General Information
Version
2.0.0
Revision date
2017-12-06
Product name
CINVANTITM
Product Synonyms
HTX-019 Emulsion; HTX-019
Chemical name
Mixture
CAS No.
170729-80-3
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; injectable formulation under mixture and uses investigation for the treatment of chemotherapy-induced nausea and vomiting
Icons in SDS
Company Information
company name
Heron
e-mail address of the competent person responsible for the Safety Data Sheet
supplychain@herontx.com
GHS Information
Signal word
None required
Section 2
SECTION 2: Hazards identification
(EC) No 1272/2008 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 labelling listed below is for bulk drug product Globally Harmonized System [GHS] Not classified
2.2 Label elements
SECTION 2 - HAZARDS IDENTIFICATION …continued
Hazard statements
None required None required
Signal word
None required
Precautionary statements
None required
2.3 Other hazards
HTX-019 contains aprepitant - a selective, high-affinity antagonist of human substance P/neurokinin-1 (NK1) receptors. The injectable formulation is being investigated for the treatment of chemotherapy-induced nausea and vomiting. An oral aprepitant formulation is approved for therapeutic use. The adverse effects reported following oral administration of aprepitant include fatigue, diarrhea, asthenia, dyspepsia, abdominal pain, hiccups, decreased white blood cell count, dehydration, and increased alanine aminotransferase enzyme. Additional adverse effects after intravenous (IV) administration include neutropenia, asthenia, peripheral neuropathy, leukopenia, urinary tract infection, and pain in extremities. 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
