Factor XIII Concentrate (Human)

Name: Factor XIII Concentrate (Human)

Pregnancy & Lactation

Pregnancy Category: C

Benefits and risks should be carefully assessed in pregnant women because of their hypercoagulable state and potential for increased risk of thromboembolic events

Lactation: Unknown if distributed in breast milk, caution advised

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.

Administration

IV Preparation

IV infusion

Prior to reconstitution, allow Corifact and the supplied diluent to reach room temperature

Use the Mix2VialTM system as directed with provided diluent (ie, 20 mL of sterile water for injection)

Do not shake the vial to reconstitute – gently swirl until the powder is completely dissolved

IV Administration

Infuse through a separate infusion line; Y-site administration not advised

Infuse at a rate not to exceed 4 mL/min

Administer within 4 hr of reconstitution

Storage

Unreconstituted product

  • Store in a refrigerator at 2-8˚C (36-46˚F) – stable for up to 24 months within the expiration date
  • Can be stored at room temperature not to exceed 25˚C (77˚F) for up to 6 months within the expiration date; do not return product to refrigerator after stored at room temperature (clearly mark beginning date of room temperature storage)
  • Do not freeze
  • Protect from light

Reconstituted product

  • Contains no preservatives
  • Product must be used within 4 hr after reconstitution
  • Do not refrigerate or freeze the reconstituted solution
  • Discard partially used vials

What do I need to tell my doctor BEFORE I take Factor XIII Concentrate?

  • If you have an allergy to Factor XIII or any other part of factor XIII concentrate (human).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Factor XIII Concentrate?

  • Tell all of your health care providers that you take factor XIII concentrate. This includes your doctors, nurses, pharmacists, and dentists.
  • Allergic side effects may rarely happen.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Blood clots have happened with this medicine. Tell your doctor if you have ever had a blood clot. Talk with your doctor.
  • Call the doctor right away if the normal dose does not work as well.
  • This medicine is made from human plasma (part of the blood) and may have viruses that may cause disease. This medicine is screened, tested, and treated to lower the chance that it carries an infection. Talk with the doctor.
  • Talk with the doctor before you travel. You will need to bring enough of factor XIII concentrate for use during travel.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about factor XIII concentrate, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

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 brief summary of general information about factor XIII concentrate. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using factor XIII concentrate (human).

Review Date: October 4, 2017

Index Terms

  • Activated Factor XIII
  • Corifact
  • Factor 13
  • FXIII

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

(web3)