Note: Ingredients listed on restricted chemical lists
EC/CAS
209-150-3
Name of the chemical
Aluminium, zinc, magnesium and calcium stearates
Concentration
<2%
General Information
Version
1.0.0
Revision date
2016-06-01
Product name
None identified
Product Synonyms
For niraparib: (S)-2-(4-(piperidin-3-yl)phenyl)-2H-indazole-7-carboxamide 4- methylbenzene sulfonate hydrate; (3S)-3-{4-[7-(Aminocarbonyl)-2H-indazol-2- yl]phenyl}piperidine (tosylate salt monohydrate); MK-4827; C-023971
Chemical name
Mixture - contains an indazole
1.2.1 Relevant identified uses
Bulk formulated pharmaceutical mixture/Formulated pharmaceutical product/ of the substance or mixture in form for patient use; under investigation for the treatment various mixture and uses cancers
Emergency telephone
+1 (800) 424-9300, +1 (703) 527-3887
Icons in SDS
Company Information
company name
TESARO, Inc
e-mail address of the competent person responsible for the Safety Data Sheet
contact@tesaro.com
GHS Information
Signal word
Warning
Hazard Codes
Hazard statements (CLP)
H302, H341, H361fd, H373
Hazard statements
Code
Statements
H302
Harmful if swallowed
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. Consult prescribing/packaging information The classification and labeling listed below is for bulk drug product HAZARDS IDENTIFICATION …continued Globally Harmonized System [GHS] Acute Toxicity (Oral) Category 4. Germ Cell Mutagenicity - Category 2 Reproductive Toxicity - Category 2. Specific Target Organ Toxicity (repeated exposure) - Category 1
Signal word
Warning
Hazard statements
H302 - Harmful if swallowed. H341 - Suspected of causing genetic defects. H361fd - Suspected of damaging fertility. Suspected of damaging the unborn child. H373 - May cause damage to bone marrow and lymphoid tissues through prolonged or repeated exposure. Use personal protective equipment as required. P308 + P313 - IF exposed or concerned: get medical advice/attention. P405 - Store locked up. P501 - Dispose of contents/container to location in accordance with local/regional/national/ international regulations. P264 - Wash hands thoroughly after handling. P270 - Do not eat, drink or smoke when using this product. P301+P312: IF SWALLOWED: Call a Poison Center or doctor/physician if you feel unwell.
Precautionary statements
P201 - Obtain special instructions before use. P260 - Do not breathe dust. P281 -
2.3 Other hazards
Niraparib (administered as a tosylate monohydrate salt) is a potent PARP inhibitor that exerts antitumorigenic activity by disabling DNA repair mechanisms, thereby sensitizing cancer cells to other anticancer agents. Adverse effects noted with oral dosing in clinical trials were myelosuppression (anemia, thrombocytopenia, and neutropenia), gastrointestinal effects (nausea, vomiting, anorexia, and constipation), and fatigue. Based on its mechanism of action, potentials for increased infection and bruising, as well as for developmental and fertility effects cannot be excluded in the absence of definitive data. Note This mixture is classified as hazardous under GHS as implemented by Regulation
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
