Indications and Usage
Eloxatin, used in combination with infusional 5-FU/LV, is indicated for adjuvant treatment of stage III colon cancer patients who have undergone complete resection of the primary tumor. The indication is based on an improvement in disease-free survival, with no demonstrated benefit in overall survival after a median follow up of 4 years.
ELOXATIN, used in combination with infusional 5-FU/LV, is indicated for the treatment of advanced carcinoma of the colon or rectum.
Clinical Safety Considerations
Eloxatin(R) should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents.
Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available.
Anaphylactic-like reactions to Eloxatin(R) have been reported and may occur within minutes of Eloxatin(R) administration. Epinephrine, corticosteroids, and antihistamines have been employed to alleviate symptoms, and discontinuation of Eloxatin(R) therapy may be required.
* Eloxatin(R) should not be administered to patients with a history of known allergy to Eloxatin(R) or other platinum compounds. Hypersensitivity and anaphylactic/anaphylactoid reactions to Eloxatin(R) have been reported and were similar in nature and severity to those reported with other platinum compounds (ie, rash, urticaria, erythema, pruritus, and, rarely, bronchospasm and hypotension). These reactions occur within minutes of administration and should be managed with appropriate supportive therapy. Drug-related deaths from this reaction have been reported * Eloxatin(R) may cause fetal harm when administered to a pregnant woman. Women of childbearin
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