Patizra Use In Pregnancy & Lactation

Pregnancy: Risk summary: For ranibizumab, no clinical data on exposed pregnancies are available.
A study in cynomolgus monkeys does not indicate direct or indirect harmful effects with respect to pregnancy or embryonal/fetal development (see Pharmacology: Toxicology: Non-clinical safety data under Actions). The systemic exposure to ranibizumab is low after ocular administration, but due to its mechanism of action, ranibizumab must be regarded as potentially teratogenic and embryo-fetotoxic. Therefore, ranibizumab should not be used during pregnancy unless the expected benefit outweighs the potential risk to the fetus. For women who wish to become pregnant and have been treated with ranibizumab, it is recommended to wait at least 3 months after the last dose of ranibizumab before conceiving a child.
Animal data: In pregnant monkeys, IVT administration of ranibizumab did not elicit developmental toxicity or teratogenicity, and had no effect on the weight or structure of the placenta. However due to restrictions dictated by the IVT route of administration, the doses used in the study did not reach maternal toxicity, but achieved a multiple (up to 100-fold) with respect to human systemic exposure.
The absence of ranibizumab-mediated effects on embryo-fetal development is plausibly related to the inability of the antigen-binding fragment (Fab) to cross the placenta due to the absence of an Fc region. Nevertheless, a case was described with high maternal ranibizumab serum levels and presence of ranibizumab in fetal serum, suggesting that the anti-ranibizumab antibody acted as a (Fc region containing) carrier protein for ranibizumab, thereby decreasing its maternal serum clearance and enabling its placental transfer. The embryo-fetal development investigations were performed in healthy pregnant animals and disease (such as diabetes) may modify the permeability of the placenta towards a Fab fragment.
Lactation: Based on limited data, ranibizumab is present in human milk and may suppress the VEGF levels. The effects of ranibizumab on the breastfed infant or the effects of ranibizumab on milk production/excretion are unknown. As a precautionary measure, breast-feeding is not recommended during the use of Patizra. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Patizra and any potential adverse effects on the breastfed child from ranibizumab.
Females and males of reproductive potential: Contraception: Females of reproductive potential should use effective contraception during treatment with ranibizumab.
Infertility: The effect of Patizra on male and female fertility has not been investigated.