OXALIPLATIN ADVAGEN CONCENTRATE FOR SOLUTION FOR INFUSION 5MG/ML [SIN16353P]

Product Info

OXALIPLATIN ADVAGEN CONCENTRATE FOR SOLUTION FOR INFUSION 5MG/ML

[SIN16353P]

4.1 Therapeutic indications

Oxaliplatin in combination with 5-fluorouracil (5-FU) and folinic acid (FA) is indicated for:

• Adjuvant treatment of stage III (Dukes C) colon cancer after complete resection of primary tumour.

• Treatment of metastatic colorectal cancer.

4.2 Posology and method of administration

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 85mg/m² intravenously repeated every 2 weeks until disease progression or unacceptable toxicity.

Dosage given should be adjusted according to tolerability (see section 4.4 – 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.

Oxaliplatin is administered as a 2- to 6-hour intravenous infusion in 250 to 500 ml of 5% glucose 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 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 must not be administered in patients with severe renal impairment (see sections 4.3 and 5.2 – 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 sections 4.4 and 5.2 – 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 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.

• 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.

• 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 tumors has not been established (see section 5.1 – 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 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 must always precede the administration of 5-fluorouracil.

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. (see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3 Contraindications

Oxaliplatin is contraindicated in patients who

• have a known history of hypersensitivity to oxaliplatin or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• are breast feeding.

• have myelosuppression prior to starting first course, as evidenced by baseline neutrophils <2×10⁹/l and/or platelet count of <100×10⁹/l.

• have a peripheral sensitive neuropathy with functional impairment prior to first course.

• have a severely impaired renal function (creatinine clearance less than 30 ml/min) (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).