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Preferred Drug List NEW DRUG REVIEW Proprietary Name: Bexxar Common Name: Tositumomab and Iodine I 131 Tositumomab PDL Category: Antineoplastic Preferred Drug List/ Recommended Drug List Status Comparable Products Summary Indications and Usage: Indicated as a single-course treatment in patients with relapsed, CD20 positive, follicular non-Hodgkin’s lymphoma, with or without transformation, who are refractory to rituzimab. Should not be used as initial therapy. Dosage Forms: BEXXAR® Dosimetric Packaging · A carton containing two single-use 225 mg vials and one single-use 35 mg vial of Tositumomab supplied by McKesson Biosciences and · A package containing a single-use vial of Iodine I 131 Tositumomab (0.61mCi/mL at calibration), supplied by MDS Nordion. BEXXAR® Therapeutic Packaging · A carton containing two single-use 225 mg vials and one single-use 35 mg vial of Tositumomab, supplied by McKesson Biosciences and · A package containing one or two single-use vials of Iodine I 131 Tositumomab (5.6 mCi/mL at calibration), supplied by MDS Nordion. Recommended Dosage: The therapeutic regimen is intended as a single course of treatment. Common Adverse Drug Reactions: Hypersensitivity reactions, including anaphylaxis and prolonged and severe cytopenias and their sequelea (infection and hemorrhage) are the most common adverse reactions. Gastrointestinal toxicity (nausea, vomiting, abdominal pain and diarrhea), infusional toxicity (fever, rigors, chills, sweating, hypotension, dyspnea, bronchospasm and nausea), hypothyroidism and human anti-murine antibodies have also been reported Contraindications: The BEXXAR® therapeutic regimen is contraindicated in patients with known hypersensitivity to murine proteins or any other component of the BEXXAR therapeutic regimen. Manufacturer: Corixa Corporation Analysis: Bexxar® is a radioimmunotherapy that pairs the targeting ability of a monoclonal antibody (Tositumomab) and the therapeutic potential of radiation (Iodine-131). A study at the University of Michigan Comprehensive Cancer Center noted 76% of patients treated with Bexxar® achieved remission with no sign of cancer. In addition, 84% of patients with evidence of lymphoma at the molecular level at the start of the trial achieved molecular remission for as long as three years with Bexxar® treatment. IME Recommendation: Preferred Drug Non-Preferred Drug Preferred Drug with Conditions Prepared By: Iowa Medicaid Enterprise Recommended Drug Non-Recommended Drug Date: 5/5/2017