American Society of Hematology

Drug Shortages Update: BiCNU Injection Shortage Resolved for Now; Manufacturers Releasing More Cytarabine and Bleomycin; and Leucovorin Supplies Imported

Published on: June 23, 2011

In the past year, shortages of drugs used to treat patients with hematologic malignancies, including leukemia and lymphoma, have become critical and life-threatening. ASH members have reported severe shortages of BiCNU (Carmustine), Bleomycin injection, Cytarabine (ARA-C), Daunorubicin, Leucovorin, and Thiotepa. ASH has taken several steps to resolve these drug shortages, including alerting and working with the Food & Drug Administration and Congress. The following is an update on the status of hematologic drug shortages, how ASH has responded to drug shortages, and resources for physicians dealing with shortages.

Status of Hematologic Drug Shortages (updated: 6/30/11)

ASH has been notified that the BICNU (Carmustine) injection shortage is resolved; manufacturers of Cytarabine and Bleomycin are able to distribute small amounts of the therapies although supplies are still limited; the Daunorubicin shortage continues, and the FDA is working with overseas suppliers of Thiotepa and Leucovorin to temporarily import the drugs into the U.S. For more information regarding these drugs, please refer to the chart below.

Drug NameCompany
Information
Reason for ShortageRelated Information

BICNU (carmustine) Injection, Bristol-Myers Squibb
(100 mg, NDC 00015-3012-60) 

Updated: 5/23/2011

Bristol-Myers Squibb
1-800-332-2056
Manufacturing delays at contract manufacturerBristol-Myers Squibb is now releasing BICNU injection.

Bleomycin Injection

Updated 6/20/2011

APP
1-888-386-1300
15 unit vial (NDC 63323-0136-10), 30 unit vial (NDC 63323-0137-20)
Increased demandAPP has Bleomycin 15 units and 30 units presentations on back order. The 15 unit is estimated to release mid-July and 30 unit is estimated to release early-August.
Teva Pharmaceuticals
1-800-545-8800
Manufacturing delaysTeva has bleomycin 15 unit and 30 unit vials on back order and anticipates release by end of August 2011.
Bedford
1-800-562-4797
15 unit vial (NDC 55390-0005-01), 30 unit vial (NDC 55390-0006-01)
Product discontinuedBedford currently has all presentations discontinued.
Hospira
1-877-946-7747
15 unit vial (NDC 61703-0332-18)
30 unit vial (NDC 61703-0323-22)
Higher than anticipated market demandProduct 15 unit vial (NDC 61703-332-18):  releases received weeks of June 6 and June 13, however, supply is tight and being managed through allocation from Hospira direct.  Next delivery expected in August.

Product 30 unit vial (NDC 61703-323-22):  releases received weeks of June 6 and June 13, however, supply is tight and being managed through allocation from Hospira direct.  Next delivery expected in July.

Cytarabine injection (powder for reconstitution)

(Solution)

Updated: 6/16/2011

Bedford Customer Service
1-800-562-4797
100 mg vial (NDC 55390-0131-10)
500 mg vial (NDC 55390-0132-10)
1 gram vial (NDC 55390-0133-01)
2 gram vial (NDC 55390-0134-01)
Manufacturing delays

 

Bedford has cytarabine 1 gram vials on intermittent back order and the company is releasing product as it becomes available. All other cytarabine presentations are on back order and the company cannot estimate a release date. 

APP
1-888-386-1300
100 mg/mL, 20 mL vial (NDC 63323-0120-20)
Manufacturing delaysLimited supplies available - please see Dear Healthcare Professional Letter (PDF - 43KB) for important information. APP has been able to increase production to help address the shortage and estimates additional supplies to be released by end of April.
Hospira Inc. 1-877-946-7747 20 mg/mL; 50 mL PBP (NDC 61703-303-46), 20 mg/mL; 25 mL (NDC 61703-304-36), 20 mg/mL; 5 mL (NDC 61703-305-38), 100 mg/mL 20 mL (NDC 61703-319-22) Higher than anticipated market demandProducts 20mg/ml; 50 mL PBP (NDC 61703-303-46): next release in June.

Product 20 mg/mL; 5 mL (NDC 61703-305-38) and 20 mg/mL; 25mL (NDC 61703-304-36): next release in July.

Product 100 mg/mL; 20 mL (NDC 61703-319-22): available now with next release in June.

Please check with your wholesaler for available inventory. Dear Healthcare Professional Letter (PDF - 75KB)

Daunorubicin hydrochloride solution for injection 

Updated: 5/10/2011

Teva Pharmaceuticals
1-800-545-8800

5 mg/mL, 4 mL single-dose vial (NDC 00703-5233-13)] 
Manufacturing issuesTeva has daunorubicin solution for injection on back order and estimates a release date of August, 2011.
Bedford Customer Service
1-800-562-4797

5 mg/mL, 4 mL single-dose vial (NDC 55390-0108-10), 10 mL single-dose vial (NDC 55390-0108-01) Cerubidine lyophilized powder for injection, 20 mg single-dose vial, package of 10 (NDC 55390-0281-10)
Manufacturing delaysBedford will release 20 mg lyophilized powder for injection in early May. Bedford will release daunorubicin solution for injection, 20 mg and 50 mg, in the next 3-months.

DOXIL (doxorubicin HCl liposome injection)

Updated:  6/22/11

Centocor Ortho Biotech Services, LLC
1-800-526-7736
N/A

Dear Healthcare Provider Letter
Additional information Regarding DOXIL can be found at www.DOXIL.com.

Doxorubicin Solution for Injection

Updated: 6/29/2011

APP
1-888-386-1300
APP Product Availability Information
Increased demandAPP is releasing the 2mg/ml 100 ml vials (NDC 63323-0101-61), the 2mg/ml 25 ml vials (NDC 63323-0883-30), and the 2mg/ml 5 ml vials (NDC 63323-0883-05) as it becomes available.
Teva Pharmaceuticals
1-800-545-8800
Manufacturing delaysTeva is releasing all strengths on allocation: Doxorubicin solution for injection, 2 mg/mL 5 mL vial (NDC 00703-5043-03) 25 mL vial (NDC 00703-5046-01) 100 mL vial (NDC 00703-5040-01).
Bedford
1-800-562-4797
Manufacturing delaysBedford anticipates release of the 50mg presentation in the next 3months and release of the 10 mg, 25 mg, and 100 mg solutions in the next 6-months.
Pfizer Injectables
1-800-533-4535
http://www.pfizerinjectables.com/
Pfizer has product availablePfizer Injectables has available vials of 10mg/5mL (NDC 0069-3030-20), 20mg/10mL (NDC 0069-3031-20), 50mg/25mL (NDC 0069-3032-20), 150mg/75mL (NDC 0069-3033-20), 200mg/100mL (NDC 0069-3034-20).

Leucovorin Calcium Lyophilized Powder for Injection

Updated:  6/20/11

Bedford Laboratories
Customer Service
1-800-562-4797
Manufacturing delays

 

Bedford anticipates releasing the 50mg lyophilized product ((NDC 55390-0051-10)  at the end of July and the 100mg lyophilized product (NDC 55390-0052-10) ) mid-June, 2011.  The 200mg (NDC 55390-0053-01) and 350mg lyophilized product (NDC 55390-0054-10)  will be released mid June, 2011.  The 500mg solution (NDC 55390-0009-01) will be released at the end of July, 2011.

Teva Pharmaceuticals
1-800-545-8800
Manufacturing delaysTeva, in conjunction with the FDA, is initiating a temporary importation of Leucovorin Calcium Folinate Solution for Injection, to the United States market to address the current shortage.
See Dear Healthcare Professional letter (PDF 692KB) for additional information.
APP Pharmaceuticals
1-888-386-1300
APP has recently launched their leucovorin injection in response to the ongoing shortage.APP is currently back-ordered. Initial supplies are limited, however APP is continuing to produce and release leucovorin calcium lyophilized powder for injection (NDC# 63323-710-50 for the 200mg SDV and NDC# 63323-711-00 for the 500mg SDV).

ONTAK (Denileukin Diftitox)

Updated:  6/29/11

Eisai
Eisai Medical Services:  1-888-422-4743
Manufacturing delays

Eisai is unable to estimate the length of the supply interruption at this time. Updates regarding product availability will be posted on http://www.ONTAK.com.

Please see Dear Healthcare Professional Letter for important information.

Thiotepa for Injection, Bedford
15 mg/mL vial (NDC 55390-0030-10)

Updated 6/21/2011

Bedford Laboratories Customer Service 1-800-562-4797

15 mg/mL vial (NDC 55390-0030-10)

Manufacturing delaysBedford anticipates release within the next three months.

Adienne

 Adienne, in conjunction with the FDA, is initiating a temporary importation of Thiotepa for injection, to the United States market. Please see the Dear Healthcare Professional Letter (PDF - 1MB) for information about emergency supplies that are now available to help address the shortage.

ASH Responds to Drug Shortages

ASH has taken the following steps to provide our membership and patients they serve with the most up-to-date information to assist them during this critical time while working with policymakers on possible solutions:

  1. Contacted specific drug companies to obtain information about the drugs in short supply, specifically what is causing the delays and when the drugs will become available. Information about specific drug shortages will be posted to the ASH website as it becomes available.
  2. Alerted the Food and Drug Administration (FDA) to the hematology/oncology drug shortages and requested an official response to the matter.
  3. Worked with Senator Amy Klobuchar's office regarding S. 296, The Preserving Access to Life-Saving Medications Act, legislation that would provide the Food and Drug Administration (FDA) with tools to help address and prevent future medication shortages. In addition, ASH also worked with Representative Diana DeGette’s office prior to the recent introduction of similar legislation in the House of Representatives, but not identical to S. 296H.R. 2245, The Preserving Access to Life-Saving Medications Act. Unlike the Senate bill, H.R. 2245 requires notification of shortages of all biological products, sets specific fines for non-compliance with reporting requirements, and authorizes a General Accountability Office study to examine the causes behind drug shortages.
  4. Notified congressional committees of the problem and requested a hearing on this issue.
  5. Developed an advocacy campaign to encourage congressional support of S. 296. ASH encourages all physicians to use the ASH Advocacy Center to contact their Senators about this issue and its impact on patients. Additionally, ASH has created a special patient advocacy campaign that physicians can share with patients. Through the campaign, patients can contact their Senators with a letter that they can personalize about how the drug shortage problem has affected them.

Additional Resources:

back to top