Oxitan Dosage/Direction for Use

For Adults Only: The recommended dose of oxaliplatin for single agent studies is 130 mg/m², given intravenously over at least 2 hours. every three-four weeks. In combination studies with 5-FU, with or without folinic acid, the recommended dose of oxaliplatin is 130 mg/m² every 3 weeks or 85 mg/m² every two weeks.
The recommended dose for oxaliplatin in adjuvant setting is 85 mg/m² intravenously repeated every two weeks for 12 cycles (6 months).
The recommended dose for oxaliplatin in treatment of metastatic colorectal cancer is 85 mg/m² intravenously repeated every 2 weeks.
The recommended dose of oxaliplatin in treatment of metastatic colorectal cancer is 130 mg/m² intravenously in combination with capecitabine repeated every 3 weeks.
Dosage given should be adjusted according to tolerability (see Precautions).
Special Populations: Renal impairment: Oxaliplatin has not been studied in patients with severe renal impairment.
In patients with moderate renal impairment, treatment may be initiated at the normally recommended dose. There is no need for dose adjustment in patients with mild renal dysfunction.
Hepatic insufficiency: Oxaliplatin has not been studied in patients with severe hepatic impairment. No increase in oxaliplatin acute toxicities was observed in the subset of patients with abnormal liver function tests at baseline. No specific dose adjustment for patients with abnormal liver function tests was performed during clinical development.
Elderly patients: No increase in severe toxicities was observed when oxaliplatin was used as a single agent or in combination with 5-fluorouracil in patients over the age of 65. In consequence no specific dose adaptation is required for elderly patients.
Method of Administration: Oxaliplatin is administered by intravenous infusion.
The administration of oxaliplatin does not require hyperhydration.
Oxaliplatin diluted in 250 to 500 ml of 5% Dextrose Injection to give a concentration not less than 0.2 mg/ml must be infused via a central venous line or peripheral vein over 2 to 6 hours. Oxaliplatin infusion should always precede that of 5-fluorouracil.
In the event of extravasation, administration must be discontinued immediately.
Instructions for use: Oxaliplatin must be diluted before use. Only the recommended diluent should be used to dilute the concentrate for solution for infusion product.
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 not less than 0.2 mg/mL. The shelf life of diluted Oxaliplatin Solution is 6 hours at room temperature [20-25 °C (68-77°F)] or up to 24 hours under refrigeration [2-8 °C (36-46 °F)].
Administer by IV infusion.
Impact 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 solution for dilution.
Infusion: The administration of oxaliplatin does not require prehydration.