THROMBATE III ANTITHROMBIN III (HUMAN) Kit
🆔 Identity & classification
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🏭 Manufacturer & labeler
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🩺 Clinical
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🧪 Inactive Ingredients / Excipients
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Thrombate Iii 13533-0602-50 | GRIFOLS | 1 kit | — | — | FDA listed | — |
| Thrombate Iiithis 13533-0603-20 | GRIFOLS | 1 kit | — | — | FDA listed | — |
| Thrombate Iii 13533-0606-12 | GRIFOLS | 1 kit | — | — | FDA listed | — |
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⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 13533-0603-20 You're viewing this | 1 KIT in 1 CARTON (13533-603-20) * 10 mL in 1 VIAL, GLASS (13533-605-21) * 10 mL in 1 VIAL, GLASS (13533-000-05) | 1991-12-30 | Active |
🧭 About this NDC listing & data coverage
Kit / multi-component package
This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full FDA label FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE SECTION THROMBATE III is indicated for the treatment of patients with hereditary antithrombin III deficiency in connection with surgical or obstetrical procedures or when they suffer from thromboembolism. Subjects with AT-III deficiency should be informed about the risk of thrombosis in connection with pregnancy and surgery and about the inheritance of the disease. The diagnosis of hereditary antithrombin III (AT-III) deficiency should be based on a clear family history of venous thrombosis as well as decreased plasma AT-III levels, and the exclusion of acquired deficiency.
AT-III in plasma may be measured by amidolytic assays using synthetic chromogenic substrates, by clotting assays, or by immunoassays. The latter does not detect all hereditary AT-III deficiencies. 16 The AT-III level in neonates of parents with hereditary AT-III deficiency should be measured immediately after birth.
(Fatal neonatal thromboembolism, such as aortic thrombi in children of women with hereditary antithrombin III deficiency, has been reported.) 17 Plasma levels of AT-III are lower in neonates than adults, averaging approximately 60% in normal term infants. 18,19 AT-III levels in premature infants may be much lower. 18,19 Low plasma AT-III levels, especially in a premature infant, therefore, do not necessarily indicate hereditary deficiency.
It is recommended that testing and treatment with THROMBATE III of neonates be discussed with an expert on coagulation. 11
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Each bottle of THROMBATE III has the functional activity, in international units (IU), stated on the label of the bottle. The potency assignment has been determined with a standard calibrated against a World Health Organization antithrombin III reference preparation. Dosage should be determined on an individual basis based on the pretherapy plasma antithrombin III (AT-III) level, in order to increase plasma AT-III levels to the level found in normal human plasma (100%).
Dosage of THROMBATE III can be calculated from the following formula: [desired-baseline AT-III level*] X weight (kg) units required (IU) = _________________________________________ 1.4 *expressed as % normal level based on functional AT-III assay The above formula is based on an expected incremental in vivo recovery above baseline levels for Antithrombin III (Human), THROMBATE III ® of 1.4% per IU per kg administered. 12 Thus, if a 70 kg individual has a baseline AT–III level of 57%, in order to increase plasma AT-III to 120%, the initial THROMBATE III dose would be [(120–57) X70]/1.4 = 3150 IU total.
However, recovery may vary, and initially levels should be drawn at baseline and 20 minutes postinfusion. Subsequent doses can be calculated based on the recovery of the first dose. These recommendations are intended only as a guide for therapy.
The exact loading dose and maintenance intervals should be individualized for each patient. It is recommended that following an initial dose of THROMBATE III, plasma levels of AT-III be initially monitored at least every 12 hours and before the next infusion of THROMBATE III to maintain plasma AT-III levels greater than 80%. In some situations, e.g., following surgery, 20 hemorrhage or acute thrombosis, and during intravenous heparin administration, 13,21–23 the half-life of Antithrombin III (Human) has been reported to be shortened.
