Baloxavir marboxil

Generic Medicine Info
Indications and Dosage
Influenza A and B
Adult: Acute uncomplicated influenza: 40-<80 kg: 40 mg; ≥80 kg: 80 mg. Given as single dose, initiate within 48 hours after the onset of symptoms.
Child: Acute uncomplicated influenza: ≥12 years Same as adult dose.
May be taken with or without food. Avoid taking w/ dairy products, Ca-fortified beverages, polyvalent cation-containing laxatives, antacids or oral supplements containing Ca, Fe, Mg, Se, or Zn.
Patients with known hypersensitivity to baloxavir marboxil.
Special Precautions
Pregnancy and lactation. Avoid concomitant administration with products containing polyvalent cations (e.g. calcium, magnesium, iron, selenium, zinc).
Adverse Reactions
Significant: Hypersensitivity reactions (e.g. anaphylaxis, angioedema, urticaria, erythema multiforme).
Gastrointestinal disorders: Diarrhoea, nausea, vomiting, melena, colitis.
Nervous system disorders: Headache.
Psychiatric disorders: Abnormal behaviour, hallucination, delirium.
Respiratory, thoracic and mediastinal disorders: Bronchitis, nasopharyngitis.
Skin and subcutaneous tissue disorders: Rash.
Monitoring Parameters
Monitor for possible secondary bacterial infections.
Drug Interactions
Reduced absorption and decreased serum concentration with polyvalent cation-containing products (e.g. calcium, iron, magnesium, selenium, zinc). May diminish the effect of live/attenuated influenza virus vaccine.
Food Interaction
Reduced absorption with dairy products.
Mechanism of Action: Baloxavir marboxil is a prodrug that is converted to baloxavir, the active form that exerts anti-influenza virus activity. It inhibits the endonuclease activity of the polymerase acidic protein, which is necessary for viral gene transcription, thus inhibiting influenza virus replication.
Absorption: Time to peak plasma concentration: 4 hours.
Distribution: Volume of distribution: 1,180 L. Plasma protein binding: Approx 93-94%.
Metabolism: Completely metabolised mainly by UGT1A3 (major) and CYP3A4 (minor) to active metabolite, baloxavir.
Excretion: Via faeces (80.1%); urine (14.7%; 3.3% as baloxavir). Elimination half-life: 79.1 hour.
Chemical Structure

Chemical Structure Image
Baloxavir marboxil

Source: National Center for Biotechnology Information. PubChem Database. CID 124081896, CID=124081896, (accessed on Mar. 24, 2020)

Store below 20-25°C.
MIMS Class
Anon. Baloxavir marboxil. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. Accessed 08/01/2020.

Buckingham R (ed). Baloxavir marboxil. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. Accessed 08/01/2020.

Xofluza (DKSH Hong Kong Ltd). MIMS Hong Kong. Accessed 08/01/2020.

Xofluza (Genentech, Inc). DailyMed. Source: U.S. National Library of Medicine. Accessed 08/01/2020.

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