Tisotumab vedotin for Injection

Pfizer Inc

Revision date : 2024-02-22

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GHS08
Health risk rating 5
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

200-334-9/57-50-1

Name of the chemical

Sucrose, pure C12H22O11

Concentration

limit (SCL

EC/CAS

200-711-8/69-65-8

Name of the chemical

D-mannitol C6H14O6

Concentration

N/A

General Information

Revision date

2024-02-22

Product name

Tisotumab vedotin for Injection

Product name

Tisotumab vedotin for Injection

Identification on the label/Trade name

TIVDAK

Product Synonyms

HuMax-1006; Tisotumab vedotin; TV; GMB-006; GEN1015; HuMax®-TF-ADC; HuMax-1006; Tisotumab vedotin; TV; GMB-006; GEN1015; HuMax®-TF-ADC; IgG1-1015-011-vcMMAE

Chemical name

Antibody Drug Conjugate

1.2.1 Relevant identified uses

Pharmaceutical product

Emergency telephone

1-800-424-9300, +1-703-527-3887

Icons in SDS

GHS08 M004 M009 M010 M011 M017

Company Information

company name

Pfizer Inc

e-mail address of the competent person responsible for the Safety Data Sheet

pfizer-MSDS@pfizer.com

GHS Information

Signal word

Danger

Hazard Codes

Hazard statements (CLP)

H341, H360FD, H372

Hazard statements

Code

Statements

H341

Suspected of causing genetic defects

Section 2

SECTION 2: Hazards identification

1272/2008 Classification of the substance or mixture

Signal word

Danger

Hazard statements

H341 - Suspected of causing genetic defects H360FD - May damage fertility. May damage the unborn child H372 - Causes damage to organs through prolonged or repeated exposure bone marrow, thymus, spleen, liver, gastrointestinal system, male reproductive system, lungs

Precautionary statements

P201 - Obtain special instructions before use P260 - Do not breathe dust/fume/gas/mist/vapors/spray P281 - Use personal protective equipment as required P308 + P313 - IF exposed or concerned: Get medical attention/advice P405 - Store locked up

Supplemental label elements

Compound, not fully tested, additional hazards may exist.

Other hazards

An Occupational Exposure Value has been established for one or more of the ingredients (see Section 8). Note This document has been prepared in accordance with standards for workplace safety, which require the inclusion of all known hazards of the product or its ingredients regardless of the potential risk. The precautionary statements and warnings included may not apply in all cases. Your needs may vary depending upon the potential for exposure in your workplace.

Additional information

The hazard classification of this material is based on a similar Anti-body Drug Conjugate, and not specific data for this material.

2.1 Classification of the substance or mixture

GHS - Classification: Regulated according to Regulation (EC) 1272/2008 and/or other applicable regulations. Germ cell mutagenicity Category 2 - (H341) Reproductive toxicity Category 1B - (H360FD) Specific target organ toxicity (repeated exposure) Category 1 - (H372)

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