Products Affected - Description

Reason for the Shortage

• APP had paclitaxel on shortage due to increase demand for the product.¹
• Bedford has paclitaxel on shortage due to manufacturing delays. Bedford anticipates full availability of each presentation the company reintroduces to market.^2,3
• Ben Venue voluntarily entered into a consent decree with FDA in late-January 2013 which allows Ben Venue to manufacture over 100 medications as long as they are compliant with the decree. Ben Venue supplies multiple products for Bedford Laboratories, a division of Ben Venue.
• Teva had paclitaxel on shortage due to manufacturing delays.⁴
• Sandoz has paclitaxel on back order due to a raw material shortage.⁵
• Hospira has paclitaxel on back order due to increased demand for the product.^6,7
• Sagent had paclitaxel on shortage, but could not provide a reason for the shortage.⁸
• Pfizer launched paclitaxel 100 mg and 300 mg vials in March, 2012 and launched the 30 mg vials in April, 2012.⁹

Available Products

Estimated Resupply Dates

• Bedford has all paclitaxel 6 mg/mL injections on back order and the company cannot estimate a release date. Paclitaxel is pending release once manufacturing and distribution resumes.^2,3
• Hospira has paclitaxel 100 mg 16.7 mL vials on back order with an estimated release date of June 2013.
• Sandoz has paclitaxel 30 mg 5 mL and 300 mg 50 mL on back order and the company cannot estimate a release date.⁷
  

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.^10-12
• 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.^10-12
• Paclitaxel is used off-label in children for treatment of refractory leukemia and recurrent Wilms tumor.^10-12

Safety

• Chemotherapy agents, such as paclitaxel, pose additional safety risks both for patients and for healthcare workers handling these agents.^10,11
• 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).^10,11

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.^10,11
• 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

• Asparaginase Injection— No Longer Available
• Bendamustine Injection— Resolved
• Bleomycin Injection— Resolved
• Busulfan— Resolved
• Capecitabine Tablets— Resolved
• Carboplatin Solution for Injection
• Carmustine Injection— Resolved
• Cisplatin Injection— Resolved
• Cyclophosphamide Injection— Resolved
• Cytarabine Injection
• Dacarbazine Injection
• Daunorubicin Hydrochloride Injection
• Denileukin Diftitox Injection
• Doxorubicin Injection
• Doxorubicin Liposomal Injection
• Etoposide Injection— Resolved
• Fludarabine Injection
• Fluorouracil Injection
• Gemtuzumab Ozogamicin Injection— No Longer Available
• Idarubicin Hydrochloride Injection— Resolved
• Interferon Alpha-2b, Intron A— Resolved
• Irinotecan Injection— Resolved
• Leuprolide Acetate 14-Day Kit
• Lomustine Capsules
• Mercaptopurine Tablets
• Methotrexate Injection
• Methotrexate Tablets
• Mitomycin Injection
• Pentostatin Injection
• Streptozocin For Injection— Resolved
• Thiotepa for Injection
• Tretinoin Oral Capsules— Resolved
• Vinblastine Injection
• Vincristine Injection— Resolved

1. APP (personal communications). May 13, and June 8 and 23, July 28, August 23, September 7 and 19, October 5, November 8 and 30, and 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, and December 12 and 19, 2012; January 6 and 23, February 6 and 26, March 6, April 3, and May 2, 2013.
2. Bedford (personal communications). May 13, June 23 and 29, July 5 and 13, August 10 and 25, September 15 and 20, October 6, November 7, and December 1, 2011.
3. Bedford (website). December 22, 2011; January 23, February 17, March 2, April 13, May 15, June 13, July 11, August 20, September 25, October 10, November 5 and 12, and December 10 and 19, 2012; January 3, February 26, and April 3, and 29, 2013.
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, and 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 and February 26, and May 9, 2013. 
5. Hospira (personal communications). May 13, June 16 and 28, July 12, August 8, September 5 and 15, October 3, November 30, and 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, and October 10 and 17, 2012; January 3 and 23, February 6 and 20, and April 3 and 29, 2013.
7. Sandoz (personal communications). May 16, June 20, July 14, August 4 and 24, September 6 and 20, November 30, and December 21, 2011; January 23, February 29, March 12, April 18, May 15, July 10 and 30, August 20, November 14, and December 10, 2012; January 3, February 26, and April 3, and May 7, 2013.
8. Sagent (personal communications). October 4, November 9 and 30, and 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, and November 5, 2012; January 3, February 25, and April 3, 2013 and May 7, 2013.
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, and December 12, 2012; February 25, and April 3, and May 2, 2013. 
10. Beckwith MC, Tyler LS, eds. Cancer Chemotherapy Manual. St. Louis, MO: Wolters Kluwer Health Inc. 2010.
11. Antineoplastic agents. In: McEvoy GK, ed. AHFS 2010 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2010: 902-1260.
12. Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. April 2011.

Updated

Updated May 9, 2013 by David M. Peterson, PharmD, Drug Information Specialist. Created May 13, 2011, by Michelle Wheeler, PharmD, and M. Christina Beckwith, PharmD, Drug Information Specialists. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.