Ophthalmic
PREGNANCY RECOMMENDATION: No Human Data—Probably Compatible
BREASTFEEDING RECOMMENDATION: No Human Data—Probably Compatible
PREGNANCY SUMMARY
No reports describing the use of ranibizumab in human pregnancy have been located. There also is no animal reproduction data. The predicted amount of antibody in the systemic circulation, however, is about 90,000-fold lower than the amounts in the vitreous and is below the estimated therapeutic concentration (1). Based on this estimation, the exposure and effect on an embryo or fetus probably is nil. Thus, if a woman requires ranibizumab, it should not be withheld because of pregnancy.
FETAL RISK SUMMARY
Ranibizumab binds to and inhibits vascular endothelial growth factor A (VEGF-A). It is a recombinant humanized immunoglobulin G1 (IgG1) kappa isotype monoclonal antibody fragment that is indicated for the treatment of neovascular (wet) age-related macular degeneration. It is in the same class as pegaptanib. Ranibizumab is administered as a once-monthly, 0.5-mg intravitreal injection. After monthly injections, the maximum ranibizumab serum concentrations are low (0.3–2.36 ng/mL) occurring about 1 day after a dose. These concentrations are less than the therapeutic levels (11–27 ng/mL) thought to be necessary to inhibit the biological activity of VEGF-A. The estimated average vitreous elimination half-life is about 9 days (1).
Reproduction, carcinogenicity, mutagenicity, and fertility studies in animals or humans have not been conducted (1).
It is not known if ranibizumab crosses the human placenta. The high molecular weight (48,000) and very low concentrations in the systemic circulation suggest that the antibody will not cross to the embryo or fetus. However, IgG crosses the placenta and so might ranibizumab.
BREASTFEEDING SUMMARY
No reports describing the use of ranibizumab during lactation have been located. Although the long plasma elimination half-life (about 9 days) favors excretion, the molecular weight (48,000) and very low plasma concentrations suggest that the antibody will not be detected in milk. However, IgG is excreted into milk. Nevertheless, even if excretion does occur it should be in clinically insignificant amounts. If a lactating woman requires ranibizumab, it should not be withheld because she is breastfeeding.
Reference
1.Product information. Lucentis. Genentech, 2007.