Atryn
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Questions & Answers
Side Effects & Adverse Reactions
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
ATryn® is a recombinant antithrombin indicated for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients1.
It is not indicated for treatment of thromboembolic events in hereditary antithrombin deficient patients.
History
There is currently no drug history available for this drug.
Other Information
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: C2191H3457N583O656S18. 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 viruses4. Results of removal and/or inactivation for each of the steps are shown in Table 4.
| NA = Not Applicable since log10 reduction was less than 1.0. | ||||
| Process Step | Pseudorabies Virus | Xenotropic Murine Retrovirus | Human Adenovirus | Porcine Parvovirus |
| Tangential Flow Filtration | ≥5.1 | |||
| Affinity Chromatography | 1.6 | 1.2 | NA | 1.4 |
| Nanofiltration | ≥3.8 | ≥6.3 | ≥3.7 | |
| Ion Exchange Chromatography | 3.6 | 1.0 | ≥7.1 | NA |
| Hydrophobic Interaction Chromatography | ≥5.6 | ≥4.4 | ≥4.8 | ≥5.7 |
| Heat Treatment | 2.8 | ≥5.0 | ≥1.8 | 2.4 |
| Total Reduction | ≥18.7 | ≥15.4 | ≥20.0 | ≥13.2 |
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).
Sources
Atryn Manufacturers
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Revo Bioloigics, Inc.
![Atryn (Antithrombin Recombinant) Injection, Powder, Lyophilized, For Solution [Revo Bioloigics, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Atryn | Revo Bioloigics, Inc.
For Intravenous Use Only after Reconstitution
2.1 Preparation for Administration Bring vials to room temperature no more than 3 hours prior to reconstitution. Reconstitute with 10 mL Sterile Water for Injection [(WFI) not supplied with ATryn] immediately prior to use. Do not shake. For the 1750 IU vial, reconstitute with 10 mL Sterile Water for Injection [(WFI) not supplied with ATryn] immediately prior to use. Do not shake. Do not use solution containing visible particulates or if it is discolored or cloudy. Draw solution from one or more vials into a sterile disposable syringe for intravenous administration or add solution to an infusion bag containing 0.9% sterile sodium chloride for injection (e.g., dilute solution to obtain a concentration of 100 IU/mL). Administer using an infusion set with a 0.22 micron pore-size, in-line filter. Administer contents of infusion syringes or diluted solution within 8 to 12 hours of preparation when stored at room temperature (68-77°F (20-25°C)). Discard unused product in accordance with local requirements. 2.2 Recommended Dose and Schedule The dosage of ATryn is to be individualized based on the patient's pre-treatment functional AT activity level (expressed in percent of normal) and body weight (expressed in kilograms) and using therapeutic drug monitoring (Table 1). The goal of treatment is to restore and maintain functional antithrombin (AT) activity levels between 80% - 120% of normal (0.8 - 1.2 IU/mL). Treatment should be initiated prior to delivery or approximately 24 hours prior to surgery to ensure that the plasma antithrombin level is in the target range at that time. Different dosing formulae are used for the treatment of surgical and pregnant patients. Pregnant women who need a surgical procedure other than Cesarean section should be treated according to the dosing formulae for pregnant patients. Administer loading dose as a 15-minute intravenous infusion, immediately followed by a continuous infusion of the maintenance dose. AT activity monitoring and dose adjustments should be made according to Table 2. Continue treatment until adequate follow-on anticoagulation is established. Table 1: Dosing Formula for Surgical Patients and Pregnant Women Loading Dose
(IU) Maintenance Dose
(IU/hour) Surgical
Patients (100 − baseline AT activity level)
2.3 x Body
Weight
(kg) (100 − baseline AT activity level)
10.2 x Body
Weight
(kg) Pregnant
Women (100 − baseline AT activity level)
1.3 x Body
Weight
(kg) (100 − baseline AT activity level)
5.4 x Body
Weight
(kg)AT Activity Monitoring and Dose Adjustment
AT activity monitoring is required for proper treatment. Check AT activity once or twice per day with dose adjustments made according to Table 2.
