Simulect Pregnancy Warnings
UK: Use is contraindicated.
AU, US: This drug should be used during pregnancy only if the benefit outweighs the risk.
AU TGA pregnancy category: D
US FDA pregnancy category: B
Comments:
-Women of childbearing potential should use effective contraception before beginning therapy, during therapy, and for up to 16 months after completion of therapy.
Animal studies failed to reveal evidence of toxicity, embryotoxicity, or teratogenicity. IgG molecules are known to cross the placental barrier and the IL-2 receptor may play an important role in development of the immune system. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.
AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
See references
Simulect Breastfeeding Warnings
No information is available on the use of this drug during breastfeeding. Because it is a large protein molecule with a molecular weight of about 144,000, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant GI tract. The manufacturer recommends that breastfeeding be discontinued during therapy.
UK: Use is contraindicated.
AU, US: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-This drug is an immunoglobulin G (IgG1) antibody; therefore, it may be excreted in human milk.
-Because of its immunosuppressive action, this drug could harm a nursing infant.
-Women receiving this drug should not breastfeed during and for 4 months after discontinuing therapy.
See references
