Oxitan

• OXITAN (Oxaliplatin Injection) used in combination with infusional 5-FU/LV, is indicated for treatment of advanced colorectal cancer.

For advanced disease, treatment is recommended until disease progression or unacceptable toxicity. For adjuvant use, treatment is recommended for a total of 6 months (12 cycles):

• Day 1: Oxaliplatin 85 mg/m2 IV infusion in 250-500 mL D5W and leucovorin 200 mg/m2 IV infusion in D5W both given over 120 minutes at the same time in separate bags using a Y-line, followed by 5-FU 400 mg/m2 IV bolus given over 2-4 minutes, followed by 5-FU 600 mg/m2 IV infusion in 500 mL D5W (recommended) as a 22-hour continuous infusion.
• Day 2: Leucovorin 200 mg/m2 IV infusion over 120 minutes, followed by 5-FU 400 mg/m2 IV bolus given over 2-4 minutes, followed by 5-FU 600 mg/m2 IV infusion in 500 mL D5W (recommended) as a 22-hour continuous infusion.

Adjuvant Therapy in Patients with Stage III Colon Cancer

• For patients who experience persistent grade 2 neurosensory events that do not resolve, a dose reduction of oxaliplatin to 75 mg/m2 should be considered.
• For patients with persistent grade 3 neurosensory events, discontinuing therapy should be considered. The infusional 5-FU/LV regimen need not be altered.
• A dose reduction of oxaliplatin to 75 mg/m2 and infusional 5-FU to 300 mg/ m2 bolus and 500 mg/m2 22-hour infusion is recommended for patients after recovery from grade 3/4 gastrointestinal (despite prophylactic treatment) or grade 4 neutropenia or grade 3/4 thrombocytopenia. The next dose should be delayed until: neutrophils ≥1.5 x 109/L and platelets ≥75 x 109/L.

• Strengths:

RTU (Ready to use) Concentrate:

Oxaliplatin Injection (Oxitan) 50 mg/ 25ml

Oxaliplatin Injection (Oxitan) 100 mg/ 50ml

For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory