Dear Healthcare Professional,

Due to the current critical shortage of Methotrexate Injection, USP 1g/40mL (25 mg/mL) (Preservative-Free) in the United States (US) market, Hospira, Inc. is coordinating with the Food and Drug Administration (FDA) to increase the availability of the drug.

To alleviate the shortage, Hospira, Inc. has initiated temporary importation into the US market of a non-US-approved product, Methotrexate Injection, USP 1g/40mL (25 mg/mL) (Preservative Free) from Hospira Healthcare Corporation, Canada. The Canadian-approved Methotrexate Injection, USP 1 g/40 mL (25 mg/mL) (Preservative-Free) contains the same active ingredient, methotrexate, in the same concentration as the US-approved Methotrexate Injection, USP 1 g/40 mL (25 mg/mL) (Preservative-Free).  This product is a clinically acceptable substitute for the out of stock product in the United States.

The Methotrexate Injection, USP from Hospira Healthcare Corporation, Canada is manufactured by Hospira, Inc. in Mulgrave, Australia, at an FDA inspected facility which is currently in compliance with FDA manufacturing standards.

At this time, no other entity except Hospira, Inc. is authorized by the FDA to import or distribute a non-US approved Methotrexate Injection, USP.  Hospira Healthcare Corporation, Canada has appointed Hospira, Inc., as their distributor of this product in the US.  Any sales of Canadian Methotrexate Injection, USP flip top vials (DIN 02182971) from any entity other than Hospira Healthcare Corporation, Canada or their distributor, Hospira, Inc., will be considered a violation of the Federal Food, Drug and Cosmetic Act and will be subject to enforcement by the FDA.

It is important to note that there are substantive differences in the format and content of the  labeling between the US-approved Methotrexate Injection, USP and the Canadian Methotrexate Injection, USP.

For full prescribing information, refer to the Methotrexate Injection, USP (Preservative-Free) US package insert as there are significant differences in information such as adverse events, boxed warnings, and preparation and administration instructions.  A copy of the US package insert can be found attached to this communication.

Please note the differences in the container label and carton labeling:

Additionally, please follow these guidelines when using the Canadian-approved Methotrexate Injection, USP:

• The barcode used for Methotrexate Injection, USP is an international pharmaceutical manufacturing code and may not be appropriately recognized by scanning systems used in the United States. Institutions should confirm that barcode systems do not provide incorrect information when the product is scanned.
• Follow instructions in the US package insert to ensure that the drug product is being correctly prepared and administered.
• For questions regarding Methotrexate Injection, USP (Preservative-Free) in the United States, please contact the Hospira customer services team at 1-877-946-7747 (Monday to Friday 7 AM to 6 PM CST).

Customers can order directly from Hospira, Inc. by contacting Customer Services at:

                                    Tel:       1-877-946-7747

                                    Fax:      1-262-577-6917

Canadian Methotrexate Injection, USP flip top vials (DIN 02182971) are not returnable and not for resale.

Hospira, Inc. will be making reasonable attempts to fill your orders.  We will be closely monitoring the distribution of Methotrexate Injection, USP to help manage supply.

If you have any additional questions, please contact Customer Service at 1-877-946-7747, Monday-Friday 7 AM-6 PM.  This communication and updated product information is available on the Hospira, Inc. website (www.hospira.com) as well as on the FDA Drug Shortage web site (http://www.fda.gov/Drugs/DrugSafety/DrugShortage/default.htm)

To report adverse events, please call Hospira at 1-800-441-4100.  Adverse events that may be related to the use of this product may also be reported to FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:

• Online:  www.fda.gov/medwatch/report.htm
• Regular Mail:  use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
  Mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD  20852-9787
• Fax:  1-800-FDA-0178

Please contact the Medical Information Department at 1-800-615-0187, 24 hours/day; 7 days/week if you have any questions about the information contained in this letter regarding the safe and effective use of Methotrexate Injection, USP 1g/40mL (25mg/mL)(Preservative-free).

Sincerely,

Judith Zutkis

VP, Global Regulatory Affairs

Hospira, Inc.

Hospira, Inc.

275 North Field Drive

Dept. 0389, Bldg. H2

Lake Forest, IL 60045

www.hospira.com

 

 

Revised: 05/2012 Hospira Worldwide, Inc.