Coagulation Factor XIII A-Subunit (Recombinant)

What is Coagulation Factor XIII A-Subunit (Recombinant)?

• Coagulation Factor XIII A-Subunit (Recombinant) (Tretten), used as routine prophylaxis of bleeding in patients with congenital factor XIII A-subunit deficiency.

What are the uses of this medicine?

• This medicine used to prevent bleeding in adults and children who have congenital factor XIII (FXIII) A-subunit deficiency.
• Tretten is not for use in patients with congenital factor XIII B‑subunit deficiency.

How does this medicine work?

• Coagulation Factor XIII A-Subunit (Recombinant) is a protransglutaminase (rFXIII [rA2] homodimer) and binds to free human FXIII B-subunit resulting in a heterotetramer [rA2B2] with a similar half-life to [A2B2].
• rFXIII has been shown to be activated by thrombin in the presence of Ca2+.
• Activated rFXIII has been shown in dose-dependent manner to increase mechanical strength of fibrin clots, retard fibrinolysis, and rFXIII has been shown to enhance platelet adhesion to the site of injury.
• After combining with available plasma B-subunits, Coagulation Factor XIII A-subunit (Recombinant) has been shown to have the same pharmacodynamic properties in plasma as endogenous FXIII.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have known hypersensitivity to the active substance or to any of the excipients.

What drug interactions can this medicine cause?

• Do not administer Tretten with recombinant factor VIIa.
• Thrombosis may occur if Tretten is administered concomitantly with factor VIIa.

Is this medicine FDA approved?

• Initial U.S. Approval: 2013

How should this medicine be used?

Recommended Dosage:

• The dose for routine prophylaxis for bleeding in patients with congenital factor XIII (FXIII) A-subunit deficiency is 35 international units (IU) per kilogram body weight once monthly to achieve a target trough level of FXIII activity at or above 10% using a validated assay.
• Consider dose adjustment if adequate coverage is not achieved with the recommended 35 IU/kg dose.

Administration

• Once reconstituted, Tretten may be diluted with 0.9% sodium chloride to facilitate measurement of small volumes.
• Inspect the reconstituted Tretten visually for particulate matter and discoloration prior to administration. Do not use if particulate matter or discoloration is observed.
• Administer at a rate not exceeding 1-2 mL per minute.
• Do not administer with other infusion solutions.
• Do not administer as drip.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Lyophilized powder in single-dose vial containing 2000 - 3125 IU of recombinant coagulation factor XIII A-subunit.
• After reconstitution with 3.2 mL of sterile water for injection, each vial contains 667-1042 IU/mL of recombinant coagulation factor XIII A-subunit.

This medicine is available in fallowing brand namesː

• Tretten

What side effects can this medication cause?

The most common side effects of this medicine include: Signs of allergic reaction including

• shortness of breath
• rash
• itching (pruritus)
• redness of the skin (erythema)
• fainting/dizziness
• Signs of a blood clot including pain, swelling, warmth, redness, or a lump in your legs or arms, chest pain, or sudden severe headache and/or loss of consciousness or function
• Unexpected bleeding

Other possible side effects may include:

• pain in your arms or legs
• headache
• pain at the injection site

What special precautions should I follow?

• Tretten may cause allergic reactions. If signs or symptoms of anaphylaxis or hypersensitivity reactions (including urticaria, rash, tightness of the chest, wheezing, hypotension) occur, discontinue immediately and institute appropriate treatment.
• Thromboembolic complications may occur. Monitor patients with conditions that predispose to thrombosis for signs and symptoms of thrombosis after administration of Tretten.
• Inhibitory antibodies may occur with Tretten. Analyze for neutralizing antibodies if FXIII activity fails to reach expected levels or if reduced therapeutic effect is observed.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies using Tretten in pregnant women to determine whether there is a drug-associated risk.

Can this medicine be used in children?

• No dose adjustment is required for pediatric age group.

What are the active and inactive ingredients in this medicine?

Active Ingredient:

• CATRIDECACOG

Inactive ingredients:

• SODIUM CHLORIDE
• SUCROSE
• POLYSORBATE 20
• HISTIDINE

Who manufactures and distributes this medicine?

Manufactured by:

• Novo Nordisk A/S
• DK-2880 Bagsvaerd, Denmark

• Novo Nordisk® is a registered trademark of Novo Nordisk A/S

What should I know about storage and disposal of this medication?

• It is important to store Tretten correctly.

Before preparing Tretten for injection

• Keep Tretten in a refrigerator at 36°F to 46°F (2°C to 8°C) and in the original package in order to protect it from light. Do not freeze Tretten.

After preparing Tretten for injection (reconstituted)

• Use Tretten immediately after it is dissolved (reconstituted) using the sterile water provided in the package.
• If you cannot inject it immediately, either leave Tretten at room temperature not above 25°C (77°F) or put
• Tretten in the refrigerator at 36°F to 46°F (2°C to 8°C) for no more than 3 hours. After more than 3 hours, DO

• NOT USE IT—THROW IT AWAY.
• Tretten does not contain a preservative. Do not store Tretten in the syringe or placed in the freezer.

• Dailymed label info on Coagulation Factor XIII A-Subunit (Recombinant)
• FDA Coagulation Factor XIII A-Subunit (Recombinant)

Coagulation Factor XIII A-Subunit (Recombinant) Resources
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