Trade Names:ATryn- Injection, lyophilized powder for solution 1,750 units (recombinant)
Trade Names:Thrombate III- Injection, lyophilized powder for solution 500 units (human)
Regulates hemostasis by neutralizing the activity of thrombin and factor Xa by forming a complex that is removed from the circulation.
Thrombate IIIForms a covalent bond with thrombin, resulting in an inactive complex. Thrombate III is also capable of inactivating other components of the coagulation cascade, including factors IXa, Xa, XIa, and XIIa, as well as plasmin.
At doses of 50 and 100 units/kg, the apparent Vd is 126.2 and 156.1 mL/kg, respectively.
At doses of 50 and 100 units/kg, the Cl is 9.6 and 7.2 mL/h/kg, respectively. At doses of 50 and 100 units/kg, the half-lives are 11.6 and 17.7 h, respectively.
Thrombate IIIThe biologic half-life was 2.5 days based on immunologic assays and 3.8 days based on functional assays of antithrombin III (AT-III).
Prevention of perioperative and peripartum thromboembolic events in hereditary AT-deficient patients.
Thrombate IIIFor the treatment of patients with hereditary AT-III deficiency in connection with surgical or obstetrical procedures or when they suffer from thromboembolism.
Hypersensitivity to goat and goat milk proteins.
Thrombate IIINone known.
IV
ATrynIndividualize the dose based on the patient's pretreatment functional AT (expressed in percent of normal) and body weight (expressed in kg), and using therapeutic monitoring. The goal of treatment is to restore and maintain functional AT activity levels in the range of 80% to 120% of normal. Loading dose (units) = ([100 − baseline AT activity level] ÷ 1.3) × body weight (kg) Maintenance dose (units/h) = ([100 − baseline AT activity level] ÷ 5.4) × body weight (kg)
Thrombate IIIDetermine the dose on an individual basis according to the pretreatment plasma AT-III level, in order to increase plasma AT-III levels to the level found in healthy human plasma. Dosage of Thrombate III can be calculated from the following formula: Units required = ([desired − baseline AT-III level expressed as percent of normal level based on functional AT-III assay] × weight in kg) ÷ 1.4
Maintenance doseAdminister 60% of initial loading dose every 24 h to maintain plasma levels between 80% and 120%.
Surgical PatientsAdultsIV
ATrynThe dose is individualized based on the patient's pretreatment functional AT (expressed in percent of normal) and body weight (expressed in kg) and using therapeutic monitoring. The goal of treatment is to restore and maintain functional AT activity levels in the range of 80% to 120% of normal. Loading dose (units) = ([100 − baseline AT activity level] ÷ 2.3) × body weight (kg) Maintenance dose (units/h) = ([100 − baseline AT activity level] ÷ 10.2) × body weight (kg)
Thrombate IIIDetermine the dose on an individual basis based on the pretreatment plasma AT-III level, in order to increase plasma AT-III levels to the level found in normal human plasma. Dosage of Thrombate III can be calculated from the following formula: Units required = ([desired − baseline AT-III level expressed as percent of normal level based on functional AT-III assay] × weight in kg) ÷ 1.4
Maintenance doseAdminister 60% of initial loading dose every 24 h to maintain plasma levels between 80% and 120%.
AT Activity Monitoring and Dosage AdjustmentAdultsIV
ATryn2 h after the initiation of treatment, if the AT level is less than 80% of normal, increase the dose by 30% and recheck the AT level 2 h after each dose adjustment. 2 h after the initiation of treatment, if the AT level is 80% to 120% of normal, no dosage adjustment is needed, and recheck the AT level 6 h after initiation of treatment or dose adjustment. 2 h after initiation of treatment, if the AT level is more than 120% of normal, decrease the dose by 30% and recheck the AT level 2 h after each dose adjustment.
Thrombate IIIMeasure preinfusion and 20 min postinfusion (peak) plasma AT-III levels following the initial loading dose, plasma AT-III level after 12 h, then preceding the next infusion (trough level). Subsequently measure levels preceding and 20 min after each infusion until predictable peak and trough levels have been achieved, generally between 80% and 120%.
Store refrigerated at 36° to 46°F. Administer contents of infusion syringes or diluted solution within 8 to 12 h of preparation when stored at 68° to 77°F.
Thrombate IIIStore at temperatures not exceeding 77°F. Avoid freezing. Administer within 3 h after reconstitution.
Effects are enhanced by AT. The half-life of AT may be altered by concurrent treatment with these anticoagulants because of an altered AT turnover.
None well documented.
Hematoma (2%).
Dizziness, light-headedness.
Hives.
Film over eye.
Bowel fullness, foul taste in mouth, nausea.
Hematuria (2%).
Hemorrhage including intra-abdominal, hemarthrosis, and postprocedural (at least 5%).
Abnormal hepatic enzymes (2%).
Infusion-site reaction (at least 5%); application-site pruritus (2%).
Shortness of breath.
Feeling hot, noncardiac chest pain (2%).
Thrombate IIIChest pain, chest tightness, chills, cramps, fever, oozing and hematoma formation.
Category C .
Thrombate IIICategory B .
Excreted in breast milk.
Thrombate IIIUndetermined.
Safety and efficacy not established.
Use with caution, usually starting at the low end of the dosage range, because of the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapy.
Allergic-type hypersensitivity reactions may occur. If hives, generalized urticaria, chest tightness, wheezing, hypotension, or anaphylaxis occur during administration, immediately discontinue treatment and administer emergency treatment.
Because Thrombate III is prepared from human plasma, there is a risk of transmitting infectious agents (eg, viruses), including Creutzfeldt-Jakob disease.
No information.
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