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Brand Name: Eloxatin Trade Name: oxaliplatin
FDA Approved For: ELOXATIN, used in combination with infusional 5-FU/LV, is indicated for the treatment of patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed during or within 6 months of completion of first line therapy with the combination of bolus 5-FU/LV and irinotecan. The approval of ELOXATIN is based on response rate and an interim analysis showing improved time to radiographic progression. No results are available at this time that demonstrate a clinical benefit, such as improvement of disease-related symptoms or increased survival (see CLINICAL STUDIES). Pediatric Use: The safety and effectiveness of ELOXATIN in pediatric patients have not been established.
Carcinogen: Long-term animal studies have not been performed to evaluate the carcinogenic potential of oxaliplatin. Mutagen: Oxaliplatin was not mutagenic to bacteria (Ames test) but was mutagenic to mammalian cells in vitro (L5178Y mouse lymphoma assay). Oxaliplatin was clastogenic both in vitro (chromosome aberration in human lymphocytes) and in vivo (mouse bone marrow micronucleus assay).
Manufacturer and/or Distributor: Sanofi Synthelabo    

Adverse Reactions:
More than 1500 patients with advanced colorectal cancer have been treated in clinical studies with Eloxatin either as a single agent or in combination with other medications. The most common adverse reactions were peripheral sensory neuropathies, neutropenia, nausea, emesis, and diarrhea (See PRECAUTIONS). Four-hundred and fifty patients (about 150 receiving the combination of ELOXATIN and 5-FU/LV) were studied in a randomized trial in patients with refractory and relapsed colorectal cancer (See CLINICAL STUDIES). The adverse event profile in this study was similar to that seen in other studies and the adverse reactions in this trial are shown in the tables below. Thirteen per cent of patients in the ELOXATIN and infusional 5-FU/LV-combination arm and 18% in the infusional 5-FU/LV arm had to discontinue treatment because of adverse effects related to gastrointestinal or hematologic adverse events, or neuropathies. Both 5-FU and ELOXATIN are associated with gastrointestinal and hematologic adverse events. When ELOXATIN is administered in combination with infusional 5-FU, the incidence of these events is increased. The incidence of death within 30 days of treatment, regardless of causality, was 5% with the ELOXATIN and infusional 5-FU/LV combination, 8% with ELOXATIN alone, and 7% with infusional 5-FU/LV. Of the 7 deaths that occurred on the ELOXATIN and infusional 5-FU/LV combination arm within 30 days of stopping treatment, 3 may have been treatment-related, associated with gastrointestinal bleeding or dehydration. The following table provides adverse events reported in the study (see CLINICAL STUDIES) in decreasing order of frequency in the ELOXATIN and infusional 5-FU/LV combination arm for events with overall incidences ?5% and for grade 3/4 events with incidences 1%. This table does not include hematologic and blood chemistry abnormalities; these are shown separately below. Table 5 – Adverse Experience Reported In Colorectal Cancer Clinical Trial (See Table) The following table provides adverse events reported in the study (see CLINICAL STUDIES) in decreasing order of frequency in the ELOXATIN and infusional 5-FU/LV combination arm for events with overall incidences ³5% but with incidences <1% NCI Grade 3/4 events. Table 6 - Adverse Experience Reported In Colorectal Cancer Clinical Trial (³5% of all patients but with <1% NCI Grade 3/4 events) Adverse events were similar in men and women and in patients <65 and ³65 years, but older patients may have been more susceptible to dehydration, diarrhea, hypokalemia and fatigue. The following additional adverse events, at least possibly related to treatment and potentially important, were reported in ³2% and <5% of the patients in the ELOXATIN and infusional 5-FU/LV combination arm (listed in decreasing order of frequency): anxiety, myalgia, erythematous rash, increased sweating, conjunctivitis, weight decrease, dry mouth, rectal hemorrhage, depression, ataxia, ascites, hemorrhoids, muscle weakness, nervousness, tachycardia, abnormal micturition frequency, dry skin, pruritis, hemoptysis, purpura, vaginal hemorrhage, melena, somnolence, pneumonia, proctitis, involuntary muscle contractions, intestinal obstruction, gingivitis, tenesmus, hot flashes, enlarged abdomen, urinary incontinence. Hematologic The following table lists the hematologic changes occurring in ³5% of patients, based on laboratory values and NCI grade. Table 7 – Adverse Hematologic Experiences (³5% of patients) Thrombocytopenia Thrombocytopenia was frequently reported with the combination of