- Indications and Usage Influenza: Indicated for the treatment of acute, uncomplicated influenza A and B infection in patients 5 years of age and older, including those at high risk of influenza-related complications. Treatment Window: Efficacy is maximized when administered within 48 hours of the onset of symptoms.
- Dosage and Administration Weight-Based Dosage: For patients weighing ≥20 kg to <80 kg, the recommended single oral dose is 40 mg. For patients weighing ≥80 kg, the recommended single oral dose is 80 mg. Administration Details: The tablet can be taken with or without food. Chelation Avoidance: Avoid concurrent administration with dairy products, calcium-fortified beverages, laxatives containing polyvalent cations, antacids, or oral supplements containing calcium, iron, magnesium, selenium, or zinc, as these significantly reduce absorption.
- Mechanism of Action Prodrug Conversion: Baloxavir marboxil is an orally active prodrug that is rapidly hydrolyzed in vivo to its active metabolite, baloxavir. Endonuclease Inhibition: Baloxavir selectively inhibits the cap-dependent endonuclease activity of the influenza virus PA protein. This blocks viral mRNA transcription and subsequent viral genome replication.
- Safety and Warnings Hypersensitivity: Anaphylaxis,荨麻疹, and angioedema have been reported. Discontinue immediately if a hypersensitivity reaction is suspected. Neuropsychiatric Events: Confusion, hallucinations, and abnormal behavior may occur, particularly in children and adolescents. Patients should be monitored closely. Secondary Infection: No evidence suggests efficacy against non-influenza pathogens. Physicians should be vigilant for potential secondary bacterial infections. Viral Resistance: Viral mutations in the PA protein can lead to decreased susceptibility to baloxavir.
- Adverse Reactions and Clinical Research Most Common Adverse Reactions: Diarrhea, bronchitis, nausea, and headache. Clinical Research: Clinical trials have demonstrated that a single dose of baloxavir marboxil significantly reduces viral load and shortens the time to symptom alleviation compared to placebo.
- Drug Interactions Polyvalent Cations: Concomitant use of products containing calcium, iron, magnesium, selenium, or zinc can form insoluble complexes, significantly reducing plasma concentrations of baloxavir. Live Vaccines: The drug may reduce the effectiveness of live attenuated influenza vaccines.
- Pharmaceutical Information Chemical Composition: Active ingredient: Baloxavir marboxil. Appearance: White to pale yellow oval film-coated tablets. Packaging: Supplied in blister packs. Storage: Store at controlled room temperature (≤25°C).
Sufuda Baloxavir Marboxil Tablets
Brand Name:速福达 ®（Sufuda®）
Generic Name: Baloxavir Marboxil
Strength: 20 mg per tablet, 2 tablets per box
Manufacturer: Shionogi Pharma Co., Ltd.
Marketing Authorization Holder: Roche Pharma (Schweiz) AG
Approval Date in China: April 27, 2021
Registration Number:国药准字 HJ20210027
Storage: Seal tightly and store at temperature not exceeding 25°C, avoid high temperature and humidity. Refer to the full package insert for detailed storage specifications.
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