Treatment Overview for the Medical Oncologist/Hematologist

This document provides an overview of the process for administering the BEXXAR therapeutic regimen (Tositumomab and Iodine I 131 Tositumomab) and discusses the role of the medical oncologist/hematologist for each step in the process.

Please click here for complete prescribing information, full indication, and Important Safety Information. This page is intended to remind healthcare professionals of some important information contained in the complete prescribing information of BEXXAR. It is not offered as medical advice, nor should it be used as a substitute for the independent medical judgment of the healthcare professionals responsible for treating patients.

Steps for the Medical Oncologist/Hematologist

Patient Considerations for the BEXXAR Therapeutic Regimen


	Contraindicated in patients with known hypersensitivity to murine protein or any components of BEXXAR Negative pregnancy test, if applicable Bone marrow biopsy with <25% lymphoma involvement of the intratrabecular space Platelet count of >100,000 platelets/mm³ Neutrophil count of >1,500 cells/mm³ Negative serum human anti-murine antibodies (HAMA) (if patient has previously received murine antibodies) Adequate baseline renal function

- Discuss Patient Education
Discuss the Patient Awareness Brochure with patient.

- Pretreatment Prescription
Prescribe thyroid-protection medication (SSKI, Lugol’s solution, or potassium iodide tablet) for patient.

- Refer for Treatment with BEXXAR
Refer patient to nuclear medicine physician/radiation oncologist to schedule the BEXXAR therapeutic regimen.

THE BEXXAR THERAPEUTIC REGIMEN IS ADMINISTERED IN 2 STEPS

Patients must begin thyroid-protection medication starting at least 24 hours prior to
dosimetric dose and continuing until 14 days after therapeutic dose.

Day 0
Dosimetric Step

Days 7-14
Therapeutic Step

450 mg Tositumomab
(1 hr infusion)*

5 mCi Iodine I 131
Tositumomab (35 mg)
(20 minute infusion)

Whole body
scans X 3^†
• Day 0
• Day 2, 3, or 4
• Day 6 or 7

450 mg Tositumomab
(1 hr infusion)*

Patient-specific activity (mCi) of Iodine I 131
Tositumomab (35 mg) to deliver desired cGy total body dose
(20 minute infusion)

* Patients will be premedicated with acetaminophen and diphenhydramine 30 minutes prior to
the Tositumomab infusion of the dosimetric and therapeutic steps.
- The benefit of premedication in preventing infusion-related toxicity has not been evaluated.

^† Scans used for dosimetry and biodistribution evaluation. If biodistribution is altered, the
therapeutic dose should not be administered.

Follow-up Lab Tests After the BEXXAR Therapeutic Regimen

A complete blood count (CBC) with differential and platelet count should be obtained at least weekly
    - Blood counts should continue for a minimum of 10 weeks and until
      severe cytopenias, if persistent, have completely resolved
    - More frequent monitoring is indicated for patients with evidence of
      moderate or more severe cytopenias
Thyroid-stimulating hormone (TSH) level should be monitored annually

INDICATIONS

The BEXXAR therapeutic regimen (Tositumomab and Iodine I 131 Tositumomab) is indicated for the treatment of patients with CD20 antigen-expressing relapsed or refractory, low-grade, follicular, or transformed non-Hodgkin’s lymphoma, including patients with Rituximab-refractory non-Hodgkin’s lymphoma.

Determination of the effectiveness of the BEXXAR therapeutic regimen is based on overall response rates in patients whose disease is refractory to chemotherapy alone or to chemotherapy and Rituximab. The effects of the BEXXAR therapeutic regimen on survival are not known.

The BEXXAR therapeutic regimen is not indicated for the initial treatment of patients with CD20-positive non-Hodgkin’s lymphoma. The BEXXAR therapeutic regimen is intended as a single course of treatment. The safety of multiple courses of the BEXXAR therapeutic regimen, or combination of this regimen with other forms of irradiation or chemotherapy, has not been evaluated.¹

Return to Treatment Overview

Click here for Important Safety Information about BEXXAR

Complete Prescribing Information for
BEXXAR (Tositumomab and Iodine I 131 Tositumomab)

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-	Discuss Patient Education Discuss the Patient Awareness Brochure with patient.
-	Pretreatment Prescription Prescribe thyroid-protection medication (SSKI, Lugol’s solution, or potassium iodide tablet) for patient.
-	Refer for Treatment with BEXXAR Refer patient to nuclear medicine physician/radiation oncologist to schedule the BEXXAR therapeutic regimen.

	For the Medical Oncologist/Hematologist

	For the Nuclear Medicine Physician/Radiation Oncologist