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ACUTE EXPOSURE INFORMATION

  1. WITH THERAPEUTIC USE
    1. Acute hypersensitivity reaction has been observed within the first 24 hours of infusion. Vascular leak syndrome has also been characterized by hypotension, edema and hypoalbuminemia during clinical trials and is often self-limited requiring minimal treatment. Flu-like syndrome has been reported several days after infusion and can include the following symptoms: fever and/or chills, asthenia, gastrointestinal effects, myalgia and arthralgia. Symptoms are generally mild to moderate. Other effects include: tachycardia, chest pain, thrombotic disorder, hypertension, hypotension, dysrhythmias, edema, pruritus, rash, sweating, hypocalcemia, hypokalemia, nausea, vomiting, diarrhea, anorexia, constipation, dyspepsia, dysphagia, proteinuria, pyuria, elevated serum creatinine, lymphocytopenia, anemia, thrombocytopenia, leukopenia, reversible transaminase elevations, hypoalbuminemia, weight loss, myalgia, arthralgia, dizziness, asthenia, paresthesia, nervousness, confusion, headache, dyspnea, cough, pharyngitis, rhinitis, fever, chills, infection, and injection site reaction.
    1. INFREQUENT: Pancreatitis, acute renal insufficiency, microscopic hematuria, oral ulcer, hyperthyroidism, and visual changes have been reported infrequently with use.
  1. WITH POISONING/EXPOSURE
    1. Clinical events in overdose are anticipated to be an extension of adverse effects. Nausea, vomiting, fever, chills, persistent asthenia were dose- limiting toxicities in patients receiving 31 mcg/kg/day.
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