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OXOL should be administered under the supervision of a qualified physician experienced in the used of antineoplastic agents.
Hypersensitivity Reactions: Hypersensitivity and anaphylactic/anaphylactoid reactions to Oxaliplatin have been reported. These allergic reactions were in similar nature and severity to those reported with other platinum-containing compounds, i.e., rash, urticaria, erythema, pruritus and rarely, bronchospasm and hypotension. These reactions occur within minutes of administration and should be managed with appropriate supportive therapy. Drug-related deaths associated with platinum compounds from this reaction have been reported.
Patients with Renal Impairment: The combination of OXOL and infusional 5-FU/LV should be used with caution in patients with preexisting renal impairment since the primary route of platinum elimination is renal. Clearance of ultrafilterable platinum is decreased
in patients with mild, moderate and severe renal impairment.
Neuropathy: Oxaliplatin is associated with two types of neuropathy: An acute, reversible, primarily peripheral, sensory neuropathy that is of early onset, occurring within hours or one to two days of dosing, that resolves within 14 days and that frequently recurs with further dosing. The symptoms may be precipitated or exacerbated by exposure to cold temperature or cold objects and they usually present as transient paresthesia, dysesthesia, and hypoesthesia in the hands, feet, perioral area or throat. Jaw spasm, abnormal tongue sensation, dysarthria, eye pain and a feeling of chest pressure have also been observed.
A persistent (>14 days), primarily peripheral, sensory neuropathy that is usually characterized by paresthesias, dysesthesias, hypoesthesias but may also include deficits in proprioception that can interfere with daily activities (e.g. writing, buttoning, swallowing and difficulty walking from impaired proprioception). Persistent neuropathy can occur without any prior acute neuropathy event. These symptoms may improve in some patients upon discontinuation of Oxaliplatin.
Pulmonary Toxicity: Oxaliplatin has been associated with pulmonary fibrosis (0.7% of study patients), which may be fatal. In case of unexplained respiratory symptoms such as non-productive cough, dsypnea, crackles, or radiological pulmonary infiltrates. Oxaliplatin should be discontinued until further pulmonary investigation excludes interstitial lung disease or pulmonary fibrosis.
Monitoring: Standard monitoring of the white blood cell count with differential, hemoglobin, platelet count and blood chemistries (including ALT, AST, bilirubin, creatinine) is recommended before each oxaliplatin cycle. Patients receiving oxaliplatin plus 5-fluorouracil/leucovorin and requiring oral anticoagulants may require close monitoring.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential of oxaliplatin. Oxaliplatin was not mutagenic to bacteria (Ames test) but was mutagenic to mammalian cells in vitro (L5178Y mouse lymphoma assay). Oxaliplatin was clastogenic both in vitro (chromosome aberration in human lymphocytes) and in vivo (mouse bone marrow micronucleus assay).
In a fertility study, male rats were given oxaliplatin at 0, 0.5, 1, or 2 mg/kg/day for five days every 21 days for a total of three cycles prior to mating with females that received two cycles of oxaliplatin on the same schedule. A dose of 2 mg/kg/day (less than one seventh the recommended human dose on a body surface are basis) did not affect pregnancy rate, but caused developmental mortality (increased early resorptions, decreased live fetuses, decreased live births) and delayed growth (decreased fetal weight). Testicular damage, characterized by degeneration, hypoplasia, and atrophy, was observed in dogs administered oxaliplatin at 0.75 mg/kg/day x 5 days every 28 days for three cycles. No effect level was not identified. This daily dose is approximately one sixth of the recommended human dose on a body surface area basis.
Use in Pregnancy: Oxaliplatin may cause fetal harm when administered to a pregnant woman. Pregnant rats were administered 1 mg/kg/day oxaliplatin (less than one-tenth the recommended human dose based on body surface area) during gestation days 1-5 (pre-implantation), 6-10 or 11-6 (during organogenesis). Oxaliplatin caused developmental mortality (increase early resorptions) when administered on days 6-10 and 11-16 and adversely affected fetal growth (decreased fetal weight, delayed ossification) when administered on days 6-10. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be appraised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with Oxaliplatin.
Use in Lactation: It is not known whether Oxaliplatin or its derivatives are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from oxaliplatin, a decision should be made whether to discontinue nursing or delay the use of the drug, taking into account the importance of the drug to the mother.
Use in Children: The safety and effectiveness of Oxaliplatin in pediatric patients have not been established.
Use in the Elderly: No significant effect of age on the clearance of ultrafilterable platinum has been observed.
