Products Affected - Description

• • Carboplatin solution for injection, Mylan Institutional, 10 mg/mL, 15 mL multiple dose vial, 1 count, NDC 67457-0492-15
  • Carboplatin solution for injection, Mylan Institutional, 10 mg/mL, 45 mL multiple dose vial, 1 count, NDC 67457-0493-46
  • Carboplatin solution for injection, Mylan Institutional, 10 mg/mL, 5 mL multiple dose vial, 1 count, NDC 67457-0491-54
  • Carboplatin solution for injection, Mylan Institutional, 10 mg/mL, 60 mL multiple dose vial, 1 count, NDC 67457-0494-61

Reason for the Shortage

• • Bedford discontinued carboplatin in May, 2011 to concentrate on the manufacturing of other products.[1]
  • Fresenius Kabi has carboplatin available.[2]
  • Mylan Institutional discontinued carboplatin in January 2018.[3]
  • Pfizer had carboplatin injection on shortage due to manufacturing delays.[4]
  • Sagent has carboplatin injection available.[5]
  • Sandoz has discontinued carboplatin injection.[6]
  • Teva had carboplatin on allocation due to increased demand.[7]

Available Products

• • Carboplatin solution for injection, Fresenius Kabi, 10 mg/mL, 15 mL multiple dose vial, 1 count, NDC 63323-0172-15
  • Carboplatin solution for injection, Fresenius Kabi, 10 mg/mL, 45 mL multiple dose vial, 1 count, NDC 63323-0172-45
  • Carboplatin solution for injection, Fresenius Kabi, 10 mg/mL, 5 mL multiple dose vial, 1 count, NDC 63323-0172-05
  • Carboplatin solution for injection, Fresenius Kabi, 10 mg/mL, 60 mL multiple dose vial, 1 count, NDC 63323-0172-60
  • Carboplatin solution for injection, Pfizer, 10 mg/mL, 15 mL multiple dose vial, 1 count, NDC 61703-0339-22
  • Carboplatin solution for injection, Pfizer, 10 mg/mL, 45 mL multiple dose vial, 1 count, NDC 61703-0339-50
  • Carboplatin solution for injection, Pfizer, 10 mg/mL, 5 mL multiple dose vial, 1 count, NDC 61703-0339-18
  • Carboplatin solution for injection, Pfizer, 10 mg/mL, 60 mL multiple dose vial, 1 count, NDC 61703-0339-56
  • Carboplatin solution for injection, Sagent, 10 mg/mL, 15 mL multiple dose vial, 1 count, NDC 25021-0202-15
  • Carboplatin solution for injection, Sagent, 10 mg/mL, 45 mL multiple dose vial, 1 count, NDC 25021-0202-45
  • Carboplatin solution for injection, Sagent, 10 mg/mL, 5 mL multiple dose vial, 1 count, NDC 25021-0205-05
  • Carboplatin solution for injection, Sagent, 10 mg/mL, 60 mL multiple dose vial, 1 count, NDC 25021-0202-51
  • Carboplatin solution for injection, Teva, 10 mg/mL, 15 mL multiple dose vial, 1 count, NDC 00703-4246-01
  • Carboplatin solution for injection, Teva, 10 mg/mL, 45 mL multiple dose vial, 1 count, NDC 00703-4248-01
  • Carboplatin solution for injection, Teva, 10 mg/mL, 5 mL multiple dose vial, 1 count, NDC 00703-4244-01
  • Carboplatin solution for injection, Teva, 10 mg/mL, 60 mL multiple dose vial, 1 count, NDC 00703-4239-01

• • All presentations are available.

• • Carboplatin is a platinum-containing alkylating agent. It is labeled for use as a single agent or in combination with other antineoplastic agents for the treatment of adults with ovarian cancer.[8-10]
  • Carboplatin is used off-label for a variety of neoplastic diseases including small cell and non-small cell lung, breast, bladder, cervical, endometrial, head and neck squamous cell, and testicular cancers, Hodgkin or non-Hodgkin lymphoma, and pediatric neuroblastoma, retinoblastoma, and sarcoma. [8-10]
  • 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 carboplatin, pose additional safety risks both for patients and for healthcare workers handling these agents.[8-10]
  • 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).[8-10]

