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Factor X (Human)


(FAK ter ten HYU man)

Index Terms

  • Coagulation Factor X
  • Stuart-Prower Factor

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous [preservative free]:

Coagadex: 250 units (1 ea); 500 units (1 ea) [latex free]

Brand Names: U.S.

  • Coagadex

Pharmacologic Category

  • Antihemophilic Agent
  • Blood Product Derivative


Replaces deficient clotting factor X needed for effective hemostasis. Factor X, an inactive zymogen, can be activated by factor IXa via the intrinsic pathway or by factor IIa via the extrinsic pathway. Factor X is then converted from its inactive form to the active form (factor Xa) by the cleavage of a 52-residue peptide from the heavy chain. Factor Xa associates with factor Va on the phospholipid surface to form the prothrombinase complex, which actives prothrombin to thrombin in the presence of calcium ions. Thrombin then acts upon soluble fibrinogen and factor XIII to generate a cross-linked fibrin clot.


Vd: 56.3 mL/kg

Half-Life Elimination

Single dose: 30.3 hours

Use: Labeled Indications

Bleeding episodes and perioperative management of bleeding: Treatment of bleeding episodes in children ≥12 years of age and adults with hereditary factor X deficiency and perioperative management of bleeding episodes in children ≥12 years of age and adults with mild hereditary factor X deficiency.

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


Life-threatening hypersensitivity reactions to factor X (human) or any component of the formulation

Dosing: Adult

Factor X deficiency: Dose, dosing frequency, and duration based on location and severity of bleeding, and the patient’s clinical condition. In general, administration of factor X 1 unit/kg will increase circulating factor X levels by ~2 units/dL

Bleeding episodes: IV: 25 units/kg/dose. Repeat every 24 hours until bleeding stops.

Perioperative management of bleeding: IV:

Pre-surgery, the calculated dose should raise plasma factor X levels to 70 to 90 units/dL (or % of normal) using the following equation:

Number of factor X units required = Body weight (kg) x desired factor X increase (%) x 0.5

For example: 50 kg x 30 (% increase) x 0.5 = 750 units factor X

Maximum daily dose: 60 units/kg/day

The expected % factor X increase may also be determined by the following equation:

Expected % factor X increase = [# units administered x 2] divided by body weight (kg)

For example: [1,400 units x 2] divided by 70 kg = 40%

Post-surgery, the calculated dose should maintain plasma factor X levels at ≥50 units/dL (or % of normal) until patient is no longer at risk of bleeding; Maximum daily dose: 60 units/kg/day

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Factor X deficiency: Children ≥12 years and Adolescents: IV: Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).


Refer to instructions provided by the manufacturer. Bring diluent and vial to room temperature before combining. To reconstitute, use the diluent (SWFI) and transfer device provided. Swirl vial gently to dissolve powder; do not shake. The reconstituted solution should be clear or slightly pearl-like in color.


IV: For IV administration only. Administer at a rate of 10 to 20 mL/minute within 1 hour of reconstitution.


Store intact vials at 2°C to 30°C (36°F to 86°F); do not freeze. Protect from light. After reconstitution, use within 1 hour.

Drug Interactions

Anticoagulants (Inhibitors of Factor Xa): May diminish the therapeutic effect of Factor X (Human). Monitor therapy

Adverse Reactions

Frequency not always defined.

Central nervous system: Fatigue (6%), infusion-site pain (6%)

Hypersensitivity: Anaphylaxis, hypersensitivity reaction

Local: Infusion site reaction (6%; erythema)

Neuromuscular & skeletal: Back pain (6%)


Concerns related to adverse effects:

• Antibody formation: The development of inhibitory antibodies may occur. Factor X inhibitory antibodies should be measured when bleeding is not controlled and/or factor X levels are suboptimal after apparent adequate dosing.

• Hypersensitivity reactions: Hypersensitivity and anaphylactic reactions may occur with use; discontinue immediately if hypersensitivity reaction develops and initiate appropriate management.

Dosage form specific issues:

• Human plasma: Product of human plasma; may potentially contain infectious agents which could transmit disease. Screening of donors, as well as testing and/or inactivation or removal of certain viruses, reduces the risk. Infections thought to be transmitted by this product should be reported to the manufacturer.

• Human proteins: Contains traces of human proteins other than factor X.

Monitoring Parameters

Factor X levels in conjunction with clinical response to assess efficacy. Factor X inhibitory antibodies if inadequate clinical response and/or factor X trough levels are suboptimal. Signs/symptoms of hypersensitivity reactions, bleeding and thrombotic events, and infection.

Pregnancy Considerations

Animal reproduction studies have not been conducted. Factor X concentrations may increase during pregnancy and women with factor X deficiency should have clotting factors monitored, particularly at 28 and 34 weeks gestation and prior to invasive procedures. Replacement therapy may be needed if factor X concentrations are <10 to 20 units/dL. Because parvovirus infection may cause hydrops fetalis or fetal death, a recombinant product is preferred if prophylaxis or treatment is needed. The neonate may also be at an increased risk of bleeding following delivery and should be tested for the coagulation disorder (Chi 2012; Kadir 2009; Nance 2012).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience injection site pain or back pain. Have patient report immediately to prescriber injection site burning, stinging, or redness; chills, dizziness, passing out, flushing, headache, severe loss of strength and energy, muscle pain, nausea, vomiting, agitation, tingling, wheezing, or tachycardia (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience,and judgment in diagnosing, treating, and advising patients.