Corifact (Factor XIII Concentrate): FDA-Approved Treatment for Congenital Factor XIII Deficiency

Corifact (also known by its generic name, factor XIII concentrate) is an injectable prescription medicine used to prevent excessive bleeding in people with congenital factor XIII deficiency, which is a rare inherited bleeding disorder. This condition affects around 1 in every 2 to 3 million people, with an incidence in the U.S. of approximately 150 people.

Corifact belongs to the drug class of coagulation factors and is also classified as a hemostatic agent that helps prevent and control bleeding by supporting proper blood clot formation. 

This drug was approved by the U.S. Food and Drug Administration (FDA) in 2011 and is available in 12 different countries around the world under the brand name Fibrogammin®- P. 

Read on to learn when it is recommended, how it works, its dosage, and important precautionary measures. 

Approved Uses

Corifact is approved only for the treatment of congenital factor XIII deficiency in both adults and pediatric patients. It is prescribed in the following situations:

• To help prevent unexpected bleeding before it happens, even if there is no injury.
• To prevent and treat bleeding during or after minor or major surgical procedures.
• To prevent uncontrolled bleeding after minor injuries.

How Corifact Works 

To better understand how Corifact works, it is important to first understand congenital factor XIII deficiency. 

This extremely rare bleeding disorder occurs when a person is born with too little or no factor XIII protein. The factor XIII protein usually helps blood clots become strong and stable. 

Normally, when you get a cut or injury, your body forms a clot to stop bleeding. Factor XIII protein strengthens the clot so it stays in place while healing occurs. 

However, when you have factor XIII deficiency, blood clots do form, but they are weak and unstable. Without enough Factor XIII, the clot breaks down too quickly, leading to prolonged or unexpected bleeding, even after minor injuries. 

Corifact Working Mechanism

Corifact contains a purified form of human factor XIII protein extracted from pooled human plasma donated by healthy individuals. It works like the body’s natural clotting protein and replaces the missing factor XIII in the bloodstream. Once infused, it:

• Increases the level of Factor XIII in the blood
• Strengthens blood clots
• Helps clots stay in place long enough for proper healing
• Reduces the risk of spontaneous or uncontrolled bleeding
• Helps prevent spontaneous bleeding episodes

By maintaining adequate Factor XIII levels, Corifact helps the body form stronger, more stable clots, lowering the risk of serious bleeding episodes.

Drug Form and Strengths

Corifact comes as a white, lyophilized (freeze-dried) powder form that must be mixed with a sterile diluent before use. It is available in two vial strengths:

• 250 IU, which is mixed with 4 ml of Sterile Water for Injection
• 1,250 IU, which is mixed with 20 ml of Sterile Water for Injection

Dosage for Adults and Children

The dose of Corifact is based on body weight, not age. This means adults and children generally receive the same weight-based dosing schedule.

Routine Preventive Treatment (Prophylaxis)

Both adults and children with congenital Factor XIII deficiency receive a dose of 40 IU/kg body weight intravenously, once every 4 weeks (every 28 days). 

The doctor may adjust the dose based on the factor XIII blood levels, bleeding history, or any upcoming surgeries or procedures. 

For Perioperative Management of Surgical Bleeding

If you need surgery or experience a bleeding episode, your healthcare provider may adjust the dose based on your Factor XIII levels, the type of surgery, and your clinical response.

Corifact: Administration 

Corifact is given as an intravenous (IV) infusion, administered directly into a vein. Before infusing, Corifact is dissolved with sterile water provided in the package.

Possible Side Effects

Corifact is generally a well-tolerated drug. But you may experience some common side effects such as:

• Joint inflammation
• Joint pain (arthralgia)
• Mild rash or itching
• Headache
• Pain at the injection site
• Mild fever
• Elevated thrombin-antithrombin levels
• Increased blood lactate dehydrogenase

Serious Side Effects (Rare)

Seek immediate medical attention if you experience:

• Hypersensitivity or allergic reactions (rash, itching, swelling)
• Acute ischemia

Corifact: Contraindications and Warnings

You should not use Corifact if you have experienced hypersensitivity reactions, including anaphylactic or severe systemic reactions to human plasma-derived products or to any ingredient in Corifact.  

In rare cases, the body may develop antibodies (inhibitors) against Factor XIII, which can reduce how well Corifact works. Your doctor may monitor your blood levels if treatment seems less effective.

Moreover, because Corifact is made from human plasma, there is a very small risk of viral transmission, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Precautionary Measures You Should Take

Before using Corifact, it is important to take some safety measures to help ensure the medicine works effectively and safely. Always consult your healthcare provider before taking Corifact if you:

• Are pregnant or plan to become pregnant, as it is not known whether Corifact can harm your unborn baby.
• Are breastfeeding or plan to breastfeed, because it is not known if Corifact passes into breast milk.
• Have experienced allergic reactions to this drug, its ingredients, or components of the container. 
• Are taking any over-the-counter medications or supplements, or herbal products.
• Have or have had any liver disease. 
• Have been told that you have inhibitors (neutralizing antibodies) against factor XIII, as Corifact may not work effectively in this case. 

Corifact: Estimated Cost

The cost of Corifact can vary widely depending on your healthcare coverage and how much medication you need. Because Corifact is a specialized clotting factor product, it is typically very expensive, often costing several thousand dollars per vial depending on dosage and insurance coverage.

Contact us if you are interested in exploring financial assistance or copay assistance for Corifact.