Lemtrada Use In Pregnancy & Lactation

Women of childbearing potential: Serum concentrations were low or undetectable within approximately 30 days following each treatment course. Therefore, women of childbearing potential have to use effective contraception when receiving a course of treatment with LEMTRADA and up to 4 months after each course of treatment.
Pregnancy: There is a limited amount of data from the use of alemtuzumab in pregnant women. LEMTRADA should be administered during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Human IgG is known to cross the placental barrier; alemtuzumab may cross the placental barrier as well and thus potentially pose a risk to the foetus. Animal studies have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). It is not known whether alemtuzumab can cause foetal harm when administered to a pregnant woman or whether it can affect reproductive capacity.
Thyroid disease (see Autoimmunity: Thyroid disorders under Precautions) poses special risks in women who are pregnant. Without treatment of hypothyroidism during pregnancy, there is an increased risk for miscarriage and foetal effects such as mental retardation and dwarfism. In mothers with Graves' disease, maternal thyroid stimulating hormone receptor antibodies can be transferred to a developing foetus and can cause transient neonatal Graves' disease.
Breast-feeding: Alemtuzumab was detected in the milk and offspring of lactating female mice.
It is unknown whether alemtuzumab is excreted in human milk. A risk to the suckling newborn/infant cannot be excluded. Therefore, breastfeeding should be discontinued during each course of treatment with LEMTRADA and for 4 months following the last infusion of each treatment course. However, benefits of conferred immunity through breast-milk may outweigh the risks of potential exposure to alemtuzumab for the suckling newborn/infant.
Fertility: There are no adequate clinical safety data on the effect of LEMTRADA on fertility. In a sub-study in 13 male LEMTRADA-treated patients (treated with either 12 mg or 24 mg), there was no evidence of aspermia, azoospermia, consistently depressed sperm count, motility disorders or an increase in sperm morphological abnormalities.
CD52 is known to be present in human and rodent reproductive tissues. Animal data have shown effects on fertility in humanised mice (see Pharmacology: Toxicology: Preclinical safety data under Actions), however a potential impact on human fertility during the period of exposure is unknown based on the available data.