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USE OF OCULAR ANTINEOVASCULARISATION AGENTS IN PREGNANCY

Date of issue: March 2024, Version: 1.0

Ocular antineovascularisation agents used in the UK include verteporfin and the intravitreal biologic vascular endothelial growth factor inhibitors (anti-VEGF) aflibercept, bevacizumab, brolucizumab, faricimab and ranibizumab.

Ocular antineovascularisation agents, including those administered intravitreally, are expected to reach the systemic circulation. However, their physical properties and/or factors related to the method of administration mean that a minimal direct fetal exposure could be expected. As adverse fetal effects could still occur following indirect exposure, data on the safety of antineovascularisation agents in pregnancy are still required.

There are limited data regarding the safety of ocular antineovascularisation agents in pregnancy. Data are mainly provided from uncontrolled case reports describing cases of single intravitreal administrations of anti-VEGF biologic in early pregnancy.

Although most uncontrolled reports of ocular antineovascularisation agent-exposed pregnancies describe healthy live-born infants, adverse pregnancy outcomes, including miscarriage, intrauterine fetal death, preterm delivery and fetal growth abnormalities have also been reported. A single study has suggested a possible association between intravitreal anti-VEGF biologic (aflibercept, bevacizumab and ranibizumab) exposure in pregnancy and miscarriage. However, these data are considered inconclusive as the study methodology is prone to bias and false positive findings. Further data are required to inform on the safety of ocular antineovascularisation agents in pregnancy.

Given the mechanism of action of ocular antineovascularisation agents, a cautious approach towards planned use in pregnancy is recommended until higher quality safety studies are available to better inform on the fetal risks. The impact of a period of untreated ocular disease on vision should also be taken into consideration when deciding treatment options during pregnancy. In cases of inadvertent exposure, discussion with UKTIS is recommended.

Exposure to ocular antineovascularisation agents at any stage in pregnancy would not usually be regarded as medical grounds for termination of pregnancy or any additional fetal monitoring. Other risk factors which could independently increase the risk of adverse pregnancy outcome may be present in individual cases. Such factors are important to consider when performing case-specific risk assessments.

This is a summary of the full UKTIS monograph for health care professionals and should not be used in isolation. The full UKTIS monograph and access to any hyperlinked related documents is available to NHS health care professionals who are logged in.

If you have a patient with exposure to a drug or chemical and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0344 892 0909 to discuss the case with a teratology specialist.

If you would like to report a pregnancy to UKTIS please click here to download our pregnancy reporting form. Please encourage all women to complete an online reporting form.

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