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Factor XIII, concentrate from human plasma: Drug information

Factor XIII, concentrate from human plasma: Drug information
(For additional information see "Factor XIII, concentrate from human plasma: Patient drug information" and see "Factor XIII, concentrate from human plasma: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Corifact
Brand Names: Canada
  • Corifact 1250;
  • Corifact 250
Pharmacologic Category
  • Antihemophilic Agent;
  • Blood Product Derivative
Dosing: Adult
Congenital factor XIII deficiency

Congenital factor XIII deficiency:

Prophylaxis:

IV: Initial: 40 units/kg.

IV: 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: IV: 10 to 50 units/kg has been reported in clinical practice but because congenital factor XIII deficiency is a rare disorder, data are limited (Janbain 2015; Naderi 2017). 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: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Factor XIII, concentrate from human plasma: Pediatric drug information")

Congenital factor XIII deficiency

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.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults and pediatrics.

1% to 10%:

Dermatologic: Erythema of skin (1% to 2%), pruritus (1% to 2%), skin rash (1% to 2%)

Endocrine & metabolic: Increased lactate dehydrogenase (1% to 2%)

Hematologic & oncologic: Disorder of hemostatic components of blood (elevated thrombin-antithrombin levels: 1% to 2%), hematoma (1% to 2%)

Hypersensitivity: Hypersensitivity reaction (1% to 2%; can be severe hypersensitivity reaction)

Nervous system: Headache (1% to 2%)

Neuromuscular & skeletal: Arthralgia (1% to 2%), arthritis (1% to 2%)

<1%:

Cardiovascular: Ischemia (acute)

Immunologic: Antibody development (neutralizing)

Postmarketing: Cardiovascular: Thromboembolic complications

Contraindications

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

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.

Dosage Forms Considerations

Potency is shown as a range for each vial (1,000 to 1,600 units/vial). The actual units of potency of FXIII are stated on each vial label and carton.

Dosage Forms: US

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

Kit, Intravenous [preservative free]:

Corifact: 1000 - 1600 units [contains albumin human]

Generic Equivalent Available: US

No

Pricing: US

Kit (Corifact Intravenous)

1000-1600 unit (Price provided is per AHF Unit): $14.45

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

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

Solution Reconstituted, Intravenous:

Corifact 250: 250 units (1 ea) [contains albumin human]

Corifact 1250: 1250 units (1 ea) [contains albumin human]

Administration: Adult

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.

Administration: Pediatric

Parenteral: IV: Administer by IV infusion at a rate not to exceed 4 mL/minute. Administer through a separate infusion line.

Use: Labeled Indications

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

Medication Safety Issues
Sound-alike/look-alike issues:

Factor XIII may be confused with Factor VIII

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

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]).

Breastfeeding Considerations

It is not known if factor XIII concentrate (human) is present in breast milk.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother

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.

Mechanism of Action

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.

Pharmacokinetics (Adult Data Unless Noted)

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

Distribution: Vd: 51.1 mL/kg

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

Half-life elimination: Children (<16 years): 5.7 ± 1 days; Adults: 7.1 ± 2.7 days

Time to peak: 1.7 hours postinfusion

Excretion: Clearance:

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

Adults: 0.22 ± 0.07 mL/hour/kg

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Fibrogammin p;
  • (AR) Argentina: Fibrogammin p;
  • (AT) Austria: Fibrogammin p;
  • (AU) Australia: Fibrogammin p;
  • (BE) Belgium: Cluvot | Fibrogammin;
  • (BR) Brazil: Fibrogammin p;
  • (CO) Colombia: Fibrogammin;
  • (CZ) Czech Republic: Fibrogammin p;
  • (DE) Germany: Fibrogammin hs;
  • (ES) Spain: Cluvot;
  • (FI) Finland: Cluvot;
  • (FR) France: Fibrogammin | Fibrogammin p;
  • (GB) United Kingdom: Fibrogammin p;
  • (GR) Greece: Fibrogammin p;
  • (HU) Hungary: Fibrogammin p;
  • (IT) Italy: Cluviat;
  • (JP) Japan: Fibrogammin p;
  • (LB) Lebanon: Fibrogammin p;
  • (LT) Lithuania: Fibrogammin p;
  • (LU) Luxembourg: Fibrogammin;
  • (MX) Mexico: Cluvot;
  • (MY) Malaysia: Fibrogammin p;
  • (NL) Netherlands: Cluvot | Factor xiii | Fibrogammin p;
  • (NO) Norway: Cluvot | Fibrogammin p;
  • (PL) Poland: Cluvot | Fibrogammin p;
  • (PR) Puerto Rico: Corifact;
  • (PT) Portugal: Cluvot | Fibrogammin p;
  • (SA) Saudi Arabia: Fibrogammin;
  • (SE) Sweden: Cluvot;
  • (TW) Taiwan: Cluvot | Fibrogammin
  1. Corifact (factor XIII concentrate, human) [prescribing information]. Kankakee, IL: CSL Behring LLC; December 2019.
  2. Corifact (Factor XIII concentrate, Human) [product monograph]. Ottawa, Ontario, Canada: CSL Behring Canada Inc; January 2018.
  3. Hsieh L and Nugent D, “Factor XIII Deficiency,” Haemophilia, 2008, 14(6):1190-200.
  4. Janbain M, Nugent DJ, Powell JS, St-Louis J, Frame VB, Leissinger CA. Use of Factor XIII (FXIII) concentrate in patients with congenital FXIII deficiency undergoing surgical procedures. Transfusion. 2015;55(1):45-50. doi:10.1111/trf.12784 [PubMed 25070582]
  5. Karimi M, Bereczky Z, Cohan N, et al, “Factor XIII Deficiency,” Semin Thromb Hemost, 2009, 35(4):426-38. [PubMed 19598071]
  6. Naderi M, Haghpanah S, Miri-Aliabad G, Tavosi H, Karimi M. A large case series on surgical outcomes in congenital factor XIII deficiency patients in Iran. J Thromb Haemost. 2017;15(12):2300-2305. doi:10.1111/jth.13872 [PubMed 29028293]
  7. Pavord S, Rayment R, Madan B, et al; for the Royal College of Obstetricians and Gynaecologists. Management of inherited bleeding disorders in pregnancy: Green-top Guideline No. 71 (joint with UKHCDO). BJOG. 2017;124(8):e193–e263. doi: 10.1111/1471-0528.14592. [PubMed 28447403]
Topic 16473 Version 122.0

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