Bortezomib for Injection

SECTION 2: Hazards identification

Hazard pictograms

GHS Class: Toxic, Category 3. Eye Damage, Category 1. Skin Irritant, Category 3. Reproductive hazard, Category 2. Hazards not otherwise classified that have been identified during the classification process Emergency Overview Bortezomib drug substance is a specific proteasome inhibitor used in anti- cancer treatments. DANGER! Toxic-Contains a pharmaceutically active ingredient. Handling should only be performed by personnel trained and familiar with handling of potent active pharmaceutical ingredients. Avoid skin contact, eye contact, and inhalation. Exercise due care wear suitable protective clothing, gloves and eye /face protection

Principle Routes of Exposure

May be absorbed following ingestion, inhalation and through skin contact or contact with mucous membranes (this includes eyes).

Potential health effects

Eye Skin Inhalation Moderate to severe eye irritant Moderate to severe skin eye irritant Inhalation data not identified. Based on the high acute toxicity reported in non- clinical IV studies, a potential for toxicity via the inhaled route cannot be excluded. Ingestion Very toxic by ingestion

Potential chronic health

Repeated occupational overexposure may cause fatigue and fever, and effects on the hematological (decreases in hemoglobin/anemia, blood counts and platelets), gastrointestinal (nausea, diarrhea, vomiting, abdominal pain), and nervous systems (headache, peripheral neuropathy). May affect fertility and fetal development based on mechanism and animal toxicity studies. Target Organs See Chronic Health Effects for potential target organ toxicity.