Prior to administration of the BEXXAR therapeutic regimen, patients should be advised that they will have a radioactive material in their body for several days upon their release from the hospital or clinic. After discharge, patients should be provided with both oral and written instructions for minimizing exposure of family members, friends and the general public. Patients should be given a copy of the written instructions for use as a reference for the recommended precautionary actions.
The pregnancy status of women of childbearing potential should be assessed and these women should be advised of the potential risks to the fetus (see CONTRAINDICATIONS). Women who are breastfeeding should be instructed to discontinue breastfeeding and should be apprised of the resultant potential harmful effects to the infant if these instructions are not followed.
Patients should be advised of the potential risk of toxic effects on the male and female gonads following the BEXXAR therapeutic regimen, and be instructed to use effective contraceptive methods during treatment and for 12 months following the administration of the BEXXAR therapeutic regimen.
Patients should be informed of the risks of hypothyroidism and be advised of the importance of compliance with thyroid blocking agents and need for life-long monitoring.
Patients should be informed of the possibility of developing a HAMA immune response and that HAMA may affect the results of in vitro and in vivo diagnostic tests as well as results of therapies that rely on murine antibody technology.
Patients should be informed of the risks of cytopenias and symptoms associated with cytopenia, the need for frequent monitoring for up to 12 weeks after treatment, and the potential for persistent cytopenias beyond 12 weeks.
Patients should be informed that MDS, secondary leukemia, and solid tumors have also been observed in patients receiving the BEXXAR therapeutic regimen.
Due to lack of controlled clinical studies, and high background incidence in the heavily pretreated patient population, the relative risk of development of myelodysplastic syndrome/acute leukemia and solid tumors due to the BEXXAR therapeutic regimen cannot be determined.
Laboratory Monitoring
A complete blood count (CBC) with differential and platelet count should be obtained prior to, and at least weekly following administration of the BEXXAR therapeutic regimen. Weekly monitoring of blood counts should continue for a minimum of 10 weeks or, if persistent, until severe cytopenias have completely resolved. More frequent monitoring is indicated in patients with evidence of moderate or more severe cytopenias (see BOXED WARNINGS and WARNINGS). Thyroid stimulating hormone (TSH) level should be monitored before treatment and annually thereafter. Serum creatinine levels should be measured immediately prior to administration of the BEXXAR therapeutic regimen.
Drug Interactions
No formal drug interaction studies have been performed. Due to the frequent occurrence of severe and prolonged thrombocytopenia, the potential benefits of medications that interfere with platelet function and/or anticoagulation should be weighed against the potential increased risk of bleeding and hemorrhage.
Drug/Laboratory Test Interactions
Administration of the BEXXAR therapeutic regimen may result in the development of HAMA. The presence of HAMA may affect the accuracy of the results of in vitro and in viv
