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Laboratory Tests

Because granulocytopenia is the most significant and dose-limiting toxicity associated with NAVELBINE (vinorelbine tartrate) Injection, laboratory tests play a critical role in monitoring the patient's status. On the day of treatment, complete blood counts with differentials should be obtained and results reviewed prior to each dose of NAVELBINE. Patients with pretreatment granulocyte counts of less than 1000 cells/cubic mm should not be treated with NAVELBINE. For patients with granulocyte counts of between 1000 and 1500 cells/cubic mm, dose modifications are required for that course of therapy (see Dosage and Administration).

There is evidence that the liver plays an important role in the elimination of NAVELBINE.[3] Because the clinical experience in patients with severe liver disease is limited, caution should be used when administering this drug to patients with severe hepatic injury or impairment. As with other vinca alkaloids, decreased doses of NAVELBINE should be administered to patients with total bilirubin levels of greater than 2.0 mg/dL (see Dosage and Administration).

If laboratory tests indicate both hematologic toxicity and hepatic insufficiency, the lower of the modified doses determined for each condition should be administered (see Dosage and Administration).

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