Antithrombin Recombinant, Atryn (antithrombin alfa) dosing, indications, interactions, adverse effects, and more

Sections

Sections antithrombin alfa
Dosing & Uses
Interactions
Adverse Effects
Warnings
Pregnancy
Pharmacology
Administration
Images
Patient Handout
Formulary

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

1750 International Unit/vial

Therapeutic Goal

Prophylaxis of thrombosis during surgical or obstetrical procedures

Increase & maintain antithrombin activity between 80-120% (0.8-1.2 International Unit/mL) during treatment

Loading dose should target 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 = units of antithrombin required IV; infuse over 15 minutes

Maintenance (International Unit/hr) = [(100 - baseline AT activity level in %)/10.2] x kg BW = units of antithrombin required/hr IV

Pregnant

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

Maintenance (International Unit/hr) = [(100 - baseline AT activity level in %)/5.4] x kg BW = units of antithrombin required/hr IV

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 30%; recheck AT level 2 hr after adjustment

If AT activity level >120%: Decrease infusion rate by 30%

No experience

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1-10%

Application site pruritus (≥5%)

Chest pain; non cardiac (≤2%)

Dizziness (2%)

Hemorrhage (≥5%)

Hematoma (<2%)

Hepatic enzyme changes ( ≤ 2%)

Post procedural hemorrhage (≥5%)

Hematuria (≥2%)

<1%

Chest tightness

Nausea

Foul taste

Cramps

Chills

Film over eyes

Hives

Lightheadedness

Bowel fullness

Contraindications

Hypersensitivity to goat protein or goat milk components

Cautions

May increase risk of bleeding

Not for treatment of thromboembolic activity in hereditary antithrombin deficient patients

Monitor patients for possible immunological reactions, including antibody status

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

Half-life and clearance differs significantly (7-9 times) between plasma derived and recombinant derived product

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

Measure antithrombin levels daily, in order to adjust individual dose

Risk of diminishing antithrombin levels with prolonged treatment with non-fractionated heparin

Pregnancy & 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.

Mechanism of Action

Serine protease inhibitor; important natural inhibitor of blood coagulation; inactivation of thrombin, plasmin, and other active serine proteases of coagulation including factors IXa, Xa, XIa, and XIIa.

Pharmacokinetics

Half-life: 12-18 hr; childbirth hemorrhage, surgery, and/or concomitant heparin may shorten half-life

Vd: 14.3 L (pregnant women); 7.7L (nonpregnant patients)

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)

BRAND	FORM.	UNIT PRICE	PILL IMAGE
ATryn intravenous -	1,750 unit vial

Patient Handout

NO MONOGRAPH AVAILABLE AT THIS TIME

USES: Consult your pharmacist.

HOW TO USE: Consult your pharmacist.

SIDE EFFECTS: Consult your pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Consult your pharmacist.

DRUG INTERACTIONS: Consult your pharmacist.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: No monograph available at this time.

MISSED DOSE: Consult your pharmacist.

STORAGE: Consult your pharmacist.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Formulary

FormularyPatient Discounts

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View the formulary and any restrictions for each plan.
Manage and view all your plans together – even plans in different states.
Compare formulary status to other drugs in the same class.
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

View explanations for tiers and restrictions

Tier	Description
1	This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2	This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC	NOT COVERED – Drugs that are not covered by the plan.

Code	Definition
PA	Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL	Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST	Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR	Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

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