- Indications and Usage Influenza: Indicated for the treatment of acute, uncomplicated influenza A and B infection in patients 5 years of age and younger.
- Dosage and Administration Weight-Based Dosage: <20 kg (2 mg/kg); 20 kg to <80 kg (40 mg); ≥80 kg (80 mg). Administration Details: Single oral dose within 48 hours of symptom onset. Reconstitution: Add 20 mL of drinking water to prepare the suspension. Gently swirl to mix (do not shake vertically). Use the provided oral喂药器 to draw the required dose. Storage Post-Reconstitution: Store at ≤30°C and administer within 2 hours of preparation.
- 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, urticaria, 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 lyophilized powder or granules. Packaging: Supplied in bottles. Storage: Store at controlled room temperature (≤25°C).

Xofluza Baloxavir Marboxil for Suspension
Brand Name: 速福达 ®(Xofluza®)
Generic Name: Baloxavir Marboxil
Strength: 40 mg per bottle; reconstitute with 20 mL drinking water to get 2 mg/mL oral suspension, 1 bottle per box
Manufacturer: Shionogi Pharma Co., Ltd.
Marketing Authorization Holder: Roche Pharma (Schweiz) AG
Approval Date in China: December 29, 2023
Registration Number:国药准字 HJ20230153
Storage: Store tightly sealed below 25°C, protected from light. After reconstitution, store at ≤30°C and use within 2 hours. Refer to the full package insert for detailed storage specifications.
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