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Factor XIII Concentrate (Human)

Medically reviewed by Drugs.com. Last updated on Jan 23, 2020.

Pronunciation

(FAK ter THIR teen KON cen trate HYU man)

Index Terms

  • Activated Factor XIII
  • Corifact
  • Factor 13
  • FXIII

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Kit, Intravenous [preservative free]:

Corifact: 1000 - 1600 units [contains albumin human]

Brand Names: U.S.

  • Corifact

Pharmacologic Category

  • Antihemophilic Agent
  • Blood Product Derivative

Pharmacology

Factor XIII (FXIII) is an endogenous plasma glycoprotein found in platelets, monocytes and macrophages that is converted to activated factor XIII (FXIIIa) in the presence of calcium ions. Once activated, FXIIIa cross-links fibrin and cross-links plasmin inhibitor to protect and strengthen the hemostatic platelet plug.

Distribution

Vd: 51.1 mL/kg

Metabolism

Factor XIII, a proenzyme, is converted to activated factor XIII

Excretion

Clearance:

Pediatric patients <16 years: 0.29 ± 0.12 mL/hour/kg

Adults: 0.22 ± 0.07 mL/hour/kg

Time to Peak

1.7 hours postinfusion

Duration of Action

Plasma levels of FXIII: ~28 days; FXIII activity maintained at ≥5% in ≥97% of patients and ≥10% in ≥85% of patients

Half-Life Elimination

Children (<16 years): 5.7 ± 1 days; Adults: 7.1 ± 2.7 days

Use: Labeled Indications

Prophylaxis against bleeding episodes and management of perioperative surgical bleeding in patients with congenital factor XIII deficiency

Contraindications

History of anaphylaxis or severe systemic reactions to human plasma-derived products or hypersensitivity to any component of the formulation

Dosing: Adult

Congenital factor XIII deficiency: IV:

Prophylaxis:

Initial: 40 units/kg

Maintenance: Dose adjustment should be based on factor XIII activity trough levels (target level of 5% to 20% using Berichrom activity assay) and clinical response; repeat every 28 days

One trough level of <5%: Increase dosage by 5 units/kg

Trough level of 5% to 20%: No dosage change

Two trough levels of >20%: Decrease dosage by 5 units/kg

One trough level of >25%: Decrease dosage by 5 units/kg

Perioperative management of surgical bleeding: Individualize dosing based on factor XIII activity level, type of surgery, and clinical response; monitor factor XIII activity levels during and after surgery:

If time since last prophylactic dose ≤7 days: Additional dose may not be needed.

If time since last prophylactic dose 8 to 21 days: Additional partial or full dose may be necessary based on factor XIII activity level

If time since last prophylactic dose 21 to 28 days: Administer full prophylactic dose

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Congenital factor XIII deficiency: Infants, Children, and Adolescents: IV:

Prophylaxis:

Initial: 40 units/kg

Maintenance: Adjust dose in 5 units/kg increments based on factor XIII activity trough levels (target level of 5% to 20% using Berichrom activity assay) and clinical response; repeat every 28 days

Factor XIII Activity Trough Level (%):

One trough level <5%: Increase dosage by 5 units/kg

Trough level 5% to 20%: No dosage change

Two trough levels >20%: Decrease dosage by 5 units/kg

One trough level >25%: Decrease dosage by 5 units/kg

Treatment, perioperative management of surgical bleeding: Individualize dosing based on factor XIII activity level, type of surgery, and clinical response; monitor factor XIII activity levels during and after surgery:

If time since last prophylactic dose ≤7 days: Additional dose may not be needed.

If time since last prophylactic dose 8 to 21 days: Additional partial or full dose may be necessary based on factor XIII activity level.

If time since last prophylactic dose 21 to 28 days: Administer full prophylactic dose.

Reconstitution

Reconstitute with provided diluent (SWFI); gently swirl; do not shake. Product and diluent should be at room temperature prior to reconstitution. Reconstituted solution should be used within 4 hours (US labeling) or 3 hours (Canadian labeling); do not refrigerate or freeze.

Administration

IV: Administer by IV infusion at a rate not to exceed 4 mL/minute. Product should be brought to room temperature prior to infusing. Administer through a separate infusion line.

Storage

Store at 2°C to 8°C (36°F to 46°F); do not freeze. Protect from light. May be stored at room temperature (≤25°C [≤77°F]) for up to 6 months; do not return to refrigerator if stored at room temperature.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

Frequency not defined.

>1%:

Central nervous system: Chills, headache

Dermatologic: Erythema, pruritus, skin rash

Endocrine & metabolic: Increased lactate dehydrogenase

Hematologic & oncologic: Hematoma

Hypersensitivity: Hypersensitivity reaction

Neuromuscular & skeletal: Arthralgia, arthritis

Miscellaneous: Fever

<1%, postmarketing, and/or case reports: Anaphylaxis, antibody development (factor XIII), infection, ischemia (acute), thromboembolism

Warnings/Precautions

Concerns related to adverse effects:

• Antibody formation: The development of factor XIII inhibitory antibodies has been reported. Factor XIII inhibitory antibodies should be measured when clinical response (breakthrough bleeding) and/or factor XIII trough levels are suboptimal after apparent adequate dosing.

• Hypersensitivity reactions: Hypersensitivity and anaphylactic reactions have been reported with use; discontinue immediately if develops and initiate appropriate management.

• Thrombotic events: Thromboembolic events have been reported. Use with caution in patients with known risk factors for thrombosis.

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. Vaccination with hepatitis A and hepatitis B vaccines is recommended.

Monitoring Parameters

Factor XIII trough levels in conjunction with clinical response to assess efficacy (ie, approximately every 28 days for prophylaxis, during and after surgery for perioperative management of surgical bleeding). Factor XIII inhibitory antibodies if inadequate clinical response and/or factor XIII trough levels are suboptimal. Signs/symptoms of hypersensitivity reactions, thrombotic events, and infection.

Pregnancy Considerations

Pregnant patients with factor XIII deficiency may have an increased risk of bleeding following abortion, antenatal procedures, and delivery. There is also a high rate of pregnancy loss without treatment; close surveillance is recommended. Maternal factor XIII concentrations decrease during pregnancy and dosing frequency should be increased. Additional treatment may be needed prior to delivery or procedures. Factor XIII concentrate (human) may be used in patients with a factor XIII deficiency (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:

• Headache

• Joint pain

• Injection site irritation

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:

• Infection

• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight

• Blood clots like numbness or weakness on one side of the body; pain, redness, tenderness, warmth, or swelling in the arms or legs; change in color of an arm or leg; angina; shortness of breath; tachycardia; or coughing up blood

• Dizziness

• Passing out

• Chills

• Bruising

• Bleeding

• 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

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