NDC 72893-007 Zevalin

The NDC code 72893-007 is assigned by the FDA to the product Zevalin which is a human prescription drug product labeled by Acrotech Biopharma Inc. The generic name of Zevalin is ibritumomab tiuxetan. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 72893-007-04 1 kit in 1 carton * 10 ml in 1 vial * 2 ml in 1 vial * 2 ml in 1 vial. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

A clearly-labeled kit is required for preparation of Yttrium-90 (Y-90) Zevalin. Follow the detailed instructions for the preparation of radiolabeled Zevalin [see Dosage and Administration (2.4)].Required materials not supplied in the kit:1.Yttrium-90 Chloride Sterile Solution 2.Three sterile 1 mL plastic syringes3.One sterile 3 mL plastic syringe4.Two sterile 10 mL plastic syringes with 18-20 G needles5.ITLC silica gel strips6.0.9% Sodium Chloride aqueous solution for the chromatography solvent7.Developing chamber for chromatography8.Suitable radioactivity counting apparatus9.Filter, 0.22 micrometer, low-protein-binding10.Appropriate acrylic shielding for reaction vial and syringe for Y-90Method:1.Allow contents of the refrigerated Y-90 Zevalin kit (Zevalin vial, 50 mM sodium acetate vial, and formulation buffer vial) to reach room temperature. 2.Place the empty reaction vial in an appropriate acrylic shield.3.Determine the amount of each component needed:a.Calculate volume of Y-90 Chloride equivalent to 40 mCi based on the activity concentration of the Y-90 Chloride stock.b.The volume of 50 mM Sodium Acetate solution needed is 1.2 times the volume of Y-90 Chloride solution determined in step 3.a, above.c.Calculate the volume of formulation buffer needed to bring the reaction vial contents to a final volume of 10 mL.4.Transfer the calculated volume of 50 mM Sodium Acetate to the empty reaction vial. Coat the entire inner surface of the reaction vial by gentle inversion or rolling.5.Transfer 40 mCi of Y-90 Chloride to the reaction vial using an acrylic shielded syringe. Mix the two solutions by gentle inversion or rolling.6.Transfer 1.3 mL of Zevalin (ibritumomab tiuxetan) to the reaction vial. Do not shake or agitate the vial contents.7.Allow the labeling reaction to proceed at room temperature for 5 minutes. A shorter or longer reaction time may adversely alter the final labeled product.8.Immediately after the 5-minute incubation period, transfer the calculated volume of formulation buffer from step 3.c. to the reaction vial. Gently add the formulation buffer down the side of the reaction vial. If necessary, withdraw an equal volume of air to normalize pressure.9.Measure the final product for total activity using a radioactivity calibration system suitable for the measurement of Y-90.10.Using the supplied labels, record the date and time of preparation, the total activity and volume, and the date and time of expiration, and affix these labels to the shielded reaction vial container.11.Patient Dose: Calculate the volume required for a Y-90 Zevalin dose [see Dosage and Administration (2.2)].  Withdraw the required volume from the reaction vial. Assay the syringe in the dose calibrator suitable for the measurement of Y-90. The measured dose must be within 10% of the prescribed dose of Y-90 Zevalin and must not exceed 32 mCi (1184 MBq). Using the supplied labels, record the patient identifier, total activity and volume and the date and time of expiration, and affix these labels to the syringe and shielded unit dose container.12.Determine Radiochemical Purity [see Dosage and Administration (2.4)].13.Store Yttrium-90 Zevalin at 2-8°C (36-46°F) until use and administer within 8 hours of radiolabeling. Immediately prior to administration, assay the syringe and contents using a radioactivity calibration system suitable for the measurement of Y-90.