MedeliX
Start asking

baloxavir marboxil

Xofluza · ATC code 464

Also known as: Baloksavir marboksil

Key facts
Active substance
baloxavir marboxil
ATC code
464
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Xofluza 20 mg film-coated tablets / Xofluza 40 mg film-coated tablets / Xofluza 80 mg film-coated tablets · Xofluza 2 mg/mL granules for oral suspension · Xofluza 10 mg granules in sachet / Xofluza 30 mg granules in sachet / Xofluza 40 mg granules in sachet
Marketing authorisation holder
Roche Registration GmbH
Information as of
2026-10-28

Key facts

Baloxavir marboxil (Xofluza) is an antiviral that inhibits the influenza virus-specific cap-dependent endonuclease; it is taken as a single dose to treat and prevent influenza.

What it is used for

  • Treatment of uncomplicated influenza in patients aged 3 weeks and above.
  • Post-exposure prophylaxis of influenza in individuals aged 3 weeks and above.
  • Use in accordance with official recommendations.

Dosing

  • A single dose taken as soon as possible within 48 hours of symptom onset or of close contact with a person known or suspected to have influenza.
  • Film-coated tablets: 20 kg to < 80 kg a single 40 mg dose; 80 kg and above a single 80 mg dose. Below 20 kg the granule formulations are used.
  • Granules for oral suspension (2 mg/mL): below 20 kg 2 mg per kg of body weight; 20 kg to < 80 kg 40 mg; 80 kg and above 80 mg.
  • Granules in sachet: weight-based bracket dosing (e.g. 20 mg or 30 mg in children below 20 kg); see the full text for details.
  • No dose adjustment for the elderly, renal impairment or mild to moderate hepatic impairment; not established in severe hepatic impairment. No data on repeat dosing within one influenza season.
  • With or without food; not to be taken with products containing polyvalent cations (laxatives, antacids, iron, zinc, selenium, calcium, magnesium).

Contraindications

  • Hypersensitivity to the active substance or any excipient.

Important warnings

  • Hypersensitivity reactions including anaphylaxis, urticaria and angioedema have been reported post-marketing.
  • The tablets contain lactose: not for patients with rare hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
  • The oral suspension contains maltitol (700 mg per 20 mL): not for patients with hereditary fructose intolerance.
  • Viruses with reduced susceptibility to baloxavir (PA/I38 mutations) emerged during treatment in studies.

Side effects

  • Common: diarrhoea and vomiting; in children also rash.
  • Uncommon: urticaria.
  • Not known: anaphylaxis, anaphylactic reactions, hypersensitivity, angioedema, ischaemic colitis.

Interactions

  • Polyvalent cations (laxatives, antacids, supplements with iron, zinc, selenium, calcium or magnesium) may decrease baloxavir plasma concentrations and should not be taken at the same time.
  • No interaction studies with influenza vaccines have been conducted.

Pregnancy and breastfeeding

  • As a precaution, use during pregnancy is preferably avoided.
  • A risk to the breast-fed infant cannot be excluded; a decision on breast-feeding or therapy is required.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • XofluzaRoche Registration GmbH · EMEA/H/C/004974

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Xofluza
Liechtenstein
Xofluza
Norway
Xofluza

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Xofluza – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/xofluza-epar-product-information_en.pdf

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.