Frequently Asked Questions About Corifact

Here are answers to some of the frequently asked questions about Corifact:

What is Corifact?

Corifact is the first and only purified Factor XIII concentrate that contains both A- and B-subunits (dual-subunits). It is a heat-treated, lyophilized concentrate of coagulation factor XIII for reconstitution for intravenous use.

What is the indication for Corifact?

Corifact is indicated for routine prophylactic treatment and perioperative management of surgical bleeding in adult and pediatric patients with congenital Factor XIII deficiency. Corifact must be administered intravenously.

How should Corifact be dosed?

Corifact should be dosed at 40 International Units (IU) per kg body weight and administered intravenously at a rate not to exceed 4 mL per minute. Adjust dose ±5 IU per kg to maintain 5% to 20% trough level of FXIII activity.

  • For routine prophylaxis, administer every 28 days.
  • For perioperative management of surgical bleeding:
    • Dosing should be individualized based on the patient's FXIII activity level, type of surgery, and clinical response.
    • Monitor patient's FXIII activity levels during and after surgery.

Corifact dosing, duration of dosing, and frequency of administration in adults and children should be individualized based on body weight, laboratory values, and the patient's clinical condition.

How often should Factor XIII levels be tested when using Corifact?

Due to the individualized pharmacokinetics of each patient and clinical conditions, there is no standard timeframe for recommended testing. This decision should be made by the treating physician.

Does Corifact contain preservatives?

No.

Can Corifact be reconstituted right after refrigeration?

No. Corifact must be brought to room temperature prior to reconstitution.

Should Corifact be reconstituted with saline or sterile water, and how much?

Corifact must be reconstituted with 20 mL Sterile Water for Injection USP, which is provided in a vial with the product. A Mix2Vial® filter transfer set is also provided.

What should Corifact look like after reconstitution?

It should be colorless to slightly yellow, opalescent, with no visible particles.5

Can I reconstitute Corifact by vigorously shaking the vial?

No. The product should be gently swirled for a few minutes.

How long after reconstitution can Corifact be used?

Corifact must be used within 4 hours after reconstitution. Do not refrigerate or freeze the reconstituted solution.

Can I use left-over product?

No. Corifact is approved as a single-use vial. Any unused product should be discarded.

Can I push the syringe hard to quickly administer the product?

No. Corifact should be administered by slow infusion at no more than 4 mL per minute.

How much Factor XIII is in each vial?

The content for each vial can range from 1000-1600 IU. The exact potency, however, is listed on both the carton and the label for each vial of Corifact.

What are the most common adverse events associated with Corifact?

The most common adverse reactions reported in clinical trials (frequency > 1%) following treatment with Corifact were joint inflammation, hypersensitivity, rash, pruritus, erythema, hematoma, arthralgia, headache, elevated thrombinantithrombin levels, and increased blood lactate dehydrogenase. Serious adverse reactions, reported in one subject each (frequency 0.5%), were hypersensitivity, acute ischemia, and neutralizing antibodies against FXIII.

In a 12-month efficacy and safety study, there were no reports of deaths, life-threatening events, or adverse events that led to discontinuation or withdrawal.

Can Corifact be used in children?

Corifact has been studied in children less than 16 years of age. Clinical observations show a shorter half-life and faster clearance in this patient population compared to adults. Dose adjustments may be needed for patients under 16. No differences were seen in the safety profiles of children and adults.

Can Corifact be used in pregnant women?

Corifact has a Pregnancy Category C rating. Corifact has not been studied in pregnant women. Corifact should be given to a pregnant woman only if clearly needed.

How is Corifact packaged?

The carton contains one single-use vial of Corifact (1000-1600 units), one 20-mL vial of Sterile Water for Injection USP, one Mix2Vial® filter transfer set, and one alcohol swab.

What are the storage requirements for Corifact?

Refrigerate Corifact at 2-8 degrees Celsius (36-46 degrees Fahrenheit) for a period of 24 months up to expiration date on carton and vial labels. Keep product in original carton to protect it from light. Do not allow to freeze.

Before its expiration date, Corifact can be stored at room temperature (not to exceed 25 degrees Celsius [77 degrees Fahrenheit]). However, once product has been stored at room temperature it cannot be returned to refrigeration and must be used within 6 months or by expiration date on label.

Once brought to room temperature, can Corifact be refrigerated?

No. Do not return the product to the refrigerator after it has been stored at room temperature. Clearly mark the beginning date of room temperature storage on the carton label. Do not use beyond the expiration date or after 6 months of room temperature storage, whichever comes first.

What is the NDC number for Corifact?

The NDC number for the Corifact carton is 63833-518-02. The NDC number for Corifact vial for reimbursement is 63833-528-01.

What is the Corifact J-Code?

The HCPCS Code for Corifact is J7180 – Factor XIII Injection (antihemophilic factor, human). Billing codes are available at: http://www.cslbehring-us.com/products/universal-billing-codes.htm

Important Safety Information

Corifact®, FXIII Concentrate (Human), is indicated for routine prophylactic treatment and perioperative management of surgical bleeding in adult and pediatric patients with congenital Factor XIII deficiency. Corifact must be administered intravenously.

Corifact is contraindicated in individuals with known anaphylactic or severe systemic reactions to human plasma-derived products.

Hypersensitivity reactions may occur with Corifact. If there are signs of anaphylaxis or hypersensitivity reactions (including urticaria, rash, tightness of the chest, wheezing, and hypotension), immediately discontinue administration and institute appropriate treatment.

Inhibitory antibodies to FXIII have been detected in patients receiving Corifact. Monitor the patient’s trough FXIII activity level during treatment. If expected plasma FXIII activity levels are not attained or breakthrough bleeding occurs, perform an assay measuring FXIII inhibitory antibody concentrations.

Thromboembolic complications have been reported with Corifact; monitor patients with known risk factors for thrombotic events.

Corifact is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

The most common adverse reactions reported in clinical trials (frequency >1%) following treatment with Corifact were joint inflammation, hypersensitivity, rash, pruritus; hematoma, arthralgia, headache, elevated thrombin-anti-thrombin levels, and increased blood lactate dehydrogenase. Serious adverse reactions included hypersensitivity, acute ischemia, and neutralizing antibodies against FXIII.

Please see full prescribing information for Corifact, including patient product information.