Yttrium-90 ibritumomab tiuxetan

Approved Use:

• treatment of relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL)
• treatment of previously untreated follicular NHL in patients who achieve a partial or complete response to first-line chemotherapy

Dose:

• 0.4 mCi/kg for patients with normal platelet count
• 0.3 mCi/kg in relapsed or refractory patients with platelet count 100,000 - 149,000 cells/mm^3
• Do not treat patients with less than 100,000 platelets/mm^3
• Maximum dose = 32 mCi

Brand Name: Zevalin®
Manufacturer: Acrotech Biopharma
Package Insert
How Supplied: Zevalin® Kit contains four vials:

1. Zevalin® vial containing 3.2 mg ibritumomab tiuxetan in 2 mL 0.9% sodium chloride as a clear, colorless solution
2. 50 mM sodium acetate vial containing 13.6 mg sodium acetate trihydrate in 2 mL water for injection, USP as a clear, colorless solution
3. Formulation buffer vial containing 750 mg albumin (human), 76 mg sodium chloride, 28 mg sodium phosphate dibasic dodecahydrate, 4 mg pentetic acid, 2 mg potassium phosphate monobasic and 2 mg potassium chloride in 10 mL water for injection, pH 7.1 as a clear yellow to amber colored solution
4. Empty reaction vial

• Yttrium-90 chloride is shipped directly from supplier upon placement of an order for a Zevalin® cold kit.  
• Rituximab (Rituxan®, Biogen Idec and Genentech USA) must be ordered separately.

Storage: Refrigerate
NDC #: 68152-103-03 

Product Website
Zevalin Slides (from product website)
Ordering Overview (2014)
*FDA Removes Indium-111 Bioscan Requirement* November 2011
Letter from Manufacturer May 2010 (new supplier of Y-90 chloride)

Clinical Guidelines:
ACR Practice Parameter for the Performance of Therapy with Unsealed Radiopharmaceutical Sources (2015)