Oxalee

In combination w/ infusional 5-fluorouracil (FU) & leucovorin in the treatment of advanced colorectal cancer; adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor.

Always administer before fluoropyrimidines. Antiemetics should be given during pre- & post-therapy w/ oxaliplatin. IV infusion Treatment of patient w/ advanced colorectal cancer Day 1: Oxaliplatin 85 mg/m² (as IV infusion diluted in 250-500 mL of 5% dextrose soln) & leucovorin 200 mg/m² IV infusion in 5% dextrose soln both given over 120 min at the same time in different bags using a Y-line, followed by 5-FU 400 mg/m² by IV bolus given over 2-4 min, followed by 5-FU 600 mg/m² diluted in 500 mL 5% dextrose soln as a 22-hr continuous IV infusion. Day 2: Leucovorin 200 mg/m² in IV infusion over 120 min, followed by 5-FU 400 mg/m² by IV bolus over 2-4 min, followed by 5-FU 600 mg/m² diluted in 500 mL 5% dextrose soln as a 22-hr continuous IV infusion. Treatment may be repeated every 2 wk. Persistent grade 2 neurosensory events that do not resolve Oxaliplatin 65 mg/m². No change in dose of leucovorin & 5-FU. After recovery from grade 3/4 GI (despite prophylactic treatment) or grade 4 neutropenia or febrile neutropenia or grade 3/4 thrombocytopenia Oxaliplatin 65 mg/m². Reduce 5-FU dose to 300 mg/m² bolus & 500 mg/m² 22-hr infusion. Postpone next dose until hematological values return to acceptable levels (neutrophils ≥1.5 x 10⁹/L & platelets ≥75 x 10⁹/L). Adjuvant treatment of patient w/ stage III (Duke's C) colon cancer who have undergone complete resection of primary tumor Total recommended duration of treatment: 6 mth (ie, 12 cycles) given every 2 wk according to the dose schedule used for treatment of patients w/ advanced colorectal cancer. Persistent grade 2 neurosensory events that do not resolve Oxaliplatin 75 mg/m². No change in 5-FU/leucovorin dose. After recovery from grade 3/4 GI (despite prophylactic treatment) or grade 4 neutropenia or febrile neutropenia or grade 3/4 thrombocytopenia Oxaliplatin 75 mg/m². Reduce 5-FU dose to 300 mg/m² bolus & 500 mg/m² 22-hr infusion. Postpone next dose until hematological values return to acceptable levels (neutrophils ≥1.5 x 10⁹/L & platelets ≥75 x 10⁹/L). Mild to moderate renal impairment Oxaliplatin 85 mg/m². Severe renal impairment Oxaliplatin 65 mg/m².

Hypersensitivity to oxaliplatin, other platinum compd (eg, cisplatin, carboplatin). Peripheral sensory neuropathy (w/ functional impairment prior to 1st course); severe renal impairment (CrCl <30 mL/min); myelosuppression prior to starting 1st course w/ baseline neutrophils <2 x 10⁹/L &/or platelet count of <100 x 10⁹/L. Pregnancy & lactation.

Risk of anaphylactoid reactions. Perform CBC w/ differential, Hb, platelets & blood chemistries including ALT, AST, bilirubin, creatinine, Mg & electrolytes prior to start of therapy & before each subsequent course. Monitor patients using oral anticoagulants & for diarrhea, vomiting & mucositis. Perform neurological examinations before each administration & periodically thereafter. QT prolongation & Torsade de Pointes. Severe diarrhea or emesis, colitis including C. difficile. Discontinue treatment if intestinal ischemia, duodenal ulcer & potential complications (duodenal ulcer hemorrhage & perforation); unexplained resp symptoms; infection & infestation occurs. Interrupt treatment if oxaliplatin extravasation occurs & initiate local symptomatic treatment. Acute neuropathy. Avoid ice during infusion. Reversible posterior leukoencephalopathy. Pulmonary fibrosis & interstitial lung disease. Neutropenia. Routinely monitor liver function. Rhabdomyolosis. May have an irreversible infertility effect. May impair ability to drive or operate machinery. Childn. Elderly.

Infections & infestations, aggravated malignant neoplasm; blood & lymphatic, immune system, metabolism & nutrition; psychiatric, nervous system, eye, ear & labyrinth, cardiac, vascular, resp, thoracic & mediastinal, GI, hepatobiliary, skin & SC tissue, musculoskeletal & connective tissue, renal & urinary disorders; reproductive system & breast effects. Fatigue, fever, asthenia, pain, hyperhidrosis/sweating, mucositis, ataxia, extravasation. Increased/decreased wt, increased prolonged PT, INR; transaminases; hepatic enzymes; blood bilirubin; blood lactate dehydrogenase, QT prolongation, decreased neutrophils. Inj site reactions, accidental injury, phlebitis, contusion/bruise. Diarrhea-colostomy.

Possible increase in plasma conc of 5-FU (during concomitant use w/ oxaliplatin 130 mg/m² every 3 wk). Anticoagulants. May decrease clearance w/ nephrotoxic drugs. Drugs that may cause QT prolongation & rhabdomyolysis.

Cytotoxic Chemotherapy

L01XA03 - oxaliplatin ; Belongs to the class of platinum-containing antineoplastic agents. Used in the treatment of cancer.

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