Summary of Use during Lactation

Favipiravir is an investigational antiviral drug in the US that is being tested for use against the novel coronavirus disease, COVID-19. Information from one patient indicates that milk levels are low with a peak level at about 2 hours. One infant has reportedly been breastfed by a mother receiving favipiravir and pumping her breasts after doses with no adverse effects reported in the infant. Favipiravir has caused liver enzyme abnormalities, gastrointestinal symptoms, and serum uric acid elevations.[1,2] If favipiravir is used in a nursing mother, these parameters should be monitored in the breastfed infant.

Drug Levels

Maternal Levels. A lactating woman took a single 200 mg dose of favipiravir (Favimol, Neutec Pharmaceutical Company) and provided milk samples at 0.5, 2 and 4 hours after the dose. Milk concentrations were 0.3, 5.5 and 2.7 mg/L, respectively.[3]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

A nursing mother with a positive PCR for COVID-19 was prescribed favipiravir with a loading dose of 1600 mg twice on the first day, then 600 mg every 12 hours from day 2 to day 5. She breastfed her 15-month-old COVID-19-negative infant just before each dose of the drug. She pumped and discarded her milk between doses. No symptoms were observed in the baby during drug use and no abnormalities were detected in the baby’s hematological and biochemistry tests. The infant was followed for 6 months and was fed breastmilk and complementary feeding, did not develop any symptoms.[4]

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Nirmatrelvir, Remdesevir

References

1.

Sissoko D, Laouenan C, Folkesson E, et al. Experimental treatment with favipiravir for Ebola virus disease (the JIKI Trial): A historically controlled, single-arm proof-of-concept trial in Guinea. PLoS Med. 2016;13:e1001967. [PMC free article: PMC4773183] [PubMed: 26930627]

2.

Scavone C, Brusco S, Bertini M, et al. Current pharmacological treatments for COVID-19: What's next? Br J Pharmacol. 2020;177:4813–24. [PMC free article: PMC7264618] [PubMed: 32329520]

3.

Tiris G, Gazioglu I, Furton KG, et al. Fabric phase sorptive extraction combined with high performance liquid chromatography for the determination of favipiravir in human plasma and breast milk. J Pharm Biomed Anal. 2022;223:115131. [PubMed: 36395627]

4.

Karabayır N, Doğan Öçal O, Canbeyli G. Use of favipiravir in lactating mother with COVID-19. Turk Arch Pediatr. 2021;56:533–4. [PMC free article: PMC8849531] [PubMed: 35110126]

Substance Name

Favipiravir

CAS Registry Number

259793-96-9

Drug Class

Breast Feeding

Lactation

Milk, Human

Antiviral Agents