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1 x 50 mg
1 x 100 mg
1 x 150 mg
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.
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 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 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.
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.
Method of administration: Oxaliplatin is administered by intravenous infusion. The administration of oxaliplatin does not require hyperhydration. Oxaliplatin diluted via a central venous line or peripheral vein in 250 to 500 ml of 5% glucose solution to give a concentration not less than 0.2 mg/ml must be infused over 2 to 6 hours. Oxaliplatin infusion should always precede that of 5-fluorouracil. In the event of extravasation, administration must be discontinued immediately.
The preparation of injectable solution of cytotoxic agents must be carried out by trained specialist personnel with knowledge of the medicinal produsts used, in condition that guarantee the integrity of medical product, the protection of the environment and in the 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.
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.
Hypersensitivity to the active substance or to any of the excipients. Breast-feeding. Myelosuppression prior to starting first course, as evidenced by baseline neutrophils9/L and/or platelet count of9/L. Peripheral sensitive neuropathy with functional impairment prior to first course. Severely impaired renal function (creatinine clearance).
Oxaliplatin should only be used in specialized departments of oncology and should be administered under the supervision of an experienced oncologist.
Renal impairment: Due to limited information on safety in patients with moderately impaired renal function, administration should only be considered after suitable appraisal of the benefit/risk for the patient. In this situation, renal function should be closely monitored and dose adjusted according to toxicity.
Hypersensitivity reactions: Special surveillance should be ensured for patients with a history of allergic reactions to other products containing platinum. In case of anaphylactic manifestations the infusion should be interrupted immediately and an appropriate symptomatic treatment started. Re-administration to such patients is contraindicated. Cross reactions, sometimes fatal, have been reported with all platinum compounds.
In case of oxaliplatin extravasation, the infusion must be stopped immediately and usual local symptomatic treatment initiated.
Neurological symptoms: Neurological toxicity should be carefully monitored, especially if co-administered with other medicinal products with specific neurological toxicity. A neurological examination should be performed before each administration and periodically thereafter.
For patients who develop acute laryngopharyngeal dysaesthesia, during or within the hours following the 2-hour infusion, the next infusion should be administered over 6 hours.
Peripheral neuropathy: If neurological symptoms (paraesthesia, dysaesthesia) occur, the following recommended dosage adjustment should be based on the duration and severity of these symptoms: If symptoms last longer than seven days and are troublesome, the subsequent dose should be reduced from 85 to 65 mg/m2 (metastatic setting) or 75 mg/m2 (adjuvant setting). If paraesthesia without functional impairment persists until the next cycle, the subsequent dose should be reduced from 85 to 65 mg/m2 (metastatic setting) or 75 mg/m2 (adjuvant setting). If paraesthesia with functional impairment persists until the next cycle, should be discontinued. If these symptoms improve following discontinuation of oxaliplatin therapy, resumption of therapy may be considered. Patients should be informed of the possibility of persistent symptoms of peripheral sensory neuropathy after the end of the treatment. Localised moderate paresthesias or paresthesias that may interfere with functional activities can persist after up to 3 years following treatment cessation in the adjuvant setting.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS) Cases of Reversible Posterior Leukoencephalopathy Syndrome (RPLS) have been reported in patients receiving oxaliplatin in combination chemotherapy. RPLS is a rare, reversible, rapidly evolving neurological condition, which can include seizure, hypertension, headache, confusion, blindness, and other visual and neurological disturbances (see section 4.8). Diagnosis of RPLS is based upon confirmation by brain imaging, preferably MRI (Magnetic Resonance Imaging).
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The most frequent adverse events of oxaliplatin in combination with 5-fluorouracil/folinic acid (5-FU/FA) were gastrointestinal (diarrhoea, nausea, vomiting and mucositis), haematological (neutropenia, thrombocytopenia) and neurological (acute and dose cumulative peripheral sensory neurophathy). Overall, these adverse events were more frequent and severe with oxaliplatin and 5-FU/FA combination than with 5-FU/FA alone.
The frequencies reported in the table below are derived from clinical trials in the metastatic and adjuvant settings (having included 416 and 1108 patients respectively in the oxaliplatin + 5-FU/FA treatment arms) and from post marketing experience.
Frequencies in this table are defined using the following convention: very common (≥ 1/10) common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10000, < 1/1000), very rare (< 1/10000), not known (cannot be estimated from the available data).
For full details see prescribing information.
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Pregnancy and Lactation
Pregnancy: To date there is no available information on safety of use in pregnant women. In animal studies, reproductive toxicity was observed. Consequently, oxaliplatin is not recommended during pregnancy and in women of childbearing potential not using contraceptive measures. The use of oxaliplatin should only be considered after suitably apprising the patient of the risk to the foetus and with the patient’s consent. Appropriate contraceptive measures must be taken during and after cessation of therapy during 4 months for women and 6 months for men.
Breast-Feeding: Excretion in breast milk has not been studied. Breast-feeding is contra-indicated during oxaliplatin therapy.
Fertility: Genotoxic effects were observed with oxaliplatin in the preclinical studies. Therefore male patients treated with oxaliplatin are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment because oxaliplatin may have an anti-fertility effect which could be irreversible.
Women should not become pregnant during treatment with oxaliplatin and should use an effective method of contraception. Oxaliplatin may have an anti-fertility effect.