Japan Attachment
Avigan Tablets 200mg
favipiravir tablets
Some excerpts
This is a drug for consideration for administration to patients only when a new or resurgent influenza virus infection has occurred in which other anti-influenza agents are ineffective or inadequate and the State determines that this drug is to be used to control the influenza virus. When using this product, the latest information, including information on countermeasures against the influenza virus indicated by the government, should be consulted from time to time, and it should be used for appropriate patients. There is no experience in administering this drug for new or resurgent influenza virus infections. Information on side effects and clinical results in the package insert is based on domestic clinical trials conducted at doses lower than the approved dosage and dosage, as well as overseas clinical results.
Avigan Tablets 200mg
Indications or effects
Avigan Tablets 200mg
New or reemerging influenza virus infection (limited to those in which other anti-influenza viruses are ineffective or inadequately effective).
side effect
Avigan Tablets 200mg
There is no experience with the approved dosage and administration. In a domestic clinical trial and an international Phase III study (conducted at doses lower than the approved dosage regimen and dose), adverse reactions were observed in 100 cases (19.96%) out of 501 cases subject to safety evaluation (including abnormal clinical laboratory values). The main adverse reactions included an increase in blood uric acid in 24 patients (4.79%), diarrhea in 24 patients (4.79%), a decrease in neutrophil count in 9 patients (1.80%), an increase in AST (GOT) in 9 patients (1.80%), and an increase in ALT (GPT) in 8 patients (1.60%) (see Clinical Results).
