Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION

PRODUCT NAME

NAFARELIN ACETATE

NFPA

PRODUCT USE

Antineoplastic (hormonal) in the treatment of prostatic carcinoma. Synthetic nonapeptide
agonist analogue of gonadorelin (LH- RH - luteinising hormone release hormone).

SYNONYMS

C66-H83-N17-O13.C2-H4-O2, "luteinizing hormone-releasing factor (pig), 6-[3-(2-
naphthalenyl)-D-alanine), monoactate (salt)", "luteinizing hormone-releasing factor
(pig), 6-[3-(2-naphthalenyl)-D-alanine), monoactate (salt)", "luteinizing hormone-
releasing hormone, [6-D-(2-naphthyl)alanine]-, acetate", "luteinizing hormone-releasing
hormone, [6-D-(2-naphthyl)alanine]-, acetate", "[6-D-(2-naphthyl)alanine]LHRH acetate",
"[6-D-(2-naphthyl)alanine]LHRH acetate", "[6-D-(2-naphthyl)alanine]luteinising hormone-
releasing hormone acetate", "[6-D-(2-naphthyl)alanine]luteinising hormone-releasing
hormone acetate", "D-NAL(2)sup 6-LHRH acetate hydrate", "D-NAL(2)sup 6-LHRH acetate
hydrate", "5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-3-(2-naphthyl)-D-
alanyl-L-leucyl-L-arginyl-L-prolylglycinamide acetate hydrate", "5-oxo-L-prolyl-L-
histidyl-L-tryptophyl-L-seryl-L-tyrosyl-3-(2-naphthyl)-D-alanyl-L-leucyl-L-arginyl-L-
prolylglycinamide acetate hydrate", NAG, RS-94991298, Nacenyl, Nasanyl, Synarel,
Synrelina, "gonadotropin-releasing factor analogue", "gonadotropin releasing factor
analogue", "LH-releasing hormone analogue", "LH-releasing factor analogue", "LH-RF
analogue", "LH-RH analogue", "LH-RH/FSH-RH analogue", "LRF analogue", "LRH analogue",
"hypothalmic neurohumoral hormone analogue", "antineoplastic (hormonal)/ cytotoxic"

Section 2 - HAZARDS IDENTIFICATION

CANADIAN WHMIS SYMBOLS

EMERGENCY OVERVIEW

RISK

POTENTIAL HEALTH EFFECTS

ACUTE HEALTH EFFECTS

EYE

  The dust may produce eye discomfort causing smarting, pain and redness.  

SKIN

  Open cuts, abraded or irritated skin should not be exposed to this material.  

INHALED

  Persons with impaired respiratory function, airway diseases and conditions such as emphysema or chronic bronchitis, may incur further disability if excessive concentrations of particulate are inhaled.  

CHRONIC HEALTH EFFECTS

  Principal routes of exposure are by accidental skin and eye contact andinhalation of generated dusts.  Gonad-regulating hormones include the gonadotrophin glycoproteins and gonadorelin and its polypeptide analogues. They are usually administered parenterally to control the level of circulating sex hormones. These hormones stimulate the synthesis and releasing of follicle-stimulating hormone and luteinising hormone in the pituitary gland. Adverse effects of therapy include nausea and abdominal pain or discomfort, disturbances of the digestive system, hot flushes, mood change, nausea, vomiting, constipation, as well as headache and lightheadedness. Joint, bone and muscle pain may also appear. Other symptoms include muscle spasms, blurred vision, itching rashes, fever, chills, dry skin, hair loss,  changes in skin pigmentation and incontinence. Increased levels of circulating luteinising hormone may produce precocious puberty and enlarged breasts (gynaecomastia) and an increase in menstrual bleeding (menorrhagia).  Serious but comparatively rare health effects associated with treatment include angina, changes in heart rate, myocardial infarction and other potentially fatal cardiac effects, anaemia and other blood disorders, loss of sensation in the hands and feet, memory loss, blackouts and taste disorders.  Hypersensitivity reactions, including anaphylaxis, have been reported. Local and generalised skin rash has also been reported after chronic administration. Bronchospasm may also occur. Anaphylactoid reactions may include hypotension, fever, chills, mental confusion and wheezing.  Tumour flare has also been reported in the initial stages of treatment for cancer of the prostate. In addition, increased bone pain, a worsening of urinary symptoms with haematuria and urinary obstruction, and weakness and paraesthesia of the lower limbs may be present during treatment of patients with prostatic cancer. Anti-androgens may reduce these symptoms.  Reproductive system disorders including hot flushes, impotence, decreased libido, decreases in testicular size, atrophic genitalia and swollen or painful breasts have also been reported.  Evidence of teratogenic effects (often specific abnormalities of the musculoskeletal system) and foetotoxicity has been produced in several studies.  Ample evidence from experiments exists that there is a suspicionthis material directly reduces fertility.  Results in experiments suggest that this material may cause disorders in the development of the embryo or fetus, even when no signs of poisoning show in the mother.  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).