Treatment Overview for the Nuclear Medicine Physician/Radiation Oncologist

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 nuclear medicine physician/radiation oncologist 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. Patient Education Brochure

- Pretreatment Prescription
Prescribe thyroid-protection medication (SSKI, Lugol’s solution, or potassium iodide tablet) for patient (this may also be done by the nuclear medicine or radiation oncology physician).

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

Steps for the Nuclear Medicine Department/Radiation Oncology

Receive patient referral from medical oncologist or hematologist
Discuss with referring oncologist to ensure patient is eligible
Utilizing The BEXXAR Therapeutic Regimen Order Form, contact the radiopharmacy to order and schedule the BEXXAR therapeutic regimen from the BEXXAR Service Center at 1-877-4-BEXXAR (877-423-9927)
Remind patient to take the thyroid-protection medication daily beginning 24 hours prior to Visit 1 (the dosimetric dose)
Evaluate patient's living and working conditions (see The BEXXAR Therapeutic Regimen: Evaluation of Patient's Living and Working Conditions, Form A [Outpatient Release Guide])

DOSIMETRIC STEP - PATIENT VISIT 1


	Confirm that patient began taking thyroid-protection medication at least 24 hours prior to dosimetric dose Premedicate with acetaminophen and diphenhydramine 30 minutes prior to the Tositumomab infusion - The benefit of premedication in preventing infusion-related toxicity has not been evaluated Infuse 450 mg of Tositumomab over 60 minutes Patient should urinate to prevent the need to urinate before the first body count Infuse the dosimetric dose of 5.0 mCi Iodine I 131 Tositumomab (35 mg) over 20 minutes Document residual activity of dosimetric dose (Iodine I 131 Tositumomab) Gamma camera count 1 (anterior and posterior). Calibrated source, background, and total body counts should be done sequentially - Calibrated source counts - Background counts - Total body counts and images (acquire within 1 hour of the end of infusion, before patient urinates) Review images for altered biodistribution - If biodistribution is altered, the therapeutic dose should not be administered Confirm patient schedule for 2 more scans Remind patient to continue taking thyroid-protection medication

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

DOSIMETRIC STEP - PATIENT VISIT 2 (DAY 2, 3, OR 4)


	Confirm that patient has been taking thyroid-protection medication Gamma camera count 2 (anterior and posterior) - Calibrated source counts - Background counts - Total body counts and images (acquire posturination) Review images for evaluation of altered biodistribution; do not administer the therapeutic dose if the biodistribution is altered Calculate an estimated therapeutic activity (mCi) to determine the need for a second vial Contact the radiopharmacy to report the estimated therapeutic activity (mCi) to the BEXXAR Service Center at 1-877-4-BEXXAR (877-423-9927) Confirm patient appointment for Visit 3 Remind patient to continue taking thyroid-protection medication

DOSIMETRIC STEP - PATIENT VISIT 3 (DAY 6 OR 7)


	Confirm that patient has been taking thyroid-protection medication Gamma camera count 3 (anterior and posterior) - Calibrated source counts - Background counts - Total body counts and images (acquire posturination) If necessary, review images for evaluation of altered biodistribution to resolve ambiguities from first and second images; do not administer the therapeutic dose if the biodistribution is altered Calculate the patient-specific therapeutic activity (mCi) based on 3 gamma camera counts, weight, and platelet count Contact the radiopharmacy to report the prescribed mCi required to prepare the therapeutic dose Confirm patient appointment for therapeutic dose Remind patient to continue taking thyroid-protection medication

THERAPEUTIC STEP - PATIENT VISIT 4 (1 DAY BETWEEN DAYS 7 AND 14)


	Confirm that patient has been taking thyroid-protection medication Premedicate with acetaminophen and diphenhydramine 30 minutes prior to the Tositumomab infusion Infuse 450 mg of Tositumomab over 60 minutes Infuse the patient-specific therapeutic dose of Iodine I 131 Tositumomab over 20 minutes Document residual activity of therapeutic dose (Iodine I 131 Tositumomab) Obtain patient dose rate at 1 meter reading immediately after the therapeutic dose of BEXXAR Evaluation for outpatient release* - Confirm patient’s living and working conditions (see The BEXXAR Therapeutic Regimen: Evaluation of Patient's Living and Working Conditions, Form A [Outpatient Release Guide]) - Determine patient releasability (see The BEXXAR Therapeutic Regimen: Determination of Patient Releasability, Form B [Outpatient Release Guide]) - Provide instructions to the releasable patient (see The BEXXAR Therapeutic Regimen: Instructions to Releasable Patient, Form C [Outpatient Release Guide]) Remind patient to continue taking thyroid-protection medication daily for 14 days after receiving the therapeutic dose of BEXXAR Provide patient with emergency contact information for the authorized physician and nuclear medicine facility Refer patient back to medical oncologist/hematologist for posttreatment follow-up

* The NRC requires that a record be maintained in order to document these steps to comply with the
provision of 10 CFR part 35.75 and NUREG-1556, Vol. 9, "Consolidated Guidance About
Materials Licenses: Program-Specific Guidance About Medical Licenses."

Please check the NRC, state, and local authorities to ensure that your patient release criteria and record keeping meet with their requirements.

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Click here for Important Safety Information about BEXXAR

Click here for Detailed Safety Information

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 (this may also be done by the nuclear medicine or radiation oncology physician).
-	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