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Corifact

Last reviewed on RxList: 2/14/2020
Corifact Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Corifact?

Corifact is a Factor XIII concentrate indicated for adult and pediatric patients with congenital Factor XIII deficiency for routine prophylactic treatment and peri-operative management of surgical bleeding.

What Are Side Effects of Corifact?

Common side effects of Corifact include:

  • joint inflammation
  • hypersensitivity
  • rash
  • itching
  • redness
  • swelling of blood clots (hematoma)
  • joint pain
  • headache
  • chills
  • fever
  • breakthrough bleeding and pain resulting from formation of antibodies against Corifact elevated thrombin-antithrombin levels and increased blood lactate dehydrogenase.
  • acute ischemia
  • neutralizing antibodies against FXIII

Dosage for Corifact

The dose of Corifact is 40 International Units (IU) per kg body weight; rate not to exceed 4 mL per min.

What Drugs, Substances, or Supplements Interact with Corifact?

Corifact may interact with other drugs. Tell your doctor all medications and supplements you use.

Corifact During Pregnancy and Breastfeeding

During pregnancyCorifact should be used only if prescribed. It is unknown if Corifact passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Corifact Factor XIII Concentrate (Human) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Corifact Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • new or worsening bleeding episodes;
  • unusual bruising;
  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
  • signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
  • signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

Common side effects may include:

  • fever, chills, flu symptoms;
  • stomach pain, vomiting, diarrhea,
  • headache;
  • joint pain;
  • mild rash or itching; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Corifact (Factor XIII Concentrate (Human) Lyophilized Powder Reconstitution for Intravenous Use)

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Corifact Professional Information

SIDE EFFECTS

The most common adverse reactions reported in clinical trials (>1%) are joint inflammation, hypersensitivity, rash, pruritus, erythema, hematoma, arthralgia, headache, elevated thrombin-antithrombin levels, and increased blood lactate dehydrogenase. The serious adverse reactions, reported (frequency 0.5%), were hypersensitivity, acute ischemia, and neutralizing antibodies against FXIII [see WARNINGS AND PRECAUTIONS].

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Twelve clinical studies included a total of 188 subjects, 108 subjects were <16 years of age [see Use In Specific Populations] and a total of approximately 4314 infusions of CORIFACT were administered in the studies.

The most common adverse reactions occurring at a rate of 1-2% are outlined [see ADVERSE REACTIONS].

Immunogenicity

A case of neutralizing antibodies against FXIII was reported in an open enrollment clinical study. The patient received prophylactic treatment with CORIFACT for ten years. Concomitant medications included interferon for hepatitis C infection. This patient presented with bruising, and post-infusion FXIII levels were found to be lower than expected. Over several weeks, FXIII recovery values decreased, so the dose and frequency of treatments were increased. Neutralizing antibodies to FXIII were detected, interferon treatment was discontinued, and the subject underwent plasmapheresis. Within a month, neutralizing antibodies were no longer detectable, FXIII recovery levels improved, and the previous prophylactic regimen was resumed.

Read the entire FDA prescribing information for Corifact (Factor XIII Concentrate (Human) Lyophilized Powder Reconstitution for Intravenous Use)

Related Resources for Corifact

© Corifact Patient Information is supplied by Cerner Multum, Inc. and Corifact Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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