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THROMBATE III is a brand name for Antithrombin III, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Adverse Drug Reaction Overview If adverse reactions are experienced, the infusion rate should be decreased, or if indicated, the infusion should be interrupted until symptoms abate. Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. 0%). The most common reported adverse reactions are presented in Table 2. 3%) Post-Market Adverse Drug Reactions The following rare adverse events have been reported during post-marketing use of THROMBATE III.
Possibly drug related: hemolytic anemia Hypocalcemia Unlikely drug related: cerebral hemorrhage gastrointestinal hemorrhage cardiac arrest Not drug related: cerebral hemorrhage cardiac arrest due to multiple organ failure renal failure DRUG INTERACTIONS Drug-Drug Interactions THROMBATE III, once reconstituted, should be given alone, without mixing with other agents or diluting solutions.
Table 3 – Established or Potential Drug-drug Interactions Proper Name Ref Effect Clinical Comment heparin T The anticoagulant effect of heparin is enhanced by concurrent treatment with THROMBATE III. In order to avoid bleeding, reduced dosage of heparin is recommended during treatment with THROMBATE III.
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C=Case Study; CT=Clinical Trial; T=Theoretical Drug-Food Interactions No interactions are known. Drug-Herb Interactions No interactions are known. Page 8 of 20 Drug-Laboratory Interactions No interactions are known. DOSAGE AND ADMINISTRATION Dosing Considerations The 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 each subject, based on the individual clinical conditions, response to therapy, and actual plasma ATIII levels achieved. , following surgery (7,8), with haemorrhage or acute thrombosis (9,10) and during intravenous heparin administration (8,11,12), in vivo survival of infused THROMBATE III has been reported to be shortened, resulting in the need to administer THROMBATE III more frequently.
Patients who are hypersensitive to this drug or other anticoagulants or to any ingredient in the formulation or component of the container. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section. WARNINGS AND PRECAUTIONS General The anticoagulant effect of heparin is enhanced by concurrent treatment with THROMBATE III in patients with hereditary ATIII deficiency.
Thus, in order to avoid bleeding, reduced dosage of heparin is recommended during treatment with THROMBATE III. 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.
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.
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 Grifols Canada Ltd. at 1-866-482-5226. The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering to the patient.
Administration and Handling Administer only by the intravenous route. THROMBATE III, once reconstituted, should be given alone, without mixing with other agents or diluting solutions. Product administration and handling of the needles must be done with caution.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Recommended Dose and Dosage Adjustment 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 pre-therapy plasma antithrombin III (ATIII) level, in order to increase plasma ATIII levels to the level found in normal human plasma (100%). Dosage of THROMBATE III can be calculated from the formula represented by Equation 1.
4% per IU per kg administered. 4 = 3150 IU total. However, recovery may vary, and initially levels should be drawn at baseline and 20 minutes post infusion. 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 THROMBATE III, plasma levels of ATIII be initially monitored at least every 12 hours and before the next infusion of THROMBATE III to Page 9 of 20 maintain plasma ATIII levels greater than 80%.
, following surgery (10), haemorrhage or acute thrombosis (9,10), and during intravenous heparin administration (8,11,12), the half-life of Antithrombin III (Human) has been reported to be shortened, and in such conditions, plasma ATIII levels should be monitored more frequently, administering THROMBATE III 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 ATIII 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 judgement 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 ATIII levels achieved: a) […]
Percutaneous puncture with a needle contaminated with blood can transmit infectious virus including HIV (AIDS) and hepatitis. Obtain immediate medical attention if injury occurs. Diagnosis The diagnosis of hereditary antithrombin III deficiency should be based on a clear family history of venous thrombosis as well as decreased plasma ATIII levels, and the exclusion of acquired deficiency.
Page 5 of 20 ATIII 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 ATIII deficiencies (2). The ATIII level in neonates of parents with hereditary ATIII 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) (3). Plasma levels of ATIII are lower in neonates than adults, averaging approximately 60% in normal term infants (4,5).
ATIII levels in premature infants may be much lower (4,5). Low plasma ATIII 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 (6).
Special Populations Pregnant Women Reproduction studies have been performed in rats and rabbits at doses up to four times the human dose and have revealed no evidence of harm to the fetus due to THROMBATE III. It is not known whether THROMBATE III can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Women Because of the potential for unknown effects from THROMBATE III in infants being nursed by mothers taking THROMBATE III, a decision should be made to either discontinue nursing or discontinue the administration of THROMBATE III, taking into account the importance of THROMBATE III therapy to the mother and the possible risk to the infant.
Pediatrics (< 18 years of age) Only a few neonates and children have so far been treated with THROMBATE III. Safety and effectiveness in children have not been established.
For diagnosis in neonates, see WARNINGS AND PRECAUTIONS:
Diagnosis. Monitoring and Laboratory Tests It is recommended that ATIII plasma levels be monitored during the treatment period. Functional levels of ATIII in plasma may be measured by amidolytic assays using chromogenic substrates or by clotting assays.
Page 6 of 20 ADVERSE REACTIONS Adverse Drug Reaction Overview If adverse reactions are experienced, the infusion rate should be decreased, or if indicated, the infusion should be interrupted until symptoms abate. Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. 0%). The most common reported adverse reactions are presented in Table 2. 3%) Post-Market […]