Vexplatin-50/Vexplatin-100

Vexplatin-50/Vexplatin-100

oxaliplatin

Manufacturer:

Vexxa Lifesciences

Distributor:

VE Pharma
Concise Prescribing Info
Contents
Oxaliplatin
Indications/Uses
In combination w/ infusional 5-fluorouracil/leucovorin for the adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. Treatment of advanced colorectal cancer.
Dosage/Direction for Use
Adjuvant therapy in patients w/ stage III colon cancer Day 1: Oxaliplatin 85 mg/m2 IV infusion in 250-500 ml of 5% (50 mg/mL) glucose soln given at the same time as leucovorin 200 mg/m2 IV infusion in 5% glucose soln over 2-6 hr in separate bags using a Y-line. Followed by 5-fluorouracil 400 mg/m2 IV bolus given over 2-4 min, followed by 5-fluorouracil 600 mg/m2 IV infusion in 500 mL of 5% glucose soln as 22-hr continuous infusion. Day 2: Oxaliplatin 85 mg/m2 IV infusion in 250-500 mL of 5% (50 mg/mL) glucose soln given at the same time as leucovorin 200 mg/m2 IV infusion in 5% glucose soln over 2-6 hr in separate bags using a Y-line. Followed by 5-fluorouracil 400 mg/m2 IV bolus given over 2-4 min, followed by 5-fluorouracil 600 mg/m2 IV infusion in 500 mL of 5% glucose soln as 22-hr continuous infusion. Advanced colorectal cancer Day 1: Oxaliplatin 85 mg/m2 IV infusion in 250-500 mL of 5% (50 mg/mL) glucose soln given as the same time as leucovorin 200 mg/m2 IV infusion in 5% glucose soln over 2-6 hr in separate bags using a Y-line. Followed by 5-fluorouracil 400 mg/m2 IV bolus given over 2-4 min, followed by 5-fluorouracil 600 mg/m2 IV infusion in 500 mL of 5% glucose soln as 22-hr continuous infusion. Repeat cycle every 2 wk.
Contraindications
Patients w/ acute, reversible, primarily peripheral, sensory neuropathy that is of early onset, occurring w/in an hr or 1-2 days of dosing that resolves w/in 14 days & that frequently recurs w/ further dosing. Persistent ( >14 days), primarily peripheral, sensory neuropathy.
Special Precautions
Do not dilute in NaCl soln or Cl containing soln. Acute neurosensory toxicity may be precipitated or exacerbated by exposure to cold or cold objects. Risk of low blood cell counts. Do not mix or administer simultaneously through the same line w/ alkaline medications or media (eg, basic soln of 5-fluorouracil). History of hypersensitivity. Myelosuppression prior to starting 1st course (baseline neutrophils <1.5 x 109/L &/or platelet count of <100 x 106/L); peripheral sensitive neuropathy w/ functional impairment prior to 1st course. Pulmonary fibrosis. Hepatotoxicity (increase in transaminases & alkaline phosphatase). Neuropathy (previously unrated & previously treated patients w/ advanced colorectal cancer). Severe renal impairment (CrCl <30 mL/min). Pregnancy & lactation. Childn.
Adverse Reactions
Anaemia, leukopenia, granulocytopenia, thrombocytopenia.
Drug Interactions
May decrease clearance of potentially nephrotoxic compd. May cause degradation of platinum compd w/ Al.
ATC Classification
L01XA03 - oxaliplatin ; Belongs to the class of platinum-containing antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Vexplatin-100 soln for infusion 100 mg/50 mL
Packing/Price
50 mL x 1's
Form
Vexplatin-50 soln for infusion 50 mg/25 mL
Packing/Price
25 mL x 1's
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