligonucleotides vary in nucleotide sequence to match and bind with a specific target genetic sequence. In clinical trials, modified oligonucleotides were generally well-tolerated. Although non- specific binding of oligonucleotides to other RNA sequences may occur, the drug candidates are designed to avoid this interaction. No genotoxic, reproductive (males or females) and/or developmental effects are expected, based on epidemiological and non- clinical data. The hazardous properties of oligonucleotides have not been fully investigated and the potential health hazards associated with exposure/handling are unknown, but these compounds are generally not irritating and are not absorbed directly through skin or oral exposure routes. While chemical modification of oligonucleotides increases their stability in the body via parenteral routes, the likelihood of systemic effects following accidental ingestion or inhalation in a workplace setting is low, due to their rapid breakdown in the digestive tract and low bioavailability via inhalation. Note This substance does not meet criteria for classification under GHS as implemented
