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Methotrexate Injection

[26 March 2015]

Products Affected - Description

Methotrexate 25 mg/mL injection, Mylan Institutional
2 mL vial, preservative-free (NDC 67457-0467-99)
4 mL vial, preservative-free (NDC 67457-0486-99)
8 mL vial, preservative-free (NDC 67457-0485-99)
10 mL vial, preservative-free (NDC 67457-0466-10)
40 mL vial, preservative-free (NDC 67457-0480-40)


Methotrexate 25 mg/mL injection, Sandoz
2 mL vial, preservative-free (NDC 66758-0040-02)
10 mL vial, preservative-free (NDC 66758-0040-08)

Reason for the Shortage

  • Mylan Institutional cannot provide a reason for the shortage.
  • Sandoz states the reason for the shortage is manufacturing delay.
  • West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired several products from Bedford Laboratories in July 2014 including methotrexate injection. West-Ward is not actively marketing methotrexate injection.

Available Products

Methotrexate 25 mg/mL injection, Accord Healthcare
2 mL vial, preservative-free (NDC 16729-0277-30)
10 mL vial, preservative-free (NDC 16729-0277-03)
40 mL preservative-free vial (NDC 16729-0277-35)

Methotrexate 25 mg/mL (with preservative), Fresenius Kabi
10 mL (with preservative) vial (NDC 63323-0123-10)


Methotrexate lyophilized powder for injection, Fresenius Kabi
1 gram vial (NDC 63323-0122-50)


Methotrexate 25 mg/mL injection, Hospira
2 mL (with preservative) vial (NDC 61703-0350-38)
40 mL preservative-free vial (NDC 61703-0408-41)


Methotrexate 25 mg/mL injection, Sandoz
40 mL vial, preservative-free (NDC 66758-0041-01)


Methotrexate 25 mg/mL injection, Teva
2 mL vial, preservative-free, package of 10 (NDC 00703-3671-03)
10 mL vial, preservative-free (NDC 00703-3675-01)
40 mL vial, preservative-free (NDC 00703-3678-01)

Otrexup subcutaneous injection, Antares Pharm, Inc.
10 mg/0.4 mL auto-injector, 4 count (NDC 54436-0010-04)
15 mg/0.4 mL auto-injector, 4 count (NDC 54436-0015-04)
20 mg/0.4 mL auto-injector, 4 count (NDC 54436-0020-04)
25 mg/0.4 mL auto-injector, 4 count (NDC 54436-0025-04)

Estimated Resupply Dates

  • Mylan Institutional has all methotrexate presentations on back order and the company cannot estimate a release date.
  • Sandoz has methotrexate 25 mg/mL 2 mL and 10 mL vials are temporarily unavailable and the company does not expect product in 2015.

Implications for Patient Care

  • Methotrexate is a folic acid antimetabolite. It is labeled for both adults and children for the treatment of osteosarcoma, acute lymphoid leukemia, and lung cancer. It is labeled for use in adults in the treatment of gestational trophoblastic tumors, meningeal leukemia, breast cancer, head and neck cancer, advanced mycosis fungoides, and advanced non-Hodgkin lymphomas. It is also labeled for treatment of psoriasis and rheumatoid arthritis. It is also labeled in children for treatment of polyarticular-course juvenile rheumatoid arthritis.12-14
  • Methotrexate is used off-label for a variety of neoplastic diseases not limited to testicular carcinoma, bladder cancer, gastrointestinal cancer, and soft tissue sarcomas. It is also used off-label for nonneoplastic not limited to the prevention of graft versus host disease, ectopic pregnancy, systemic lupus erythematosus, and Crohn disease.12-14
  • Otrexup is a subcutaneous auto-injection labeled for use in adults with severe rheumatoid arthritis or psoriasis, and for use in children with polyarticular juvenile arthritis.11
  • Methotrexate can be used alone or in combination with other antineoplastic agents.12-14

Safety

  • Chemotherapy agents, such as methotrexate, pose additional safety risks both for patients and for healthcare workers handling these agents.12,13
  • 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).12,13

