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2/25/2024

Topotecan Injection

Products Affected - Description

    • Topotecan lyophilized powder for injection, Accord, 4 mg, vial, 1 count, NDC 16729-0151-31
    • Topotecan solution for injection, Accord, 1 mg/mL, 4 mL vial, 1 count, NDC 16729-0243-31
    • Topotecan lyophilized powder for injection, Fresenius Kabi, 4 mg, vial, 1 count, NDC 63323-0762-10
    • Topotecan solution for injection, Pfizer, 1 mg/mL, 4 mL vial, 1 count, NDC 00409-0302-01
    • Topotecan lyophilized powder for injection, Teva, 4 mg, vial, 1 count, NDC 45963-0615-56

Reason for the Shortage

    • Accord has topotecan injection on shortage due to manufacturing delays.
    • Fresenius Kabi did not provide a reason for the shortage.
    • Pfizer has topotecan injection on shortage due to manufacturing delays.
    • Teva did not provide a reason for the shortage.

Available Products

    • There is insufficient supply for usual ordering

Estimated Resupply Dates

    • Accord has topotecan 1 mg/mL 4 mL vials and 4 mg powder for injection vials on intermittent back order and the company is allocating product upon release.
    • Fresenius Kabi has topotecan 4 mg powder for injection vials on back order and the company estimates a release date of late-April 2024.
    • Pfizer has topotecan 1 mg/mL 4 mL vials on back order and the company estimates a release date of March 2024.
    • Teva has topotecan 4 mg powder for injection vials on allocation.

Alternative Agents & Management

    • Consider evaluating the health-care system's total supply of topotecan before beginning patients on combination chemotherapy regimens containing topotecan. If adequate supplies are not available, select an alternative regimen.
    • The choice of an alternative agent must be patient-specific and based on renal function, liver function, and the neoplasm type and location. No single agent can be substituted for topotecan.
    • Consult a Hematology/Oncology specialist for patient- and neoplasm-specific recommendations.
    • Refer to the ASHP Guidelines on Managing Drug Product Shortages for more guidance on developing a multidisciplinary plan when the supply must be allocated. https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/managing-drug-product-shortages.pdf
    • Refer to national guidelines such as those from the National Comprehensive Cancer Network (www.nccn.org) or American Society of Clinical Oncology (http://www.asco.org/) for additional information regarding therapeutic use.

Updated

Updated February 25, 2024 by Michelle Wheeler, PharmD, Drug Information Specialist. Created February 5, 2024 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2024, 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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