Xaliptine Dosage/Direction for Use

The preparation of injectable solutions of cytotoxic agents must be carried out by trained specialist personnel with knowledge of the medical product used, in conditions that guarantee the integrity of the medical product, the protection of the environment and in particular the protection of the personnel handling the medicinal products, in accordance with the hospital policy. It requires a preparation area reserved for this purpose. It is forbidden to smoke, eat or drink in this area (see Special precautions for disposal and other handling under Cautions for Usage for detailed information).
Dosage: 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. Dose given should be adjusted according to tolerability (see Precautions).
Oxaliplatin should always be administered before fluoropyrimidines-i.e. 5-fluorouracil (5FU).
Oxaliplatin is administered as a 2- to 6-hour intravenous infusion in 250 to 500 mL of 5% glucose solution (50 mg/mL) to give a concentration between 0.2 mg/mL and 0.70 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 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 impairment: In a phase I study including patients with several levels of hepatic impairment, frequency and severity of hepato-biliary 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.
Older 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 older 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 Pharmacology: Pharmacodynamics under Actions).
Method of administration: Oxaliplain is administered by intravenous infusion.
The administration of oxaliplatin does not require hyperhydration.
Oxaliplatin diluted in 250 to 500 mL of 5% glucose 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 should always precede that of 5-fluorouracil.
In the event of extravasation, administration must be discontinued immediately.
Instructions for use: Oxaliplatin must be further diluted before use. Only 5% glucose diluent is to be used to dilute the concentrate for solution for infusion (see Special precautions for disposal and other handling under Cautions for Usage).