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Indications and Dosage
Oral
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. |
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Administration
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.
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Contraindications
Patients with known hypersensitivity to baloxavir marboxil.
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Special Precautions
Pregnancy and lactation. Avoid concomitant administration with products containing polyvalent cations (e.g. calcium, magnesium, iron, selenium, zinc).
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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. |
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Monitoring Parameters
Monitor for possible secondary bacterial infections.
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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.
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Food Interaction
Reduced absorption with dairy products.
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Action
Description:
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. Pharmacokinetics: 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. |
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Chemical Structure
 Source: National Center for Biotechnology Information. PubChem Database. CID 124081896, CID=124081896, https://pubchem.ncbi.nlm.nih.gov/compound/cid-124081896 (accessed on Mar. 24, 2020) |
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Storage
Store below 20-25°C.
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MIMS Class
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References
Anon. Baloxavir marboxil. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 08/01/2020. Buckingham R (ed). Baloxavir marboxil. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/01/2020. Xofluza (DKSH Hong Kong Ltd). MIMS Hong Kong. http://www.mims.com/hongkong. Accessed 08/01/2020. Xofluza (Genentech, Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 08/01/2020.
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