Eloxatin 5mg/ml Concentrate for solution for infusion

SANOFI-AVENTIS SINGAPORE PTE. LTD.

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

INJECTION, SOLUTION, CONCENTRATE

**Posology and method of administration** Posology FOR ADULTS ONLY 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 until disease progression or unacceptable toxicity. The dose should be adjusted according to tolerability (see section _Special warnings and precautions for use_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Oxaliplatin should always be administered before fluoropyrimidines – i.e. 5-fluorouracil (5-FU).** Oxaliplatin is administered as a 2-to 6-hour intravenous infusion in 250 to 500 ml of glucose 5% (50mg/ml) solution to give a concentration between 0.2 mg/ml and 0.70 mg/ml; 0.70 mg/ml is the highest concentration in clinical practice for an oxaliplatin dose of 85 mg/m2. Oxaliplatin has mainly been used in combination with continuous infusion 5-fluorouracil (5-FU) based regimens. For the two-weekly treatment schedule 5-fluorouracil (5-FU) regimens combining bolus and continuous infusion were used. Special Populations _Renal impairment_ Oxaliplatin must not be administered in patients with severe renal impairment (see section _Contraindications_ and _Pharmacokinetic properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). In patients with mild to moderate renal impairment, the recommended dose of oxaliplatin is 85 mg/m2 (see section _Special warnings and precautions for use_ and _Pharmacokinetic properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Hepatic insufficiency_ In a phase I study including patients with several levels of hepatic impairment, frequency and severity of hepatobiliary disorders appeared to be related to progressive disease and impaired 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 (5-FU) in patients over the age of 65. In consequence no specific dose adaptation is required for elderly patients. _Paediatric patients_ There is no relevant indication for use of oxaliplatin in children. The effectiveness of oxaliplatin single agent in the paediatric populations with solid tumours has not been established (see section _Pharmacodynamic properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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 glucose 5% (50mg/ml) solution 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 must always precede the administration of 5-fluorouracil (5-FU). In the event of extravasation, administration must be discontinued immediately. _Instructions for use_ Oxaliplatin must be diluted before use. Only glucose 5% (50mg/ml) solution is to be used to dilute the concentrate for solution for infusion. (see section _Special precautions for disposal and other handling_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).