Products Affected - Description
Cisplatin injection 1 mg/mL solution, Fresenius Kabi
100 mL vial (NDC 63323-0103-65)
200 mL vial (NDC 63323-0103-64)
Cisplatin injection 1 mg/mL solution, Mylan Institutional
50 mL vial (NDC 67457-0425-51)
100 mL vial (NDC 67457-0424-10)
Cisplatin injection 1 mg/mL solution, Teva
50 mL vial (NDC 00703-5747-11)
100 mL vial (NDC 00703-5748-11)
Cisplatin injection 1 mg/mL solution, WG Critical Care4
50 mL vials (NDC 44567-0509-01)
100 mL vial (NDC 44567-0510-01)
Reason for the Shortage
- Fresenius states the shortage was due to increased demand and manufacturing delays.1
- Mylan Institutional has cisplatin only available with short-dating.2
- Teva is allocating cisplatin to prevent stockpiling.3
- WG Critical Care is allocating product due to increased demand.4
Cisplatin injection 1 mg/mL solution, Fresenius Kabi
50 mL vials (NDC 63323-0103-51)
Estimated Resupply Dates
- Fresenius Kabi has cisplatin 100 mL vials on allocation. Cisplatin 200 mL vials are on back order with an estimated release date of early-September 2014.1
- Mylan Institutional has cisplatin 50 mL and 100 mL vials available but with expiration dates of December 2014 for the 50 mL vials and November 2014 for the 100 mL vials.2
- Teva has limited supplies of cisplatin 50 mL and 100 mL vials and is allocating product.3
- WG Critical Care is allocating cisplatin 50 mL and 100 mL vials to contracted customers.4
Implications for Patient Care
- Cisplatin is a platinum-based alkylating agent. It is labeled for use as a single agent for the treatment of advanced transitional cell bladder cancer, and in combination with other antineoplastic agents for the treatment of metastatic testicular cancer and metastatic ovarian cancer.5-7
- Cisplatin is used off-label for a variety of neoplastic diseases including squamous cell head and neck cancer, squamous cell ovarian cancer, lung cancer, osteosarcoma, esophageal cancer, adrenal cortex carcinoma, breast cancer, endometrial cancer, or liver cancer, and in patients undergoing hematopoietic stem cell transplantation. It has also been used off-label in children for the treatment of brain tumors and osteosarcoma.5-7
- Cisplatin is typically used in combination with other antineoplastic agents. 5-7
- Chemotherapy agents, such as cisplatin, pose additional safety risks both for patients and for healthcare workers handling these agents.5,6
- Use additional caution when processing orders for chemotherapy drugs, especially when switching between chemotherapy agents or when processing orders for chemotherapy agents with which staff may be unfamiliar (eg, those not normally prescribed at a specific institution).5,6
Alternative Agents & Management
- 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.5-7
- 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.
- 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.
- Fresenius Kabi (personal communications). May 16, 19, and 28, June 23, and August 4, 11, and 19, 2014.
- Mylan Institutional (personal communications). May 16, June 9, and August 1, 2014.
- Teva (personal communications). May 19 and August 4, 2014.
- WG Critical Care (personal communications). May 21 and August 1, 2014.
- Beckwith MC, Tyler LS, eds. Cancer Chemotherapy Manual. St. Louis, MO: Wolters Kluwer Health Inc. 2010.
- Antineoplastic agents. In: McEvoy GK, ed. AHFS 2010 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2010: 902-1260.
- Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. May 2014.
Updated August 21, 2014 by Jane Chandramouli, PharmD, Drug Information Specialist. Created September 10, 2010, by Michelle M. Wheeler, PharmD, and M. Christina Beckwith, PharmD, Drug Information Specialists. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.
This information is provided through the support of Novation to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Novation, 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, which 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 Novation, 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 Novation, ASHP nor University of Utah endorses or recommends the use of any drug.
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