Use with caution

Dexamethasone can be used with caution, although there is no published evidence for use in breastfeeding.

See Using oral or parenteral corticosteroids during breastfeeding for further information

Use with caution

Paxlovid (nirmatrelvir + ritonavir) can be used with caution and infant monitoring during breastfeeding.

Infant monitoring

Monitoring the infant will quickly pick up any potential issues, but usually further investigation is required before the cause can be identified. If a side effect is suspected, contact a healthcare professional for further advice.

As a precaution, monitor the infant for:

• poor feeding and adequate weight gain
• irritability
• gastro-intestinal disturbances including vomiting and diarrhoea
• poor sleeping and fatigue
• hypersensitivity reactions, including rash
• signs of jaundice.

Further information

A moderate amount of published evidence for ritonavir shows negligible levels in breast milk resulting in variable infant serum levels, ranging from undetectable to low. There have been no side effects reported in breastfed infants to date.

There is no published evidence for the excretion of nirmatrelvir into breast milk, but it is likely to pass through in very low amounts due to its favourable pharmacokinetics. Its poor oral bioavailability also means the infant is unlikely to absorb a significant amount from breast milk.

Paxlovid is administered as a short course, and nirmatrelvir and ritonavir both have a short half-life, so the risk of accumulation in the infant is very low.

Two case reports in which Paxlovid was given to breastfeeding women did not report any side effects in their infants.

The manufacturer’s advice to avoid breastfeeding during treatment and for 7 days after the last dose is not considered necessary.

Use with caution

Sotrovimab can be used with caution and infant monitoring during breastfeeding.

Infant monitoring

Monitoring the infant will quickly pick up any potential issues, but usually further investigation is required before the cause can be identified. If a side effect is suspected, contact a healthcare professional for further advice.

As a precaution, monitor the infant for:

• adequate feeding
• hypersensitivity reactions, including rash.

Further information

There is no published evidence for sotrovimab in breastfeeding. However, it is a large molecule so it is difficult for it to pass into breast milk.

As sotrovimab has limited oral bioavailability, and is a protein molecule that is likely to be partially destroyed in the infant’s gastrointestinal tract, infant absorption via breast milk would be limited. Therefore side effects are unlikely.

Absorption may be increased slightly in the neonatal period due to increased gastrointestinal permeability, although this has not been proven.

Use with caution

Tocilizumab can be used with caution and infant monitoring during breastfeeding.

Infant monitoring

Monitoring the infant will quickly pick up any potential issues, but usually further investigation is required before the cause can be identified. If a side effect is suspected, contact a healthcare professional for further advice.

As a precaution monitor the infant for:

• changes in feeding
• fever or frequent infections
• gastro-intestinal disturbances including diarrhoea, nausea, and constipation
• hypersensitivity reactions, including rash.
• unusual behaviour or irritability
• poor sleeping

Further information

Evidence for tocilizumab during breastfeeding comes from other licensed indications which may use different dosing schedules and may have involved prior exposure in pregnancy.

Tocilizumab is a large molecule, so it will be difficult for it to pass into breast milk. Limited published evidence confirms levels in milk are often negligible. The infant is estimated to be exposed to 0.007–3.9% of the weight-adjusted maternal dose.

Tocilizumab has negligible oral bioavailability, and since it is a protein molecule that will be mostly destroyed in the infant’s gastrointestinal tract, infant absorption via breast milk is likely to be insignificant. Absorption may be increased slightly in the neonatal period due to increased gastrointestinal permeability, although this has not been proven.

There is only one case report in which infant serum levels have been sampled. Levels were initially influenced by pregnancy exposure, but at about 4 weeks infant levels were undetectable. After a further tocilizumab dose, levels were also undetectable after about 4 weeks.

Effects in infants

Since tocilizumab is given as a single infusion for COVID-19 treatment, the potential for it to accumulate and cause any effect in the infant is minimised.

Side effects such as immunological reactions or severe infections have not been reported in any infants exposed to date. Most were followed for up to 12 months.

Live (attenuated) vaccination

Tocilizumab is an immunosuppressive therapy. However, routine infant vaccinations, including live (attenuated) vaccinations, do not need to be withheld due to exposure to tocilizumab via breast milk. The risk of immunosuppression in the infant is negligible, and therefore:

• rotavirus vaccine can be given according to normal routine immunisation schedules
• BCG (Bacillus Calmette-Guérin) vaccine can be given if there is clinical need.

Some infants exposed to tocilizumab via breast milk were given live vaccination (rotavirus and BCG vaccines) with no adverse effects experienced.

If the infant was exposed to tocilizumab during pregnancy, it is likely that infant serum levels will be affected for a period of time after birth. Contact the UK Drugs In Lactation Advisory Service (UKDILAS), or the UK Teratology Information Service (UKTIS) for further advice regarding live vaccination in this scenario.