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.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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