Oxaliplatin Ebewe Special Precautions

Oxaliplatin should only be used in specialised departments of oncology and should be administered under the supervision of an experienced oncologist.
For use in pregnant women see Use in Pregnancy & Lactation.
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.
Patients with a history of allergic reaction to platinum compounds should be monitored for allergic symptoms. In case of an anaphylactic-like reaction to oxaliplatin, the infusion should be immediately discontinued and appropriate symptomatic treatment initiated. Oxaliplatin rechallenge is contra-indicated.
In case of oxaliplatin extravasation, the infusion must be stopped immediately and usual local symptomatic treatment initiated.
Neurological toxicity of oxaliplatin should be carefully monitored, especially if co-administered with other medications with specific neurological toxicity. A neurological examination should be performed before each administration and periodically thereafter.
For patients who develop acute laryngopharyngeal dysaesthesia (see Adverse Reactions), during or within the hours following the 2-hour infusion, the next oxaliplatin infusion should be administered over 6 hours.
If neurological symptoms (paraesthesia, dysaesthesia) occur, the following recommended oxaliplatin 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 oxaliplatin dose should be reduced from 85 to 65mg/m² (metastatic setting) or 75mg/m² (adjuvant setting).
If paraesthesia without functional impairment persists until the next cycle, the subsequent oxaliplatin dose should be reduced from 85 to 65mg/m² (metastatic setting) or 75mg/m² (adjuvant setting).
If paraesthesia with functional impairment persists until the next cycle, oxaliplatin 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 paraesthesias or paraesthesias that may interfere with functional activities can persist after up to 3 years following treatment cessation in the adjuvant setting.
Gastrointestinal toxicity, which manifests as nausea and vomiting, warrants prophylactic and/or therapeutic anti-emetic therapy (see Adverse Reactions).
Dehydration, paralytic ileus, intestinal obstruction, hypokalemia, metabolic acidosis and renal impairment may be caused by severe diarrhoea/emesis particularly when combining oxaliplatin with 5-fluorouracil. In single cases pancreatitis is reported.
If haematological toxicity occurs (neutrophils < 1.5 x 10⁹/l or platelets < 50 x 10⁹/l), administration of the next course of therapy should be postponed until haemotological values return to acceptable levels. A full blood count with white cell differential should be performed prior to start of therapy and before each subsequent course.
Patients must be adequately informed of the risk of diarrhoea/emesis, mucositis/stomatitis and neutropenia after oxaliplatin and 5-fluorouracil administration so that they can urgently contact their treating physician for appropriate management.
If mucositis/stomatitis occurs with or without neutropenia, the next treatment should be delayed until recovery from mucositis/stomatitis to grade 1 or less and/or until the neutrophil count is 1.5 x 10⁹/l.
For oxaliplatin combined with 5-fluorouracil (with or without folinic acid), the usual dose adjustments for 5-fluorouracil associated toxicities should apply.
If grade 4 diarrhoea, grade 3-4 neutropenia (neutrophils < 1.0 x 10⁹/l), grade 3-4 thrombo-cytopenia (platelets < 50 x 10⁹/l) occur, the dose of oxaliplatin should be reduced from 85mg/m² to 65mg/m² (metastatic setting) or 75mg/m² (adjuvant setting), in addition to any 5-fluorouracil dose reductions required.
In the case of unexplained respiratory symptoms such as non-productive cough, dyspnoea, crackles or radiological pulmonary infiltrates, oxaliplatin should be discontinued until further pulmonary investigations exclude an interstitial lung disease (see Adverse Reactions).
Effects on ability to drive and use machines: No data available.