Zevalin (kit for prep yttrium-90/ibritumomab tiuxetan/albumin human)

The ibritumomab tiuxetan therapeutic regimen is intended for use as a single course of treatment. The regimen consists of 2 low doses of rituximab (to deplete peripheral B lymphocytes and to improve distribution of ibritumomab tiuxetan) and a therapeutic dose of yttrium Y 90 ibritumomab tiuxetan. Biodistribution evaluation (administration of an imaging dose of indium In 111 ibritumomab tiuxetan followed by 2 or 3 whole body scans) previously was required after the first dose of rituximab; however, such evaluation is no longer required as part of the ibritumomab tiuxetan therapeutic regimen.

For the treatment of relapsed or refractory low-grade or follicular B-cell NHL, or for consolidation treatment of newly diagnosed follicular NHL in patients who have achieved partial or complete response to first-line induction chemotherapy, the ibritumomab tiuxetan therapeutic regimen is administered in 2 steps. Step 1 (administered on day 1) involves IV infusion of rituximab. Step 2 (administered on day 7, 8, or 9) consists of a second IV infusion of rituximab, followed within 4 hours by IV injection of yttrium Y 90 ibritumomab tiuxetan.

Step 1 (administered on day 1) begins with IV infusion of a single dose (250 mg/m2) of rituximab, infused at an initial rate of 50 mg/hour. If infusion-related events do not occur, the infusion rate may be increased in increments of 50 mg/hour every 30 minutes to a maximum infusion rate of 400 mg/hour. If severe infusion-related events develop, rituximab infusion should be immediately stopped and the ibritumomab tiuxetan therapeutic regimen discontinued. If less severe infusion-related events develop, rituximab infusion should be temporarily slowed or interrupted; the infusion may be resumed at one-half the previous rate when symptoms improve.

Step 2 (administered on day 7, 8, or 9) begins with a second IV infusion of rituximab (250 mg/m2), infused at an initial rate of 100 mg/hour; the infusion rate may be increased, as tolerated, in increments of 100 mg/hour every 30 minutes to a maximum infusion rate of 400 mg/hour. If infusion-related events developed during administration of the first dose of rituximab (on day 1), the second dose of rituximab should be infused at an initial rate of 50 mg/hour, and the infusion rate should be increased in increments of 50 mg/hour every 30 minutes to a maximum infusion rate of 400 mg/hour. The second rituximab dose should be followed within 4 hours by slow IV injection (over 10 minutes) of yttrium Y 90 ibritumomab tiuxetan at a therapeutic dose of 0.4 mCi/kg (for patients with relapsed or refractory NHL or newly diagnosed NHL who have platelet counts of 150,000/mm3 or greater) or 0.3 mCi/kg (for patients with relapsed or refractory NHL who have platelet counts of 100,000-149,000/mm3). The prescribed, measured, and administered dose of yttrium Y 90 ibritumomab tiuxetan must not exceed the absolute maximum allowable dose of 32 mCi, regardless of the patient's weight.

No dosing information is available for this tab.

No dosing information is available for this tab.

No dosing information is available for this tab.

No formal drug interaction studies of ibritumomab tiuxetan have been performed.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

The manufacturer states that there are no contraindications to the use of ibritumomab tiuxetan.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Adverse effects occurring in 10% or more of patients receiving the ibritumomab tiuxetan therapeutic regimen include cytopenias (e.g., thrombocytopenia, neutropenia, anemia ), fatigue, nasopharyngitis, nausea, abdominal pain, asthenia, cough, diarrhea, and pyrexia.

Because the ibritumomab tiuxetan therapeutic regimen includes the use of rituximab, the prescribing information for rituximab also should be consulted for detailed information on the safety profile of this drug.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

Safety and efficacy of the ibritumomab tiuxetan therapeutic regimen have not been established in children younger than 18 years of age.

Category D. (See Users Guide.) (See Fetal/Neonatal Morbidity and Mortality under Warnings/Precautions: Other Warnings and Precautions, in Cautions.)

Category D. (See Users Guide.) (See Fetal/Neonatal Morbidity and Mortality under Warnings/Precautions: Other Warnings and Precautions, in Cautions.)

Because human immunoglobulin G (IgG) is distributed into milk, it is expected that ibritumomab tiuxetan would be present in milk. Because of the potential for adverse reactions to yttrium Y 90 ibritumomab tiuxetan in nursing infants, a decision should be made whether to discontinue nursing or not administer the ibritumomab tiuxetan therapeutic regimen, taking into account the importance of the regimen to the woman.

Of the 349 patients with relapsed or refractory NHL receiving the ibritumomab tiuxetan therapeutic regimen in clinical studies, 38% were 65 years of age or older and 12% were 75 years of age or older. Of the 206 patients with newly diagnosed NHL receiving the ibritumomab tiuxetan therapeutic regimen as consolidation therapy in the controlled clinical study, 14% were 65 years of age or older and 2% were 75 years of age or older.

No overall differences were observed between geriatric and younger patients in clinical studies; however, the possibility that some older patients may exhibit increased sensitivity to the ibritumomab tiuxetan therapeutic regimen cannot be ruled out.