Zevalin (Page 2 of 6)

2.4 Procedure for Determining Radiochemical Purity

Use the following procedures for radiolabeling Y-90 Zevalin:

1.
Place a small drop of Y-90 Zevalin at the origin of an ITLC silica gel strip.
2.
Place the ITLC silica gel strip into a chromatography chamber with the origin at the bottom and the solvent front at the top. Allow the solvent (0.9% NaCl) to migrate at least 5 cm from the bottom of the strip. Remove the strip from the chamber and cut the strip in half. Count each half of the ITLC silica gel strip for one minute (CPM) with a suitable counting apparatus.
3.
Calculate the percent RCP as follows:
Calculate per RCP
(click image for full-size original)
4.
Repeat the ITLC procedure if the radiochemical purity is <95%. If repeat testing confirms that radiochemical purity is <95%, do not administer the Y-90 Zevalin dose.

2.5 Radiation Dosimetry

During clinical trials with Zevalin, estimations of radiation-absorbed doses for Y-90 Zevalin were performed using sequential whole body images and the MIRDOSE 3 software program. The estimated radiation absorbed doses to organs and marrow from a course of the Zevalin therapeutic regimen are summarized in Table 1. Absorbed dose estimates for the lower large intestine, upper large intestine, and small intestine have been modified from the standard MIRDOSE 3 output to account for the assumption that activity is within the intestine wall rather than the intestine contents.

Table 1. Estimated Radiation Absorbed Doses from Y-90 Zevalin
*
Organ region of interest
Sacrum region of interest
Whole body region of interest
Organ Y-90 Zevalin cGy /mCi (mGy/MBq)
Median Range
Spleen * 34.78 (9.4) 6.66 — 74.00 (1.8 — 20.0)
Liver * 17.76 (4.8) 10.73 — 29.97 (2.9 — 8.1)
Lower Large Intestinal Wall * 17.39 (4.7) 11.47 — 30.34 (3.1 — 8.2)
Upper Large Intestinal Wall * 13.32 (3.6) 7.40 — 24.79 (2.0 — 6.7)
Heart Wall * 10.73 (2.9) 5.55 — 11.84 (1.5 — 3.2)
Lungs * 7.4 (2) 4.44 — 12.58 (1.2 -3.4)
Testes * 5.55 (1.5) 3.70 — 15.91 (1.0 — 4.3)
Small Intestine * 5.18 (1.4) 2.96 — 7.77 (0.8 — 2.1)
Red Marrow 4.81 (1.3) 2.22 — 6.66 (0.6 — 1.8)
Urinary Bladder Wall 3.33 (0.9) 2.59 — 4.81 (0.7 — 1.3)
Bone Surfaces 3.33 (0.9) 1.85 — 4.44 (0.5 — 1.2)
Total Body 1.85 (0.5) 1.48 — 2.59 (0.4 — 0.7)
Ovaries 1.48 (0.4) 1.11 — 1.85 (0.3 — 0.5)
Uterus 1.48 (0.4) 1.11 — 1.85 (0.3 — 0.5)
Adrenals 1.11 (0.3) 0.74 — 1.85 (0.2 — 0.5)
Brain 1.11 (0.3) 0.74 — 1.85 (0.2 — 0.5)
Breasts 1.11 (0.3) 0.74 — 1.85 (0.2 — 0.5)
Gallbladder Wall 1.11 (0.3) 0.74 — 1.85 (0.2 — 0.5)
Muscle 1.11 (0.3) 0.74 — 1.85 (0.2 — 0.5)
Pancreas 1.11 (0.3) 0.74 — 1.85 (0.2 — 0.5)
Skin 1.11 (0.3) 0.74 — 1.85 (0.2 — 0.5)
Stomach 1.11 (0.3) 0.74 — 1.85 (0.2 — 0.5)
Thymus 1.11 (0.3) 0.74 — 1.85 (0.2 — 0.5)
Thyroid 1.11 (0.3) 0.74 — 1.85 (0.2 — 0.5)
Kidneys * 0.37 (0.1) 0.00 — 1.11 (0.0 — 0.3)

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