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antithrombin (recombinant)

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Overview

What is Atryn?

ATryn for Injection is a nanofiltered, sterile, terminally heat treated, lyophilized dosage form. Antithrombin (Recombinant), active ingredient of ATryn, is a recombinant human antithrombin. It is a 432 amino acid glycoprotein with a molecular weight of approximately 57,215 Daltons. The molecular formula is: CHNOS. Antithrombin (Recombinant) 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 the expression of the antithrombin into the milk. The goats in which antithrombin (Recombinant) is produced are USDA certified scrapie-free, and controlled for specific pathogens.

The amino acid sequence of Antithrombin (Recombinant) is identical to that of human plasma-derived antithrombin. Antithrombin (Recombinant) and plasma-derived antithrombin both contain six cysteine residues forming three disulphide bridges and 3-4 N-linked carbohydrate moieties. The glycosylation profile of Antithrombin (Recombinant) is different from plasma-derived antithrombin, which results in an increased heparin affinity. When assayed in the presence of excess of heparin the potency of the recombinant product is not different from that of plasma-derived product.

Each vial of ATryn is tested for potency stated on the product label using a reference standard calibrated against the World Health Organization international standard for antithrombin concentrate. In addition to Antithrombin (Recombinant), each vial of the product contains 100 mg glycine, 79 mg sodium chloride, and 26 mg sodium citrate. When reconstituted with 10 mL Sterile Water for Injection, the pH is approximately 7.0. Following reconstitution, the solution may be further diluted into 0.9% sodium chloride for injection.

ATryn does not contain any preservatives nor is it formulated with human plasma proteins. Antithrombin (Recombinant) is affinity purified using a heparin immobilized resin and contains no detectable heparin (<0.0002 IU heparin per IU antithrombin) in the final product.

The purification and drug product manufacturing processes have been validated to demonstrate its capacity for removal and/or inactivation of viruses. Results of removal and/or inactivation for each of the steps are shown in Table 4.

In addition, although the goats are from a closed, USDA certified scrapie-free herd, the purification process was challenged to remove prions. The manufacturing steps were shown capable of achieving the following log10 reductions: 2.0 (tangential filtration), 2.2 (affinity column), ≥ 3.3 (ion exchange column), ≥ 3.8 (hydrophobic interaction column).



What does Atryn look like?



What are the available doses of Atryn?

ATryn is a sterile lyophilized formulation. Each vial of ATryn contains the potency stated on the label, which is approximately 1750 IU.

What should I talk to my health care provider before I take Atryn?

How should I use Atryn?

ATryn is a recombinant antithrombin indicated for the of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients.

It is not indicated for of thromboembolic events in hereditary antithrombin deficient patients.

For Intravenous Use Only after Reconstitution


What interacts with Atryn?

Sorry No Records found


What are the warnings of Atryn?

Sorry No Records found


What are the precautions of Atryn?

Sorry No Records found


What are the side effects of Atryn?

Sorry No records found


What should I look out for while using Atryn?

ATryn is contraindicated in patients with known hypersensitivity to goat and goat milk proteins.


What might happen if I take too much Atryn?

Sorry No Records found


How should I store and handle Atryn?

Store at 20° to 25ºC (68° to 77°F).[See USP Controlled Room Temperature]Dispense in a tight container as defined in the USP.Store at 20° to 25ºC (68° to 77°F).[See USP Controlled Room Temperature]Dispense in a tight container as defined in the USP.Store at 20° to 25ºC (68° to 77°F).[See USP Controlled Room Temperature]Dispense in a tight container as defined in the USP.Dosage FormNDC 67386-521-51Approximately 1750 IU/vial in a sterile white to off-white lyophilized powder for reconstitution. Each carton contains one single dose vial of ATryn.The actual potency of ATryn is stated on the vial label and carton. Storage and HandlingStore ATryn refrigerated at between 2-8°C (36-46°F). Do not use product beyond the expiration date printed on the package. Discard unused portions.Dosage FormNDC 67386-521-51Approximately 1750 IU/vial in a sterile white to off-white lyophilized powder for reconstitution. Each carton contains one single dose vial of ATryn.The actual potency of ATryn is stated on the vial label and carton. Storage and HandlingStore ATryn refrigerated at between 2-8°C (36-46°F). Do not use product beyond the expiration date printed on the package. Discard unused portions.Dosage FormNDC 67386-521-51Approximately 1750 IU/vial in a sterile white to off-white lyophilized powder for reconstitution. Each carton contains one single dose vial of ATryn.The actual potency of ATryn is stated on the vial label and carton. Storage and HandlingStore ATryn refrigerated at between 2-8°C (36-46°F). Do not use product beyond the expiration date printed on the package. Discard unused portions.Dosage FormNDC 67386-521-51Approximately 1750 IU/vial in a sterile white to off-white lyophilized powder for reconstitution. Each carton contains one single dose vial of ATryn.The actual potency of ATryn is stated on the vial label and carton. Storage and HandlingStore ATryn refrigerated at between 2-8°C (36-46°F). Do not use product beyond the expiration date printed on the package. Discard unused portions.Dosage FormNDC 67386-521-51Approximately 1750 IU/vial in a sterile white to off-white lyophilized powder for reconstitution. Each carton contains one single dose vial of ATryn.The actual potency of ATryn is stated on the vial label and carton. Storage and HandlingStore ATryn refrigerated at between 2-8°C (36-46°F). Do not use product beyond the expiration date printed on the package. Discard unused portions.Dosage FormNDC 67386-521-51Approximately 1750 IU/vial in a sterile white to off-white lyophilized powder for reconstitution. Each carton contains one single dose vial of ATryn.The actual potency of ATryn is stated on the vial label and carton. Storage and HandlingStore ATryn refrigerated at between 2-8°C (36-46°F). Do not use product beyond the expiration date printed on the package. Discard unused portions.Dosage FormNDC 67386-521-51Approximately 1750 IU/vial in a sterile white to off-white lyophilized powder for reconstitution. Each carton contains one single dose vial of ATryn.The actual potency of ATryn is stated on the vial label and carton. Storage and HandlingStore ATryn refrigerated at between 2-8°C (36-46°F). Do not use product beyond the expiration date printed on the package. Discard unused portions.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Antithrombin (AT) plays a central role in the regulation of hemostasis. AT is the principal inhibitor of thrombin and Factor Xa, 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 from the circulation. The ability of antithrombin to inhibit thrombin and Factor Xa can be enhanced by greater than 300 to 1000 fold when AT is bound to heparin.

Non-Clinical Toxicology
ATryn is contraindicated in patients with known hypersensitivity to goat and goat milk proteins.

Bile acid sequestering agents such as cholestyramine and colestipol may interfere with the action of ursodiol by reducing its absorption. Aluminum-based antacids have been shown to adsorb bile acids and may be expected to interfere with ursodiol in the same manner as the bile acid sequestering agents. Estrogens, oral contraceptives, and clofibrate (and perhaps other lipid-lowering drugs) increase hepatic cholesterol secretion, and encourage cholesterol gallstone formation and hence may counteract the effectiveness of ursodiol.

Allergic-type hypersensitivity reactions are possible. Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis. If these symptoms occur during administration, treatment must be discontinued immediately and emergency treatment should be administered.

The serious adverse reaction that has been reported in clinical studies is hemorrhage (intra-abdominal, hemarthrosis and post procedural). The most common adverse events reported in clinical trials at a frequency of ≥ 5% are hemorrhage and infusion site reaction.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Interactions

Interactions

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