If vomiting occurs within a few of drug intake, administration of the dose should not be repeated. Prophylactic treatment with metoclopramide or oral antiemetics may reduce the incidence. It is recommended that the capsule be taken with food. Myelosuppresion Neutropenia is dose-limiting. Complete blood counts with differentials should be performed and results reviewed prior to administering each dose of NAVELBINE® Oral. Patients treated with NAVELBINE® Oral should be frequently monitored for myelosuppresion both during and after therapy. NAVELBINE® Oral should not be administered to patients with neutrophil counts < 1500 cells/mm3. Patients developing severe neutropenia should be monitored carefully for evidence of infection and/or fever. If patients present signs or symptoms suggestive of infection, a prompt investigation should be carried out (see DOSAGE AND ADMINISTRATION for recommended dose adjustments for neutropenia). NAVELBINE® Oral should be used with extreme caution in patients whose bone marrow reserve may have been compromised by prior irradiation or chemotherapy, or whose marrow function is recovering from the effects of previous chemotherapy (see DOSAGE AND ADMINISTRATION). During clinical trials, where treatment was initiated at a weekly dose of 80 mg/m2 (corresponding to an IV dose of 30 mg/m2 in terms of systemic exposure), febrile neutropenia, in some cases fatal, was encountered in about 15% of patients. Therefore, it is recommended that the starting dose should be 60 mg/m2 and increased to 80 mg/m2 only if the dose is tolerated (see DOSAGE AND ADMINISTRATION). Laboratory tests Since dose-limiting clinical toxicity is the result of depression of the white blood cell count, it is imperative that complete blood counts with differentials be obtained and reviewed on the day of treatment prior to each dose of NAVELBINE® Oral. If the neutrophil count is below 1500/mm3 and/or the platelet count is between 75,000 and below 100,000/mm3, then treatment should be delayed until recovery. General Most drug-related adverse events of NAVELBINE® Oral are reversible. If severe adverse events occur, NAVELBINE® Oral should be reduced in dosage or discontinued and appropriate corrective measures taken. Reinstitution of therapy
If vomiting occurs within a few of drug intake, administration of the dose should not be repeated. Prophylactic treatment with metoclopramide or oral antiemetics may reduce the incidence. It is recommended that the capsule be taken with food. Myelosuppresion Neutropenia is dose-limiting. Complete blood counts with differentials should be performed and results reviewed prior to administering each dose of NAVELBINE® Oral. Patients treated with NAVELBINE® Oral should be frequently monitored for myelosuppresion both during and after therapy. NAVELBINE® Oral should not be administered to patients with neutrophil counts < 1500 cells/mm3. Patients developing severe neutropenia should be monitored carefully for evidence of infection and/or fever. If patients present signs or symptoms suggestive of infection, a prompt investigation should be carried out (see DOSAGE AND ADMINISTRATION for recommended dose adjustments for neutropenia). NAVELBINE® Oral should be used with extreme caution in patients whose bone marrow reserve may have been compromised by prior irradiation or chemotherapy, or whose marrow function is recovering from the effects of previous chemotherapy (see DOSAGE AND ADMINISTRATION). During clinical trials, where treatment was initiated at a weekly dose of 80 mg/m2 (corresponding to an IV dose of 30 mg/m2 in terms of systemic exposure), febrile neutropenia, in some cases fatal, was encountered in about 15% of patients. Therefore, it is recommended that the starting dose should be 60 mg/m2 and increased to 80 mg/m2 only if the dose is tolerated (see DOSAGE AND ADMINISTRATION). Laboratory tests Since dose-limiting clinical toxicity is the result of depression of the white blood cell count, it is imperative that complete blood counts with differentials be obtained and reviewed on the day of treatment prior to each dose of NAVELBINE® Oral. If the neutrophil count is below 1500/mm3 and/or the platelet count is between 75,000 and below 100,000/mm3, then treatment should be delayed until recovery. General Most drug-related adverse events of NAVELBINE® Oral are reversible. If severe adverse events occur, NAVELBINE® Oral should be reduced in dosage or discontinued and appropriate corrective measures taken. Reinstitution of therapy