ZADAXIN is well tolerated. During clinical experience involving over 2000 individuals with various diseases distributed over all age groups, no clinically significant adverse reactions attributable to thymosin alpha 1 administration were reported (see table below).

Adverse experiences have been infrequent and mild, consisting primarily of local discomfort at the injection site, and rare instances of erythema, transient muscle atrophy, polyarthralgia combined with hand edema, and rash.

and Incompatibilities

Interactions between ZADAXIN and other drugs have not been fully evaluated. Caution should be exercised when administering ZADAXIN therapy in combination with other immunomodulating drugs. ZADAXIN should not be mixed with any other drug.

Long term studies with thymosin alpha 1 have not been done to determine carcinogenicity. Mutagenicity studies with thymosin alpha 1 showed no adverse findings.

Teratology studies in mice and rabbits have shown no difference in fetal abnormalities in control animals and animals given thymosin alpha 1. It is not known whether ZADAXIN can cause fetal harm when administered to a pregnant woman or affect reproduction capacity. ZADAXIN should be given to a pregnant woman only if the benefits clearly outweigh the risks.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ZADAXIN is administered to a nursing woman.

Safety and effectiveness have not been established in patients below the age of 18 years.

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