Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION

PRODUCT NAME

VINORELBINE

NFPA

PRODUCT USE

A semisynthetic vinca (alkaloid) derivative related to vinblastine. Vinblastine is an
antineoplastic agent with anti- mitotic properties (ie inhibits cell division). Also has
immuno- suppressive activity. Vinorelbine is approved for the treatment of advanced non-
small- cell lung cancer (NSCLC). Vinorelbie disrupts malignant cell division during
metaphase by binding tubulin, the basic subunit of microtubules in the mitotic spindle
apparatus. The drug is less neurotoxic than than other vinca alkaloids because it has less
affinity for microtubules in nerve axons. Given by intravenous infusion, either alone or
in combination with cisplatin.

SYNONYMS

C45-H54-N4-O8, "C'-norvincaleukoblastine, 3', 4'-didehydro-4'-deoxy-", "C'-
norvincaleukoblastine, 3', 4'-didehydro-4'-deoxy-", nor-5'-anhydrovinblastine, nor-5'-
anhydrovinblastine, Navelbine, NVB, "semi-synthetic vinca alkaloid", "anti-cancer agent",
tumoristat, tumouristat, antineoplastic, cytotoxic

Section 2 - HAZARDS IDENTIFICATION

CANADIAN WHMIS SYMBOLS

EMERGENCY OVERVIEW

RISK

Irritating to respiratory system.
Risk of serious damage to eyes.
May cause harm to the unborn child.
Toxic: danger of serious damage to health by prolonged exposure through
inhalation and if swallowed.
Very toxic by inhalation, in contact with skin and if swallowed.
Very toxic: danger of very serious irreversible effects through inhalation and
if swallowed.

POTENTIAL HEALTH EFFECTS

ACUTE HEALTH EFFECTS

SWALLOWED

  Severely toxic effects may result from the accidental ingestion of the material; animal experiments indicate that ingestion of less than 5 gram may be fatal or may produce serious damage to the health of the individual.  Limited evidence exists that the substance may cause irreversible but non-lethal mutagenic effects following a single exposure.  The killing action of antineoplastic drugs used for cancer chemotherapy is not selective for cancerous cells alone but affect all dividing cells. Acute side effects include loss of appetite, nausea and vomiting, allergic reaction (skin rash, itch, redness, low blood pressure, unwellness and anaphylactic shock) and local irritation. Gout and renal failure can occur.  

EYE

  If applied to the eyes, this material causes severe eye damage.  

SKIN

  Skin contact with the material may produce severely toxic effects; systemic effects may result following absorption and these may be fatal.  The material is not thought to be a skin irritant (as classified using animal models). Abrasive damage however, may result from prolonged exposures. Good hygiene practice requires that exposure be kept to a minimum and that suitable gloves be used in an occupational setting.  Open cuts, abraded or irritated skin should not be exposed to this material.  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 produce severely toxic effects; these may be fatal.  There is strong evidence to suggest that this material can cause, if inhaled once, very serious, irreversible damage of organs.  The material can cause respiratory irritation in some persons. The body's response to such irritation can cause further lung damage.  Side effects of topoisomerase I and II inhibitors (acting as antineoplastics/ cytotoxics) include early diarrhoea which may occur within 24 hours of exposure to the drug; this may be accompanied by symptoms including runny nose, increased salivation, watery eyes, sweating, flushing, abdominal cramping. Late diarrhoea may occur after 24 hours and usually peaks at about 11 days after treatment. Because of concerns of dehydration and electrolyte imbalances with diarrhoea it is important to be in contact with health care professionals for monitoring, and for medication and diet modifications advice.  Other common side-effects of therapy may include nausea and vomiting may also occur; low red and white blood cell counts may also result; anaemia may follow. Hair loss, poor appetite, fever and weight loss may also ensue. Less common symptoms include constipation,  shortness of breath, insomnia, cough, headache, dehydration, chills, skin rash, flatulence, flushing of the face, mouth sores, heartburn and swelling of the feet and ankles.  

CHRONIC HEALTH EFFECTS

  Toxic: danger of serious damage to health by prolonged exposure through inhalation and if swallowed.  Toxic: danger of serious damage to health by prolonged exposure through inhalation and if swallowed.  This material can cause serious damage if one is exposed to it for long periods. It can be assumed that it contains a substance which can produce severe defects. This has been demonstrated via both short- and long-term experimentation.  Ample evidence exists, from results in experimentation, that developmental disorders are directly caused by human exposure to the material.  There has been some concern that this material can cause cancer or mutations but there is not enough data to make an assessment.  Limited evidence suggests that repeated or long-term occupational exposure may produce cumulative health effects involving organs or biochemical systems.  Exposure to the material may result in a possible risk of irreversible effects. The material may produce mutagenic effects in man. This concern is raised, generally, on the basis ofappropriate studies with similar materials using mammalian somatic cells in vivo. Such findings are often supported by positive results from in vitro mutagenicity studies.  Anti-cancer drugs used for chemotherapy can depress the bone marrow with reduction in the number of white blood cells and platelets and bleeding. Susceptibility to infections and bleeding is increased, which can be life- threatening. Digestive system effects may include inflammation of the mouth cavity, mouth ulcers, esophagus inflammation, abdominal pain and bleeds, diarrhea, bowel ulcers and perforation. Reversible hair loss can result and wound healing may be delayed. Long-term effects on the gonads may cause periods to stop and inhibit sperm production. Most anti-cancer drugs can potentially cause mutations and birth defects, and coupled with the effects of the suppression of the immune system, may also cause cancer.  Topoisomerase inhibitors represent a subgroup of plant alkaloids, which also encompasses the vinca alkaloids such as vincristine and vinblastine, taxanes and podophyllotoxin derivatives. Topoisomerase inhibitors act by preventing the unpackaging of DNA that must occur prior to transcription and replication. The earliest drugs in this class were inhibitors of topoisomerase II, however topoisomerase I inhibitors such as topotecan started entering the market in the mid-1990鎶  	   
         
    
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