Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION

PRODUCT NAME

HERCEPTIN

NFPA

PRODUCT USE

In the treatment of metastatic breast cancer. targets cells that over- express or make too
much of a protein called HER- 2 (or erb- B2), found on the surface of cancer cells.

SYNONYMS

"immunoglobulin IgG1", "recombinant humanised monoclonal antibody", rhuMAb, "HER2 (human
epidermal growth factor receptor 2 protein) inactivator", Trastuzumab, "antineoplastic/
cytotoxic"

Section 2 - HAZARDS IDENTIFICATION

CANADIAN WHMIS SYMBOLS

EMERGENCY OVERVIEW

RISK

POTENTIAL HEALTH EFFECTS

ACUTE HEALTH EFFECTS

SWALLOWED

  The material has NOT been classified as "harmful by ingestion". This is because of the lack of corroborating animal or human evidence. The material may still be damaging to the health of the individual, following ingestion, especially where pre-existing organ (e.g. liver, kidney) damage is evident. Present definitions of harmful or toxic substances are generally based on doses producing mortality (death) rather than those producing morbidity (disease, ill-health). Gastrointestinal tract discomfort may produce nausea and vomiting. In an occupational setting however, unintentional ingestion is not thought to be cause for concern.  

EYE

  Although the material is not thought to be an irritant, direct contact with the eye may cause transient discomfort characterized by tearing or conjunctival redness (as with windburn). Slight abrasive damage may also result. The material may produce foreign body irritation in certain individuals.  

SKIN

  The material is not thought to produce adverse health effects or skin irritation following contact (as classified using animal models). Nevertheless, good hygiene practice requires that exposure be kept to a minimum and that suitable gloves be used in an occupational setting.  Entry into the blood-stream, through, for example, cuts, abrasions or lesions, may produce systemic injury with harmful effects. Examine the skin prior to the use of the material and ensure that any external damage is suitably protected.  

INHALED

  Inhalation of dusts, generated by the material during the course of normal handling, may be damaging to the health of the individual.  The material is not thought to produce respiratory irritation (as classified using animal models). Nevertheless inhalation of dusts, or fume, especially for prolonged periods, may produce respiratory discomfort and occasionally, distress.  Use of blood and related products can cause infection and immune reactions. Aerosols containing blood may contain the risk of infection to AIDS, hepatitis and other infectious diseases. Immune responses include anaphylaxis and delayed symptoms including itch, chills, fever, fatigue and swollen lymph nodes.  The material is not thought to produce adverse health effects or irritation of the respiratory tract (as classified using animal models). Nevertheless, good hygiene practice requires that exposure be kept to a minimum and that suitable control measures be used in an occupational setting.  Side effects that most commonly occur during first infusion of proteins (including monoclonal antibodies) may include fever/ chills. Other side effects may include pain, weakness, nausea, vomiting, diarrhoea, headaches, difficult breathing and rashes. Serious side effects may include damage to the heart muscle that may lead to heart failure. Symptoms of heart failure include shortness of breath, difficult breathing, a fast or irregular heartbeat, increased cough and swelling of the feet an lower legs. Infusion may also affect the lungs causing severe or life-threatening breathing problems that require immediate attention.  Allergic reactions may also be severe or life-threatening and may involve a drop in blood pressure, shortness of breath, and wheezing.  

CHRONIC HEALTH EFFECTS

  Dusts produced by proteins can sometimes sensitize workers like other foreign bodies. Symptoms include asthma appearing soon after exposure, with wheezing, narrowing of the airways and breathing difficulties. There may also be a chronic cough, phlegm, fever, muscle pains, fatigue and airway obstruction; chest X-rays may show a characteristic net-  like pattern or scarring at the tip and base. There may also be chest discomfort, headache, stomachache and a general feeling of unwellness. Often the clinical picture is similar to "farmer's lung" and other allergic lung inflammations. Prolonged contact with the skin can cause pain, redness, inflammation and ulceration. Repeated attacks can cause loss of lung function due to scarring.  Long term exposure to high dust concentrations may cause changes in lung function i.e. pneumoconiosis; caused by particles less than 0.5 micron penetrating and remaining in the lung. Prime symptom is breathlessness; lung shadows show on X-ray.  Limited evidence suggests that repeated or long-term occupational exposure may produce cumulative health effects involving organs or biochemical systems.  There is some evidence that inhaling this product is more likely to cause a sensitization reaction in some persons compared to the general population.  There is limited evidence that, skin contact with this product is more likely to cause a sensitization reaction in some persons compared to the general population.  Respiratory sensitization may result in allergic/asthma like responses; from coughing and minor breathing difficulties to bronchitis with wheezing, gasping.  Exposure to small quantities may induce hypersensitivity reactions characterized by acute bronchospasm, hives (urticaria), deep dermal wheals (angioneurotic edema), running nose (rhinitis) and blurred vision . Anaphylactic shock and skin rash (non-thrombocytopenic purpura) may occur. An individual may be predisposed to such anti-body mediated reaction if other chemical agents have caused prior sensitization (cross-sensitivity).  Inhaling this product is more likely to cause a sensitization reaction in some persons compared to the general population.  Side effects during therapy may include dyspnea, hypotension, tachycardia,  bronchospasm, wheezing, reduced oxygen saturation. Herceptin administration (in  therapeutic doses) can result in the development of ventricular dysfunction and  congestive heart failure. Elimination half-life (after multiple dose):  7-32.8  days