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Coagulation Factor X Human

Class: Hemostatics
Brands: Coagadex

Introduction

Coagulation factor X human is a hemostatic.

Uses for Coagulation Factor X Human

Coagulation factor X human has the following uses:

Coagulation factor X human is a plasma-derived human blood coagulation factor indicated in adults and children (aged 12 years and above) with hereditary factor X deficiency for on-demand treatment and control of bleeding episodes and perioperative management of bleeding in patients with mild hereditary factor X deficiency). 1

Coagulation factor X human has the following limitation of use:

Perioperative management of bleeding in major surgery in patients with moderate and severe hereditary factor X deficiency has not been studied. 1

Coagulation Factor X Human Dosage and Administration

General

Coagulation factor X human is available in the following dosage form(s) and strength(s):

Coagulation factor X human is available as a lyophilized powder for reconstitution in single-use vials containing nominally (approximately) 250 IU or 500 IU of factor X activity. When reconstituted using the sterile water for injection supplied with the kit, the final concentration is approximately 100 IU/mL).1

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage, preparation, and administration of this drug. Dosage summary:

For intravenous use only after reconstitution. 1

  • Each vial of coagulation factor X human contains the labeled amount of factor X in international units (IU).1

  • The dosage and duration of treatment depend on the severity of the factor X deficiency, on the location and extent of the bleeding and on the patient's clinical condition.1

  • For treatment of bleeding episodes: Use 25 IU per kg body weight, repeated at intervals of 24 hours until the bleed stops.1

  • For perioperative management: Pre-surgery, raise plasma factor X levels to 70-90 IU/dL.1

  • For perioperative management: Post-surgery, maintain plasma factor X levels at a minimum of 50 IU/dL until the patient is no longer at risk of bleeding due to surgery.1

  • For perioperative management: Required dose (IU) = Body weight (kg) × Desired factor X rise (IU/dL or % of normal) × 0.5.1

Cautions for Coagulation Factor X Human

Contraindications

Do not use in patients who have had life-threatening hypersensitivity reactions to coagulation factor X human or any of the components.1

Warnings/Precautions

Hypersensitivity Reactions

Allergic type hypersensitivity reactions, including anaphylaxis, are possible. Early signs of hypersensitivity reactions including angioedema, infusion site inflammation (e.g., burning, stinging, erythema), chills, cough, dizziness, fever, flushing, generalized urticaria, headache, hives, hypotension, lethargy, musculoskeletal pains, nausea, pruritus, rash, restlessness, tachycardia, tightness of the chest, tingling, vomiting, and wheezing. If hypersensitivity symptoms occur, discontinue use of the product immediately and administer appropriate emergency treatment.1

Coagulation factor X human contains traces of human proteins other than factor X.1

Neutralizing Antibodies

The formation of neutralizing antibodies (inhibitors) to factor X may occur. Monitor all patients treated with coagulation factor X human for the development of inhibitors by appropriate clinical observations and laboratory tests. 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.1

Transmissible Infectious Agents

As coagulation factor X human is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. There is also the possibility that unknown infectious agents may be present in the product. The risk that the product will transmit viruses has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and removing certain viruses during manufacture. Despite these measures, this product may still potentially transmit diseases.1

All infections suspected by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare providers to BPL Inc. at 1-866-398-0825.1

Monitoring and Laboratory Tests

  • Monitor plasma factor X activity by performing a validated test (e.g., one-stage clotting assay), to confirm that adequate factor X levels have been achieved and maintained.1

  • Monitor for the development of factor X inhibitors. Perform a Nijmegen-Bethesda inhibitor assay if expected factor X plasma levels are not attained, or if bleeding is not controlled with the expected dose of coagulation factor X human. Use Nijmegen-Bethesda Units (BU) to report inhibitor levels.1

Specific Populations

Pregnancy

There are no data with coagulation factor X human use in pregnant women to inform on drug-associated risk. Animal reproduction studies have not been conducted using coagulation factor X human. It is not known whether coagulation factor x human can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Coagulation factor X human should be given to a pregnant woman only if clearly needed. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.1

Lactation

There is no information regarding the presence of coagulation factor X human in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for coagulation factor X human and any potential adverse effects on the breastfed infant from coagulation factor X human or from the underlying maternal condition.1

Pediatric Use

Safety and efficacy in patients under the age of 12 years have not been studied. 1

Geriatric Use

Clinical studies of coagulation factor X human did not include any subjects aged 65 and over to determine whether they respond differently from younger subjects. Individualize dose selection for geriatric patients.1

Common Adverse Effects

The most common adverse drug reactions (frequency ≥ 5% of subjects) observed in clinical trials were infusion site erythema, infusion site pain, fatigue, and back pain.1

Drug Interactions

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Drug interaction studies have not been performed. Use with caution in patients who are receiving other plasma products that may contain factor X, (e.g., fresh frozen plasma, prothrombin complex concentrates). Based on the mechanism of action, coagulation factor X human is likely to be counteracted by direct and indirect factor Xa inhibitors.1

Actions

Mechanism of Action

Coagulation factor X human temporarily replaces the missing factor X needed for effective hemostasis. Factor X is an inactive zymogen, which can be activated by factor IXa (via the intrinsic pathway) or by factor VIIa (via the extrinsic pathway). Factor X is 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 a phospholipid surface to form the prothrombinase complex, which activates 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.1

Advice to Patients

Patient Counseling Information

Advise the patients to read the FDA-approved patient labeling (Patient Information and Instructions for Use).1

Inform patients to immediately report the following early signs and symptoms of hypersensitivity reactions to their healthcare professional: angioedema, infusion site inflammation (e.g., burning, stinging, erythema), chills, cough, dizziness, fever, flushing, generalized urticaria, headache, hives, hypotension, lethargy, musculoskeletal pains, nausea, pruritus, rash, restlessness, tachycardia, tightness of the chest, tingling, vomiting, or wheezing.1

Inform patients that the development of inhibitors to factor X is a possible complication of treatment with coagulation factor X human. Advise the patients to contact their healthcare provider for further treatment and/or assessment if they experience a lack of clinical response to coagulation factor X human because this may be a manifestation of an inhibitor.1

Inform patients that coagulation factor X human is made from human plasma and may contain infectious agents that can cause diseases. While the risk that coagulation factor X human can transmit an infection has been reduced by screening plasma donors for prior exposure, testing donated plasma, and inactivating or removing certain viruses during manufacturing, patients should report any symptoms that concern them.1

Additional Information

AHFS First Release. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Coagulation Factor X Human

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, Powder, Lyophilized, For Solution

100 [IU] /1 mL*

Coagadex

Bio Products Laboratory Limited

AHFS DI Essentials. © Copyright, 2016, American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

Date published: September 08, 2016
Last reviewed: September 08, 2016
Date modified: October 12, 2016

References

1. Bio Products Laboratory Limited. Coagadex (Coagulation Factor X Human) prescribing information. 2015 Oct.

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