Products Affected - Description

• • 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

Reason for the Shortage

• • Accord has cisplatin available.
  • Fresenius Kabi has cisplatin available.
  • Hikma has cisplatin in shortage due to increased demand.
  • Sagent has cisplatin available.
  • Teva has cisplatin available.
  • WG Critical Care has cisplatin available.

Available Products

• • 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, 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
  • 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

• • Hikma has cisplatin 1 mg/mL 50 mL vials on back order and the company cannot estimate a release date. The 100 mL vials are 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 is allowing Fresenius Kabi to temporarily import cisplatin injection BP (Kemoplat) 1 mg/mL 50 mL vials. The product is marketed in Europe and manufactured in India. There is a Dear Healthcare Professional Letter describing the differences between the US products and the imported product. Some of the most notable differences are that the imported product carton and container labeling do not include warning statements that are on the US product, the product is a single dose vial and extended stability data is not available, the product is a clear, colorless to pale yellow solution, and the linear barcode may not track appropriately. Additionally, the imported product is labeled cisplatin injection BP (Kemoplat) 50 mg/50 mL (1 mg/mL). The BP stands for British Pharmacopeia. The Dear Healthcare Professional letter can be found at: https://www.fresenius-kabi.com/us/documents/CISplatin-DHCP-Letter.pdf
  • 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.

• • 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.