Simponi Use In Pregnancy & Lactation

Pregnancy: An embryofetal developmental toxicology study was performed in which pregnant cynomolgus monkeys were treated with golimumab during the first trimester at dosages up to 50 mg/kg twice weekly (over 500-fold higher in terms of dose/body weight ratio than the proposed clinical dose of 50 mg every 4 weeks). The mean peak maternal serum concentration obtained in this study (1576 mcg/mL) is over 900-fold higher than median steady-state C_max value (1.71 mcg/mL) following 50 mg every 4-week SC dosing in patients with RA, PsA, and AS. Umbilical cord blood samples collected at the end of the second trimester showed that fetuses were exposed to golimumab during gestation. Fetal serum concentrations were approximately 50% of the maternal serum concentrations. In this study, in utero exposure to golimumab produced no developmental defects to the fetus.
A pre- and postnatal developmental study was performed in which pregnant cynomolgus monkeys were treated with golimumab during the second and third trimesters and during lactation. Golimumab was present in the neonatal serum from the time of birth and for up to 6 months postpartum. The mean peak maternal serum concentration obtained in this study (1482 mcg/mL) is over 860-fold higher than median steady-state C_max value (1.71 mcg/mL) following 50 mg every 4-week SC dosing in patients with RA, PsA, and AS. Exposure to golimumab during gestation and during the postnatal period caused no developmental defects in the infants. However, animal reproductive and developmental studies are not always predictive of human response.
Golimumab crosses the placenta. Following treatment with another TNF-blocking monoclonal antibody during pregnancy, the antibody has been detected for up to 6 months in the serum of the infant born by the treated women. Consequently, these infants may be at increased risk of infection. Administration of live vaccines to infants exposed to golimumab in utero is not recommended for 6 months following the mother's last golimumab injection during pregnancy (see Precautions and Interactions).
It is not known whether SIMPONI can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. SIMPONI should be given to a pregnant woman only if clearly needed.
Breast-feeding: In the pre- and post-natal development study in cynomolgus monkeys (see Pregnancy previously) in which golimumab was administered during pregnancy and lactation, golimumab was detected in the breast milk at concentrations that were approximately 350-fold lower than the maternal serum concentrations. It is not known whether golimumab is excreted in human milk or absorbed systemically after ingestion. Because many drugs and immunoglobulins are excreted in human milk, and because of the potential for adverse reactions in nursing infants from SIMPONI, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.