Pregnancy Considerations
Casirivimab and imdevimab are currently available under FDA emergency use authorization (EUA) for the treatment of COVID-19. Reproductive toxicity studies have not been conducted (FDA 2021).
Casirivimab and imdevimab are humanized monoclonal antibodies (IgG1). Placental transfer of human IgG is dependent upon the IgG subclass, maternal serum concentrations, newborn birth weight, and GA, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009). The potential benefits or risks of in utero exposure to casirivimab/imdevimab to the fetus are not known (FDA 2021).
The risk of severe illness from COVID-19 infection is increased in pregnant patients, and pregnancy is one of the high-risk medical conditions defined by the CDC. An increased risk of adverse pregnancy outcomes may also occur in COVID-19 positive patients with symptomatic infection. These include preterm birth, preeclampsia, coagulopathy, and stillbirth. Pregnant patients with symptomatic COVID-19 infection are more likely to require ICU admission, mechanical ventilation, and ventilatory support (ECMO) compared to nonpregnant symptomatic patients. Maternal age and comorbidities may also increase the risk of severe illness in pregnant and recently pregnant patients (ACOG 2020; NIH 2021).
In general, the treatment of COVID-19 infection during pregnancy is the same as in nonpregnant patients (NIH 2021). Although monoclonal antibodies have not been tested in pregnant patients, pregnancy is one of the medical conditions listed in the EUA eligibility criteria for casirivimab/imdevimab (FDA 2021). Use may be considered in pregnant patients, particularly those with ≥1 additional risk factor (ACOG 2020). According to the EUA, dose adjustments are not recommended for patients who are pregnant (FDA 2021). Monoclonal antibodies should not be withheld from pregnant patients when otherwise appropriate (NIH 2021). Information related to the treatment of COVID-19 during pregnancy continues to emerge; refer to current guidelines for the treatment of pregnant patients.
The American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine have developed an algorithm to aid practitioners in assessing and managing pregnant patients with suspected or confirmed COVID-19 (https://www.acog.org/covid-19; https://www.smfm.org/covid19). Interim guidance is also available from the CDC for pregnant patients who are diagnosed with COVID-19 (https://www.cdc.gov/coronavirus/2019-ncov/hcp/inpatient-obstetric-healthcare-guidance.html).
Data collection to monitor maternal and infant outcomes following exposure to COVID-19 during pregnancy is ongoing. Health care providers are encouraged to enroll patients exposed to COVID-19 during pregnancy in the Organization of Teratology Information Specialists pregnancy registry (877-311-8972; https://mothertobaby.org/join-study/) or the PRIORITY (Pregnancy CoRonavIrus Outcomes RegIsTrY) (415-754-3729, https://priority.ucsf.edu/).
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