Table 2: AT Activity Monitoring and Dose Adjustment Initial Monitor Time AT Level Dose Adjustment Recheck AT Level 2 hours after initiation of treatment < 80% Increase 30% 2 hours after each dose adjustment 80% to 120% None 6 hours after initiation of treatment or dose adjustment > 120% Decrease 30% 2 hours after each dose adjustmentAs surgery or delivery may rapidly decrease the AT activity levels, check the AT level just after surgery or delivery. If AT activity level is below 80%, an additional bolus dose may be administered to rapidly restore decreased AT activity level. In such instances, the loading dose formulae in Table 1 should be used, utilizing in the calculation the last available AT activity result. Thereafter, restart the maintenance dose at the same rate of infusion as before the bolus.
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Lundbeck Inc.
Atryn | Lundbeck Inc.
For Intravenous Use Only after Reconstitution
2.1 Preparation for Administration Bring vials to room temperature no more than 3 hours prior to reconstitution. Reconstitute with 10 mL Sterile Water for Injection [(WFI) not supplied with ATryn] immediately prior to use. Do not shake. Do not use solution containing visible particulates or if it is discolored or cloudy. Draw solution from one or more vials into a sterile disposable syringe for intravenous administration or add solution to an infusion bag containing 0.9% sterile sodium chloride for injection (e.g., dilute solution to obtain a concentration of 100 IU/mL). Administer using an infusion set with a 0.22 micron pore-size, in-line filter. Administer contents of infusion syringes or diluted solution within 8 to 12 hours of preparation when stored at room temperature (68-77°F (20-25°C)). Discard unused product in accordance with local requirements. 2.2 Recommended Dose and Schedule The dosage of ATryn is to be individualized based on the patient's pre-treatment functional AT activity level (expressed in percent of normal) and body weight (expressed in kilograms) and using therapeutic drug monitoring (Table 1). The goal of treatment is to restore and maintain functional antithrombin (AT) activity levels between 80% - 120% of normal (0.8 - 1.2 IU/mL). Treatment should be initiated prior to delivery or approximately 24 hours prior to surgery to ensure that the plasma antithrombin level is in the target range at that time. Different dosing formulae are used for the treatment of surgical and pregnant patients. Pregnant women who need a surgical procedure other than Cesarean section should be treated according to the dosing formulae for pregnant patients. Administer loading dose as a 15-minute intravenous infusion, immediately followed by a continuous infusion of the maintenance dose. AT activity monitoring and dose adjustments should be made according to Table 2. Continue treatment until adequate follow-on anticoagulation is established. Table 1: Dosing Formula for Surgical Patients and Pregnant Women Loading Dose
(IU) Maintenance Dose
(IU/hour) Surgical Patients (100 - baseline AT activity level) x Body Weight (kg) / 2.3 (100 - baseline AT activity level) x Body Weight (kg) / 10.2 Pregnant Women (100 - baseline AT activity level) x Body Weight (kg) / 1.3 (100 - baseline AT activity level) Body Weight (kg) / 5.4AT Activity Monitoring and Dose Adjustment
AT activity monitoring is required for proper treatment. Check AT activity once or twice per day with dose adjustments made according to Table 2.
Table 2: AT Activity Monitoring and Dose Adjustment Initial Monitor Time AT Level Dose Adjustment Recheck AT Level 2 hours after initiation of treatment < 80% Increase 30% 2 hours after each dose adjustment 80% to 120% None 6 hours after initiation of treatment or dose adjustment > 120% Decrease 30% 2 hours after each dose adjustmentAs surgery or delivery may rapidly decrease the AT activity levels, check the AT level just after surgery or delivery. If AT activity level is below 80%, an additional bolus dose may be administered to rapidly restore decreased AT activity level. In such instances, the loading dose formulae in Table 1 should be used, utilizing in the calculation the last available AT activity result. Thereafter, restart the maintenance dose at the same rate of infusion as before the bolus.
