https://wikimd.org/index.php?action=history&feed=atom&title=Coagulation_Factor_XIII_A-Subunit_%28Recombinant%29Coagulation Factor XIII A-Subunit (Recombinant) - Revision history2026-04-27T19:56:35ZRevision history for this page on the wikiMediaWiki 1.44.2https://wikimd.org/index.php?title=Coagulation_Factor_XIII_A-Subunit_(Recombinant)&diff=4756289&oldid=prevDeepika vegiraju at 12:43, 27 December 20222022-12-27T12:43:49Z<p></p>
<p><b>New page</b></p><div>== '''What is Coagulation Factor XIII A-Subunit (Recombinant)?''' ==<br />
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* Coagulation Factor XIII A-Subunit (Recombinant) ('''Tretten'''), used as routine [[prophylaxis]] of bleeding in patients with congenital factor XIII A-subunit deficiency.<br />
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== '''What are the uses of this medicine?''' ==<br />
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* This medicine used to prevent bleeding in adults and children who have congenital [[Factor XIII deficiency, congenital|factor XIII]] (FXIII) A-subunit deficiency. <br />
* Tretten is not for use in patients with congenital factor XIII B‑subunit deficiency. <br />
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== '''How does this medicine work?''' ==<br />
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* 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]'''. <br />
* rFXIII has been shown to be activated by thrombin in the presence of Ca2+. <br />
* 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. <br />
* 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.<br />
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== '''Who Should Not Use this medicine ?''' ==<br />
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This medicine cannot be used in patients who:<br />
* have known [[hypersensitivity]] to the active substance or to any of the excipients.<br />
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== '''What drug interactions can this medicine cause?''' ==<br />
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* Do not administer Tretten with recombinant factor VIIa. <br />
* Thrombosis may occur if Tretten is administered concomitantly with factor VIIa.<br />
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== '''Is this medicine FDA approved?''' ==<br />
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* '''Initial U.S. Approval:''' 2013<br />
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== '''How should this medicine be used?''' ==<br />
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'''Recommended Dosage:'''<br />
* 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.<br />
* Consider dose adjustment if adequate coverage is not achieved with the recommended 35 IU/kg dose.<br />
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'''Administration'''<br />
* Once reconstituted, Tretten may be diluted with 0.9% sodium chloride to facilitate measurement of small volumes. <br />
* Inspect the reconstituted Tretten visually for particulate matter and discoloration prior to administration. Do not use if particulate matter or discoloration is observed.<br />
* Administer at a rate not exceeding 1-2 mL per minute.<br />
* Do not administer with other infusion solutions.<br />
* Do not administer as drip.<br />
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== '''What are the dosage forms and brand names of this medicine?''' ==<br />
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This medicine is available in fallowing doasage form:<br />
* As [[Lyophilized|Lyophilized powder]] in single-dose vial containing 2000 - 3125 IU of recombinant coagulation factor XIII A-subunit.<br />
* 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.<br />
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This medicine is available in fallowing brand namesː<br />
*'''Tretten'''<br />
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=='''What side effects can this medication cause?'''==<br />
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The most common side effects of this medicine include:<br />
Signs of allergic reaction including<br />
* shortness of breath<br />
* rash<br />
* itching ([[pruritus]])<br />
* redness of the skin ([[erythema]])<br />
* fainting/dizziness<br />
* 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<br />
* Unexpected bleeding<br />
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Other possible side effects may include:<br />
* pain in your arms or legs<br />
* headache<br />
* pain at the injection site<br />
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==''' What special precautions should I follow?''' ==<br />
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* 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.<br />
* [[Thromboembolic]] complications may occur. Monitor patients with conditions that predispose to [[thrombosis]] for signs and symptoms of thrombosis after administration of Tretten.<br />
* 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. <br />
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== '''What to do in case of emergency/overdose?''' ==<br />
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* {{overdose}}<br />
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== '''Can this medicine be used in pregnancy?''' ==<br />
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* There are no adequate and well-controlled studies using Tretten in pregnant women to determine whether there is a drug-associated risk.<br />
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=='''Can this medicine be used in children?'''==<br />
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* No dose adjustment is required for pediatric age group.<br />
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== '''What are the active and inactive ingredients in this medicine?''' ==<br />
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'''Active Ingredient:'''<br />
* CATRIDECACOG <br />
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'''Inactive ingredients:'''<br />
* SODIUM CHLORIDE<br />
* SUCROSE<br />
* POLYSORBATE 20<br />
* HISTIDINE <br />
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== '''Who manufactures and distributes this medicine?''' ==<br />
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'''Manufactured by:'''<br />
* [[Novo Nordisk A/s|Novo Nordisk A/S]]<br />
* DK-2880 Bagsvaerd, Denmark<br />
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* Novo Nordisk® is a registered trademark of Novo Nordisk A/S<br />
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== '''What should I know about storage and disposal of this medication?''' ==<br />
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* It is important to store Tretten correctly.<br />
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'''Before preparing Tretten for injection'''<br />
* 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.<br />
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'''After preparing Tretten for injection (reconstituted)'''<br />
* Use Tretten immediately after it is dissolved (reconstituted) using the sterile water provided in the package.<br />
* If you cannot inject it immediately, either leave Tretten at room temperature not above 25°C (77°F) or put<br />
* 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<br />
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* NOT USE IT—THROW IT AWAY.<br />
* Tretten does not contain a preservative. Do not store Tretten in the syringe or placed in the freezer.<br />
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[[Category:Coagulation system]]<br />
[[Category:EC 2.3.2]]<br />
[[Category:Zymogens]]</div>Deepika vegiraju