Factor X, human (Rx)

Brand and Other Names:Coagadex
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

lyophilized powder for reconstitution

  • ~250 IU/vial of factor X activity
  • ~500 IU/vial of factor X activity
  • When vials are reconstituted using the sterile water for injection supplied with the kit, the final concentration is ~100 IU/mL

Factor X Deficiency

Indicated for routine prophylaxis tn hereditary factor X deficiency to reduce the frequency of bleeding episodes, for on-demand treatment and control of bleeding episodes, and for perioperative management of bleeding in patients with mild hereditary factor X deficiency

Dose and duration depend on the severity of the factor X deficiency, location and extent of the bleeding, and the patient’s clinical condition

Base the dose and frequency on the individual clinical response

Do not administer >60 IU/kg daily

Each vial is labeled with the actual factor X potency/content in International Units (IU)

Estimate in vivo peak increase in factor X

  • Estimate the expected in vivo peak increase in Factor X level expressed as IU/dL (or % of normal) using the following:
  • Estimated Increment of Factor X (IU/dL or % of normal) = [Total Dose (IU)/Body Weight (kg)] x 2

Calculate desired in vivo peak increase in factor X

  • The dose to achieve a desired in vivo peak increase in factor X level may be calculated using the following formula:
  • Dose (IU) = Body Weight (kg) x Desired Factor X Rise (IU/dL) x 0.5
  • Note: The desired factor X rise is the difference between the patient’s plasma factor X level and the desired level
  • The dosing formula is based on the observed recovery of 2 IU/dL per IU/kg

On-demand treatment and control of bleeding episodes

  • Infuse 25 IU/kg when the first sign of bleeding occurs
  • Repeat at intervals of 24 hr until the bleeding stops

Perioperative management of bleeding

  • Measure postinfusion plasma factor X levels for each patient before and after surgery to ensure that hemostatic levels are obtained and maintained
  • Presurgery: Calculate the dose to raise plasma factor X levels to 70-90 IU/dL using the following formula: Required dose (IU) = Body Weight (kg) x Desired Factor X Rise (IU/dL) x 0.5
  • Postsurgery: Repeat dose as necessary to maintain plasma factor X levels at a minimum of 50 IU/dL until the patient is no longer at risk of bleeding

Prophylaxis of bleeding episodes

  • 25 mg IV twice weekly
  • Owing to inter-and intra-patient variability, it is recommended that trough blood levels of FX should be monitored at intervals, especially in the first weeks of therapy or after dosages changes
  • Adjust dosage regimen to clinical response and trough levels of FX of at least 5 IU/dL
  • Not to exceed peak level of 120 IU/dL

Dosing Considerations

Perioperative management of bleeding in major surgery in patients with moderate and severe hereditary factor X deficiency has not been studied

Plasma-derived human blood coagulation factor

Dosage Forms & Strengths

lyophilized powder for reconstitution

  • ~250 IU/vial of factor X activity
  • ~500 IU/vial of factor X activity
  • When vials are reconstituted using the sterile water for injection supplied with the kit, the final concentration is ~100 IU/mL

Factor X Deficiency

Indicated for routine prophylaxis tn hereditary factor X deficiency to reduce the frequency of bleeding episodes, for on-demand treatment and control of bleeding episodes, and for perioperative management of bleeding in patients with mild hereditary factor X deficiency

Dose and duration depend on the severity of the factor X deficiency, location and extent of the bleeding, and the patient’s clinical condition

Base the dose and frequency on the individual clinical response

Do not administer >60 IU/kg daily

Each vial is labeled with the actual factor X potency/content in International Units (IU)

Estimate in vivo peak increase in factor X

  • Estimate the expected in vivo peak increase in factor X level expressed as IU/dL (or % of normal) using the following:
  • <12 years: Estimated Increment of Factor X (IU/dL or % of normal) = [Total Dose (IU)/Body Weight (kg)] x 1.7
  • ≥12 years: Estimated Increment of Factor X (IU/dL or % of normal) = [Total Dose (IU)/Body Weight (kg)] x 2

Calculate desired in vivo peak increase in factor X

  • The dose to achieve a desired in vivo peak increase in factor X level may be calculated using the following formula:
  • <12 years: Dose (IU) = Body Weight (kg) x Desired Factor X Rise (IU/dL) x 0.6
  • ≥12 years: Dose (IU) = Body Weight (kg) x Desired Factor X Rise (IU/dL) x 0.5
  • Note: The desired factor X rise is the difference between the patient’s plasma factor X level and the desired level
  • The dosing formula is based on the observed recovery of 2 IU/dL per IU/kg

