Istodax (Romidepsin) for Injection

Hazard statements (CLP)

H301, H317, H361fd, H372

Code

Statements

H301

Toxic if swallowed

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 Globally Harmonized System [GHS] Acute Toxicity - Oral - Category 3. Skin Sensitizer - Category 1B. Reproductive Toxicity - Category 2. Specific Target Organ Toxicity (repeated exposure) - Category 1 HAZARDS IDENTIFICATION …continued

Signal word

Danger

Hazard statements

H301 - Toxic if swallowed. H317 - May cause allergic skin reaction. H361fd - Suspected of damaging fertility. Suspected of damaging the unborn child. H372 - Causes damage to hematological, reproductive, and gastrointestinal systems through prolonged or repeated exposure. Wash hands thoroughly after handling. P270 - Do not eat, drink or smoke when using this product. P272 - Contaminated work clothing should not be allowed out of the workplace. P280 - Wear protective gloves/eye protection/face protection. P301+P310 IF SWALLOWED Immediately call a Poison Center or doctor/ physician. P302 + P352 - IF ON SKIN: Wash with plenty of soap and water. P308 + P313 - IF exposed or concerned: get medical advice/attention. P333 + P313 - If skin irritation or rash occurs: Get medical advice/attention. P405 - Store locked up. P501 - Dispose of contents/container to location in accordance with local/regional/ national/international regulations.

Precautionary statements

P201 - Obtain special instructions before use. P260 - Do not breathe dust. P264 -

2.3 Other hazards

Contains an antiproliferative agent used for treatment of cancer. The most commonly observed adverse effects in clinical trials with romidespsin were hematotoxicity (anemia, neutropenia, thrombocytopenia), gastrointestinal disturbances (nausea, vomiting, constipation, diarrhea), infection, fatigue, lethargy, asthenia, and transient liver enzyme abnormalities. Other frequent effects included anorexia, clinical chemistry abnormalities, fever, taste alteration, and ECG abnormalities without clinically significant sequelae. Serious and sometimes fatal infections,and reactivation of latent viruses, have been reported. May cause skin sensitization (based on animal data). There are no adequate and well-controlled studies of romidepsin in pregnancy. However, based on its mechanism of action and the embryocidal/developmental effects seen in rats, it is reasonable to predict that romidepsin may cause fetal harm when administered to pregnant women. There are scientific studies suggesting that personnel (e.g., nurses, pharmacists) who prepare and administer parenteral antineoplastics may be at some risk due to potential mutagenicity, adverse effects on reproduction and/or carcinogenicity if these materials in the workplace if exposures are not properly controlled. The actual risk in the workplace is not known.

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