Usual Adult Dose for non-Hodgkin's Lymphoma

Day 7, 8, or 9 following initial rituximab infusion:

• Within 4 hours of rituximab, administer Y-90 ibritumomab 0.4 mCi/kg (14.8 MBq/kg) actual body weight intravenously over 10 minutes for patients with normal platelet count (Platelet count greater than 150,000/mm3).

• Do not treat if platelets less than 100,000/mm3
• Initiate the regimen following recovery of platelet counts to at least 150,000/mm3 at least 6 weeks, but not more than 12 weeks, following the last dose of first-line chemotherapy

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Platelet count between 100,000/mm3 and 149,000/mm3 (in relapsed or refractory patients): Y-90 ibritumomab 0.3 mCi/kg (11.1 MBq/kg) actual body weight intravenously over 10 minutes

Precautions

US BOXED WARNINGS:
SERIOUS INFUSION REACTIONS, PROLONGED AND SEVERE CYTOPENIAS, and SEVERE CUTANEOUS AND MUCOCUTANEOUS REACTIONS:

• Serious Infusion Reactions: Deaths have occurred within 24 hours of rituximab infusion, an essential component of ibritumomab therapeutic regimen. These fatalities were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Most (80%) fatalities occurred with the first rituximab infusion. Discontinue rituximab and Y-90 ibritumomab infusions in patients who develop severe infusion reactions.
• Prolonged and Severe Cytopenias: Y-90 ibritumomab administration results in severe and prolonged cytopenias in most patients. Do not administer this drug to patients with equal or more than 25% lymphoma marrow involvement and/or impaired bone marrow reserve.
• Severe Cutaneous and Mucocutaneous Reactions: Severe cutaneous and mucocutaneous reactions, some fatal, can occur with the ibritumomab therapeutic regimen. Discontinue rituximab and Y-90 ibritumomab infusions in patients experiencing severe cutaneous or mucocutaneous reactions.

Dialysis

Data not available

Other Comments

Administration advice:

• Administer Y-90 ibritumomab through a free-flowing intravenous line.
• Use a 0.22 micron low-protein-binding in-line filter between the syringe and the infusion port.
• After injection, flush the line with at least 10 mL normal saline.

• Store the kit at 2C to 8C (36F to 46F). Do not freeze.

• For information about the preparation of ibritumomab, see the manufacturer's product information.

• Monitor for extravasation during the injection