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ELOXATIN

Package(a):
SOLUTION (concentrate for infusion): 10 ml (50 mg oxaliplatin).
Dosage(a):
Only for use in adults. 
Adjuvant setting: 85 mg/m² I.V., repeated every 2 weeks for 12 cycles (6 months).
Treatment of metastatic colorectal cancer: 85 mg/m² I.V., repeated every 2 weeks.
Prescribing Restrictions:  None

Package(b):
SOLUTION (concentrate for infusion): 20 ml (100 mg oxaliplatin).
Dosage(b):
Only for use in adults. 
Adjuvant setting: 85 mg/m² I.V., repeated every 2 weeks for 12 cycles (6 months).
Treatment of metastatic colorectal cancer: 85 mg/m² I.V., repeated every 2 weeks.
Prescribing Restrictions:  None

Package(c):
SOLUTION (concentrate for infusion): 40 ml (200 mg oxaliplatin).
Dosage(c):
Only for use in adults. 
Adjuvant setting: 85 mg/m² I.V., repeated every 2 weeks for 12 cycles (6 months).
Treatment of metastatic colorectal cancer: 85 mg/m² I.V., repeated every 2 weeks.
Prescribing Restrictions:  None


Indications:
In combination with 5-fluorouracil and folinic acid (FA), for adjuvant treatment of stage III (Duke’s C) colon cancer after complete resection of primary tumor. The treatment of metastatic colorectal cancer.
Contra-Indications:
History of hypersensitivity. Lactation. Myelosuppression (neutrophils< 2x10⁹/l and/or platelets count<100 x10⁹/l before the first cycle of treatment. Sensory peripheral neuropathy with functional impairment before the first cycle of treatment. Severe renal insufficiency (creatinine clearance<30 ml/min).
Special Precautions:
Should only be used in units specialized in the administration of cytotoxic medicines, under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Only for use in adults. Should always be administered before fluoropyramidines. Administration does not require hyperhydration. Diluted in 250-500 ml of 5% sucrose solution to give a concentration not less than 0.2 mg/ml, must be infused either via central venous line or a peripheral vein over 2-6 hours. Must be diluted prior to administration. Only the recommended diluent should be used to dilute the concentrate. Has not been studied in patients with severe renal impairment. In moderate renal impairment treatment should only be considered after suitable appraisal of the benefit/risk for the patient, but treatment may be initiated at the recommended dose. Patients with a history of allergic reactions to other platinum-containing products should be particularly closely monitored. A neurological examination should be carried out before each administration and periodically thereafter. 
In case of acute laryngopharyngeal dysaesthesia subsequent administrations should be given over a period of six hours. If neurological symptoms occur (paraesthesia, dysaesthesia), the following recommended dosage adjustment should be based on the duration and severity of these symptoms: If symptoms last for more than 7 days and are painful, or if paraesthesia without functional impairment persists until the next cycle, dose should be reduced from 85 to 65 mg/m² (treatment of metastases) or to 75 mg/m² (adjuvant treatment). If paraesthesia with functional impairment persists until the next cycle, treatment should be discontinued. If symptoms improve following discontinuation of oxaliplatin therapy, resumption of therapy may be considered. 
A full blood count with white cell differential should be performed prior to initiating therapy and before each subsequent cycle. If any unexplained respiratory symptoms develop, such as non-productive cough, dyspnea, crepitant rale or radiological pulmonary infiltrates, treatment should be discontinued until pulmonary investigations have excluded the possibility of interstitial lung disease. 
Pregnancy and lactation: Not recommended during pregnancy and should only be considered once the patient has been clearly informed as to the risks to the fetus, and her consent obtained. Breastfeeding is contraindicated. 
See prescribing information for full details.
Side Effects:
The most common undesirable effects during combination with 5-fluorouracil/folinic acid (5-FU/FA) are diarrhea, nausea, vomiting and mucositis, neutropenia, thrombocytopenia and acute and dose-cumulative sensory peripheral neuropathy). The effects have been generally more frequent and more severe when in combination with 5-FU/FA than with 5-FU/FA alone. See prescribing information for full details.
Drug Interactions:
Not to be used in association with alkaline medicinal products or media (in particular 5-fluourouracil, base solutions, trometamol and folinic acid products containing trometamol as an excipients. Not to be diluted with saline solutions. Not to be mixed with other medicinal products in the same infusion bag/line. Not to be injected with equipment containing aluminum. See prescribing information for full details.