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11/21/2023

Carboplatin Solution for Injection

Products Affected - Description

    • Carboplatin solution for injection, Accord, 10 mg/mL, 15 mL multiple dose vial, 1 count, NDC 16729-0295-33
    • Carboplatin solution for injection, Accord, 10 mg/mL, 45 mL multiple dose vial, 1 count, NDC 16729-0295-34
    • Carboplatin solution for injection, Accord, 10 mg/mL, 5 mL multiple dose vial, 1 count, NDC 16729-0295-31
    • Carboplatin solution for injection, Accord, 10 mg/mL, 60 mL multiple dose vial, 1 count, NDC 16729-0295-12
    • Carboplatin solution for injection, Eugia US, 10 mg/mL, 45 mL multiple dose vial, 1 count, NDC 55150-0335-01
    • Carboplatin solution for injection, Eugia US, 10 mg/mL, 60 mL multiple dose vial, 1 count, NDC 55150-0386-01
    • Carboplatin solution for injection, Fresenius Kabi, 10 mg/mL, 60 mL multiple dose vial, 1 count, NDC 63323-0172-60
    • Carboplatin solution for injection, Ingenus Pharmaceuticals, 10 mg/mL, 45 mL multiple dose vial, 1 count, NDC 50742-0447-45
    • Carboplatin solution for injection, Ingenus Pharmaceuticals, 10 mg/mL, 60 mL multiple dose vial, 1 count, NDC 50742-0448-60
    • Carboplatin solution for injection, Pfizer, 10 mg/mL, 15 mL multiple dose vial, 1 count, NDC 61703-0339-22
    • Carboplatin solution for injection, Pfizer, 10 mg/mL, 45 mL multiple dose vial, 1 count, NDC 61703-0339-50
    • Carboplatin solution for injection, Pfizer, 10 mg/mL, 5 mL multiple dose vial, 1 count, NDC 61703-0339-18
    • Carboplatin solution for injection, Pfizer, 10 mg/mL, 60 mL multiple dose vial, 1 count, NDC 61703-0339-56
    • Carboplatin solution for injection, Teva, 10 mg/mL, 15 mL multiple dose vial, 1 count, NDC 00703-4246-01
    • Carboplatin solution for injection, Teva, 10 mg/mL, 45 mL multiple dose vial, 1 count, NDC 00703-4248-01
    • Carboplatin solution for injection, Teva, 10 mg/mL, 60 mL multiple dose vial, 1 count, NDC 00703-4239-01

Reason for the Shortage

    • Accord has carboplatin on shortage due to manufacturing delays.
    • Eugia has carboplatin on shortage due to increased demand.
    • Fresenius Kabi has carboplatin on shortage due to increased demand.
    • Ingenus did not provide a reason for the shortage.
    • Pfizer has carboplatin on shortage due to increased demand.
    • Teva did not provide a reason for the shortage.

Available Products

    • Carboplatin solution for injection, Teva, 10 mg/mL, 5 mL multiple dose vial, 1 count, NDC 00703-4244-01

Estimated Resupply Dates

    • Accord has carboplatin 10 mg/mL 5 mL, 15 mL, 45 mL, and 60 mL vials on back order and the company cannot estimate a release date.
    • Eugia has carboplatin 10 mg/mL 45 mL vials and 60 mL vials on back order and the company estimates a release date of November 2023.
    • Fresenius Kabi has carboplatin 10 mg/mL 60 mL vials on back order and the company estimates a release date of late-November to early-December 2023.
    • Ingenus has carboplatin 10 mg/mL 45 mL vials available in limited supply. The 60 mL vials are on back order and the company cannot estimate a release date.
    • Pfizer has carboplatin 10 mg/mL 5 mL, 15 mL, 45 mL, and 60 mL vials available in limited supply.
    • Teva has carboplatin 10 mg/mL 15 mL, 45 mL, and 60 mL vials on back order and the company estimates a release date of January 2024.

Implications for Patient Care

Alternative Agents & Management

    • Consider evaluating the health-care system's total supply of carboplatin before beginning patients on combination chemotherapy regimens containing carboplatin. 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 carboplatin.
    • 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 November 21, 2023 by Michelle Wheeler, PharmD, Drug Information Specialist. Created March 28, 2023 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2023, 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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