In such conditions, plasma AT-III levels should be monitored more frequently, and THROMBATE III administered as necessary. When an infusion of THROMBATE III is indicated for a patient with hereditary deficiency to control an acute thrombotic episode or prevent thrombosis following surgical or obstetrical procedures, it is desirable to raise the AT-III level to normal and maintain this level for 2 to 8 days, depending on the indication for treatment, type and extent of surgery, patient’s medical condition, past history and physician’s judgment.
Concomitant administration of heparin in each of these situations should be based on the medical judgment of the physician. As a general recommendation, the following therapeutic program may be utilized as a starting program for treatment, modifying the program based on the actual plasma AT-III levels achieved: a)An initial loading dose of THROMBATE III calculated to elevate the plasma AT-III level to 120%, assuming an expected rise over the baseline plasma AT-III level of 1.4% (functional activity) per IU per kg of THROMBATE III administered.
Thus, if an individual has a baseline AT-III level of 57%, the initial THROMBATE III dose would be (120–57)/1.4 = 45 IU/kg. b)Measure preinfusion and 20 minutes postinfusion (peak) plasma antithrombin III levels following the initial loading dose, plasma antithrombin III level after 12 hours, then preceding the next infusion (trough level). Subsequently measure antithrombin III levels preceding and 20 minutes after each infusion until predictable peak and trough levels have been achieved, generally between 80%–120%.
Plasma levels between 80%–120% may be maintained by administration of maintenance doses of 60% of the initial loading dose, administered every 24 hours. Adjustments in the maintenance dose and/or interval between doses should be made based on actual plasma AT-III levels achieved. The above recommendations for dosing are provided as a general guideline for therapy only.
The exact loading and maintenance dosages and dosing intervals should be individualized for eac…
⛔ Contraindications ▾
CONTRAINDICATIONS None known.
⚠️ Warnings ▾
WARNINGS SECTION THROMBATE III is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses and theoretically, the Creutzfeldt-Jakob (CJD) agent that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses.
Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C.
ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Talecris Biotherapeutics, Inc. [1800-520-2807] The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering it to a patient. The anticoagulant effect of heparin is enhanced by concurrent treatment with THROMBATE III in patients with hereditary AT-III deficiency. Thus, in order to avoid bleeding, reduced dosage of heparin is recommended during treatment with THROMBATE III.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS In clinical studies involving THROMBATE III, adverse reactions were reported in association with 17 of the 340 infusions during the clinical studies. Included were dizziness (7), chest tightness (3), nausea (3), foul taste in mouth (3), chills (2), cramps (2), shortness of breath (1), chest pain (1), film over eye (1), light-headedness (1), bowel fullness (1), hives (1), fever (1), and oozing and hematoma formation (1). If adverse reactions are experienced, the infusion rate should be decreased, or if indicated, the infusion should be interrupted until symptoms abate.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Antithrombin III (AT-III), an alpha 2 -glycoprotein of molecular weight 58,000, is normally present in human plasma at a concentration of approximately 12.5 mg/dL 2,3 and is the major plasma inhibitor of thrombin. 4 Inactivation of thrombin by AT-III occurs by formation of a covalent bond resulting in an inactive 1:1 stoichiometric complex between the two, involving an interaction of the active serine of thrombin and an arginine reactive site on AT-III. 4 AT-III is also capable of inactivating other components of the coagulation cascade including factors IXa, Xa, XIa, and XIIa, as well as plasmin.
4 The neutralization rate of serine proteases by AT-III proceeds slowly in the absence of heparin, but is greatly accelerated in the presence of heparin. 4 As the therapeutic antithrombotic effect in vivo of heparin is mediated by AT-III, heparin is ineffective in the absence or near absence of AT-III. 4–8 The prevalence of the hereditary deficiency of AT-III is estimated to be one per 2000 to 5000 in the general population.
4–7 The pattern of inheritance is autosomal dominant. In affected individuals, spontaneous episodes of thrombosis and pulmonary embolism may be associated with AT-III levels of 40%–60% of normal. 7 These episodes usually appear after the age of 20, the risk increasing with age and in association with surgery, pregnancy and delivery.
