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antithrombin alfa (Antithrombin Recombinant, Atryn)

 

Classes: Anticoagulants, Hematologic

Dosing and uses of Antithrombin Recombinant, Atryn (antithrombin alfa)

 

Adult dosage forms and strengths

injectable solution

  • 1750 International Unit/vial

Therapeutic treatment goal: to increase & maintain antithrombin activity between 80-120% (0.8-1.2 International Unit/mL) during treatment

Initial treatment: Loading dose targeting 100% AT activity level based on weight & pretreatment AT activity leveL

 

Surgical Patients

Load = [(100 - baseline AT activity level in %)/2.3] x kg Body Weight IV infuse over 15 minutes

Maintenance (International Unit/hr) = [(100 - baseline AT activity level in %)/10.2] x kg BW IV continuous infusion

 

Pregnant

Load = [(100 - baseline AT activity level in %)/1.3] x kg Body Weight IV infuse over 15 minutes

Maintenance (International Unit/hr) = [(100 - baseline AT activity level in %)/5.4] x kg BW IV continuous infusion

 

Dose Adjustments

Draw AT activity levels 2 hours after start of loading dose, AFTER start of maintenance dose infusion

  • IF AT activity level 80%-120% (0.8-1.2 International Unit/mL): NO dose adjustment
  • If AT activity level <80%: Increase maintenance infusion rate by 50%
  • If AT activity level >120%: Decrease infusion rate by 30%

 

Other Indications & Uses

Prophylaxis of venous thromboembolism in surgery of patients with congenital antithrombin deficiency

Given in association with heparin or LMW heparin

 

Pediatric dosage forms and strengths

No experience

 

Antithrombin Recombinant, Atryn (antithrombin alfa) adverse (side) effects

1-10%

Application site pruritus (2%)

Chest pain; non cardiac (2%)

Dizziness

Dyspnea

Headache

Hemorrhage (5%)

Hepatic enzyme changes ( 2%)

Infusion site reaction (5%)

Nausea

Venipuncture site hemorrhage

Post procedural hemorrhage

Wound secretion

 

Warnings

Contraindications

Hypersensitivity to goat protein or goat milk components

 

Cautions

May incr risk of bleeding

Monitor pts for possible immunological rxns, incl antibody status

Provide appropriate clinical testing when antithrombin is used with heparin or other anticoagulants

Perform anticoagulation studies (APTT, anti-Factor Xa) at close intervals when starting antithrombin Tx

Measure antithrombin levels daily, in order to adjust individual dose

Risk of diminishing antithrombin levels with prolonged Tx w/ non-fractionated heparin

 

Pregnancy and lactation

Pregnancy category: C

Lactation: enters breast milk; use with caution

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Antithrombin Recombinant, Atryn (antithrombin alfa)

Half-Life, distribution: 1.74±1.28 hr; elimination: 10.16±1.28 hr

 

Mechanism of action

Serine protease inhibitor; important natural inhibitor of blood coagulation; inhibits thrombin & Factor VIIa/tissue factor complex

 

Administration

IV Preparation

Bring vial to room temp prior to reconstitution; keep no longer than 3 hr

Reconstitute preparation with 10 mL SWI injected along side walL

Gently swirl, don't shake

Inspect visually for particulate matter & discoloration prior to administration

  • do NOT use if deposits or cloudiness present

Draw reconstituted product into sterile disposable syringe

 

IV Administration

Administer by IV infusion using sterile syringe or infusion bag w/ 0.22 micron pore inline filter

May add NS to dilute for admininistration purposes

Use infusion soln within 8 hr of preparation

Compatible w/ PVC infusion lines with inline filters

Initial infusion over 15 min, then continuous infusion

 

Storage

Store in refrigerator (2-8°C)