Catridecacog

Mechanism of Action

Recombinant human factor XIII-A2 homodimer composed of 2 FXIII A-subunits

FXIII is the terminal enzyme in the blood coagulation cascade; when activated by thrombin at the site of vessel wall injury, FXIII plays an important role in the maintenance of hemostasis through cross-linking of fibrin and other proteins in the fibrin clot

Absorption

Peak plasma concentration: 0.71 IU/mL (adults); 0.48 IU/mL (children)

AUC: 128.3 IU•hr/mL (adults); 107.8 IU•hr/mL (children)

Distribution

Vd: 65.9 mL/kg (adults); 61.2 mL/kg (children)

Elimination

Half-life: 5.1 days (adults); 7.1 days (children)

Clearance: 0.33 mL/hr/kg (adults); 0.41 mL/hr/kg (children)

Mean residence time (MRT): 7.9 (adults); 7.5 (children)

Before taking catridecacog, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• If you are pregnant, think you may be pregnant or planning to become pregnant. It is not known if catridecacog can harm you or your unborn baby.
• Labor and Delivery: It is not known if catridecacog is safe and effective during labor and delivery.
• Breast feeding: It is not known if catridecacog passes into your breast milk.
• If you have a history of blood clots.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following your weight.

The recommended dose/dose range of catridecacog (Tretten) is 35 IU/kg dose.

Catridecacog is a prescription medication used to prevent bleeding in people with a rare blood clotting disorder known as congenital Factor XIII A-subunit deficiency. This medication replaces an important protein necessary for normal clotting.

Catridecacog comes in an injectable form to be given directly into a vein (IV) by a healthcare professional. In some cases, patients can be taught to properly administer this medication.

Common side effects include headache and pain at the site of injection.

In clinical trials, the most frequent adverse drug reactions were non-neutralizing antibodies. The antibodies had no inhibitory effect and the patients did not experience any adverse events or bleeding in association with these antibodies.

Serious side effects can occur including:

• hypersensitivity reactions. This medication is a recombinant protein and it may cause allergic reactions including anaphylactic reaction (a severe allergic response). Tell your healthcare provider if you have signs of an allergic reaction including hives, rash, tightness of the chest, wheezing, low blood pressure and anaphylaxis.
• thrombosis (blood clot formation). Increased levels of activated rFXIII may increase the risk of thrombosis. In case of predisposition to conditions of thrombosis, caution should be exercised due to the fibrin-stabilizing effect of this medication.

• Reconstituted (prepared) catridecacog should be used immediately.
• If it is not used immediately, it should be used within 3 hours if stored at room temperature. After this period discard it.
• It should be used within 24 hours if stored in the refrigerator at 2ºC–8ºC. After this period discard it. 
• Do not store reconstituted catridecacog in a syringe.
• Do not freeze reconstituted catridecacog.

If you take too much catridecacog, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If catridecacog is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.