COAGADEX Rx

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COAGADEX

Bleeding disorders
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Generic Name and Formulations:

Coagulation Factor X (human) 250 IU, 500 IU; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free.

Company:

BPL Inc.

Select therapeutic use:

Indications for COAGADEX:

In patients with Factor X deficiency: for on-demand treatment and control of bleeding episodes and for perioperative management in mild hereditary Factor X deficiency.

Limitations Of use:

Not studied in perioperative management in major surgery for patients with moderate and severe hereditary Factor X deficiency.

Adult:

Dosage Required (IU) = Body Weight (kg) × Desired Factor X Increase (IU/dL) × 0.5 (IU/kg per IU/dL). Give by IV infusion at a rate of 10mL/min; max 20mL/min. Bleeding: 25 IU/kg at first sign of bleeding; repeat every 24hrs until the bleed stops. Perioperative: Pre-op: raise plasma FX levels to 70–90 IU/dL; Post-op: repeat dose as needed to maintain FX levels at minimum of 50 IU/dL until patient is no longer at bleeding risk. All: max 60 IU/kg daily. Adjust based on response.

Children:

Not established.

Warnings/Precautions:

Monitor for development of Factor X inhibitors. Immediately discontinue if hypersensitivity reactions occur. Contains human plasma; monitor for possible infection transmission (eg, viruses, Creutzfeldt-Jakob disease agent). Pregnancy. Nursing mothers.

Interactions:

Caution with concomitant other Factor X-containing plasma products (eg, fresh frozen plasma, prothrombin complex concentrates).

Pharmacological Class:

Clotting factor.

Adverse Reactions:

Infusion site erythema/pain, fatigue, back pain; anaphylaxis, possible antibody formation.

Generic Availability:

NO

How Supplied:

Single-dose vial—1 (w. diluent, supplies)