This medicinal product is registered under the registration procedure for medicinal products intended for use in conditions of threat of occurrence, occurrence and elimination of emergency situations. The instruction was prepared based on the limited amount of clinical data on the use of the drug and will be supplemented as new data becomes available. The use of the drug is possible only in inpatient medical care. Antiviral drug. Antiviral activity in vitro. Favipiravir has antiviral activity against laboratory strains of influenza A and B viruses (EC50 0.014-0.55 μg / ml). For strains of influenza A and B viruses resistant to adamantane (amantadine and rimantadine), oseltamivir or zanamivir, the EC50 is 0.03-0.94 μg / ml and 0.09-0.83 μg / ml, respectively. For influenza A virus strains (including strains, resistant to adamantane, oseltamivir and zanamivir), such as type A swine flu and type A avian influenza, including highly pathogenic strains (including H5N1 and H7N9), the EC50 is 0.06-3.53 μg / ml. Favipiravir inhibits the SARS-CoV-2 virus, which causes the new coronavirus infection (COVID-19). The EC50 in Vero E6 cells is 61.88 μmol, which corresponds to 9.72 μg / ml. Mechanism of action. Favipiravir is metabolized in cells to ribosyl triphosphate favipiravir (Favipiravir RTF) and selectively inhibits RNA-dependent RNA polymerase involved in influenza virus replication. RTF favipiravir (1000 μmol / L) showed no inhibitory effect on β of human DNA, but showed an inhibitory effect in the range from 9.1 to 13.5% per β and in the range from 11.7 to 41.2% for? human DNA. The inhibitory concentration (IC50) of RTF favipiravir for human RNA polymerase II was 905 μmol / L. Resistance. After 30 passages in the presence of favipiravir, no changes were observed in the susceptibility of influenza type A viruses to favipiravir, and no resistant strains were observed either. In clinical studies, the emergence of influenza viruses resistant to favipiravir was not detected.
Treatment for a new coronavirus infection (COVID-19).
Inside, 30 minutes before meals. For patients weighing less than 75 kg: 1600 mg 2 times / day on the 1st day, then 600 mg 2 times / day from 2 to 10 days. For patients weighing 75 kg or more: 1800 mg 2 times / day on the 1st day, then 800 mg 2 times / day from 2 to 10 days. The total duration of the course of treatment is 10 days or until confirmation of the elimination of the virus, if it occurs earlier (two consecutive negative PCR test results obtained with an interval of at least 24 hours).
From the side of the blood and lymphatic system: often - neutropenia, leukopenia; rarely - leukocytosis, monocytosis, reticulocytopenia. From the side of metabolism: often - hyperuricemia, hypertriglyceridemia; infrequently - glucosuria; rarely, hypokalemia. From the immune system: infrequently - rash; rarely - eczema, itching. From the respiratory system: rarely - bronchial asthma, sore throat, rhinitis, nasopharyngitis. From the digestive system: often - diarrhea; infrequently - nausea, vomiting, abdominal pain; rarely - abdominal discomfort, duodenal ulcer, bloody stools, gastritis. From the liver and biliary tract: often - increased activity of ALT, AST, GGT; rarely - an increase in ALP activity, an increase in the concentration of bilirubin in the blood. Others: rarely - abnormal behavior, increased CPK activity, hematuria, laryngeal polyp, hyperpigmentation,
Hypersensitivity to favipiravir; severe hepatic impairment (class C according to Child-Pugh classification); severe renal failure and end-stage renal disease (GFR
Application is possible only in a hospital environment. With the development of side effects, it is necessary to report this in the prescribed manner for the implementation of pharmacovigilance measures. Before starting to take favipiravir, it is necessary to provide written information to the patient about the effectiveness of the drug and the risks associated with its use (including the risk of affecting the embryo and fetus) and obtain written consent to use the drug. Influence on the ability to drive vehicles and mechanisms. Care should be taken when driving and operating machinery.
Favipiravir is not metabolized by isoenzymes of the cytochrome P450 system, mainly metabolized by aldehyde oxidase and partially metabolized by xanthine oxidase. Inhibits aldehyde oxidase and CYP2C8 isoenzyme, but does not induce cytochrome P450 isoenzymes. With simultaneous use with pyrazinamide, hyperuricemia is observed due to an additional increase in the reabsorption of uric acid in the renal tubules. With simultaneous use with repaglinide, it is possible to increase the concentration of repaglinide in the blood and develop undesirable reactions due to the action of repaglinide. With simultaneous use with famciclovir, sulindac, their effectiveness may decrease due to inhibition of aldehyde oxidase by favipiravir, which can lead to a decrease in the concentration of active forms of these substances in the blood.
1 tablet favipiravir 200 mg. Excipients: povidone K30, colloidal silicon dioxide, low-substituted hyprolose, microcrystalline cellulose type 101, crospovidone, stearic acid. The composition of the film casing: ready-made film coating Opadray? 03F220114 yellow [hypromellose. titanium dioxide, macrogol 4000 (polyethylene glycol 4000), dye iron oxide yellow E172].
|The purpose of the medication||Antivirus|