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Paclitaxel Injection

[20 August 2014]

Products Affected - Description

Paclitaxel 6 mg/mL injection, West-Ward (formerly Bedford product)
30 mg/5 mL vial (NDC 55390-0114-05)
100 mg/16.7 mL vial (NDC 55390-0114-20)
300 mg/50 mL vial (NDC 55390-0114-50)
 
Paclitaxel 6 mg/mL injection, Fresenius Kabi
30 mg/5 mL vial (NDC 63323-0763-05)
300 mg/50 mL vial (NDC 63323-0763-50)
 
Paclitaxel 6 mg/mL injection, Mylan Institutional
30 mg/5 mL vial (NDC 67457-0471-52)
30 mg/5 mL vial (NDC 00069-0079-01) - NDC discontinued
100 mg/16.7 mL vial (NDC 00069-0076-01) - NDC discontinued
300 mg/50 mL vial (NDC 00069-0078-01) - NDC discontinued

Paclitaxel 6 mg/mL injection, Sagent
30 mg/5 mL vial (NDC 25021-0213-05)
100 mg/16.7 mL vial (NDC 25021-0213-07)
300 mg/50 mL vial (NDC 25021-0213-50)
 
Paclitaxel 6 mg/mL injection, Sandoz
30 mg/5 mL vial (NDC 66578-0043-01)
100 mg/16.7 mL vial (NDC 66578-0043-02)
300 mg/50 mL vial (NDC 66578-0043-03)
 
Paclitaxel 6 mg/mL injection, Teva
30 mg/5 mL vial (NDC 00703-4764-01)
100 mg/16.7 mL vial (NDC 00703-4766-01)
150 mg/25 mL vial (NDC 00703-4767-01)
300 mg/50 mL vial (NDC 00703-4768-01)

Reason for the Shortage

  • Fresenius Kabi (formerly APP) has paclitaxel on shortage due to increase demand for the product.1
  • West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired paclitaxel injection from Bedford in July 2014. West-Ward is not actively marketing paclitaxel.2,3
  • Teva has paclitaxel on shortage due to manufacturing delays.4
  • Sandoz has paclitaxel on back order due to a raw material shortage.5
  • Hospira had paclitaxel on shortage due to increased demand.6,7
  • Sagent has paclitaxel on shortage due to increased demand.8
  • Pfizer launched paclitaxel 100 mg and 300 mg vials in March, 2012 and launched the 30 mg vials in April, 2012.9
  • Mylan Institutional acquired paclitaxel injection from Pfizer on December 7, 2013.9,10

Available Products

Paclitaxel 6 mg/mL injection, Fresenius Kabi
100 mg/16.7 mL vial (NDC 63323-0763-16)
 
Paclitaxel 6 mg/mL injection, Hospira
30 mg/5 mL vial (NDC 61703-0342-09)
100 mg/16.7 mL vial (NDC 61703-0342-22)
300 mg/50 mL vial (NDC 61703-0342-50)
 
Paclitaxel 6 mg/mL injection, Mylan Institutional
100 mg/16.7 mL vial (NDC 67457-0449-17)
300 mg/50 mL vial (NDC 67457-0434-51)

Estimated Resupply Dates

  • Fresenius Kabi has paclitaxel 300 mg/50 mL vials on allocation. The 30 mg/5 mL vials are on back order and the company estimates a release date of mid-September 2014.1
  • Mylan Institutional has paclitaxel 30 mg/5mL vials on back order and the company estimates release date of mid-to-late August 2014.10
  • Sagent has all three paclitaxel presentations on allocation.8
  • Sandoz has all paclitaxel presentations temporarily unavailable and the company cannot estimate when product will be available again.7
  • Teva has all four paclitaxel presentations on allocation.4
  • West-Ward is not actively marketing paclitaxel.3

Implications for Patient Care

  • Paclitaxel is a mitotic inhibitor. It is labeled as a single agent or as adjuvant therapy in treatment of ovarian cancer and breast cancer, as combination therapy for non-small cell lung cancer, and as a single agent for the treatment of Kaposi sarcoma related to AIDS in adults.11-13
  • Paclitaxel is used off-label in adults for treatment of bladder, prostate, and testicular cancers, esophageal cancer, endometrial and cervical cancer, squamous cell head and neck cancer, small cell lung cancer, gastric cancer, and germ cell tumors.11-13
  • Paclitaxel is used off-label in children for treatment of refractory leukemia and recurrent Wilms tumor.11-13

