Oxitan Dosage/Direction for Use

Recommended Dose: Oxaliplatin injection should be administered under the supervision of a qualified 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.
Dosage: Administer oxaliplatin in combination with 5-fluorouracil/leucovorin every 2 weeks. For advanced disease, treatment is recommended until disease progression or unacceptable toxicity. For adjuvant use, treatment is recommended for a total of 6 months (12 cycles): Day 1: Oxaliplatin 85 mg/m² IV infusion in 250-500 mL D5W and leucovorin 200 mg/m² IV infusion in D5W both given over 120 minutes at the same time in separate bags using a Y-line, followed by 5-FU 400 mg/m² IV bolus given over 2-4 minutes, followed by 5-FU 600 mg/m² IV infusion in 500 mL 5% Dextrose Injection (recommended) as a 22-hour continuous infusion.
Day 2: Leucovorin 200 mg/m² IV infusion over 120 minutes, followed by 5-FU 400 mg/m² IV bolus given over 2-4 minutes, followed by 5-FU 600 mg/m² IV infusion in 500 mL 5% Dextrose Injection (recommended) as a 22-hour continuous infusion.
The recommended dose for oxaliplatin in treatment of unresectable advanced or metastatic gastric cancer are: 100 mg/m² intravenously repeated every two weeks in combination with infusional 5-FU and folinic acid.
85 mg/m² intravenously (FLO regimen) every 2 weeks in combination with fluorouracil 2,600 mg/m² and leucovorin 200 mg/m².
85 mg/m² intravenously (modified FOLFOX regimen) every 2 weeks in combination with fluorouracil 1,000 mg/m² and leucovorin 200 mg/m².
130 mg/m² intravenously (EOX or EOF regimen) every 3 weeks cycle in combination with Epirubicin 50 mg/m² and Capecitabine 625 mg/m² or fluorouracil 200 mg/m².
The recommended dose of Oxaliplatin in combination with 5-fluorouracil and folinic acid (FOLFOX) in the treatment of unresectable hepatocellular carcinoma is 85 mg/m² intravenously, repeated every two weeks until disease progression or unacceptable toxicity.
The administration of oxaliplatin does not require prehydration. Premedication with antiemetics, including 5-HT₃ blockers with or without dexamethasone, is recommended.
Dose Modification Recommendations: Prior to subsequent therapy cycles, patients should be evaluated for clinical toxicities and laboratory tests. Prolongation of infusion time for oxaliplatin from 2 hours to 6 hours decreases the C_max by an estimated 32% and may mitigate acute toxicities. The infusion times for 5-FU and leucovorin do not need to be changed.
Adjuvant Therapy in Patients with Stage III Colon Cancer: Neuropathy and other toxicities were graded using the NCI CTC scale, version 1.
For patients who experience persistent grade 2 neurosensory events that do not resolve, a dose reduction of oxaliplatin to 75 mg/m² should be considered. For patients with persistent grade 3 neurosensory events, discontinuing therapy should be considered. The infusional 5-FU/LV regimen need not be altered.
A dose reduction of oxaliplatin to 75 mg/m² and infusional 5-FU to 300 mg/m² bolus and 500 mg/m² 22-hour infusion is recommended for patients after recovery from grade 3/4 gastrointestinal (despite prophylactic treatment) or grade 4 neutropenia or grade 3/4 thrombocytopenia. The next dose should be delayed until: neutrophils ≥1.5 x 10⁹/L and platelets ≥75 x 10⁹/L.
Dose Modifications in Therapy in Previously Untreated and Previously Treated Patients with Advanced Colorectal Cancer: Neuropathy was graded using a study-specific neurotoxicity scale. Other toxicities were graded by the NCI CTC, version 2.0.
For patients who experience persistent Grade 2 neurosensory events that do not resolve, a dose reduction of oxaliplatin to 65 mg/m² should be considered. For patients with persistent grade 3 neurosensory events, discontinuing therapy should be considered. The 5-FU/LV regimen need not be altered.
A dose reduction of oxaliplatin to 65 mg/m² and 5-FU (300 mg/m² bolus and 500 mg/m² 22-hour infusion) is recommended for patients after recovery from grade 3/4 gastrointestinal (despite prophylactic treatment) or grade 4 neutropenia or grade 3/4 thrombocytopenia. The next dose should be delayed until: neutrophils >1.5 x 10⁹/L and platelets >75 x 10⁹/L.
Dose Modifications in Therapy for Patients with Renal Impairment: In patients with normal renal function or mild to moderate renal impairment, the recommended dose of oxaliplatin is 85 mg/m². In patients with severe renal impairment, the initial recommended oxaliplatin dose should be reduced to 65 mg/m².
Mode of Administration: Infusion: The administration of oxaliplatin does not require prehydration.
Oxaliplatin diluted in 250 to 500 mL of a 5% Dextrose Injection to give a concentration not less than 0.2 mg/mL must be infused either by peripheral vein or central venous line over 2 to 6 hours. When oxaliplatin is administered with 5-fluorouracil, the oxaliplatin infusion must precede the administration of 5-fluorouracil.
Preparation of Infusion solution: Do not freeze and protect from light the concentrated solution.
A final dilution must never be performed with a sodium chloride solution or other chloride-containing solutions.
Oxaliplatin is incompatible in solution with alkaline medications or media (such as basic solutions of 5-fluorouracil) and must not be mixed with these or administered simultaneously through the same infusion line. The infusion line should be flushed with 5% Dextrose Injection prior to administration of any concomitant medication. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration and discarded if present.
Needles or intravenous administration sets containing aluminum parts that may come in contact with oxaliplatin should not be used for the preparation or mixing of the drug. Aluminum has been reported to cause degradation of platinum compounds.
Dilution before Infusion: Withdraw the required amount of concentrate from the vial(s) and then dilute with 250 mL to 500 mL of a 5% Dextrose Injection to give an oxaliplatin concentration between not less than 0.2 mg/mL and 0.7 mg/mL. The concentration range for which the physico-chemical stability of oxaliplatin has been demonstrated is 0.2 mg/mL to 0.7 mg/mL.
Administer by IV infusion: After dilution in 5% Dextrose, chemical and physical in-use stability has been demonstrated for 48 hours at 2°C to 8°C and for 6 hours at 30°C. From a microbiological point of view, this infusion preparation should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C unless dilution has taken place in controlled and validated aseptic conditions.
Inspect visually prior to use. Only clear solutions without particles should be used.
The medicinal product is for single use only. Any unused infusion solution should be discarded.
Never use sodium chloride or chloride containing solutions for dilution.
The compatibility of oxaliplatin solution for infusion has been tested with representative, PVC based, administration sets.