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 hereditary factor X deficiency 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 hereditary factor X deficiency 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

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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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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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