Products Affected - Description
Cisplatin injection, Mylan Institutional
1 mg/mL, 50 mL vial, 1 count (NDC 67457-0425-51)
1 mg/mL, 100 mL vial, 1 count (NDC 67457-0424-10)
Reason for the Shortage
- Fresenius Kabi did not provide a reason for the shortage.1
- Mylan Institutional could not provide a reason for the shortage.2
- Teva was allocating cisplatin to prevent stockpiling.3
- WG Critical Care could not provide a reason for the shortage.4
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, 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)
Cisplatin injection, WG Critical Care
1 mg/mL, 50 mL vial, 1 count (NDC 44567-0509-01)
1 mg/mL, 100 mL vial, 1 count (NDC 44567-0510-01)
Estimated Resupply Dates
Mylan Institutional has cisplatin 50 mL and 100 mL vials on back order and the company cannot estimate a release date.2
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, 2015; January 14 and 28, March 10, May 11, July 22, September 23, October 6, December 1 and 19, 2016; and January 4, 2017.
- 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, October 19, December 15, 2015; February 1, March 7, May 9, July 18, and September 27, 2016.
- 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, October 19, December 18, 2015; February 3, March 7, May 10, July 28, and September 30, 2016.
- 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, December 14, 2015; February 2, March 10, May 9, July 19, August 6, and September 26, 2016.
- 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 January 6, 2017 by Michelle Wheeler, PharmD, Drug Information Specialist. Created June 25, 2015 by Jane Chandramouli, PharmD, Drug Information Specialist. Copyright 2017, Drug Information Service, University of Utah, Salt Lake City, UT.
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