The FDA issued a shortage update for leucovorin on July 21, 2011.
While leucovorin remains in shortage from all three US manufacturers, the FDA is temporarily allowing Teva Pharmaceuticals to import calcium folinate solution for injection from Europe. The imported solution is the same strength as powdered leucovorin calcium for injection once water is added to the US product.
In a Dear Healthcare Professional letter, Teva provides a chart comparing the two products and tells doctors and pharmacists that currently Teva is the only organization with regulatory discretion to import and distribute calcium folinate solution.
Calcium folinate for injection is being imported through the Teva affliate in the United Kingdom. It is manufactured in Hungary at a Teva facility that meets European Good Manufacturing Practice regulations.
Calcium folinate differs from leucovorin calcium in that:
- It comes as a solution ready for injection while leucovorin is a powder that needs to be reconstituted with water.
- It needs to be refrigerated. Leucovorin powder can be stored at room temperature.
- US bar coding systems may not read Teva UK information correctly so extra care needs to be taken in dispensing it.
An alternative to leucovorin, Fusilev® (levoleucovorin) has been approved by the FDA for treatment of advanced colorectal cancer in combination with 5-FU.
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