Pharmagen Watch List: Leucovorin Calcium Lyophilized Powder for Injection

On October 10th, Pharmagen let readers of the Drug Shortage Report know that Ben Venue Laboratories (Bedford Pharma) Ohio Plant Closed, Shortages Coming. As their products have worked though the wholesale channel, supplies of various products are starting to become exhausted.

One product we would warn our hospital partners to keep an eye on is Leucovorin Calcium Lyophilized Powder for Injection. There are three manufactures of Leucovorin; Teva, APP and Bedford.

That said, Beford made up the vast majority of the supply, in various sizes. 350mg vial being the most widely used.

50 mg vial, 10 count (NDC 55390-0051-10)
100 mg vial, 10 count (NDC 55390-0052-10)
200 mg vial, 1 count (NDC 55390-0053-01)
350 mg vial, 1 count (NDC 55390-0054-01)

Teva and APP make;

500 mg vial, 1 count (NDC 63323-0711-00)
100 mg vial, 1 count (NDC 00703-5140-01)

Pharmagen would recommend to all hospitals to coordinate with their primary wholesaler on how to maintain supply because there is no solution on the horizon.

According to ASHP

Ben Venue has stopped production in its plant in Bedford, Ohio and will close in early 2014. Ben Venue supplies multiple sterile injectable products for Bedford Laboratories. Supplies of product that has already been manufactured will continue to be released until inventory is depleted. Bedford Laboratories has a small number of products manufactured elsewhere that are not affected by this closure.¹

Teva has leucovorin on shortage due to manufacturing delays.²

Spectrum has Fusilev (levoleucovorin) readily available.³

APP and Sagent had leucovorin on shortage due to increase demand.^4,5

Leucovorin oral tablets are not affected by the shortage.^6-8

http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=488

While Sicor does also make a 350mg, the question is weather or not they'll be overwhelmed with orders?