Products Affected - Description

Mustargen, Lundbeck Inc.  

Reason for the Shortage

Lundbeck states the reason for the shortage was a change in manufacturing site. There are no other manufacturers of mechlorethamine injection.¹ Lundbeck sent a Dear Healthcare Professional letter regarding the Mustargen shortage.

Available Products

Mustargen, 10 mg vial, package of 4, NDC 67386-0911-51, Lundbeck Inc.

Estimated Resupply Dates

Lundbeck has Mustargen 10 mg vials available.¹

Implications for Patient Care

• Mechlorethamine is an antineoplastic alkylating agent. It is labeled for use as a single agent or in combination with other antineoplastic agents for the treatment of Hodgkin disease stage III and IV (palliative), lymphosarcoma, chronic myelocytic or chronic lymphocytic leukemia, mycosis fungoides, bronchogenic carcinoma, and polycythemia vera. It is also administered intracavitary for palliative treatment of metastatic carcinoma resulting in effusion.^2-4
• Mechlorethamine is used off-label for a variety of neoplastic diseases including topical treatment of mycosis fungoides. It has also been used for non-Hodgkin lymphoma and in children for the treatment of advanced Hodgkin disease or brain tumors.^2-4
• Mechlorethamine is typically used in combination with other antineoplastic agents.^2-4

Safety

• Chemotherapy agents, such as mechlorethamine, pose additional safety risks both for patients and for healthcare workers handling these agents.^2,3
• 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).^2,3

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 mechlorethamine.^2-4
• Consider evaluating the health-care system’s total supply of mechlorethamine before beginning patients on combination chemotherapy regimens containing mechlorethamine. 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

• Alcohol Dehydrated Injection (Ethanol)
• Allopurinol Injection
• Amifostine Injection
• Azathioprine Injection
• Colchicine Tablets— Resolved
• Dexrazoxane Injection
• Drotrecogin Alfa (Activated) Injection— No Longer Available
• Foscarnet Injection— Resolved
• Leucovorin Calcium Injection
• Levocarnitine Injection
• Metyrosine Capsules
• Octreotide Injection
• Sodium Fluoride Oral Drops— Resolved
• Surgical Lubricant— Resolved
• Trace Elements Injection
• Zinc Injection

1. Lundbeck (personal communications). November 24 and December 22, 2009; January 4, February 8, March 1, April 13, 20, 27, May 10 and 28, June 23, July 19, August 12, September 1, 14, and 27 November 24, 2010; January 11, February 16, April 12, June 10, August 2, and October 5, 2011; January 3, March 30, June 15, July 25, August 29, September 24, October 19, and November 5, 2012.
2. Beckwith MC, Tyler LS, eds. Cancer Chemotherapy Manual. St. Louis, MO: Wolters Kluwer Health Inc. 2010.
3. Antineoplastic agents. In: McEvoy GK, ed. AHFS 2010 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2010: 902-1260.
4. Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. September 2010.

Updated

Updated November 5, 2012 by Jane Chandramouli, PharmD, Drug Information Specialist. Created September 8, 2010 by Leslie Jensen, PharmD and M. Christina Beckwith, PharmD, Drug Information Specialists, Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.