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Fougera (AAA) and Protherics PLC Increase DigiFab(R) Digoxin Immune Fab (Ovine) Supply Following Strong Demand


3/19/2008 7:54:00 AM

MELVILLE, N.Y., March 17 /PRNewswire/ -- Fougera, a division of Nycomed US Inc., the distributor of DigiFab(R) Digoxin Immune Fab (Ovine) in the United States and Protherics Inc., the manufacturer of DigiFab(R), have recently released another batch of DigiFab into the market in response to the high demand for the product.

According to the FDA, the availability of two antibody products, DigiFab(R) and GlaxoSmithKline's Digibind(R), have been reduced to "limited inventories." Both products are used to treat the effects of life- threatening, or potentially life-threatening toxicity or overdose of the common heart medication, digoxin.

Both Fougera and Protherics have been successful in responding to a sharp increase in demand over the last several months, and production has been increased to further ensure adequate market supply. Fougera is not aware of a shortage of DigiFab(R) at the patient level and there has been no disruption to the manufacturing supply chain at Protherics.

"DigiFab(R) is the market leader in the US, and we monitor inventory and delivery of DigiFab(R) very closely. While a recent spike in sales did lead to a short-term reduction in our inventory, we can assure our customers that the wholesaler pipeline has an adequate supply," said Jackie Beltrani, Senior Director of Institutional Sales and Specialty Marketing for Fougera.

Any healthcare professional concerned about his or her DigiFab(R) supply can call Fougera Customer Service at 800-231-0206.

About DigiFab(R)

DigiFab(R) is indicated for the treatment of patients with life- threatening or potentially life-threatening digoxin toxicity or overdose.

DigiFab(R) full prescribing information is available at http://www.fougera.com.

Important Safety Information

Based on experience with Digibind(R)*, the following adverse reactions could occur with the use of DigiFab(R):

Exacerbation of low cardiac output states and congestive heart failure due to the withdrawal of inotropic effect of digitalis; hypokalemia due to reactivation of the sodium-potassium ATPase; rapid ventricular response in patients with atrial fibrillation due to the withdrawal of the effects of digitalis on the atrioventricular node and rare allergic reactions. Patients with allergies to papain, chymopapain, other papaya extracts or the pineapple enzyme bromelain may be at risk for an allergic reaction to DigiFab(R). DigiFab(R) is an animal protein; monitor for delayed allergic reactions and hypersensitivity.

Suicidal ingestion may involve more than one drug. Toxic effects of other drugs or poisons should not be overlooked.

In the clinical trials of DigiFab(R), 6 of 15 patients in the digoxin overdose study had a total of 17 adverse experiences; most were mild to moderate in nature and all were deemed "remotely associated" with DigiFab. Three events were deemed "severe," all occurred in one patient and consisted of the following: pulmonary edema, bilateral pleural effusion and renal failure. After reviewing the case, it was determined that these events were likely due to the loss of digoxin inotropic support in combination with the patient's underlying medical condition. Of 8 healthy volunteers who received DigiFab(R), only 2 experienced an adverse reaction that was considered to be associated with DigiFab(R). The reactions were 1 episode of phlebitis of the infusion vein and 1 episode of moderate postural hypotension, which became mild prior to resolving.

*Digibind(R) is a registered trademark of GlaxoSmithKline. Neither GlaxoSmithKline nor Digibind(R) are related or affiliated with Nycomed US Inc.

About Fougera

Fougera is a leading manufacturer and distributor of a wide range of multi-source topical and ophthalmic pharmaceuticals in prescription and over- the-counter dosage forms, as well as treatments for emergency/critical care.

CONTACT: Angie Cecil of HLD Public Relations, +1-516-536-2020,
acecil@hldpr.com, for Fougera

Web site: http://www.fougera.com/


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