Name: Lytenava (bevacizumab-vikg) in Neovascular age-related macular degeneration: Special populations
Published: 2026-09-28T12:24:10-04:00

Product information and disease description Product description Product information

Special populations

5 evidence topics · 1 source

Pregnancy

“Based on the anti-VEGF mechanism of action for bevacizumab products [see Clinical Pharmacology (12.1)], treatment with LYTENAVA may pose a risk to human embryofetal development.” (opens the prescribing information at this quote)
“There are no adequate and well-controlled studies of LYTENAVA administration in pregnant women or pregnant animals. It is not known whether bevacizumab-vikg can cause fetal harm when administered to a pregnant woman. LYTENAVA should be given to a pregnant woman only if clearly needed.” (opens the prescribing information at this quote)
“All pregnancies have a background risk of birth defect, loss, and other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.” (opens the prescribing information at this quote)

Lactation

“There are no data available on the presence of bevacizumab-vikg in human milk, the effects of bevacizumab-vikg on the breastfed infant or the effects of bevacizumab-vikg on milk production/excretion.” (opens the prescribing information at this quote)
“Because many drugs are excreted in human milk, and because the potential for absorption and harm to infant growth and development exists, caution should be exercised when LYTENAVA is administered to a nursing woman.” (opens the prescribing information at this quote)
“The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for LYTENAVA and any potential adverse effects on the breastfed child from bevacizumab-vikg.” (opens the prescribing information at this quote)

Females and males of reproductive potential

“Females of reproductive potential should use effective contraception during treatment with LYTENAVA and for at least 3 months after the last dose when stopping treatment with LYTENAVA.” (opens the prescribing information at this quote)
“There are no data regarding the effects of LYTENAVA on human fertility. Based on the anti-VEGF mechanism of action LYTENAVA may pose a risk to reproductive capacity [see Clinical Pharmacology (12.1)].” (opens the prescribing information at this quote)

Pediatric use

“The safety and effectiveness of LYTENAVA in pediatric patients have not been established.” (opens the prescribing information at this quote)

Geriatric use

“In the three completed Phase 3 clinical studies, approximately 70% (238/341) of patients treated with LYTENAVA were ≥ 65 years of age and approximately 47 % (160/341) were ≥ 75 years of age. No overall differences in efficacy or safety were seen with increasing age in these studies [see Clinical Studies (14)].” (opens the prescribing information at this quote)