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Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-.

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Drugs and Lactation Database (LactMed) [Internet].

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Ranibizumab

Last Revision: December 21, 2020.

Estimated reading time: 3 minutes

CASRN: 347396-82-1

Drug Levels and Effects

Summary of Use during Lactation

Ranibizumab inhibits vascular endothelial growth factor (VEGF). Ranibizumab is a is a large protein molecule with a molecular weight of 48,000 Da, absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract, so systemic effects in infants are not expected. Since VEGF is present in human milk and is thought to help in maturation of the infant’s gastrointestinal tract, concern has been raised about the maternal use of VEGF inhibitors during breastfeeding. One infant was breastfed, apparently without noticeable harm, following maternal intravitreal ranibizumab injections. VEGF levels in breastmilk were not changed following the injection. In another woman who did not breastfeed had decreasing VEGF levels in milk over a 28-day period. The role that breastfeeding has in maintaining VEGF levels in not clear. Ranibizumab has the shortest half-life of the VEGF inhibitors used in the eye, and thus might be the preferred agent.[1] Note that the typical alternative to breastmilk is infant formula, which contains no VEGF.

Ranibizumab is a human immunoglobulin G1 (IgG1) kappa antibody. Holder pasteurization (62.5 degrees C for 30 minutes) decreases the concentration of endogenous immunoglobulin G by up to 79%.[2-4] A study of 67 colostrum samples that underwent Holder pasteurization found that IgG amounts decreased by 34 to 40%. Specific IgG subclasses decreased by different amounts, with IgG1 activity decreasing by about 37%.[5] None of the studies measured IgG activity.

Drug Levels

Maternal Levels. One mother who was nursing a 16-month-old infant received an unspecified dose of ranibizumab intraocular injection for myopic choroidal neovascularization. After her first dose, breastfeeding was stopped and milk samples were obtained 1 hour before the injection and on days 1 through 7, 14, 21, and 28 after injection. Ranibizumab was undetectable (<1.6 mcg/L) for the first 2 days after injection and then was 34.7 mcg/L on day 3. On day 6, the concentration was about 55 mcg/L, then it drifted slowly up to a concentration of about 30 mcg/L on day 28 after the injection. Another mother studied at the same center was given ranibizumab 0.5 mg intravitreal injections for myopic choroidal neovascularization and continued to breastfeed her 1 month-old infant. Milk samples were taken 4 weeks after a dose and on days 1 through 7, 14, 21, and 28 after injection. All milk samples had ranibizumab concentrations below the lower limit of quantification of 1.6 mcg/L. The investigators hypothesized that continuous nursing resulted in the lower levels of ranibizumab in milk.[6]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

A woman was given 3 intravitreal injections of bevacizumab for scar-associated choroidal neovascularization in her left eye. Vascular endothelial growth factor (VEGF) was measured in serum and breastmilk. After the intravitreal injection of bevacizumab, the VEGF level in breastmilk decreased from 13.3 to 8.6 mcg/L over a 2-week period. After changing therapy to ranibizumab therapy, no decrement in breastmilk VEGF was seen during the 42 days following injection.[7] It is not clear from the article if the mother continued breastfeeding after the injection.

Two women received ranibizumab intraocular injections for myopic choroidal neovascularization. In one who did not breastfeed, VEGF decreased from 22.8 mcg/L at baseline to 12.3 mcg/L on day 1 and to 4.9 mcg/L on day 28 after her dose. The second woman who did breastfeed her infant, had VEGF levels that were largely unchanged, varying between about 8 and 12 mcg/L over the 28-day follow up. The investigators hypothesized that continuous nursing resulted in the lower levels in the relative lack of VEGF reduction in milk.[6]

Alternate Drugs to Consider

(Intravitreal) Bevacizumab

References

1.
Dalal PJ, Patel AL, Carle M, et al. Review of ophthalmic and breastfeeding medicine evidence: Real and theoretical risks of intravitreal Anti-VEGF administration in lactating women. Retina. 2020;40:2065–9. [PubMed: 32796446]
2.
Koenig A, de Albuquerque Diniz EM, Barbosa SF, et al. Immunologic factors in human milk: The effects of gestational age and pasteurization. J Hum Lact. 2005;21:439–43. [PubMed: 16280560]
3.
Adhisivam B, Vishnu Bhat B, Rao K, et al. Effect of Holder pasteurization on macronutrients and immunoglobulin profile of pooled donor human milk. J Matern Fetal Neonatal Med. 2019;32:3016–19. [PubMed: 29587541]
4.
Rodríguez-Camejo C, Puyol A, Fazio L, et al. Impact of Holder pasteurization on immunological properties of human breast milk over the first year of lactation. Pediatr Res. 2020;87:32–41. [PubMed: 31288249]
5.
Rodríguez-Camejo C, Puyol A, Fazio L, et al. Antibody profile of colostrum and the effect of processing in human milk banks: Implications in immunoregulatory properties. J Hum Lact. 2018;34:137–47. [PubMed: 28586632]
6.
Juncal VR, Paracha Q, Bamakrid M, et al. Ranibizumab and aflibercept levels in breast milk after intravitreal injection. Ophthalmology. 2020;127:278–80. [PubMed: 31526521]
7.
Ehlken C, Martin G, Stahl A, et al. Reduction of vascular endothelial growth factor a in human breast milk after intravitreal injection of bevacizumab but not ranibizumab. Arch Ophthalmol. 2012;130:1226–7. [PubMed: 22965611]

Substance Identification

Substance Name

Ranibizumab

CAS Registry Number

347396-82-1

Drug Class

Breast Feeding

Lactation

Antibodies, Monoclonal

Angiogenesis Inhibitors

Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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