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Carboplatin Solution for Injection

[15 May 2015]

Products Affected - Description

Carboplatin solution for injection, 10 mg/mL, Fresenius Kabi
15 mL multi-dose vial, single count, (NDC 63323-0172-15)
 
Carboplatin solution for injection, 10 mg/mL, Mylan Institutional
5 mL multi-dose vial, single count (NDC 67457-0491-54)
15 mL multi-dose vial, single count (NDC 67457-0492-15)
45 mL multi-dose vial, single count (NDC 67457-0493-46)
60 mL multi-dose vial, single count (NDC 67457-0494-61)
 
Carboplatin solution for injection, 10 mg/mL, Sandoz
5 mL multi-dose vial, single count (NDC 66758-0047-01)
15 mL multi-dose vial, single count (NDC 66758-0047-02)
45 mL multi-dose vial, single count (NDC 66758-0047-03)
60 mL multi-dose vial, single count (NDC 66758-0047-04)

Carboplatin solution for injection, 10 mg/mL, Teva
15 mL multi-dose vial, single count (NDC 00703-4246-01)

Reason for the Shortage

  • Bedford discontinued carboplatin in May, 2011 to concentrate on the manufacturing of other products.1
  • Fresenius Kabi has carboplatin on shortage due to increased demand for the product.2
  • Hospira has carboplatin injection available.3
  • Mylan Institutional cannot provide a reason for the shortage.4
  • Sagent has carboplatin injection available.5
  • Sandoz has carboplatin on shortage due to manufacturing delays.6
  • Teva has carboplatin injection on short-term back order due to standard quality inspections.7

Available Products

Carboplatin solution for injection, 10 mg/mL, Fresenius Kabi
5 mL multi-dose vial, single count (NDC 63323-0172-05)
45 mL multi-dose vial, single count (NDC 63323-0172-45)
60 mL multi-dose vial, single count (NDC 63323-0172-60)

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

Estimated Resupply Dates

  • Fresenius Kabi has carboplatin 15 mL vials on back order and the company cannot estimate a release date.2
  • Mylan Institutional has all carboplatin injection on back order and the company cannot estimate a release date.4
  • Sandoz has temporarily discontinued all carboplatin presentations, and the company does not plan to release product until 2016.6
  • Teva has carboplatin 15 mL vials on back order and the company estimates a release date of late-May 2015.7

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 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.

Safety

  • 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

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. 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, 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, and May 13, 2015.
  3. Hospira (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, and 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, and May 15, 2015.
  4. Mylan Institutional (personal communications). November 3 and 21, December 31, 2014; January 30, March 9, April 6, and May 14, 2015.
  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, and May 14, 2015.
  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; January 30, 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, and 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, and May 13, 2015.
  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. March 2015.
  10. Lexi-Drugs Online. Lexi-Comp, Inc.; 2015.

Updated

Updated May 15, 2015 by Michelle Wheeler, PharmD, Drug Information Specialist. Created September 10, 2010, by Michelle M. Wheeler, PharmD, and M. Christina Beckwith, PharmD, Drug Information Specialists. Copyright 2015, 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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