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 methotrexate.12-14
  • Reserve preservative-free methotrexate for intrathecal doses.
  • Consider reserving methotrexate injection for oncology indications.
  • Use oral methotrexate whenever possible for non-oncology indications.
  • Consider evaluating the health-care system’s total supply of methotrexate before beginning patients on combination chemotherapy regimens containing methotrexate. If adequate supplies are not available, select an alternative regimen.
  • Consult a Hematology/Oncology specialist for patient- and neoplasm-specific recommendations and other specialists for non-oncology uses.
  • 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, USA (personal communications). November 18, December 17, 2010; February 16, March 1, April 4, June 7, July 13, August 3 and 23, September 16, October 28, November 28, 2011; February 6, 21, and 29, March 9 and 26, April 18, May 23, June 18, July 30, August 27, October 2, and December 12, 2012; and January 14 and 28, February 28, April 1, May 29, June 18, July 16, September 9, November 7 and 19, and December 9 and 16, 2013; and January 18, February 5 and 28, March 28, April 30, May 12 and 30, June 3 and 17, July 1, August 1, September 2 and 16, October 23, November 19, December 7 and 22, 2014; January 26, February 11 and 18, and March 9, 2015.
  2. Bedford (personal communications). November 19, December 15, 2010; February 15, March 1, April 4, June 7 and 23, July 12 and 20, August 3, 10, and 25, September 2 and 14, October 24, November 28, 2011; February 6 , 15, and 28, March 12 and 22, April 13 and 20, May 21, June 18, July 13, September 25, and December 12 and 17, 2012; and January 18 and 29, March 4 and 28, May 29, June 18, July 16, September 9, October 21, and December 9 and 17, 2013; and January 21, February 5 and 26, March 31, April 14, May 12 and 27, June 16 and 25, and August 1, 2014.
  3. Hospira (personal communications). November 18, December 14, 2010; February 14, March 1, April 5, June 6 and 21, July 12 and 18, August 2, 8, 23, and 31, September 13, October 12 and 27, November 7 and 29, 2011; February 6,12, 21, and 27, March 12 and 26, April 12 and 23, May 24, June 18, July 13 and 30,August 27, October 1, and December 12, 2012; January 4,16, and 28, March 4, April 1, May 29, June 18, July 16, September 9, November 4, and December 9 and 20, 2013; and January 22, March 3 and 31, April 29, May 12, June 5 and 19, July 2, August 1, September 3, 16, and 23, October 23, November 19, and December 1 10, and 22, 2014; February 10, 2015.
  4. Mylan Institutional (personal communications). August 2, 11, 23, and 31, September 14 and 27, October 12 and 28, November 8 and 23, 2011; February 8, 13, and 29, March 13, April 11 and 23, May 24, June 18, and July 13, and August 2 and 27, October 4, and December 12, 2012; January 4,17, and 28, and February 13, March 4, April 3, May 28, June 18, July 16, September 9, November 6, and December 9 and 12, 2013; and January 22, March 3 and 20, April 2 and 29, May 14 and 19, June 2, 19, and 30, August 1, September 3 and 18, October 23, November 20, December 1, 10, and 22, 2014; January 26 and March 11, 2015.
  5. Sandoz (personal communications). November 18, December 14, 2010; February 14, March 1, April 6, June 7, August 3 and 24, September 13, October 27, November 30, December 5, 2011; February 7, 13, 16, 23, and 29, March 13, April 12 and 23, May 22, June 18, July 31, August 27, October 1, December 12 and 18, 2012; January 3 and 28, April 1, May 21, June 18, September 9, October 30, and December 9, 2013; and January 22, March 3 and 20, May 14, June 2, July 2, September 3, November 20, and December 3, 2014; February 11, 2015.
  6. Bioniche (personal communications). November 19, December 16, 2010; February 16, March 1, April 7, and June 7 and 30, 2011.
  7. Pfizer (personal communications). October 10 and December 12, 2012; and January 28, March 4 and 29, May 24, June 18, July 16, September 9, and December 9, 2013.
  8. Teva (personal communications). August 1 and 27, October 1, and December 12, 2012; and January 28 May 13, June 19, July 16, September 9, November 1, and December 9, 2013; and January 23, February 5, March 3, April 2, May 12, June 19, August 1, September 3 and 16, October 27, December 10 and 22, 2014; January 26, February 12, and March 11, 2015.
  9. Accord Healthcare (personal communications). April 30, May 14, June 2, September 16, and October 23, 2014.
  10. West-Ward (personal communications). August 1 and 5, and October 23, 2014; February 11, 2015.
  11. Antares Pharm, Inc. (personal communication). August 12, September 15, October 23, and December 22, 2014; February 11, 2015. 
  12. Beckwith MC, Tyler LS, eds. Cancer Chemotherapy Manual. St. Louis, MO: Wolters Kluwer Health Inc. 2012.
  13. Antineoplastic agents. In: McEvoy GK, ed. AHFS 2010 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2011: 905-1276.
  14. Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. February, 2012.

Updated

March 11 and 26, February 11 and 18, January 26, 2015; December 3, 12, and 22, November 20, October 29, September 5, 18, and 24, August 1 and 13, July 2, June 5 and 19, May 14 and 22, April 3 and 30, March 3 and 20, February 6, and January 24, 2014; December 9 and 20, November 6 and 19, September 12, July 16, June 19, May 30, April 3, March 4, February 13, and January 4, 18, and 30, 2013; December 12 and 18, October 4 and 11, August 2 and 27, July 13, June 21, May 24, April 13 and 23, March 13 and 26, February 8, 10, 13,14,16, 22, 24, and 29, 2012. University of Utah, Drug Information Service. 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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