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11/5/2021

Alteplase Injection

Products Affected - Description

    • Activase intravenous lyophilized powder for injection, Genentech, 100 mg, kit, 1 count, NDC 50242-0065-27

Reason for the Shortage

    • Genentech has Alteplase 100 mg kits on shortage because the transfer device included as part of the 100 mg kits is not available.

Available Products

    • Activase intravenous lyophilized powder for injection, Genentech, 50 mg, kit, 1 count, NDC 50242-0044-13

Estimated Resupply Dates

    • Genentech has Activase 100 mg kits in limited supply and the company is allocating product. The company cannot estimate a replenishment date for additional 100 mg kits.

Alternative Agents & Management

    • Genentech recommends using two 50 mg vials for doses over 50 mg and provides additional information in a Dear Health Care Provider letter https://www.gene.com/download/pdf/Activase_DHCP_Letter_October2021.pdf. Instructions on how to prepare doses over 50 mg using two 50 mg vials are available at https://www.gene.com/download/pdf/activase_instructions_for_alternate_preparation.pdf.

Updated

Created November 5, 2021 by Leslie Jensen, PharmD, Drug Information Specialist. © 2021, Drug Information Service, University of Utah, Salt Lake City, UT.

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Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. ASHP and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this Bulletin. Neither ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

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