Oxaliplatin Ebewe Dosage/Direction for Use

Posology: FOR ADULTS ONLY.
The recommended dose for oxaliplatin in adjuvant setting is 85mg/m² intravenously repeated every two weeks for 12 cycles (6 months).
The recommended dose for oxaliplatin in treatment of metastatic colorectal cancer is 85mg/m² intravenously repeated every 2 weeks.
Dosage given should be adjusted according to tolerability (see Precautions).
Oxaliplatin should always be administered before fluoropyrimidines.
Oxaliplatin is administered as a 2- to 6-hour intravenous infusion in 250 to 500ml of 5% glucose solution.
Oxaliplatin was mainly used in combination with continuous infusion 5-fluorouracil based regimens. For the two-weekly treatment schedule 5-fluorouracil regimens combining bolus and continuous infusion were used.
Special Populations: Renal impairment: Oxaliplatin has not been studied in patients with severe renal impairment (see Contraindications).
In patients with moderate renal impairment, treatment may be initiated at the normally recommended dose (see Precautions). There is no need for dose adjustment in patients with mild renal dysfunction.
Hepatic insufficiency: Oxaliplatin has not sufficiently 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. ln 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 500ml of 5% glucose solution to give a concentration not less than 0.2mg/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 reconstituted and further diluted before use. Only the recommended diluents should be used to reconstitute and then dilute the freeze-dried product. (See Instructions for use/handling and disposal under Cautions for Usage).