BAMLANIVIMAB / ETESEVIMAB | TERIS agent: 6846

TERIS agent: 6846 BAMLANIVIMAB / ETESEVIMAB

TERIS Agent Number:

6846

Bibliographic Search Date:

05/2022

Agent Name:

BAMLANIVIMAB / ETESEVIMAB

Bamlanivimab/Etesevimab (bamlanivimab and etesevimab) is a combination of two neutralizing monoclonal antibodies that target the receptor-binding domain of the SARS-CoV-2 spike protein. Bamlanivimab/Etesevimab is administered intravenously in the treatment of COVID-19.

Magnitude of Teratogenic Risk to Child Born After Exposure During Gestation:

UNDETERMINED

Quality and Quantity of Data on Which Risk Estimate is Based:

VERY LIMITED

Comments:

BECAUSE BAMLANIVIMAB/ETESEVIMAB IS AN ANTIBODY MIXTURE, IT MAY BE ACTIVELY TRANSPORTED ACROSS THE PLACENTA IN LATER PREGNANCY.

Summary of Teratology Studies:

MAJOR CONGENITAL ANOMALIES

No epidemiological studies of congenital anomalies among infants born to women who were treated with bamlanivimab and etesevimab during pregnancy have been reported.

Of three pregnant women who were infused with bamlanivimab and etesevimab for COVID-19 treatment, two delivered healthy neonates, while one had an ongoing pregnancy at the time the report was published (Thilagar et al., 2022). In the same study, four women received bamlanivimab therapy alone and delivered healthy full-term infants.

ANIMAL TERATOLOGY STUDIES

Animal teratology studies of bamlanivimab and etesevimab conducted by the manufacturer have not been published in the peer-reviewed literature.

Selected References:
(Each paper is classified as a review [R], human case report [C], human epidemiological study [E], human clinical series [S], animal study [A], or other [O].)

Thilagar BP, Ghosh AK, Nguyen J, Theiler RN, Wick MJ, Hurt RT, Razonable RR, Ganesh R: Anti-spike monoclonal antibody therapy in pregnant women with mild-to-moderate coronavirus disease 2019 (COVID-19). Obstet Gynecol 139(4):616-618, 2022, 2022. [S]