On-demand treatment and control of bleeding episodes

  • <12 years: 30 IU/kg IV
  • ≥12 years: 25 IU/kg IV
  • Infuse when the first sign of bleeding occurs
  • Repeat at intervals of 24 hr until the bleeding stops

Perioperative management of bleeding

  • Measure postinfusion plasma factor X levels for each patient before and after surgery to ensure that hemostatic levels are obtained and maintained
  • Presurgery: Calculate the dose to raise plasma factor X levels to 70-90 IU/dL using the following formula: Required dose (IU) = Body Weight (kg) x Desired Factor X Rise (IU/dL) x 0.5 (aged ≥12 yr) OR x 0.6 (aged <12 yr)
  • Postsurgery: Repeat dose as necessary to maintain plasma factor X levels at a minimum of 50 IU/dL until the patient is no longer at risk of bleeding

Prophylaxis of bleeding episodes

  • <12 years: 40 IU/kg IV twice weekly
  • ≥12 years: 25 IU/kg IV twice weekly
  • Owing to inter-and intra-patient variability, it is recommended that trough blood levels of FX should be monitored at intervals, especially in the first weeks of therapy or after dosages changes
  • Adjust dosage regimen to clinical response and trough levels of FX of at least 5 IU/dL
  • Not to exceed peak level of 120 IU/dL

Dosing Considerations

Perioperative management of bleeding in major surgery in patients with moderate and severe hereditary factor X deficiency has not been studied

Plasma-derived human blood coagulation factor

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Interactions

Interaction Checker

and Factor X, human

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (12)

              • antithrombin alfa

                antithrombin alfa will decrease the level or effect of Factor X, human by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Based on the mechanism of action, Factor X is likely to be counteracted by direct and indirect Factor Xa inhibitors.

              • antithrombin III

                antithrombin III will decrease the level or effect of Factor X, human by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Based on the mechanism of action, Factor X is likely to be counteracted by direct and indirect Factor Xa inhibitors.

              • apixaban

                apixaban will decrease the level or effect of Factor X, human by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Based on the mechanism of action, Factor X is likely to be counteracted by direct and indirect Factor Xa inhibitors.

              • argatroban

                argatroban will decrease the level or effect of Factor X, human by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Based on the mechanism of action, Factor X is likely to be counteracted by direct and indirect Factor Xa inhibitors.

              • bivalirudin

                bivalirudin will decrease the level or effect of Factor X, human by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Based on the mechanism of action, Factor X is likely to be counteracted by direct and indirect Factor Xa inhibitors.

              • dalteparin

                dalteparin will decrease the level or effect of Factor X, human by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Based on the mechanism of action, Factor X is likely to be counteracted by direct and indirect Factor Xa inhibitors.

              • desirudin

                desirudin will decrease the level or effect of Factor X, human by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Based on the mechanism of action, Factor X is likely to be counteracted by direct and indirect Factor Xa inhibitors.

              • edoxaban

                edoxaban will decrease the level or effect of Factor X, human by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Based on the mechanism of action, Factor X is likely to be counteracted by direct and indirect Factor Xa inhibitors.

              • enoxaparin

                enoxaparin will decrease the level or effect of Factor X, human by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Based on the mechanism of action, Factor X is likely to be counteracted by direct and indirect Factor Xa inhibitors.

              • fondaparinux

                fondaparinux will decrease the level or effect of Factor X, human by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Based on the mechanism of action, Factor X is likely to be counteracted by direct and indirect Factor Xa inhibitors.

              • heparin

                heparin will decrease the level or effect of Factor X, human by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Based on the mechanism of action, Factor X is likely to be counteracted by direct and indirect Factor Xa inhibitors.

              • rivaroxaban

                rivaroxaban will decrease the level or effect of Factor X, human by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Based on the mechanism of action, Factor X is likely to be counteracted by direct and indirect Factor Xa inhibitors.

              Monitor Closely (5)

              • fresh frozen plasma

                Factor X, human, fresh frozen plasma. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Caution is advised in patients who are receiving other plasma products that may contain Factor X, (eg, fresh frozen plasma, prothrombin complex concentrates).

