Thymogam Special Precautions

antithymocyte immunoglobulin, equine






BSV Bioscience Phils
Full Prescribing Info
Special Precautions
Only physicians experienced in immunosuppressive therapy should use Thymogam. Use Thymogam only in facilities equipped and staffed with adequate laboratory and supportive medical resources. Discontinue therapy if anaphylaxis or severe and unremitting thrombocytopenia or leucopenia occurs. As observed with products derived from or purified with human blood components, the possibility of transmission of some infectious diseases should be borne in mind. Monitor patients carefully for concurrent infection. Several studies have suggested and increase in the incidence of cytomegalovirus infection in patients receiving Thymogam. To identify those at greatest risk of systemic anaphylaxis, physician should strongly recommend skin testing before commencing treatment. A conservative, conventional approach would first employ epicutaneous (prick) testing with undiluted Thymogam. If the subject does not show a wheal ten minutes after pricking, proceed to intradermal testing with 0.02 mL of a 1:1000 dilution of Thymogam in Sodium chloride injection with a separate Sodium chloride injection control of similar volume. Observe the results every 10 minutes over the first hour after intradermal injection. A wheal of 3 mm or greater in diameter at the site of Thymogam injection than that at the Sodium chloride injection control site (or a positive prick test) shows clinical sensitivity and an increased possibility of systemic allergic reactions.
Note: The predictive value of this test has not been proved clinically. Allergic reactions such as anaphylaxis have occurred in patients whose skin test is negative. In the presence of a locally positive skin test to Thymogam, serious consideration to alternative forms of therapy should be given.
A systemic reaction such as a generalized rash, tachycardia, dyspnea, hypotension, or anaphylaxis precludes any additional administration of Thymogam.
Use in pregnancy & lactation: Thymogam has not been evaluated in either pregnant or lactating women. Animal reproduction studies have not been conducted with Thymogam. It is also not known whether Thymogam can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity. Thymogam administration to pregnant women is not recommended and should be considered only under exceptional circumstances. It is not known whether Thymogam is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Thymogam, caution should be exercised when Thymogam is administered to a nursing woman.
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