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Factor X (Human)

Medically reviewed by Drugs.com. Last updated on May 27, 2020.

Pronunciation

(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

Pharmacology

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.

Distribution

Vd: Children ≥12 years, Adolescents, and Adults: 56.3 mL/kg

Half-Life Elimination

Single dose: Children ≥12 years, Adolescents, and Adults: 30.3 hours

Use: Labeled Indications

Bleeding episodes and perioperative management of bleeding: Prophylaxis and treatment of bleeding episodes in children and adults with hereditary factor X deficiency and perioperative management of bleeding episodes in children and adults with mild and moderate hereditary factor X deficiency.

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

Contraindications

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

Dosing: Adult

Factor X deficiency: Dose, dosing frequency, and duration are 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:

Prophylaxis: Initial: 25 units/kg twice weekly. Adjust dose to clinical response and factor X trough levels targeting ≥ 5 units/dL; do not exceed a peak of 120 units/dL

Treatment: 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 (units/dL or % of normal) 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: Dose, dosing frequency, and duration are based on location and severity of bleeding, patient age, and the patient's clinical condition. In general, administration of 1 unit/kg of factor X will increase circulating factor X concentrations by ~1.7 units/dL in children <12 years or by ~2 units/dL in children ≥12 years and adolescents.

Bleeding episodes:

Prophylaxis: Adjust dose to clinical response and factor X trough concentration targeting ≥5 units/dL; do not exceed a peak of 120 units/dL

Children <12 years: IV: Initial: 40 units/kg/dose twice weekly

Children ≥12 years and Adolescents: IV: Initial: 25 units/kg/dose twice weekly

Treatment:

Children <12 years: IV: 30 units/kg/dose. Repeat every 24 hours until bleeding stops.

Children ≥12 years and Adolescents: IV: 25 units/kg/dose. Repeat every 24 hours until bleeding stops.

Perioperative management of bleeding: IV:

Pre-surgery: Formula to calculate dosage required is based on desired increase in factor X concentrations (may be expressed as units/dL or as %). The calculated dose should raise plasma factor X concentrations to a desired target of 70 to 90 units/dL (or % of normal) using the following equation:

Children <12 years:

Dose (units) = Body weight (kg) x desired factor X increase (units/dL or % of normal) x 0.6

For example: 25 kg x 30 (% increase) x 0.6 = 450 units factor X

Maximum daily dose: 60 units/kg/day

The estimated factor X increase may be determined by the following equation:

Estimated increase of factor X (units/dL or % of normal) = [Total dose administered (units) x 1.7] divided by body weight (kg)

For example: [1,400 units x 1.7] divided by 35 kg = 68%

Children ≥12 years and Adolescents:

Dose (units) = Body weight (kg) x desired factor X increase (units/dL or % of normal) 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 estimated factor X increase may be determined by the following equation:

Estimated increase of factor X (units/dL or % of normal) = [Total dose administered (units) x 2] divided by body weight (kg)

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

Post-surgery: Children and Adolescents: Repeat pre-surgery dose as needed to maintain plasma factor X concentrations at ≥50 units/dL (or % of normal) until patient is no longer at risk of bleeding; maximum daily dose: 60 units/kg/day

Reconstitution

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.

Administration

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

Storage

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%)

Warnings/Precautions

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

Pregnant patients with factor X deficiency may have an increased risk of bleeding following abortion, antenatal procedures, delivery, and miscarriage; close surveillance is recommended. Clotting factors should be monitored at the first antenatal visit, once or twice during the third trimester, at delivery, and prior to surgical or invasive procedures. Although factor X concentrations may increase during pregnancy, patients with severe deficiency remain at risk for bleeding. In addition, treatment may be needed if concentrations are <0.3 IU/mL at term or prior to procedure. Hemostatic concentrations should be maintained for at least 3 days following procedures or postpartum. When available, factor X concentrate may be used (RCOG [Pavord 2017]).

Patient Education

What is this drug used for?

• It is used to treat or prevent bleeding.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Injection site pain

• Back pain

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• 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

• Fast heartbeat

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.