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Carboplatin Solution for Injection

[23 September 2014]

Products Affected - Description

Carboplatin solution for injection, 10 mg/mL, Fresenius Kabi (formerly APP)
15 mL multi-dose vial (NDC 63323-0172-15)
45 mL multi-dose vial (NDC 63323-0172-45)
 
Carboplatin solution for injection, 10 mg/mL, Sandoz
5 mL multi-dose vial (NDC 66758-0047-01)
15 mL multi-dose vial (NDC 66758-0047-02)
45 mL multi-dose vial (NDC 66758-0047-03)
60 mL multi-dose vial (NDC 66758-0047-04)

Reason for the Shortage

  • Bedford discontinued carboplatin in May, 2011 to concentrate on the manufacturing of other products.1 
  • Teva has carboplatin injection on shortage due to manufacturing delays.2,3,4
  • Fresenius Kabi has carboplatin on shortage due to increased demand for the product.5 
  • Sandoz has carboplatin on shortage due to manufacturing delays.6
  • Sagent launched carboplatin in November 2013.7 

Available Products

Carboplatin solution for injection, 10 mg/mL, Fresenius Kabi (formerly APP)
5 mL multi-dose vial (NDC 63323-0172-05)
60 mL multi-dose vial (NDC 63323-0172-60)

Carboplatin solution for injection, 10 mg/mL, Hospira
5 mL multi-dose vial (NDC 61703-0339-18)
15 mL multi-dose vial (NDC 61703-0339-22)
45 mL multi-dose vial (NDC 61703-0339-50)
60 mL multi-dose vial (NDC 61703-0339-56)
 
Carboplatin solution for injection, 10 mg/mL, Sagent
5 mL multi-dose vial (NDC 25021-0205-05)
15 mL multi-dose vial (NDC 25021-0202-15)
45 mL multi-dose vial (NDC 25021-0202-45)
60 mL multi-dose vial (NDC 25021-0202-51)
 
Carboplatin solution for injection, 10 mg/mL, Teva
5 mL multi-dose vial, (NDC 00703-4244-01)
15 mL multi-dose vial (NDC 00703-4246-01)
45 mL multi-dose vial (NDC 00703-4248-01)
60 mL multi-dose vial (NDC 00703-3249-11)

Estimated Resupply Dates

  • Fresenius Kabi (formerly APP) has carboplatin 15 mL and 45 mL vials on back order and the company cannot estimate a release date.5
  • Sandoz has temporarily discontinued all carboplatin presentations, and the company does not plan to release product until 2015.6

Implications for Patient Care

  • 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 in adults including small cell and non-small cell lung cancer, brain tumors, breast cancer, bladder cancer, cervical cancer, Hodgkin or non-Hodgkin lymphoma, head and neck squamous cell cancer, neuroblastoma, testicular cancer, and Wilms tumor.8-10
  • Carboplatin is used off-label for retinoblastoma in children.8-10

Safety

  • Chemotherapy agents, such as carboplatin, pose additional safety risks both for patients and for healthcare workers handling these agents.8,9
  • 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

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 carboplatin.8-10
  • 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.

Related Shortages

References

  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. Hospira (personal communications). May 5, July 6, July 29, August 26, and 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, September 16, October 31, November 16, 2011; March 21, April 2, May 18, and June 18, July 13 and 25, September 17, and December 31, 2012; March 6, 2013; May 14, 2014.
  3. Hospira (website). July 28, November 2 and 14, December 15, 2011; January 9 and 30, February 20, and March 5, 2012; March 6, May 28, July 10, August 19, September 30, October 28, and November 18, 2013; January 6, March 12, April 3, May 14, July 14, August 4 and 18, and September 22, 2014.
  4. 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, and October 28, 2013; January 6, March 12, May 14, July 14, and August 4 and 18, 2014.
  5. 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, and 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, and September 22, 2014.
  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, and December 31, 2012; May 28 and October 28, 2013; January 6 and March 12, 2014.
  7. Sagent (personal communications). November 1 and 18, 2013; January 6, March 12, April 2, May 15, July 11, August 1 and 15, and September 19, 2014.
  8. Beckwith MC, Tyler LS, eds. Cancer Chemotherapy Manual. St. Louis, MO: Wolters Kluwer Health Inc. 2010.
  9. Antineoplastic agents. In: McEvoy GK, ed. AHFS 2010 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2010: 902-1260.
  10. Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. September 2010.

Updated

Updated September 23, 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.

Disclaimer

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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