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Gtc Biotherapeutics, Inc.
Atryn | Gtc Biotherapeutics, Inc.
For Intravenous Use Only after Reconstitution
2.1 Preparation for Administration Bring vials to room temperature no more than 3 hours prior to reconstitution. Reconstitute with 10 mL Sterile Water for Injection [(WFI) not supplied with ATryn] immediately prior to use. Do not shake. Do not use solution containing visible particulates or if it is discolored or cloudy. Draw solution from one or more vials into a sterile disposable syringe for intravenous administration or add solution to an infusion bag containing 0.9% sterile sodium chloride for injection (e.g., dilute solution to obtain a concentration of 100 IU/mL). Administer using an infusion set with a 0.22 micron pore-size, in-line filter. Administer contents of infusion syringes or diluted solution within 8 to 12 hours of preparation when stored at room temperature (68-77°F (20-25°C)). Discard unused product in accordance with local requirements. 2.2 Recommended Dose and Schedule The dosage of ATryn is to be individualized based on the patient's pre-treatment functional AT activity level (expressed in percent of normal) and body weight (expressed in kilograms) and using therapeutic drug monitoring (Table 1). The goal of treatment is to restore and maintain functional antithrombin (AT) activity levels between 80% - 120% of normal (0.8 - 1.2 IU/mL). Treatment should be initiated prior to delivery or approximately 24 hours prior to surgery to ensure that the plasma antithrombin level is in the target range at that time. Different dosing formulae are used for the treatment of surgical and pregnant patients. Pregnant women who need a surgical procedure other than Cesarean section should be treated according to the dosing formulae for pregnant patients. Administer loading dose as a 15-minute intravenous infusion, immediately followed by a continuous infusion of the maintenance dose. AT activity monitoring and dose adjustments should be made according to Table 2. Continue treatment until adequate follow-on anticoagulation is established. Table 1: Dosing Formula for Surgical Patients and Pregnant Women Loading Dose
(IU) Maintenance Dose
(IU/hour) Surgical
Patients (100 − baseline AT activity level)
2.3 x Body
Weight
(kg) (100 − baseline AT activity level)
10.2 x Body
Weight
(kg) Pregnant
Women (100 − baseline AT activity level)
1.3 x Body
Weight
(kg) (100 − baseline AT activity level)
5.4 x Body
Weight
(kg)AT Activity Monitoring and Dose Adjustment
AT activity monitoring is required for proper treatment. Check AT activity once or twice per day with dose adjustments made according to Table 2.
Table 2: AT Activity Monitoring and Dose Adjustment Initial Monitor Time AT Level Dose Adjustment Recheck AT Level 2 hours after initiation of treatment < 80% Increase 30% 2 hours after each dose adjustment 80% to 120% None 6 hours after initiation of treatment or dose adjustment > 120% Decrease 30% 2 hours after each dose adjustmentAs surgery or delivery may rapidly decrease the AT activity levels, check the AT level just after surgery or delivery. If AT activity level is below 80%, an additional bolus dose may be administered to rapidly restore decreased AT activity level. In such instances, the loading dose formulae in Table 1 should be used, utilizing in the calculation the last available AT activity result. Thereafter, restart the maintenance dose at the same rate of infusion as before the bolus.
![Atryn (Antithrombin (Recombinant)) Injection, Powder, Lyophilized, For Solution [Lundbeck Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e17ed76e-bc13-4ba2-bf1c-886fe748df4c&name=atryn-01.jpg)
![Atryn (Antithrombin (Recombinant)) Injection, Powder, Lyophilized, For Solution [Gtc Biotherapeutics, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ed3eaf69-1cbd-4b01-a6fa-1fe02c90c3e1&name=atryn-01.jpg)
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