Oxitan

Oxaliplatin

In combination w/ 5-fluorouracil (5-FU) & folinic acid for adjuvant treatment of stage III (Duke's C) colon cancer after complete resection of primary tumor; metastatic CRC; unresectable advanced or metastatic gastric cancer; unresectable hepatocellular carcinoma (HCC).

IV infusion Infuse by peripheral vein or central venous line over 2-6 hr. Premed w/ antiemetics including 5-HT₃ blockers w/ or w/o dexamethasone. In combination w/ 5-FU/leucovorin: Day 1: 85 mg/m² & leucovorin 200 mg/m² both given over 120 min at same time in separate bags using Y-line, followed by 5-FU 400 mg/m² IV bolus given over 2-4 min, then 5-FU 600 mg/m² IV infusion as 22-hr continuous infusion. Day 2: Leucovorin 200 mg/m² over 120 min, followed by 5-FU 400 mg/m² IV bolus given over 2-4 min, then 5-FU 600 mg/m² IV infusion as 22-hr continuous infusion. Repeat infusion every 2 wk for total of 6 mth (12 cycles). Unresectable advanced or metastatic gastric cancer 100 mg/m² IV repeated every 2 wk in combination w/ infusional 5-FU & folinic acid. FLO regimen: 85 mg/m² IV every 2 wk in combination w/ fluorouracil 2,600 mg/m² & leucovorin 200 mg/m². Modified FOLFOX regimen: 85 mg/m² IV every 2 wk in combination w/ fluorouracil 1,000 mg/m² & leucovorin 200 mg/m². EOX or EOF regimen: 130 mg/m² IV every 3 wk cycle in combination w/ epirubicin 50 mg/m² & capecitabine 625 mg/m² or fluorouracil 200 mg/m². Unresectable HCC FOLFOX regimen: 85 mg/m² IV, repeated every 2 wk until disease progression or unacceptable toxicity. Dose modifications: Stage III colon cancer Patient w/ persistent grade 2 neurosensory events that do not resolve Reduce dose to 75 mg/m². Patient after recovery from grade 3/4 GI (despite prophylactic treatment) or grade 4 neutropenia or grade 3/4 thrombocytopenia Reduce dose to 75 mg/m² & infusional 5-FU (300 mg/m² bolus & 500 mg/m² 22-hr infusion). Delay next dose until neutrophils ≥1.5 x 10⁹/L & platelets ≥75 x 10⁹/L. Previously untreated & treated w/ advanced CRC Patient w/ persistent Grade 2 neurosensory events that do not resolve Reduce dose to 65 mg/m². Patient after recovery from grade 3/4 GI (despite prophylactic treatment) or grade 4 neutropenia or grade 3/4 thrombocytopenia Reduce dose to 65 mg/m² & 5-FU (300 mg/m² bolus & 500 mg/m² 22-hr infusion). Delay next dose until neutrophils >1.5 x 10⁹/L & platelets >75 x 10⁹/L. Severe renal impairment Reduce initial dose to 65 mg/m².

History of hypersensitivity to oxaliplatin or other platinum compd.

Grade 3/4 hypersensitivity including anaphylactic/anaphylactoid reactions in colon cancer patients. Discontinue treatment if hypersensitivity reactions eg, urticaria, pruritus, flushing of face, diarrhea associated w/ infusion, shortness of breath, bronchospasm, diaphoresis, chest pains, hypotension, disorientation & syncope occur; in case of unexplained resp symptoms eg, non-productive cough, dyspnea, crackles, or radiological pulmonary infiltrates; if any signs or symptoms of rhabdomyolysis occur. Withhold treatment if sepsis or septic shock occurs. Delay treatment until neutrophils are ≥1.5 x 10⁹/L. Consider treatment discontinuation if rapid onset of thrombocytopenia & greater risk of bleeding are observed. Avoid ice or exposure to cold temp or objects during infusion due to exacerbation of acute neurological symptoms; use in patients w/ congenital long QT syndrome. Acute, reversible, primarily peripheral, sensory neuropathy; acute syndrome of pharyngolaryngeal dysesthesia. Reversible posterior leukoencephalopathy syndrome. Grade 3 or 4 neutropenia; sepsis, neutropenic sepsis & septic shock. Hepatotoxicity; peliosis, nodular regenerative hyperplasia or sinusoidal alterations, perisinusoidal fibrosis, & veno-occlusive lesions on liver biopsies. QT prolongation & ventricular arrhythmias including fatal Torsade de Pointes. Prolonged prothrombin time & INR associated w/ hemorrhage; thrombocytopenia & immune-mediated thrombocytopenia. Monitor patients receiving oxaliplatin + 5-FU/leucovorin & requiring oral anticoagulants; WBC count w/ differential, Hb, platelet count, & blood chemistries (including ALT, AST, bilirubin & creatinine) before each cycle. Investigate for hepatic vascular disorders in case of abnormal LFTs or portal HTN. Consider ECG monitoring in patients w/ CHF, bradyarrhythmias, drugs known to prolong QT interval including class Ia & III antiarrhythmics, & electrolyte abnormalities. Correct hypokalemia or hypomagnesemia prior to initiating treatment & monitor these electrolytes periodically during therapy. Severe renal impairment (CrCl <30 mL/min). Verify pregnancy status in females of reproductive potential prior to treatment. Advise pregnant women of potential risk to fetus. Advise females of reproductive potential & males w/ female partners of reproductive potential to use effective contraception during treatment & for 9 mth (females) or 6 mth (males) after final dose. Avoid becoming pregnant while on therapy. Not to breastfeed during treatment & for 3 mth after final dose. Childn.

Peripheral sensory neuropathy, neutropenia, thrombocytopenia, anemia, nausea, increased transaminases & alkaline phosphatase, diarrhea, emesis, fatigue & stomatitis.

Cytotoxic Chemotherapy

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

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