Bio Products Laboratory Announces Supply of COAGADEX® Now Available in the United States

ELSTREE, England & DURHAM, N.C.--()--Bio Products Laboratory, Ltd. (BPL), a leading manufacturer of plasma-derived therapies, today announced that supply of COAGADEX is now available in the U.S. COAGADEX was approved by the U.S. Food and Drug Administration on October 20, 2015 for the treatment of adults and children (aged 12 years and over) with hereditary factor X deficiency for on-demand treatment and control of bleeding episodes, and perioperative management of bleeding in patients with mild hereditary factor X deficiency.

COAGADEX is the first and only FDA-approved product to treat hereditary factor X deficiency, and is the only specific factor X concentrate available in the U.S. COAGADEX will be available through a network of specialty pharmacies and authorized distributors who have received specialized disease state and product training from BPL. For additional information, including how to order COAGADEX, please visit www.coagadex.com or call 1-844-4BPLUSA.

In clinical studies, the most common adverse reactions (frequency ≥5% of subjects) with COAGADEX were infusion site erythema, infusion site pain, fatigue and back pain.

Please see the Important Safety Information below and www.coagadex.com for full prescribing information.

Indications for COAGADEX

COAGADEX, a plasma-derived blood coagulation factor X concentrate, is indicated in adults and children (aged 12 years and above) with hereditary Factor X deficiency for:

  • On-demand treatment and control of bleeding episodes
  • Perioperative management of bleeding in patients with mild hereditary Factor X deficiency

Perioperative management of bleeding in major surgery in patients with moderate and severe hereditary Factor X deficiency has not been studied.

Important Safety Information for COAGADEX

COAGADEX is contraindicated in patients with known hypersensitivity to any of the components of the product.

Allergic type hypersensitivity reactions, including anaphylaxis, are possible with COAGADEX. If symptoms occur, patients should discontinue use of the product immediately and contact their physician.

The formation of neutralizing antibodies (inhibitors) to factor X is a possible complication in the management of individuals with factor X deficiency. Carefully monitor patients taking COAGADEX for the development of inhibitors by appropriate clinical observations and laboratory tests.

COAGADEX is made from human plasma and may contain infectious agents, e.g. viruses, the variant Creutzfeldt-Jakob agent (vCJD) and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. No cases of transmission of viral diseases, vCJD or CJD, have been associated with the use of COAGADEX.

In clinical studies, the most common adverse reactions (frequency ≥5% of subjects) with COAGADEX were infusion site erythema, infusion site pain, fatigue and back pain.

About Bio Products Laboratory, Ltd.

Bio Products Laboratory, Ltd. (BPL) is a leading manufacturer of plasma-derived protein therapies with global headquarters in Elstree, England, US headquarters in Durham, NC, and a presence in more than 45 countries worldwide. The company has over 60 years of experience developing and manufacturing plasma-derived therapies since being established as part of the Lister Institute in 1950, and currently markets a wide range of products including coagulation factors, human immunoglobulins, and albumin. BPL is committed to continued investment in research and development to maintain its key position as a reliable supplier of high-quality products to patients and healthcare providers worldwide.

LINKS:

http://www.coagadex.com

http://www.bpl-us.com/

http://www.bpl.co.uk/about-bpl/

Contacts

Stanton PR & Marketing
Charlyn Lusk, 646-502-3549
clusk@stantonprm.com

Contacts

Stanton PR & Marketing
Charlyn Lusk, 646-502-3549
clusk@stantonprm.com