Oxaliplatin………………………………………..100 mg
Water for injection q.s to……………………….50 ml
Injection solution
Box of 1 bottle x 50 ml
– Oxaliplatin, used in combination with infusional 5-fluorouracil/leucovorin, is indicated for:
+ Adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor.
+ Treatment of advanced colorectal cancer.
Store in dry places, at temperature below 30°C.
– Dosage will be determined by your doctor.
– Adjuvant Setting: 85 mg/m² IV repeated every 2 weeks for 12 cycles (6 months).
– Treatment of Metastatic Colorectal Cancer: 85 mg/m2 IV 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-hr IV infusion in 250-500 mL of 5% glucose solution to give a concentration between 0.2 mg/mL and 0.7 mg/mL; 0.7 mg/mL is the highest concentration in clinical practice for an oxaliplatin dose of 85 mg/m².
Oxaliplatin was mainly used in combination with continuous infusion 5-fluorouracil-based regimens. For the 2-weekly treatment schedule 5-fluorouracil regimens combining bolus and continuous infusion were used.
+ 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 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: No increase in severe toxicities was observed when oxaliplatin was used as a single agent or in combination with 5-fluorouracil in patients >65 years. In consequence, no specific dose adaptation is required for elderly patients.
– The administration of oxaliplatin does not require hyperhydration.
– Oxaliplatin diluted in 250-500 mL of 5% glucose solution to give a concentration not <0.2 mg/mL must be infused via a central – venous line or peripheral vein over 2-6 hrs. Oxaliplatin infusion must always precede the administration of 5-FU.
– In the event of extravasation, administration must be discontinued immediately.
– Instructions for Use: Oxaliplatin must be diluted before use. Only 5% glucose diluent is to be used to dilute the concentrate for solution for infusion product.
Please read carefully the leaflet before using
