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We also market LEUSTATIN, a treatment for a rare form of cancer called hairy cell leukemia.
Important Safety Information
LEUSTATIN Injection should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. Suppression of bone marrow function should be anticipated. This is usually reversible and appears to be dose-dependent. Serious neurological toxicity (including irreversible paraparesis and quadriparesis) has been reported in patients who received LEUSTATIN Injection by continuous infusion at high doses (4 to 9 times the recommended dose for HCl). Neurologic toxicity appears to demonstrate a dose relationship; however, severe neurological toxicity has been reported rarely following treatment with standard cladribine dosing regimens.
Acute nephrotoxicity has been observed with high doses of LEUSTATIN (4 to 9 times the recommended dose for HCl), especially when given concomitantly with other nephrotoxic agents/therapies.
In clinical trials, at the recommended dose, the side effects most frequently experienced by patients following initiation of treatment included myelosuppression (including neutropenia (70%), fever (T>100°F) (69%), fatigue (45%), infection (28%), nausea (28%), rash (27%), headache (22%) and injection site reaction (19%). Most nonhematologic side effects were mild to moderate in severity.
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