From the Guidelines
Paxlovid can generally be taken during breastfeeding, as the benefits of treating COVID-19 in the mother outweigh the theoretical risks to the breastfed infant. According to the World Health Organization (WHO) guideline on drugs for COVID-19 1, breastfeeding individuals with non-severe COVID-19 may consider using nirmatrelvir/ritonavir. The guideline is based on data available through the WHO Vigibase and suggests that the use of nirmatrelvir/ritonavir is consistent with previous recommendations.
Key points to consider when taking Paxlovid during breastfeeding include:
- The oral bioavailability of nirmatrelvir and ritonavir in infants is likely poor, meaning very little would be absorbed by the breastfeeding infant
- Small amounts of the drugs may pass into breast milk, but the risks to the infant are considered low
- The standard adult dosage is nirmatrelvir 300 mg with ritonavir 100 mg taken twice daily for 5 days, but this may need adjustment if you have kidney problems
- It's essential to inform your healthcare provider about all medications you're taking, as Paxlovid has many drug interactions
The WHO guideline 1 emphasizes the importance of considering the benefits and risks of using nirmatrelvir/ritonavir in breastfeeding individuals. In general, the benefits of treating COVID-19 in the mother outweigh the theoretical risks to the breastfed infant, especially since untreated COVID-19 in the mother poses risks to both mother and baby. Therefore, breastfeeding can continue while taking Paxlovid, as breast milk provides important antibodies and nutrition to the baby.
From the FDA Drug Label
Nirmatrelvir and ritonavir are present in human breast milk in small amounts (less than 2%). In a clinical lactation study in 8 lactating women, nirmatrelvir and ritonavir were estimated to be present in human milk at a mean weight-normalized infant daily dose of 0.16 mg/kg/day (1.8% of maternal weight-adjusted daily dose) and 0.006 mg/kg/day (0. 2% of maternal weight-adjusted daily dose), respectively... The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for PAXLOVID and any potential adverse effects on the breastfed infant from PAXLOVID or from the underlying maternal condition.
Safety of Paxlovid during breastfeeding:
- There are limited data on the effects of nirmatrelvir or ritonavir on the breastfed infant.
- The drug is present in breast milk in small amounts.
- Caution is advised when taking Paxlovid during breastfeeding, as the potential adverse effects on the breastfed infant are not well understood.
- The decision to use Paxlovid during breastfeeding should be made after considering the mother's clinical need for the drug and the potential risks to the infant 2.
From the Research
Safety of Paxlovid during Breastfeeding
There is no direct evidence in the provided studies regarding the safety of taking Paxlovid (nirmatrelvir/ritonavir) during breastfeeding.
- The studies primarily focus on the efficacy and safety of nirmatrelvir/ritonavir in treating COVID-19 in various patient populations, including outpatients with mild COVID-19 and inpatients with moderate to severe COVID-19 3, 4.
- They also discuss the potential of nirmatrelvir/ritonavir as an antiviral therapy for COVID-19, including its development, clinical trials, and regulatory approvals 5.
- Additionally, the studies compare nirmatrelvir/ritonavir with other oral antiviral agents, such as VV116 and molnupiravir, in terms of efficacy and safety in treating COVID-19 6, 7.
- However, none of the studies specifically address the safety of taking Paxlovid during breastfeeding, highlighting a gap in the current evidence base.
Key Findings
- Nirmatrelvir/ritonavir has shown promise in reducing the risk of all-cause mortality and hospital admission or death in high-risk, unvaccinated COVID-19 outpatients infected with the Delta variant of SARS-CoV-2 3, 4.
- The safety of nirmatrelvir/ritonavir has been evaluated in various studies, with low- to moderate-certainty evidence suggesting that it is safe in people without prior or concomitant therapies, including medications highly dependent on CYP3A4 3, 4.
- However, the lack of evidence on the safety of Paxlovid during breastfeeding means that healthcare providers must exercise caution when prescribing this medication to breastfeeding women.
Limitations
- The current evidence base is limited by the lack of studies specifically addressing the safety of Paxlovid during breastfeeding.
- Further research is needed to fill this knowledge gap and provide guidance for healthcare providers on the safe use of Paxlovid in breastfeeding women.