General Information
Revision date
2021-02-11
Product name
Givlaari
Product Synonyms
ALN-AS1; ALN-60519 (active pharmaceutical ingredient)
Chemical name
Mixture - containing a double-stranded oligonucleotide
CAS No.
1639325-43-1
1.2.1 Relevant identified uses
Formulated pharmaceutical mixture; indicated for the treatment of acute hepatic porphyria
Emergency telephone
+1 (800) 424-9300, +1 (703) 527-3887
Icons in SDS
Company Information
company name
Alnylam Pharmaceuticals
e-mail address of the competent person responsible for the Safety Data Sheet
SDS@alnylam.com
GHS Information
Signal word
Warning
Hazard Codes
Hazard statements (CLP)
H373
Hazard statements
Code
Statements
H373
May cause damage to organs through prolonged or repeated exposure
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. Specific target organ toxicity (repeated exposure) Category 2 May cause damage to organs (liver) through prolonged or repeated exposure
Signal word
Warning
Hazard statements
H373 - May cause damage to organs (liver) through prolonged or repeated exposure
Precautionary statements
P260 - Do not breathe mist, vapors, spray. P314 - Get medical advice/attention if you feel unwell. P501 - Dispose of contents/container to hazardous or special waste collection point in accordance with local/regional/national/international regulations..
2.3 Other hazards
Givosiran is a small interfering RNA (siRNA) that suppresses expression of ALAS1 (that is essential for the formation of toxic heme intermediate). It is administered by subcutaneous (SC) injection. The most common adverse effects include nausea and injection site reactions. Less frequent adverse effects include anaphylactic reactions hepatic and renal toxicities. Note This mixture is classified as hazardous under GHS as implemented by Regulation EC No
