Posted from: Friday, October 30, 2015 - 11:26 AM - Present

Coagadex Approved for the Treatment of Hereditary Factor X

October 20, 2015 – The U.S. Food and Drug Administration (FDA) approved Bio Products Laboratory’s Coagadex (Coagulation Factor X (humans)), for the treatment of patients 12 years of age and older with Hereditary Factor X (HFX) deficiency for on-demand treatment and control of bleeding episodes, and for perioperative management of bleeding in patients with a mild HFX deficiency. HFX deficiency affects men and women equally with symptoms including blood in urine, easy bruising, excessive bleeding from injuries, and frequent nosebleeds. Additionally in the case of women, prolonged heavy menstrual bleeding may occur. Currently, Coagadex is the only FDA-approved treatment for HFX deficiency, with previous treatments being limited to infusions of fresh plasma or plasma derived prothrombin complex concentrates.

Recommended dosing for Coagadex is 25 international units (IUs) per Kg of body weight infused intravenously (IV) once every 24 hours until bleeding stops. Prior to surgery Coagadex should be administered to a patient to increase plasma levels of Factor X to between 70 IU and 90 IU per deciliter (dL). After surgery, plasma Factor X levels should be kept at 50IU/dL or higher by infusing Coagadex, as often as needed, until the risk of bleeding from surgery ends.

Dosage forms available include single-use vials containing either approximately 250 IU or 500 IU of powdered Coagadex packaged in kits with 3mL of sterile water for injection. Coagadex is anticipated to be launched in December, and supplied by authorized distributors and specialty pharmacies. 

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.

Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability. All trademarks are the property of their respective owners.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

Last Updated Thursday, October 17, 2019 - 01:58 AM.