At this time, while there are a number of medicines being investigated for treatment and/or prevention of COVID-19, optimal therapy has not been established. We continue to monitor developments and synthesize content based on expert clinical experience and published literature and guidelines from major health organizations. Our UpToDate and Lexicomp infectious disease / critical care teams are continuously reviewing and updating our content for clinicians during this crisis.
Further information may be found at:
CDC: https://www.cdc.gov/coronavirus/2019-ncov/hcp/therapeutic-options.html
Clinicaltrials.gov: https://clinicaltrials.gov/ct2/results?cond=COVID&term=favipiravir&cntry=&state=&city=&dist=
Note: Favipiravir is currently under investigation for use in the treatment of coronavirus disease 2019 (COVID-19) (See ClinicalTrials.gov). At this time, safety and efficacy data are limited. However, preliminary dosing information based on the available published evidence and ongoing clinical trials is provided. Whenever possible, treatment should be given as part of a clinical trial.
Coronavirus disease 2019 (COVID-19) (off-label use): Oral: Optimal dose and duration unknown, limited data available; 1.6 g twice daily on day 1, followed by 600 mg twice daily for a total duration of 7 to 14 days (Cai 2020; Ivashchenko 2020). For mild to moderate COVID-19, some international markets have studied and approved a dose of 1.8 g twice daily on day 1, followed by 800 mg twice daily for a total duration of up to 14 days (FabiFlu 2020; Udwadia 2021).
Mild to moderate impairment: There are no specific dosage adjustments recommended.
Severe impairment: Use is contraindicated.
Mild to moderate impairment: There are no specific dosage adjustments recommended.
Severe impairment: Use is contraindicated.
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Generic: 200 mg (investigational agent; not commercially available in US)
Yes
Favipiravir is not commercially available in the United States; however, it may be available as part of a clinical trial for the management of coronavirus disease 2019 (COVID-19) (see http://ClinicalTrials.gov).
Coronavirus disease 2019 (COVID-19)
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs that have a heightened risk of causing significant patient harm when used in error.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Favipiravir is currently under investigation for use in the treatment of coronavirus disease 2019 (COVID-19) (see ClinicalTrials.gov). At this time, safety data is limited.
Frequency not defined:
Cardiovascular: Chest pain (Ivashchenko 2020)
Endocrine & metabolic: Hyperuricemia (Chen 2020; Sanders 2020)
Gastrointestinal: Decreased appetite (Cai 2020), diarrhea (Cai 2020; Ivashchenko 2020; Sanders 2020), nausea (Ivashchenko 2020), vomiting (Ivashchenko 2020)
Hematologic & oncologic: Decreased neutrophils (Sanders 2020)
Hepatic: Hepatic injury (Cai 2020), increased serum transaminases (Ivashchenko 2020; Sanders 2020)
Hypersensitivity to favipiravir or any component of the formulation; severe renal or hepatic impairment; pregnancy; breastfeeding.
Concerns related to adverse effects:
• Hyperuricemia: Use with caution in patients with a history of uric acid metabolism abnormalities.
Disease-related concerns:
• Gout: Use with caution; may increase uric acid.
Inhibits CYP2C8 (weak)
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Influenza Virus Vaccine (Live/Attenuated): Antiviral Agents (Influenza A and B) may diminish the therapeutic effect of Influenza Virus Vaccine (Live/Attenuated). Management: Avoid administration of live influenza virus vaccine (LAIV) within 2 weeks before or 48 hours after administration of antiviral agents. Consider avoiding LAIV if peramivir was given within the last 5 days or baloxavir was given within the last 17 days. Risk D: Consider therapy modification
Pyrazinamide: Favipiravir may enhance the adverse/toxic effect of Pyrazinamide. Specifically, the risk for increased uric acid concentrations may be increased. Risk C: Monitor therapy
Repaglinide: CYP2C8 Inhibitors (Weak) may increase the serum concentration of Repaglinide. Risk C: Monitor therapy
Favipiravir is under investigation for the treatment of coronavirus disease 2019 (COVID-19) (Cai 2020; Ivashchenko 2020; Udwadia 2021).
Based on data from animal reproduction studies, use is contraindicated for use in patients who may become pregnant. Pregnancy status should be evaluated prior to use. Patients who may become pregnant should use effective contraception during therapy and for 1 week after the last favipiravir dose. Males with female partners of reproductive potential should use effective contraception during therapy and for 1 week after the last dose of favipiravir (Hayden 2019).
Favipiravir is under investigation for the treatment of coronavirus disease 2019 (COVID-19); however, pregnant patients were not included in the initial clinical trials (Cai 2020; Ivashchenko 2020; Udwadia 2021). Based on data from animal reproduction studies, use is contraindicated in pregnant patients (Hayden 2020; Li 2020).
Outcome data are limited following use of favipiravir for the treatment of COVID-19 during pregnancy (Tırmıkçıoğlu 2021) or immediately postpartum (Jafari 2020).
The risk of severe illness from COVID-19 infection is increased in pregnant patients compared to nonpregnant patients. Patients with severe illness may require hospitalization, ICU admission, mechanical ventilation, or ventilatory support (ECMO). Other adverse pregnancy outcomes include preterm birth and stillbirth. The risk of preeclampsia, coagulopathy, emergency cesarean delivery, and maternal death may be increased; neonates have an increased risk for NICU admission. Maternal age and comorbidities may also increase the risk of severe illness in pregnant and recently pregnant patients (ACOG FAQ 2022; 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.
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 (OTIS) pregnancy registry (877-311-8972; https://mothertobaby.org/join-study/).
It is not known if favipiravir is present in breast milk.
Based on data from animal studies, breastfeeding is contraindicated during favipiravir therapy (Hayden 2019).
Favipiravir is under study for the treatment of coronavirus disease 2019 (COVID-19); however, lactating patients were not included in the initial clinical trials (Cai 2020).
Interim guidance is available from the Centers for Disease Control and Prevention for the care of lactating patients who are diagnosed with COVID-19 (https://www.cdc.gov/coronavirus/2019-ncov/hcp/care-for-breastfeeding-women.html). Information related to COVID-19 and breastfeeding is also available from the World Health Organization (https://www.who.int/news/item/28-04-2020-new-faqs-address-healthcare-workers-questions-on-breastfeeding-and-covid-19).
Tablets (Favipiravir Oral)
200 mg (per each): $0.01
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