Coagadex (coagulation factor x (human)) · Bio Products Laboratory

In a clinical study of COAGADEX in subjects with severe or moderate Factor X deficiency (basal FX:C < 5 IU/dL), the pharmacokinetics of COAGADEX were assessed after intravenous infusion (mean [range] infusion rate 5.9 [1.3-17.1] mL/min) of 25 IU/kg COAGADEX. Pharmacokinetic (PK) parameters were calculated from plasma Factor X:C activity measurements after subtraction of the pre-dose value. The PK assessment was repeated at least 6 months after the first dose. The PK parameters following a single...

Prophylaxis of Bleeding Episodes In a multicenter, open-label, non-randomized clinical trial, the use of COAGADEX in routine prophylaxis of bleeding episodes was evaluated in nine children aged less than 12 years of age. The mean age was 7.3 (range 2.6 to 11.9) years. Eight subjects had severe FX deficiency and the other had moderate deficiency. Four subjects were between 0 and 5 years of age and five were between 6 and 11 years of age inclusive. The majority of subjects were Asian (7; 77.8%) and the remainder were Caucasian/White (2; 22.2%). After the first dose of COAGADEX 50 IU/kg, given at...

The most common adverse drug reactions (frequency ≥ 5% of subjects) observed in clinical trials were infusion site erythema, infusion site pain, fatigue, and back pain. The most common adverse drug reactions (frequency ≥ 5% of subjects) observed in clinical trials were infusion site erythema, infusion site pain, fatigue and back pain ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Kedrion Biopharma, Inc. at 1-855-3KDRION (1-855-353-7466) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch...

COAGADEX is contraindicated in patients who have had life-threatening hypersensitivity reactions to COAGADEX [see Description (11) ]. Do not use in patients who have had life-threatening hypersensitivity reactions to COAGADEX ( 4 ).

Hypersensitivity reactions, including anaphylaxis, are possible. Should symptoms occur, discontinue COAGADEX and administer appropriate treatment ( 5.1 ). Development of neutralizing antibodies (inhibitors) may occur. If expected plasma Factor X activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures Factor X inhibitor concentration ( 5.2 ). COAGADEX is made from human blood and therefore carries a risk of transmitting infectiou...

7 DRUG INTERACTIONS Drug interaction studies have not been performed. Use with caution in patients who are receiving other plasma products that may contain Factor X (e.g. fresh frozen plasma, prothrombin complex concentrates). Based on the mechanism of action, COAGADEX is likely to be counteracted by direct and indirect Factor Xa inhibitors [see Clinical Pharmacology (12.1) ].