Carcinogenesis, Mutagenesis, Impairment of Fertility
Long term studies with thymosin alpha 1 have not been done to determine carcinogenicity.
Mutagenicity studies with thymosin alpha 1 showed no adverse findings.
Pregnancy Category C
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 (thymalfasin) can cause fetal harm when administered to a pregnant woman or affect
reproduction capacity. ZADAXIN (thymalfasin) should be given to a pregnant woman only if the
benefits clearly outweigh the risks
Nursing Mothers
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 (thymalfasin) is
administered to a nursing woman.
Pediatric Use
Safety and effectiveness have not been established in patients below the age
of 18 years.
Last reviewed on RxList: 3/3/2009
This monograph has been modified to include the generic and brand name in many instances.