              • prothrombin complex concentrate, human

                Factor X, human, prothrombin complex concentrate, human. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Caution is advised in patients who are receiving other plasma products that may contain Factor X, (eg, fresh frozen plasma, prothrombin complex concentrates).

              • red blood cells

                Factor X, human, red blood cells. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Caution is advised in patients who are receiving other plasma products that may contain Factor X, (eg, fresh frozen plasma, prothrombin complex concentrates).

              • washed red blood cells

                Factor X, human, washed red blood cells. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Caution is advised in patients who are receiving other plasma products that may contain Factor X, (eg, fresh frozen plasma, prothrombin complex concentrates).

              • whole blood

                Factor X, human, whole blood. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Caution is advised in patients who are receiving other plasma products that may contain Factor X, (eg, fresh frozen plasma, prothrombin complex concentrates).

              Minor (0)

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                Adverse Effects

                1-10%

                Infusion site erythema (5.6%)

                Fatigue (5.6%)

                Back pain (5.6%)

                Infusion site pain (5.6%)

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                Warnings

                Contraindications

                Documented life-threatening hypersensitivity to factor X, human or its components

                Cautions

                Allergic-type hypersensitivity reactions may occur (eg, anaphylaxis, angioedema, infusion site inflammation, chills, cough, dizziness, fever, flushing, generalized urticaria, headache, hives, hypotension, lethargy, musculoskeletal pains, nausea, pruritus, rash, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing); discontinue product immediately and administer appropriate emergency treatment

                Formation of neutralizing antibodies (inhibitors) to factor X may occur; if expected factor X activity levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures factor X inhibitor concentration

                Transmission of infectious agents may occur; the product is derived from human blood, and despite measures to screen and inactivate/remove certain viruses, it may carry risk of transmitting infectious agents (eg, viruses, the variant Creutzfeldt-Jakob disease [vCJD] agent and, theoretically, the Creutzfeldt-Jakob disease [CJD] agent)

                Monitor plasma factor X activity and monitor for factor X inhibitors

                Caution when coadministered with other plasma products that may contain factor X (eg, fresh frozen plasma, prothrombin complex concentrates)

                Based on the mechanism of action, factor X, human is likely to be counteracted by direct and indirect factor Xa inhibitors (eg, apixaban, edoxaban, dabigatran)

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                Pregnancy

                Pregnancy

                There are no data with factor X concentrate use in pregnant women to inform on drug-associated risk

                Animal reproduction studies have not been conducted

                It is not known whether factor X concentrate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity

                Should be given to a pregnant woman only if clearly needed

                Lactation

                Unknown if distributed in human breast milk

                Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

                Pregnancy Categories

                A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                NA: Information not available.

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                Pharmacology

                Mechanism of Action

                Increases plasma levels of factor X and can temporarily correct the coagulation defect in these patients, as reflected by decrease in the aPTT and PT

                Factor X is the first coagulation factor of the final common pathway (thrombin pathway); it is activated into factor Xa by both factor IX and VII, along with cofactors; Xa cleaves prothrombin in 2 places, which yields the active thrombin

                Absorption

                Peak plasma concentration: 0.504 IU/mL

                AUC: 18 IU·hr/mL

                Distribution

                Vd: 56.3 mL/kg

                Elimination

                Half-life: 30.3 hr

                Clearance: 1.35 mL/kg/hr

                Mean residence time: 41.8 hr

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                Administration

                IV Preparation

                Lyophilized powder for reconstitution using Mix2Vial transfer device provided in the kit

                Vials contain ~250 IU or 500 IU of factor X

                When vials are reconstituted using the sterile water for injection supplied with the kit, the final concentration is ~100 IU/mL

                See prescribing information for full instructions

                Note: Do not shake; gently swirl during mixing process

                IV Administration

                For intravenous administration only following reconstitution

                Use solution within 1 hr following reconstitution

                Reconstituted solution should be clear or a slightly pearl-like solution; do not use if the solution is cloudy, discolored, or contains any particles

                Following reconstitution, draw up solution for dose into a single syringe

                Attach a suitable needle to the syringe

                Administer by IV infusion at a rate of 10 mL/min; may increase rate if tolerated, but do not exceed 20 mL/min

                Storage

                Store in original package to protect it from light

                Store in refrigerator or at room temperature (36-86°F)

                Do not freeze

                Do not use after the expiration date printed on the vial and carton labels (expiration date refers to the last day of that month)

                Do not store reconstituted solution (use within 1 hr)

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                Formulary

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                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.