Amgevita Use In Pregnancy & Lactation

Women of child bearing potential/Contraception in males and females: Women of childbearing potential are strongly recommended to use adequate contraception to prevent pregnancy and continue its use for at least five months after the last AMGEVITA treatment.
Pregnancy: For adalimumab, limited clinical data on exposed pregnancies are available.
In a developmental toxicity study conducted in monkeys, there was no indication of maternal toxicity, embryotoxicity or teratogenicity. Preclinical data on postnatal toxicity of adalimumab are not available (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Due to its inhibition of TNFα, adalimumab administered during pregnancy could affect normal immune responses in the newborn. Administration of AMGEVITA is not recommended during pregnancy.
Adalimumab may cross the placenta into the serum of infants born to women treated with adalimumab during pregnancy. Consequently, these infants may be at increased risk for infection. Administration of live vaccines to infants exposed to adalimumab in utero is not recommended for 5 months following the mother's last adalimumab injection during pregnancy.
Breast-feeding: It is not known whether adalimumab is excreted in human milk or absorbed systemically after ingestion.
However, because human immunoglobulins are excreted in milk, women must not breast-feed for at least five months after the last AMGEVITA treatment.
Fertility: Preclinical data on fertility effects of adalimumab are not available.