Anruiwei Onradivir Tablets

1. Indications and Usage
Treatment of Influenza A: Indicated for the treatment of uncomplicated influenza A in adult patients.
Patient Exclusion: This indication excludes patients who are at high risk of complications related to influenza infection.
2. Dosage and Administration
Recommended Dose: The recommended dosage is 600 mg (three 200 mg tablets) taken orally once daily for 5 days.
Timing: The medication should be initiated within 48 hours of the onset of symptoms.
Administration: Tablets can be taken with or without food.
Dose Adjustments for Special Populations:
Renal Impairment: No dosage adjustment is required for mild renal impairment. The safety and efficacy for moderate to severe renal impairment have not been established.
Hepatic Impairment: The recommended dosage is 400 mg once daily for patients with mild hepatic impairment. The safety and efficacy for moderate to severe hepatic impairment have not been established.
3. Mechanism of Action
PB2 Inhibition: Onradivir is a “cap” structure analog that binds to the PB2 subunit of the influenza virus RNA polymerase complex.
Replication Blockade: By inhibiting the initiation of viral RNA replication, it blocks the interaction between the viral PB2 subunit and host cell mRNA cap structures (cap-snatching). This ultimately suppresses the synthesis of viral mRNA and inhibits the replication of the influenza A virus.
4. Safety and Warnings
Drug Resistance: The antiviral benefits of onradivir may be diminished by factors such as changes in the type or subtype of circulating influenza viruses, or the emergence of drug resistance.
Off-Label Use: There is no evidence that the drug is effective for diseases other than influenza A.
Pregnancy and Lactation: Use during pregnancy is not recommended. Breastfeeding should be discontinued during treatment and for 7 days after the final dose.
5. Adverse Reactions and Clinical Research
Adverse Reactions: Common adverse reactions include gastrointestinal disorders (diarrhea, nausea, abdominal pain, abdominal distension), laboratory abnormalities (decreased neutrophil count, decreased white blood cell count, prolonged activated partial thromboplastin time, increased blood bilirubin), and nervous system disorders (dizziness).
Clinical Research: Clinical trials have demonstrated that onradivir significantly reduces the median time to relief of influenza symptoms, the median time to relief of fever, and the viral load of influenza A compared to placebo.
6. Drug Interactions
UGT Inhibitors: Concomitant use with probenecid (a UGT enzyme inhibitor) increases onradivir plasma concentrations (Cmax increased by 40.79% and AUC0-∞ increased by 51.87%).
P-gp/BCRP Inhibitors: Concomitant use with P-gp and BCRP inhibitors (e.g., itraconazole) has shown no significant effect on the pharmacokinetics of onradivir.
7. Pharmaceutical Information
Composition: The active ingredient is onradivir.
Appearance: The tablets are film-coated and appear light yellow, potentially with scattered white spots after removing the coating.
Storage: Store at controlled room temperature and protect from moisture.