Last Updated: February 7, 2013
Products Affected - Description
10,000 units, 10 mL vial (NDC 67386-0411-51) - discontinued
Reason for the Shortage
- Lundbeck discontinued the sale of Elspar in December 2012.1,2
- Lundbeck states the decision to discontinue Elspar was a business decision.2
- Lundbeck recommends that remaining product be allocated for human use and current patients finish treatment protocols with Elspar. Patients should consult with their healthcare provider to discuss if alternative treatment may be appropriate.2
- Asparaginase Erwinia Chrysanthemi (Erwinaze) and pegaspargase (Oncaspar) are not affected by this shortage.
- Recordati acquired several products including Elspar from Lundbeck in late 2012. However, the company made a business decision in early 2013 to discontinue Elspar and not pursue further manufacturing.3
No presentations are available.
Estimated Resupply Dates
Lundbeck discontinued Elspar in late-December 2012.1,2
Implications for Patient Care
- Elspar is an asparagine specific enzyme with labeled use as part of a multi-agent chemotherapy regimen in patients with acute lymphoblastic leukemia (ALL).4
- Potential alternatives agents include pegaspargase (Oncaspar) or asparaginase Erwinia chrysanthemi (Erwinaze). Labeled uses for these medications include:
- a) Pegaspargase is an asparagine specific enzyme labeled as part of a multi-agent chemotherapy regimen in patients with first-line ALL, or ALL and hypersensitivity to asparaginase. This product is L-asparaginase covalently conjugated to monomethoxypolyethylene glycol (mPEG). L-asparaginase is produced endogenously by E. coli.5
b) Asparaginase Erwinia chrysanthemi is an asparagine specific enzyme labeled as part of a multi-agent chemotherapeutic regimen in patients with ALL who have developed hypersensitivity to E. coli derived asparaginase.6
- Chemotherapy agents, such as asparaginase, pose additional safety risks both for patients and for healthcare workers handling these agents.7,8
- 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).7,8
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 asparaginase.7-9
- 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.
- Aldesleukin Injection — Resolved
- Bendamustine Injection — Resolved
- Bleomycin Sulfate Injection — Current
- Busulfan — Resolved
- Capecitabine Tablets — Resolved
- Carbidopa and Levodopa Extended-Release Tablets — Resolved
- Carboplatin Solution for Injection — Current
- Carmustine Injection — Resolved
- Cisplatin Injection — Current
- Cyclophosphamide Injection — Resolved
- Cyclophosphamide Tablets — No Longer Available
- Cytarabine Injection — Current
- Dacarbazine Injection — Resolved
- Dactinomycin Injection — Resolved
- Daunorubicin Hydrochloride Injection — Resolved
- Denileukin Diftitox Injection — No Longer Available — No Commercially Available Preparations
- Doxorubicin Injection — Current
- Doxorubicin Liposomal Injection — Resolved
- Etoposide Injection — Resolved
- Fludarabine Injection — Resolved
- Fluorouracil Injection — Current
- Gemtuzumab Ozogamicin Injection — No Longer Available
- Idarubicin Hydrochloride Injection — Resolved
- Interferon Alpha-2b, Intron A — Resolved
- Irinotecan Injection — Resolved
- Leuprolide Acetate 14-Day Kit — Current
- Lomustine Capsules — Resolved
- Mercaptopurine Tablets — Resolved
- Methotrexate Injection — Resolved
- Methotrexate Tablets — Resolved
- Mitomycin Injection — Resolved
- Mitoxantrone Hydrochloride Injection — Current
- Paclitaxel Injection — Resolved
- Peginterferon alfa-2b Injection — Resolved
- Pentostatin Injection — Resolved
- Streptozocin For Injection — Resolved
- Tamoxifen Tablets — Resolved
- Thiotepa for Injection — Current
- Tretinoin Oral Capsules — Current
- Vinblastine Injection — Resolved
- Vincristine Injection — Resolved
- Lundbeck (personal communications). September 5, October 15, and December 12, 2012; and January 2, 2013.
- Lundbeck. Dear Healthcare Professional Letter (customer letter). Accessed September 5, 2012.
- Recordati (personal communications) January 2, and February 6, 2013.
- Elspar (asparaginase) injection product information. Deerfield, IL; Lundbeck Inc; 2010.
- Oncaspar (pegaspargase) injection product information. Gaithersburg, MD; Sigma-Tau Pharmaceuticals, Inc; 2011.
- Erwinaze (asparaginase Erwinia chrysanthemi) injection product information. Langhorne, PA; EUSA Pharma, Inc; 2011.
- Beckwith MC, Tyler LS, eds. Cancer Chemotherapy Manual. St. Louis, MO: Wolters Kluwer Health Inc. 2012.
- Antineoplastic agents. In: McEvoy GK, ed. AHFS 2010 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2010: 902-1260.
- Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. September 2012.
Updated February 7, 2013 by Christina Bechwith, PharmD, Drug Information Specialist; January 2, 2013 by Michelle Wheeler, PharmD, Drug Information Specialist. Created 5 September, 2012 by Leslie Jensen, PharmD, Drug Information Specialist. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.