The frequency of thromboembolic events in hereditary antithrombin III (AT-III) deficiency during pregnancy has been reported to be 70%, and several studies of the beneficial use of Antithrombin III (Human) concentrates during pregnancy in women with hereditary deficiency have been reported. 9–11 In many cases, however, no precipitating factor can be identified for venous thrombosis or pulmonary embolism. 7 Greater than 85% of individuals with hereditary AT-III deficiency have had at least one thrombotic episode by the age of 50 years.
7 In about 60% of patients thrombosis is recurrent. Clinical signs of pulmonary embolism occur in 40% of affected individuals. 7 In some individuals, treatment with oral anticoagulants leads to an increase of the endogenous levels of AT-III, and treatment with oral anticoagulants may be effective in the prevention of thrombosis in such individuals.
6,7 In clinical studies of THROMBATE III conducted in 10 asymptomatic subjects with hereditary deficiency of AT-III, the mean in vivo recovery of AT-III was 1.6% per unit per kg administered based on immunologic AT-III assays, and 1.4% per unit per kg administered based on functional AT-III assays. 12 The mean 50% disappearance time (the time to fall to 50% of the peak plasma level following an initial administration) was approximately 22 hours and the biologic half-life was 2.5 days based on immunologic assays and 3.8 days based on functional assays of AT-III.
12 These values are similar to the halflife for radiolabeled Antithrombin III (Human) reported in the literature of 2.8–4.8 days. 13–1 5 In clinical studies of THROMBATE III, none of the 13 patients with hereditary AT-III deficiency and histories of thromboembolism treated prophylactically on 16 separate occasions with THROMBATE III for high thrombotic risk situations (11 surgical procedures, 5 deliveries) developed a thrombotic complication. Heparin was also administered in 3 of the 11 surgical procedures and all 5 deliveries.
Eight patients with hereditary AT-III deficiency were treated therapeutically with THROMBATE III as well as heparin for major thrombotic or thromboembolic complications, with seven patients recovering. Treatment with THROMBATE III reversed heparin resistance in two patients with hereditary AT-III deficiency being treated for thrombosis or thromboembolism. During clinical investigation of THROMBATE III, none of 12 subjects monitored for a median of 8 months (range 2–19 months) after receiving THROMBATE III, became antibody positive to human immunodeficiency virus (HIV-1).
None of 14 subjects moni…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED THROMBATE III is supplied in the following single use vials with the potency in international units stated on the label of each vial. A suitable volume of Sterile Water for Injection, USP, a sterile doubleended transfer needle, and a sterile filter needle are provided. NDC Number Approximate Antithrombin III Potency Diluent 13533-603-20 500 IU 10 mL
📦 Storage and Handling ▾
STORAGE THROMBATE III should be stored at temperatures not to exceed 25°C (77°F). Freezing should be avoided as breakage of the diluent bottle might occur.
📋 Description ▾
DESCRIPTION Antithrombin III (Human), THROMBATE III ® is a sterile, nonpyrogenic, stable, lyophilized preparation of purified human antithrombin III. THROMBATE III is prepared from pooled units of human plasma from normal donors by modifications and refinements of the cold ethanol method of Cohn. 1 When reconstituted with Sterile Water for Injection, USP, THROMBATE III has a pH of 6.0–7.5, a sodium content of 110–210 mEq/L, a chloride content of 110–210 mEq/L, an alanine content of 0.075–0.125 M, and a heparin content of not more than
0.1IU heparin/IU AT-III. THROMBATE III contains no preservative and must be administered by the intravenous route. In addition, THROMBATE III has been heat-treated in solution at 60°C ±0.5°C for not less than 10 hours.
Each vial of THROMBATE III contains the labeled amount of antithrombin III in international units (IU) per vial. The potency assignment has been determined with a standard calibrated against a World Health Organization (WHO) antithrombin III reference preparation. The manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents.
24-27 An individual production step in the THROMBATE III manufacturing process has been shown to decrease TSE infectivity of that experimental model agent. The TSE reduction step is the Effluent I to Effluent II + III fractionation step (6.0 logs). These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.
Thrombate Use Figures