Products Affected - Description
Cisplatin injection, Fresenius Kabi
1 mg/mL, 50 mL vial, 1 count (NDC 63323-0103-51)
1 mg/mL, 100 mL vial, 1 count (NDC 63323-0103-65)
1 mg/mL, 200 mL vial, 1 count (NDC 63323-0103-64)
Cisplatin injection, Mylan Institutional
1 mg/mL, 100 mL vial, 1 count (NDC 67457-0424-10)
Cisplatin injection, Teva
1 mg/mL, 50 mL vial, 1 count (NDC 00703-5747-11)
1 mg/mL, 100 mL vial, 1 count (NDC 00703-5748-11)
Reason for the Shortage
- Fresenius Kabi states the shortage was due to increased demand and manufacturing delays.1
- Mylan Institutional could not provide a reason for the shortage.2
- Teva was allocating cisplatin to prevent stockpiling.3
- WG Critical Care has product available for contracted customers.4
Cisplatin injection, Mylan Institutional
1 mg/mL, 50 mL vial, single count (NDC 67457-0425-51)
Cisplatin injection, WG Critical Care
1 mg/mL, 50 mL vial, single count (NDC 44567-0509-01)
1 mg/mL, 100 mL vial, 1 count (NDC 44567-0510-01)
Estimated Resupply Dates
- Fresenius Kabi has cisplatin 100 mL and 200 mL vials on back order and the company estimates a release date of mid-December 2015 for the 100 mL vials and late-December 2015 for the 200 mL vials. Cisplatin 50 mL vials are available with short expiration dating (8 months or less).1
- Mylan Institutional has cisplatin 100 mL vials on back order and the company cannot estimate a release date.2
- Teva is currently shipping cisplatin 50 mL and 100 mL vials with short expiration dating only (March 2016 for the 50 mL vials and February 2016 for the 100 mL vials).3
- WG Critical Care has cisplatin 100 mL vials on back order and the company estimates a release date in early-to-mid November 2015.4
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, cervical 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
- Refer to national guidelines such as those from the National Comprehensive Cancer Network (www.nccn.org) or American Society of Clinical Oncology (www.asco.org) for additional information regarding therapeutic use.
- Chemotherapy agents, such as cisplatin, pose additional safety risks both for patients and for healthcare workers handling these agents.5-7
- 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).5-7
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, August 4, 11, and 19, September 5, 12, and 22, October 7, November 4, December 3, 2014; January 14, February 24, March 25, April 20, June 25, July 17 and 23, August 25, September 23, October 15, and November 11, 2015.
- Mylan Institutional (personal communications). May 16, June 9, August 1, September 8, October 7, November 4, December 3, 2014; and January 14, March 26, April 27, June 25, July 23, September 9, and October 19, 2015.
- Teva (personal communications). May 19, August 4, September 11, October 7, December 3, 2014; January 15, February 25, April 27, June 23, September 9 and 23, and October 19, 2015.
- WG Critical Care (personal communications). May 21, August 1, September 8, October 7, November 5, December 3, 2014; January 15, February 25, April 27, June 23, July 27, September 9, October 20, and November 11, 2015.
- Antineoplastic agents. In: McEvoy GK, ed. AHFS 2015 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2015: 839-1281.
- Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. March 2015.
- Lexi-Drugs Online. Lexi-Comp, Inc.; 2015.
Updated November 11, 2015 by Leslie Jensen, PharmD, Drug Information Specialist. Created June 25, 2015 by Jane Chandramouli, PharmD, Drug Information Specialist. Copyright 2015, 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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