Baloxavir marboxil


Concise Prescribing Info
Indications/Uses
Influenza A and B.
Dosage/Direction for Use
Adult : PO 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.
Dosage Details
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.
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.
Contraindications
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.
MonitoringParameters
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.
Action
Description: 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.
Chemical Structure

Chemical Structure Image
Baloxavir marboxil

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)

Storage
Store below 20-25°C.
MIMS Class
ATC Classification
J05AX25 - baloxavir marboxil ; Belongs to the class of other antivirals. Used as a direct acting antiviral in the systemic treatment of viral infections.
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.

Disclaimer: This information is independently developed by MIMS based on Baloxavir marboxil from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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