ELOXATIN and infusional 5-FU/LV. The incidence of Grade 3/4 thrombocytopenia was 4%. Grade 3/4 hemorrhagic events were reported at low frequency and the incidence of these events was similar for the combination of ELOXATIN and infusional 5-FU/LV and the infusional 5-FU/LV control group. The incidence of all hemorrhagic events, however, was higher on the ELOXATIN combination arm compared to the 5-FU/LV arm. These events included gastrointestinal bleeding, hematuria and epistaxis. Neutropenia Neutropenia was frequently observed with the combination of ELOXATIN and infusional 5-FU/LV, with Grade 3 and 4 events reported in 27% and 17% of previously treated patients, respectively. The incidence of febrile neutropenia was 1% in the infusional 5-FU/LV arm and 6% (less than 1% of cycles) in the ELOXATIN and infusional 5-FU/LV combination arm. Gastrointestinal In patients receiving the combination of ELOXATIN and infusional 5-FU/LV, the incidence of Grade 3 and 4 nausea, vomiting, diarrhea, and mucositis/stomatitis increased compared to infusional 5-FU/LV controls (See table). The incidence of gastrointestinal adverse events appears to be similar across cycles. Premedication with antiemetics, including 5-HT3 blockers, is recommended. Diarrhea and mucositis may be exacerbated by the addition of ELOXATIN to infusional 5-FU/LV, and should be managed with appropriate supportive care. Since cold temperature can exacerbate acute neurological symptoms, ice (mucositis prophylaxis) should be avoided during the infusion of ELOXATIN. Dermatologic ELOXATIN did not increase the incidence of alopecia compared to infusional 5-FU/LV alone. No complete alopecia was reported. The incidence of hand-foot syndrome was 13% in the infusional 5-FU/LV arm and 11% in the ELOXATIN and infusional 5-FU/LV combination arm. Care of Intravenous Site: Extravasation may result in local pain and inflammation that may be severe and lead to complications, including necrosis. Injection site reaction, including redness, swelling, and pain have been reported. Neurologic ELOXATIN is consistently associated with two types of peripheral neuropathy (see PRECAUTIONS, Neuropathy). Seventy-four percent of patients experienced neuropathy. The incidence of overall and Grade 3/4 persistent peripheral neuropathy was 48% and 6%, respectively, in the study. These events can occur without any prior acute event. The majority of the patients (80%) that developed grade 3 persistent neuropathy progressed from prior Grade 1 or 2 events. The median number of cycles administered on the ELOXATIN with infusional 5-FU/LV combination arm was 6 cycles. In clinical trials that have studied similar administration schedules of this combination regimen, (median cycles ranged 10-12), a higher incidence (17%) of Grade 3/4 persistent neurotoxicity was observed. Allergic reactions Hypersensitivity to ELOXATIN has been observed (<1% Grade 3/4) in clinical studies. These allergic reactions, which can be fatal, were similar in nature and severity to those reported with other platinum-containing compounds- i.e., rash, urticaria, erythema, pruritis, and, rarely, bronchospasm and hypotension. These reactions are usually managed with standard epinephrine, corticosteroid, and antihistamine therapy, (see WARNINGS for anaphylactic/anaphylactoid reactions.) Renal About 10% of patients in all groups had some degree of elevation of serum creatinine. The incidence of Grade 3/4 elevations in serum creatinine in the ELOXATIN and infusional 5-FU/LV combination arm was 1%. Hepatic The following table lists the clinical chemistry changes associated with hepatic toxicity occurring in ³ 5% of patients, based on laboratory values and NCI CTC grade. Table 8 – Adverse Hepatic – Clinical Chemistry Experience (³5% of patients) Thromboembolism The incidence of thromboembolic events was 4% in the infusional 5-FU/LV arm, and 9% in the ELOXATIN and infusional 5-FU/LV combination arm. Postmarketing Experience The following events have been reported from worldwide postmarketing experience. Body as a whole: - angioedema, anaphylactic shock Central and peripheral nervous system disorders: - loss of deep tendon reflexes, dysarthria, Lhermittes’ sign, cranial nerve palsies, fasciculations Gastrointestinal system disorders: - severe diarrhea/vomiting resulting in hypokalemia, metabolic acidosis; ileus; intestinal obstruction, pancreatitis Hearing and vestibular system disorders: - deafness Platelet, bleeding, and clotting disorders: - immuno-allergic thrombocytopenia Red Blood Cell disorders - hemolytic uremic syndrome Respiratory system disorders: - pulmonary fibrosis, and other interstitial lung diseases Vision disorders: - decrease of visual acuity, visual field disturbance, optic neuritis


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