Products Affected - Description

• • Cisplatin injection, Mylan Institutional, 1 mg/mL, 100 mL vial, 1 count, NDC 67457-0424-10
  • Cisplatin injection, Mylan Institutional, 1 mg/mL, 50 mL vial, 1 count, NDC 67457-0425-51

Reason for the Shortage

• • Accord has cisplatin available.[1]
  • Alvogen has cisplatin available.[2]
  • Athenex has cisplatin available.[3]
  • Mylan Institutional discontinued cisplatin in January 2018.[5]
  • Fresenius Kabi has cisplatin available.[4]
  • Teva had cisplatin on allocation due to increased demand.[6]
  • WG Critical Care has cisplatin available.[7]

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, Alvogen, 1 mg/mL, 100 mL vial, 1 count, NDC 47781-0610-23
  • Cisplatin injection, Alvogen, 1 mg/mL, 50 mL vial, 1 count, NDC 47781-0609-25
  • Cisplatin injection, Athenex, 1 mg/mL, 100 mL vial, 1 count, NDC 70860-0206-51
  • Cisplatin injection, Athenex, 1 mg/mL, 50 mL vial, 1 count, NDC 70860-0206-50
  • 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, 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, 100 mL vial, 1 count, NDC 44567-0510-01
  • Cisplatin injection, WG Critical Care, 1 mg/mL, 200 mL vial, 1 count, NDC 44567-0511-01
  • Cisplatin injection, WG Critical Care, 1 mg/mL, 50 mL vial, 1 count, NDC 44567-0509-01

• • All marketed presentations are available.

• • 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.[8,9,10]
  • 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.[8,9,10]
  • 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.[8,9,10]
  • 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).[8,9,10]

• • 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.[8,9,10]
  • 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. http://www.ashp.org/DocLibrary/Policy/DrugShortages/ASHP_shortage_guide09.pdf

• 1. Accord (personal communications). December 18, 2018.
  2. Alvogen (personal communications). December 17, 2018.
  3. Athenex (personal communications). March 8, April 10, August 6, and October 10, 2018.
  4. Fresenius Kabi (personal communications). May 16, 19, 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; January 4, February 20, March 21, April 13, May 2, 19, and 25, June 8 and 20, July 3 and 27, September 7, October 4 and 27, November 17, 2017; January 26, February 5, March 2 and 9, April 6, and May 3, 19, and 25, June 28, August 3, September 28, October 5, and December 14, 2018.
  5. 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, September 27, 2016; February 21, May 15, and October 4, 2017.
  6. 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, September 30, 2016; March 20, May 8, June 13, July 29, September 4, October 2, November 6, 2017; January 22, February 5, March 5, April 9, and May 21, June 29, August 8, October 5, and December 10, 2018.
  7. 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, September 26, 2016; February 21, May 19, July 31, October 4, November 20, 2017; April 10, May 3 and 18, August 6, October 10, and December 17, 2018.
  8. Antineoplastic agents. In: McEvoy GK, ed. AHFS 2015 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2015: 839-1281.
  9. Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. (http://online.factsandcomparisons.com/index.aspx). March 2015.
  10. Lexi-Drugs Online. Lexi-Comp, Inc.; 2015.