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  • Oxaliplatin Teva
    / Salomon, Levin & Elstein Ltd


    Active Ingredient
    Oxaliplatin 5 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    50 mg/10mg

    partial basket chart 64971

    Vial

    100 mg/20 mg

    partial basket chart 64987

    Vial

    200 mg/40 mg

    partial basket chart 47334 15421

    Related information


    Dosage

    The preparation of injectable solutions of cytotoxic agents must be carried out by trained specialist personnel with knowledge of the medicinal products used, in conditions that guarantee the integrity of the medicinal 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.
    Posology: 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. Dosage given should be adjusted according to tolerability.
    Oxaliplatin should always be administered before fluoropyrimidines – i.e. 5 fluorouracil (5 FU). Oxaliplatin is administered as a 2- to 6-hour intravenous infusion in 250 to 500 ml of glucose 5 % (50 mg/ml) 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 (5 FU) based regimens. For the two-weekly treatment schedule 5 fluorouracil (5 FU) regimens combining bolus and continuous infusion were used.
    Special Populations: Renal impairment: This drug has not been studied in patients with severe renal impairment. In patients with moderate renal impairment, treatment may be initiated at the normally recommended dose. There is no need for dose adjustment in patients with mild renal dysfunction.
    Hepatic insufficiency: In a phase I study including patients with several levels of hepatic impairment, the frequency and severity of the hepatobiliary disorders appeared to be related to a 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 (5 FU) in patients over the age of 65. In consequence no specific dose adaptation is required for elderly patients.
    Pediatric 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.
    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 glucose 5 % (50 mg/ml) 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 (5 FU). In the event of extravasation, administration must be discontinued immediately.


    Indications

    In combination with 5-fluorouracil (5-FU) and folinic acid (FA) for: Adjuvant treatment of stage III (Duke’s C) colon cancer after complete resection of primary tumor; treatment of metastatic colorectal cancer.


    Contra-Indications

    Hypersensitivity to oxaliplatin or to any of the excipients. Lactation. Patients with a peripheral sensitive neuropathy with functional impairment prior to first course. Myelosuppression prior to starting first course, as evidenced by baseline neutrophils 9/l and/or platelet count of 9/l. Patients with severely impaired renal function (creatinine clearance less than 30 ml/min).


    Special Precautions

    See prescribing information for full details.


    Side Effects

    See prescribing information for full details.


    Drug interactions

    See prescribing information for full details.


    Manufacturer
    Pharmachemie, Teva Group (S.L.E)
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