Factor X, Human

Factor X, human is used for routine prophylaxis in 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.

Factor X, human is available under the following different brand names: Coagadex.

Dosages of Factor X, Human:

Dosage Forms and Strengths

Lyophilized Powder for Reconstitution

• Approximately 250 IU/vial of factor X activity
• Approximately 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 approximately 100 IU/mL

Dosage Considerations – Should be Given as Follows:

Factor X Deficiency

• Indicated for routine prophylaxis in hereditary factor X deficiency to reduce the frequency of bleeding episodes, for on-demand treatment and control of bleeding episodes, and 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 more than 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:
• Adults and children over 12 years: Estimated Increment of Factor X (IU/dL or % of normal) = [Total Dose (IU)/Body Weight (kg)] x 2
• Children under 12 years: Estimated Increment of Factor X (IU/dL or % of normal) = [Total Dose (IU)/Body Weight (kg)] x 1.7

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:
• Adults and children over 12 years: Dose (IU) = Body Weight (kg) x Desired Factor X Rise (IU/dL) x 0.5
• Children under 12 years: Dose (IU) = Body Weight (kg) x Desired Factor X Rise (IU/dL) x 0.6
• 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

• Adults and children over 12 years: Infuse 25 IU/kg when the first sign of bleeding occurs
• Children under 12 years: 30 IU/kg IV
• Repeat at intervals of 24 hours until the bleeding stops

Perioperative management of bleeding

• Measure post-infusion 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 (adults and children over 12 years) OR x 0.6 (children under 12 years)
• 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

• Adults and children over 12 years: 25 mg IV twice weekly
• Children under 12 years: 40 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

Common side effects of factor X, human include:

• Infusion site redness
• Fatigue
• Back pain
• Infusion site pain

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Factor X, human has no listed severe interactions with other drugs.
 

Serious interactions of factor X, human include:

• antithrombin alfa
• antithrombin III
• apixaban
• argatroban
• bivalirudin
• dalteparin
• desirudin
• edoxaban
• enoxaparin
• fondaparinux
• heparin
• rivaroxaban

Moderate interactions of factor X, human include:

• fresh frozen plasma
• prothrombin complex concentrate, human
• red blood cells
• washed red blood cells
• whole blood

Factor X, human has no listed mild interactions with other drugs.
 

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings
 

This medication contains factor X, human. Do not take Coagadex if you are allergic to factor X, human or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

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

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Factor X, Human?”

Long-Term Effects

• See "What Are Side Effects Associated with Using Factor X, Human?”

Cautions

• Allergic-type hypersensitivity reactions may occur (e.g., anaphylaxis, angioedema, infusion site inflammation, chills, cough, dizziness, fever, flushing, generalized hives, headache, hives, hypotension, lethargy, musculoskeletal pains, nausea, itching, rash, restlessness, fast heart rate, 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 the risk of transmitting infectious agents (e.g., 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 co-administered with other plasma products that may contain factor X (e.g., 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 (e.g., apixaban, edoxaban, dabigatran)

Pregnancy and Lactation

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 if it can affect reproduction capacity. Factor X, human should be given to a pregnant woman only if clearly needed

It is unknown if factor X, human is distributed in human breast milk. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for factor X, human, and any potential adverse effects on the breastfed infant from the drug or the underlying maternal condition.