Safety

  • Chemotherapy agents, such as paclitaxel, pose additional safety risks both for patients and for healthcare workers handling these agents.11,12
  • 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).11,12

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 paclitaxel.11,12
  • Consider evaluating the health-care system’s total supply of paclitaxel before beginning patients on combination chemotherapy regimens containing paclitaxel. 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. Fresenius Kabi (personal communications). May 13, June 8 and 23, July 28, August 23, September 7 and 19, October 5, November 8 and 30, December 20, 2011; January 24, February 14, March 2, April 17, May 15, June 13, July 9, August 2 and 20, September 4 and 25, October 10 and 15, November 5, 12, and 28, December 12 and 19, 2012; January 6 and 23, February 6 and 26, March 6, April 3, May 2, June 28, July 18, August 6, 19, and 30, September 12, October 7, November 1, 11 and 18, December 5, 2013; January 16, February 10, April 11, May 6, June 2, 10, and 27, July 14 and 25, and August 14, 2014.
  2. Bedford (personal communications). May 13, June 23 and 29, July 5 and 13, August 10 and 25, and September 15 and 20, October 6, November 7, and December 1, 2011.
  3. West-Ward (personal communications). July 25 and August 5, 2014.
  4. Teva (personal communications). May 13 and 26, June 27, July 1 and 28, August 3, 9, and 26, September 7 and 13, October 4, November 9 and 30, December 22, 2011; January 24, February 15, March 1 and 12, April 17, May 17, June 13, July 13, and November 16, 2012; January 3, February 26, May 9, July 3, August 19 and 29, September 13, October 18, December 6, 2013; January 15, April 14, June 10, and August 19, 2014.
  5. Hospira (personal communications). May 13, June 16 and 28, July 12, August 8, September 5 and 15, October 3, November 30, December 20, 2011; January 26, February 13 and 27, March 12, April 17, May 15, June 13, July 11 and 30, September 4 and 18, November 7, 12, and 28, and December 10 and 19, 2012.
  6. Hospira (website). July 28 and August 23, 2011; August 21, October 10 and 17, 2012; January 3 and 23, February 6 and 20, April 3 and 29, July 3 and 15, August 6, 19, and 30, September 13, October 7 and 28, November 18, December 5, 2013; January 16, February 10, April 14, May 8, June 2, 5, 13, 16, and 30, July 14, 23, and 29, and August 19, 2014.
  7. Sandoz (personal communications). May 16, June 20, July 14, August 4 and 24, September 6 and 20, November 30, December 21, 2011; January 23, February 29, March 12, April 18, May 15, July 10 and 30, August 20, November 14, December 10, 2012; January 3, February 26, April 3, May 7, July 1, July 15, August 19, September 13, October 7, December 5, 2013; February 10 and April 14, 2014.
  8. Sagent (personal communications). October 4, November 9 and 30, December 22, 2011; February 15 and 29, March 12, April 17 and 30, May 7, 15, and 21, June 4, July 9 and 30, August 20, September 20, October 10, November 5, 2012; January 3, February 25, April 3, May 7, June 27, July 16, August 19 and 30, September 12, October 7, November 1 and 13, December 6, 2013; January 16, February 10, 20 and 27, April 9, May 7, June 2, 13, and 27, July 14 and 25, and August 15, 2014.
  9. Pfizer (personal communications). October 3, 2011; January 23, March 1 and 15, April 17, May 15, July 10 and 26, August 20, September 26, December 12, 2012; February 25, April 3, May 2, June 28, July 12, August 16 and 23, September 6, October 7 and 28, November 11 and 15, and December 6, 2013.
  10. Mylan Institutional (personal communications). December 6 and 12, 2013; January 16, February 10, April 14, June 10, July 14, and August 13, 2014.
  11. Beckwith MC, Tyler LS, eds. Cancer Chemotherapy Manual. St. Louis, MO: Wolters Kluwer Health Inc. 2010.
  12. Antineoplastic agents. In: McEvoy GK, ed. AHFS 2010 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2010: 902-1260.
  13. Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. April 2011.

Updated

Updated August 20, 2014 by Jane Chandramouli, PharmD, Drug Information Specialist. Created May 13, 2011, by Michelle 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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