Products Affected - Description

• • Cisplatin injection, Accord, 1 mg/mL, 100 mL vial, 1 count, NDC 16729-0288-38
  • Cisplatin injection, Accord, 1 mg/mL, 50 mL vial, 1 count, NDC 16729-0288-11
  • Cisplatin injection, Fresenius Kabi, 1 mg/mL, 100 mL vial, 1 count, NDC 63323-0103-65
  • Cisplatin injection, Fresenius Kabi, 1 mg/mL, 200 mL vial, 1 count, NDC 63323-0103-64
  • Cisplatin injection, Fresenius Kabi, 1 mg/mL, 50 mL vial, 1 count, NDC 63323-0103-51
  • Cisplatin injection, Hikma, 1 mg/mL, 100 mL vial, 1 count, NDC 00143-9505-01
  • Cisplatin injection, Hikma, 1 mg/mL, 50 mL vial, 1 count, NDC 00143-9504-01
  • Cisplatin injection, Sagent, 1 mg/mL, 100 mL vial, 1 count, NDC 25021-0253-51
  • Cisplatin injection, Sagent, 1 mg/mL, 50 mL vial, 1 count, NDC 25021-0253-50
  • Cisplatin injection, Teva, 1 mg/mL, 100 mL vial, 1 count, NDC 00703-5748-11
  • Cisplatin injection, Teva, 1 mg/mL, 50 mL vial, 1 count, NDC 00703-5747-11

Reason for the Shortage

• • Accord has cisplatin on shortage due to manufacturing delays.
  • Fresenius Kabi has ciplatin on shortage due to increased demand.
  • Hikma did not provide a reason for the shortage.
  • Sagent launched cisplatin in July 2023.
  • Teva did not provide a reason for the shortage.
  • WG Critical Care has cisplatin available.

Available Products

• • Cisplatin injection, WG Critical Care, 1 mg/mL, 200 mL vial, 1 count, NDC 44567-0511-01
  • Cisplatin lyophilized powder for injection, WG Critical Care, 50 mg vial, 1 count, NDC 44567-0530-01

• • Accord has cisplatin 1 mg/mL 50 mL and 100 mL vials on back order and the company cannot estimate a release date.
  • Fresenius Kabi has cisplatin 1 mg/mL 50 mL, 100 mL, and 200 mL vials on back order and the company estimates a release date of late-October 2023 for the 50 mL vials, early-October 2023 for the 100 mL vials, and late-September 2023 for the 200 mL vials.
  • Hikma has cisplatin 1 mg/mL 50 mL vials on allocation. The 100 mL vials are on back order and the company estimates a release date of September 2023.
  • Sagent has cisplatin 1 mg/mL 50 mL and 100 mL vials on back order and the company estimates a release date of November 2023 for the 50 mL vials and September 2023 for the 100 mL vials.
  • Teva has cisplatin 1 mg/mL 50 mL and 100 mL vials on allocation.

• • The Society of Gynecologic Oncology has a statement on conservation strategies during this shortage. This statement is available at: https://www.sgo.org/news/drugshortage/

• • FDA was allowing temporary importation of Chinese cisplatin 1 mg/mL 50 mL vials from Qilu Pharmaceutical through Apotex authorized distributors. Apotex is no longer importing this product at this time. https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Cisplatin%20Injection&st=c&tab=tabs-1. There is a Dear Healthcare Professional Letter describing the differences between the US products and the Chinese product. Some of the most notable differences are that the Chinese box and labels are in Chinese, there is no NDC, and the linear barcode may not track appropriately. The Dear Healthcare Professional letter can be found at: https://www.fda.gov/media/169001/download
  • ISMP has an article on the imported cisplatin presentation from China. This information can be found at: https://www.ismp.org/resources/fda-authorizes-cisplatin-importation-china.

• • Consider evaluating the health-care system's total supply of cisplatin before beginning patients on combination chemotherapy regimens containing cisplatin. 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 cisplatin.
  • 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.