ATRYN REVIEW PDF

The drug approved in Europe, ATryn, is recombinant human antithrombin, rabbits, and received a fast-track designation for review by the FDA on July ATryn is a recombinant antithrombin indicated for the prevention of peri-operative .. concurrently conducted retrospective chart review. Supporting Documents older than three years – ATryn Ā· Approval History, Letters, Reviews and Related Documents – ATryn (ZIP – MB).

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Year Company Conditions Areas Names Atryn antithrombin recombinant lyophilized powder for reconstitution The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Atryn (antithrombin recombinant lyophilized powder for reconstitution)

Atryn is a recombinant antithrombin. Recombinant antithrombin is produced by recombinant DNA technology using genetically engineered goats. The amino acid sequence of recombinant antithrombin is identical to that of human plasma-derived antithrombin. Antithrombin plays a central role in the regulation of hemostasis and is the principal inhibitor of thrombin and Factor Xa5, the serine proteases that play pivotal roles in blood coagulation.

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Antithrombin neutralizes the activity of thrombin and Factor Xa by forming a complex which is rapidly removed from the circulation. Atryn is specifically indicated for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients.

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Atryn is supplied as a powder for reconstitution designed for intravenous administration. Treatment should be initiated prior to delivery or approximately 24 hours prior to surgery.

Administer loading dose as a minute intravenous infusion, immediately followed by a continuous infusion of the maintenance dose. Adverse events associated with the use of Atryn may include, but are not limited to, the following: Recombinant antithrombin is produced by recombinant DNA technology using genetically engineered goats into which the DNA coding sequence for human antithrombin has been introduced, along with a mammary gland specific DNA sequence, which directs ztryn expression of the antithrombin into the milk.

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Antithrombin plays a central role in the regulation of hemostasis. AT is the principal inhibitor of thrombin and Factor Xa5, the serine proteases that play pivotal roles in blood coagulation.

AT neutralizes the activity of thrombin and Factor Xa by forming a complex which is rapidly removed ateyn the circulation. Transfusion March;43 3: Blood June 15;91 Toggle navigation View By: Year Company Conditions Areas Names.

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations. These single-arm, open-label studies were conducted in 31 ATryn treated hereditary antithrombin AT deficient patients and 35 human plasma-derived AT treated hereditary AT deficient patients.

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The endpoint was non-inferiority in the reduction in the incidence of the occurrence of venous thromboembolic events between the two treatment arms.

ATryn was administered as a continuous infusion for at least 3 days, starting one day prior reviee the surgery or delivery. Plasma AT was administered for at least two days as single bolus infusions.

The efficacy was assessed during treatment with AT and up to 7 days reciew stopping AT treatment. In the human plasma derived AT group, there were 0 incidences of thromboembolic events and in the ATryn treated arm, there was one confirmed diagnosis of an acute deep vein thrombosis DVT.

For additional information regarding Atryn or the prevention of peri-operative and peri-partum thromboembolic events, please visit the Atryn web page.