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Thrombate III (Antithrombin III) - Warnings and Precautions

 
 



WARNINGS

THROMBATE III is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, 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 Bayer Corporation [1-888-765-3203].

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.

PRECAUTIONS

GENERAL

  1. Administer within 3 hours after reconstitution. Do not refrigerate after reconstitution.
  2. Administer only by the intravenous route.
  3. THROMBATE III, once reconstituted, should be given alone, without mixing with other agents or diluting solutions.
  4. Product administration and handling of the needles must be done with caution. Percutaneous puncture with a needle contaminated with blood can transmit infectious virus including HIV (AIDS) and hepatitis. Obtain immediate medical attention if injury occurs.
    Place needles in sharps container after single use. Discard all equipment including any reconstituted THROMBATE III product in accordance with biohazard procedures.

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.

LABORATORY TESTS

It is recommended that AT-III plasma levels be monitored during the treatment period. Functional levels of AT-III in plasma may be measured by amidolytic assays using chromogenic substrates or by clotting assays.

DRUG INTERACTIONS

The anticoagulant effect of heparin is enhanced by con-current treatment with Antithrombin III (Human), 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.

PREGNANCY CATEGORY B

Reproduction studies have been performed in rats and rabbits at doses up to four times the human dose and have revealed no evidence of impaired fertility or 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.

PEDIATRIC USE

Safety and effectiveness in the pediatric population have not been established. 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

CAUTION

Rx only

U.S. federal law prohibits dispensing without prescription.

Page last updated: 2006-02-02

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