Zadaxin Special Precautions

Information for Patients: Patients receiving Zadaxin treatment should be directed in its use and informed of the benefits and risks associated with treatment. If home use is prescribed, a puncture-resistant container for the disposal of used syringes and needles should be supplied to the patient. Patients should be thoroughly instructed in the importance of proper disposal and cautioned against any reuse of syringes or needles.
Carcinogenicity, Mutagenicity & Impairment of Fertility: Long-term studies with thymosin α₁ have not been done to determine carcinogenicity. Mutagenicity studies with thymosin α₁ showed no adverse findings.
Use in pregnancy: Teratology studies in mice and rabbits have shown no differences in fetal abnormalities in control animals and animals given thymosin α₁. It is not known whether Zadaxin can cause fetal harm when administered to pregnant women or can affect reproduction capacity. Zadaxin should be given to pregnant women only if the benefits clearly outweigh the risks.
Use in lactation: It is not known whether Zadaxin 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.
Use in children: Safety and effectiveness have not been established in patients <18 years.