Intron A Powder

SECTION 2: Hazards identification

EMERGENCY OVERVIEW White to cream-color Powder Odor unknown May be harmful by inhalation. May cause allergic reactions in susceptible individuals. May cause effects to: - gastrointestinal tract - respiratory system - immune system - cardiovascular system - endocrine system - nervous system - eye - brain - liver - female reproductive system - fetus

Potential health effects

The following summary is based upon available information about the individual ingredients of the mixture, or of the expected properties of the mixture. Interferon alfa-2b (active ingredient of Intron A) is an alfa interferon protein used for the treatment of certain types of cancer, chronic hepatitis B, anal/genital warts (condylomata acuminata), and AIDS-related Kaposi's Syndrome. Intron A is administered by injection either alone or as peginterferon alfa-2b (active ingredient of PEG-Intron), a covalent conjugate of interferon alfa-2b and polyethylene glycol. The most common effects observed during therapy with interferon alfa-2b or peginterferon alfa-2b products were "flu-like" symptoms (e.g. fever, headache, fatigue, chills, muscle or joint pain, dizziness), gastrointestinal effects (e.g. anorexia, diarrhea, dizziness, nausea, vomiting, stool changes), depression, taste alteration, or parasthesia (tingling or numbness of extremities). These effects were mild to moderate in severity and were reversible. Other effects observed during therapy include skin rashes (psoriasis), effects to eyes (decrease or loss of vision), bone marrow toxicity (decreases in white blood cell and platelet counts), life-threatening or fatal neuropsychiatric events (suicidal tendencies, hallucinations, aggressive behavior), hypo- or hyperthyroidism, hyperglycemia, diabetes, cardiovascular effects (decreases in blood pressure, abnormal heart rhythm, decreased blood flow), lung effects (shortness of breath, pneumonia, bronchitis), colon inflammation, liver effects (elevated serum liver enzyme levels, insufficiency, failure), or serious hypersensitivity reactions (i.e. anaphylaxis). Human leukocyte interferon has been reported to cause decreases in serum estradiol and progesterone concentrations in women as well as irregular menstrual cycles. In monkeys, embryolethality was reported in two separate studies, one of which also reported maternal toxicity at the same doses. However, four women treated with interferon alfa-2a during pregnancy gave birth without complication and infants appeared normal at birth and had normal development. Relevance of animal developmental toxicity to humans is unclear. Glycine is a nonessential amino acid found in the body. Glycine is not expected to produce adverse effects when handled according to safe work practices. It may cause irritation to the eyes, skin, and respiratory tract from mechanical action. Exposure to large amounts of glycine may cause transurethral resection of the prostate (TURP) syndrome. Symptoms of TURP syndrome may include ammonia toxicity including nausea, vomiting, and central nervous depression, low blood pressure, headache, visual disturbance or loss, restlessness, chest pain, agitation, confusion, or weakness. LISTED CARCINOGENS No carcinogens or potential carcinogens listed by