Calcium Folinate Injection: Package Insert / Prescribing Info

URGENT: LEUCOVORIN UPDATE

June 2011

Dear Healthcare Professional:

Due to the current critical shortage of Leucovorin Calcium Injection in the United States market, the FDA has asked Teva to help increase the availability of this product. The following letter is being sent to you at FDA’s request.

Teva is working with the FDA to initiate a temporary importation of the product from our European counterparts. The European product, known as Calcium Folinate Solution for Injection, has not previously been reviewed or approved by the FDA, but is of the same qualitative formulation as Leucovorin Calcium for Injection previously approved for marketing in the U.S. when the latter is reconstituted with water. Calcium Folinate Solution for Injection is manufactured in accord with European Good Manufacturing Practice regulations at our site in Godollo, Hungary and marketed through our Teva UK affiliate.

At this time, no other entity except Teva has been given regulatory enforcement discretion to import or distribute Calcium Folinate Solution for Injection. Any sales of Calcium Folinate Solution for Injection from any entity other than Teva will be considered in violation of the Federal Food, Drug and Cosmetic Act and may be subject to enforcement action by the FDA.

Effective immediately, and pursuant to the FDA’s authorization, Teva will offer Leucovorin Calcium (Calcium Folinate) in the following versions:

10 mg folinic acid/mL in vial sizes of 10 and 30 mL

Calcium Folinate Solution for Injection contains the same active ingredient in the same concentration as Leucovorin Calcium for Injection when the latter is reconstituted with water. The naming convention for the active ingredient varies. The barcode used on Calcium Folinate Solution for Injection 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 used. Alternative procedures should be implemented to assure that the correct drug product is being dispensed and administered to individual patients.

For questions regarding Calcium Folinate Solution for Injection in the United States, please contact Teva Medical Affairs at (888) 838-2872 or (800) 227-7522 between the hours of 8 am and 5 pm EST. This communication and updated product information is available on the Teva website at www.tevausa.com as well as on the FDA Drug Shortage website at www.fda.gov/Drugs/DrugSafety/DrugShortages.

The product comparison table below highlights the minor differences between Leucovorin Calcium for Injection and Calcium Folinate Solution for Injection.

• Wholesalers can place orders directly with Teva using normal procedures.
• Customers can order directly from Teva by contacting Customer Service at (800) 545-8800 between the hours of 8 am and 5 pm EST.
• Calcium Folinate Solution for Injection will be covered under Teva’s Return Goods Policy.

Teva will make reasonable attempts to fill your orders. Teva will be closely monitoring the distribution of Calcium Folinate Solution for Injection to help manage the supply.

To report adverse events among patients administered, please call (215) 293-6351 or (866) 832-8537 between the hours of 8 am and 5 pm EST, or email drug.safety@tevausa.com.

Alternatively, adverse events that may be related to the use of these products may be reported to the FDA’s Med Watch program by fax at 1/800/FDA-0178, by mail at Med Watch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the Med Watch website at www.fda.gov/Safety/MedWatch.

Sincerely,

Deborah A. Jaskot, M.S., RAC

Vice President, North America Regulatory Affairs

Policy & Governance