Tretten Injection: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Tretten Injection (Coagulation Factor XIII A-Subunit, Recombinant) is a man-made injectable medicine used to prevent bleeding in adults and children with congenital factor XIII A-subunit deficiency. It contains no animal or human materials and is not intended for congenital factor XIII B-subunit deficiency. It is given once a month by intravenous injection, with the dose based on body weight.

What is Tretten Injection

Tretten is an injectable medicine used to prevent bleeding in adults and children who have congenital factor XIII (FXIII) A-subunit deficiency. It is man-made and does not contain animal or human materials. It is not for use in patients with congenital factor XIII B-subunit deficiency.

Tretten Injection uses

• Prevents bleeding in patients with congenital factor XIII A-subunit deficiency.
• Helps reduce recurrent spontaneous bleeding.
• Maintains factor XIII activity in patients with inherited deficiency.
• Supports normal fibrin clot stabilization.

Benefits of Tretten Injection

• Replaces missing or deficient factor XIII A-subunit activity.
• Helps strengthen and stabilize fibrin blood clots.
• Reduces the frequency of bleeding episodes in responsive patients.
• Provides prolonged protection through monthly administration.

How Tretten Injection works

Tretten works by maintaining the body's factor XIII activity levels, which helps make blood clots stronger and less likely to break down.

Tretten Injection dosage

Tretten is given as an injection into a vein (intravenous injection) once a month. Your dose depends on your body weight, so use the dose your healthcare provider has prescribed for you based on your weight. Before injecting, it must be dissolved (reconstituted) using the sterile water provided in the package. If needed for a small dose, it may be diluted with sodium chloride solution. Do not inject faster than the rate your provider recommends per minute. Throw away any medicine left in the vial after you inject your dose because it may become unsterile.

Available forms and strengths

• Intravenous injection (powder for reconstitution with sterile water)

Side effects of Tretten Injection

Common

• Headache
• Pain in the extremities (arms or legs)
• Injection site pain, redness, or irritation
• Increased fibrin D-dimer levels (shown in blood tests)
• Bruising or minor nosebleeds

Serious

• Severe allergic reaction (anaphylaxis): hives, itching, swelling of the face or lips, dizziness, difficulty breathing, rash, redness of the skin, fainting
• Blood clots (thrombosis): pain, swelling, warmth, redness, or a lump in the legs or arms, chest pain, or sudden severe headache and/or loss of consciousness or function
• Development of antibodies against the medication, leading to an inadequate response or breakthrough bleeding
• Unexpected bleeding

Warnings and precautions

• Do not use Tretten if you have ever had an allergic reaction, including a severe whole-body reaction (anaphylaxis), to Tretten or any of its ingredients.
• Do not use Tretten together with recombinant factor VIIa, as this can increase the risk of blood clots.
• Tell your healthcare provider if you have a history of blood clots.
• Tretten is not for use in patients with congenital factor XIII B-subunit deficiency, since it only replaces the A-subunit.
• Do not use Tretten for any condition it was not prescribed for, and do not share it with others even if they have similar symptoms.
• It is not known if Tretten can harm you or your unborn baby. Tell your healthcare provider if you are pregnant, think you may be pregnant, or are planning to become pregnant.
• It is not known if Tretten passes into breast milk.
• Kidney: No established renal-specific dosage adjustment is available. Patients with significant kidney disease require individualized medical assessment.
• Liver: No standardized hepatic dose adjustment is established. Patients with liver disease require evaluation because liver disorders may independently affect blood clotting.
• Alcohol: No major direct interaction has been established. Excessive alcohol consumption may worsen underlying medical conditions affecting clotting or liver function.
• Driving: Tretten is not generally associated with substantial sedation. Avoid driving or operating machinery if dizziness or other impairing symptoms occur.

Storage

• Keep in a refrigerator at 36°F to 46°F (2°C to 8°C) and in the original package to protect it from light
• Do not freeze
• Use immediately after it is dissolved (reconstituted) using the sterile water provided in the package
• If you cannot inject it immediately, either leave it at room temperature not above 25°C (77°F) or put it 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
• Does not contain a preservative
• Do not store in the syringe or place in the freezer

When to see a doctor

• Get medical help right away if you have signs of an allergic reaction such as shortness of breath, rash, itching, skin redness, or fainting/dizziness.
• Get medical help right away if you have signs of a blood clot, such as pain, swelling, warmth, redness, or a lump in your legs or arms, chest pain, or a sudden severe headache and/or loss of consciousness or function.
• Get medical help right away if you have any unexpected bleeding.

Alternatives

• Plasma-derived factor XIII replacement products
• Fibrogammin
• Corifact