ZynyzTM, Retifanlimab

Hazard statements (CLP)

H360, H372

Code

Statements

H360

May damage fertility or the unborn child

SECTION 2: Hazards identification

(EC) No 1272/2008 Classification of the Substance WARNING – This is a medicinal compound, designed to be prescribed by a licensed health care professional. Should any employee, while handling or processing this compound, observe any adverse health effects, they should contact their health care provider immediately. In addition, they should evacuate the work environment. Follow all instructions and packaging labels Other Non GHS This product contains a pharmaceutical compound. All precautions for pharmaceutical compounds Classifiable hazards should be thoroughly observed Classifications below are for Active Ingredient Only Regulation 2021 (GHS): Specific organ toxicity (repeated exposure): Category 1; Reproductive Toxicity – Category 1B Label Elements: Assessment according to Regulation Classifications below are for Active Ingredient Only GHS)

Hazard statements

For PICTOGRAM H360 -- May damage fertility or the unborn child. H372 -- Causes damage to organs (immune system) through prolonged or repeated exposure swallowed. P201 – Obtain special instructions before use. P202 – Do not handle until all safety precautions have been read and understood. P260 – Do not breath mist or vapors. P264 – Wash skin thoroughly after handling. P270 – Do not eat, drink, or smoke when using this product. P280 – Wear protective gloves/eye protection/face protection. P308 + P313 – If exposed or concerned: get medical advice/attention. P405 – Store locked up. P501 – Dispose of contents/container in accordance with state or federal regulations.

Signal word

Danger

2.3 Other hazards

Only ZynyzTM is a humanized monoclonal antibody (mAb) used for the treatment of solid tumors and hematological cancers. It is intended to be administered by intravenous (IV) infusion. ZynyzTM blocks the programmed cell death pathway (PD-1) that is normally involved in promoting immune tolerance and preventing tissue damage caused by chronic inflammation. In clinical trials with similar mAbs, adverse effects included fatigue, fever, rash/itching, musculoskeletal pain, cough/difficulty breathing, headache, nausea, diarrhea, and swelling of or nerve damage to the extremities. Less frequent effects included inflammation of the lung, intestine, liver, and brain, as well as immune-mediated endocrine (involving the pituitary gland, thyroid, or pancreas) and kidney dysfunction. Because PD-1 is linked to the maintenance of pregnancy, the risk of fetal harm cannot be excluded in the absence of definitive data. The potential for adverse immune-mediated effects along the respiratory tract of workers who might be exposed via inhalation 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

WARNING – This is a medicinal compound, designed to be prescribed by a licensed health care professional. Should any employee, while handling or processing this compound, observe any adverse health effects, they should contact their health care provider immediately. In addition, they should evacuate the work environment. Follow all instructions and packaging labels. Other Non GHS This product contains a pharmaceutical compound. All precautions for pharmaceutical compounds Classifiable hazards: should be thoroughly observed. Classifications below are for Active Ingredient Only Regulation 2021 (GHS): Specific organ toxicity (repeated exposure): Category 1; Reproductive Toxicity – Category 1B. For