• • 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 carboplatin.[6-10]
  • Consider evaluating the health-care system's total supply of carboplatin before beginning patients on combination chemotherapy regimens containing carboplatin. 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. Bedford (personal communications). May 5, July 6, July 27, August 30, September 28, November 10, December 2, 2010; January 12, February 8, April 20, and May 3, 2011.
  2. Fresenius Kabi (personal communications). May 5, July 6, July 28, August 30, September 22 and 30, November 12, December 1, 2010; January 14, February 11 and 18, March 2 and 31, April 20, May 11, June 8 and 22, July 26, September 16, November 2, December 14, 2011; January 11, February 1 and 22, March 5 and 22, April 4, May 18, June 18, July 25, September 10, December 19, 2012; March 4, May 28, July 8, August 19, September 24, October 22, and November 18, 2013; January 3, March 12, April 2, May 15, July 11 and 30, August 14, September 22, October 29, November 21 and 26, December 29, 2014; January 30, March 3 and 31, May 13, June 9 and 30, August 25, and September 23, October 27, November 24, December 2 and 17, 2015; January 20, February 19 and 26, March 10, April 22, May 2, 11, and 23, June 30, July 7, 22, and 29, September 23, December 1 and 18, 2016; February 2, March 10 and 21, April 24, July 6, August 4, September 7, October 27, 2017; January 26, February 5 and 24, and March 2, 2018.
  3. Mylan Institutional (personal communications). November 3 and 21, December 31, 2014; January 30, March 9, April 6, May 14, June 8, September 2, December 17, 2015; February 24, April 25, July 11, September 27, 2016; February 6 and August 9, 2017.
  4. Pfizer (personal communications and website). May 5, July 6, July 29, August 26, September 7 and 27, October 13, November 9, December 2, 2010; January 12, February 7, 14, 22, and 25, March 8, 11, 24, and 29, April 22, June 16 and 28, July 28, September 16, October 31, November 2, 14, and 16, December 15, 2011; January 9 and 30, February 20, March 5 and 21, April 2, May 18, June 18, July 13 and 25, September 17, December 31, 2012; March 6, May 28, July 10, August 19, September 30, October 28, November 18, 2013; January 6, March 6 and 12, April 3, May 14, July 14, August 4 and 18, September 22, October 31, November 21, 2014; January 2 and 30, March 2, April 6, May 15, June 8, July 8, September 2, October 1 and 23, November 24, December 17, 2015; January 28, February 22, March 2 and 16, April 28, May 26, July 1, 12, and 26, September 29, December 2 and 19, 2016; February 6, March 13 and 21, April 28, July 10, August 2, September 8, October 30, 2017; January 26, February 2, and March 7, 2018.
  5. Sagent (personal communications). November 1 and 18, 2013; January 6, March 12, April 2, May 15, July 11, August 1 and 15, September 19, October 30, November 21, December 29, 2014; January 30, March 5, April 2, May 14, June 4, July 2, September 3, October 1 and 22, November 24, December 3 and 17, 2015; January 21 and 28, February 18, March 3, April 28, May 12 and 26, June 30, July 7, 21, and 29, September 29, December 1 and 15, 2016; February 2, March 9 and 16, April 27, July 6, August 3, September 7, October 26, 2017; January 25, February 1, and March 1, 2018.
  6. Sandoz (personal communications). May 5, July 7, July 30, August 30, September 16 and 30, October 1 and 11, November 10 and 18, December 2, 2010; January 13, February 9, March 31, April 20, June 20, July 27, September 13, October 31, November 18, and December 15, 2011; February 1, July 23, September 17, December 31, 2012; May 28 and October 28, 2013; January 6 and March 12, 2014; January 30 and June 8, 2015.
  7. Teva (personal communications). May 5, July 6, July 28, August 30, September 14 and 30, November 11 and 22, 2010; January 12, February 9, 15, and 25, March 8 and 29, April 20, May 4, July 1 and 28, September 13, October 27, November 17, December 15, 2011; January 11 and 30, March 7 and 22, April 2 and 17, May 17, June 18, July 23, and September 17, 2012; January 4, March 4, May 28, July 11, August 19, September 30, October 28, 2013; January 6, March 12, May 14, July 14, August 4 and 18, October 31, November 21, December 29, 2014; February 2, March 11, April 6, May 13, June 2 and 8, July 8, September 3, October 28, November 24, 2015; January 28, February 24, April 29, July 6, September 30, November 29, 2016; January 11, February 9, March 6 and 20, June 13, July 31, September 4, October 17, 2017; February 5, and March 2, 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.