Hospira already markets irinotecan in Canada, Australia and several European countries.
Indications and Safety Information
Irinotecan hydrochloride injection is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. Common adverse events include diarrhea (early and late), neutropenia, leukopenia, anemia, thrombocytopenia, nausea, vomiting, abdominal cramping, cholinergic symptoms, dizziness, visual disturbances, alopecia, mucositis, pain, weakness and fever.
Boxed Warning: Irinotecan HCl Injection should be administered only
under the supervision of a physician who is experienced in the use of
cancer chemotherapeutic agents. Appropriate management of complications is
possible only when adequate diagnostic and treatment facilities are readily
available. Irinotecan HCl Injection can induce both early and late forms of
diarrhea that appear to be mediated by different mechanisms. Both forms of
diarrhea may be severe. Early diarrhea (occurring during or shortly after
infusion of Irinotecan HCl Injection may be accompanied by cholinergic
symptoms of rhinitis, increased salivation, miosis, lacrimation,
diaphoresis, flushing, and intestinal hyperperistalsis that can cause
abdominal cramping. Early diarrhea and other cholinergic symptoms may be
prevented or ameliorated by atropine (see PRECAUTIONS, General). Late
diarrhea (generally occurring more than 24 hours after administration of
Irinotecan HCl Injection) can be life threatening since it may be prolonged
and may lead to dehydration, electrolyte imbalance, or sepsis. Late
diarrhea should be treated promptly with loperamide. Patients with diarrhea
should be carefully monitored and given fluid and electrolyte repla
|SOURCE Hospira, Inc.|
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