Using Tocilizumab or Sarilumab for hospitalised patients with COVID-19 who are pregnant

Paula Russell, Principal Pharmacist, Regional Drug and Therapeutics Centre (Newcastle Upon Tyne)Published Last updated See all updates

A careful risk assessment should be done on the benefits of this off-label use to the mother, and the risks it poses to the fetus or neonate.

Information Sources

Information on the use, benefits and risks of a number of medicines used in patients with COVID-19 are available. These should be regularly checked for updates as more information becomes available to inform choice.

The UK Royal College of Obstetricians and Gynaecologists (RCOG) guidance on Coronavirus (COVID-19) Infection in Pregnancy contains information on current therapeutic options including IL-6 receptor inhibitors tocilizumab and sarilumab.

The UK Teratology Information Service (UKTIS) summary information on medications used to treat COVID-19 in pregnancy describes the available evidence on the fetal risks associated with COVID-19 treatments.

Healthcare professionals are encouraged to contact UKTIS should these agents be considered for use. This will aid the timely collection of pregnancy outcome data.

UKTIS has a position statement on the use of sarilumab in place of tocilizumab.

Tocilizumab

Evidence

Although data for the use of tocilizumab in pregnancy in this situation are limited, there is currently no evidence that tocilizumab is teratogenic or fetotoxic.

Guidance

Owing to the potential for COVID-19 to cause significant disease and mortality in pregnant women, the benefits of maternal treatment should be carefully considered against the fetal and/or neonatal risks.

The UK Royal College of Obstetricians and Gynaecologists current guidance is that for women meeting certain criteria the use of tocilizumab should be strongly considered.

It is recommended that any decision to treat with an IL-6 receptor inhibitor, such as tocilizumab, should be taken by a multidisciplinary team, including obstetric and infection specialists, and given if the benefits outweigh the risks. The decision, when feasible, should also be taken in discussion with the woman.

Sarilumab

Evidence

There are currently no published data regarding the safety of sarilumab use in human pregnancy.

Guidance

The UKTIS position statement includes the advice that where tocilizumab is unavailable, the benefits of sarilumab treatment in hospitalised pregnant patients with severe COVID-19 who meet the requirements for an IL-6 receptor inhibitor treatment, will likely outweigh the risks.

Delayed live-vaccine immunisation of new-borns

The Green Book (Chapter 6 Contraindications and Special Considerations) advises that immunisation with live vaccines should be delayed until 6 months of age in children born to mothers who received immunosuppressive biological therapy during pregnancy.

If there is any doubt as to whether an infant due to receive a live attenuated vaccine may be immunosuppressed due to the mother’s therapy, specialist advice should be sought.

Change history

  1. Information about delayed live-vaccine immunisation of new-borns to mothers who received immunosuppressive biologics during pregnancy, added. Another RCOG link updated.
  1. RCOG link updated.
  1. Published