Oxaltero Injection

Oxaliplatin Injection, in combination with infusional fluorouracil and leucovorin, is indicated for: adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. treatment of advanced colorectal cancer. Oxaliplatin Injection is a platinum-based drug used in combination with infusional fluorouracil and leucovorin, which is indicated for: adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. treatment of advanced colorectal cancer.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Boxed warning. HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS Serious and fatal hypersensitivity adverse reactions, including anaphylaxis, can occur with Oxaliplatin within minutes of administration and during any cycle. Oxaliplatin is contraindicated in patients with hypersensitivity reactions to Oxaliplatin and other platinum-based drugs. Immediately and permanently discontinue Oxaliplatin for hypersensitivity reactions and administer appropriate treatment for management of the hypersensitivity reaction. WARNING: HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS See full prescribing information for complete boxed warning. Serious and fatal hypersensitivity adverse reactions, including anaphylaxis, can occur with Oxaliplatin within minutes of administration and during any cycle. Immediately and permanently discontinue Oxaliplatin for hypersensitivity reactions and administer appropriate treatment. Peripheral Sensory Neuropathy: Acute and delayed neuropathy can occur. Avoid topical application of ice. Reduce the dose or permanently discontinue Oxaliplatin as recommended. Severe Myelosuppression: Delay Oxaliplatin until neutrophils are greater than or equal to 1.5 × 10 9 /L and platelets are greater than or equal to 75 × 10 9 /L. Withhold Oxaliplatin for sepsis or septic shock. Dose reduce after recovery from grade 4 neutropenia, febrile neutropenia, or grade 3 to 4 thrombocytopenia as recommended. Posterior Reversible Encephalopathy Syndrome (PRES): Permanently discontinue Oxaliplatin in patients who develop PRES. Pulmonary Toxicity: Withhold Oxaliplatin until investigation excludes interstitial lung disease or pulmonary fibrosis. Hepatotoxicity: Monitor liver function tests at baseline, before each subsequent cycle, and as clinically indicated. QT Interval Prolongation: Avoid in patients with congenital long QT syndrome. Monitor electrocardiograms in patients with congestive heart failure, bradyarrhythmias, and electrolyte abnormalities, and in patients taking drugs known to prolong the QT interval. Correct electrolyte abnormalities prior to initiating Oxaliplatin and periodically during treatment. Rhabdomyolysis: Permanently discontinue Oxaliplatin if rhabdomyolysis occurs. Hemorrhage: Increase frequency of monitoring in patients who are receiving Oxaliplatin with fluorouracil/leucovorin and oral anticoagulants Embryo-Fetal Toxicity: Can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise males and females of reproductive potential to use an effective method of contraception. Hypersensitivity Reactions Serious and fatal hypersensitivity reactions, including anaphylaxis, can occur with Oxaliplatin within minutes of administration and during any cycle. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following clinically significant adverse reactions are described elsewhere in labeling: Hypersensitivity Reactions Peripheral Sensory Neuropathy Severe Myelosuppression Reversible Posterior Leukoencephalopathy Syndrome Pulmonary Toxicity Hepatotoxicity QT Interval Prolongation and Ventricular Arrhythmias Rhabdomyolysis Hemorrhage Most common adverse reactions (incidence greater than or equal to 40%) were peripheral sensory neuropathy, neutropenia, thrombocytopenia, anemia, nausea, increase in transaminases and alkaline phosphatase, diarrhea, emesis, fatigue, and stomatitis. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. More than 1100 patients with stage II or III colon cancer and more than 4,000 patients with advanced colorectal cancer were treated in trials with Oxaliplatin. The most common adverse reactions in patients with stage II or III colon cancer receiving adjuvant treatment were peripheral sensory neuropathy, neutropenia, thrombocytopenia, anemia, nausea, increase in transaminases and alkaline phosphatase, diarrhea, emesis, fatigue and stomatitis. The most common adverse reactions in previously untreated and treated patients with advanced colorectal cancer were peripheral sensory neuropathies, fatigue, neutropenia, nausea, emesis, and diarrhea. Adjuvant Treatment The safety of Oxaliplatin in combination with fluorouracil (FU)/leucovorin (LV) was evaluated in patients with stage II or III colon cancer, who had undergone complete resection of the primary tumor in the adjuvant treatment trial. Fatal adverse reactions in patients who received Oxaliplatin in the combination arm included sepsis/neutropenic sepsis (n=3), intracerebral hemorrhage (n=2), and eosinophilic pneumonia (n=1). Thromboembolic events occurred in 6% (grade 3 to 4, 1.2%) of patients in the Oxaliplatin arm. Grade 3 or 4 adverse reactions occurred in 70% of patients in the Oxaliplatin arm. Grade 3 to 4 gastrointestinal bleeding occurred in 0.2% of patients. Febrile neutropenia occurred in 0.7% and documented infection with concomitant grade 3 to 4 neutropenia occurred in 1.1%. Discontinuation due to an adverse reaction occurred in 15% of the patients in the Oxaliplatin arm. Tables 5, 6, and 7 summarize the adverse reactions reported in patients with colon cancer receiving adjuvant treatment. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.