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At a glance

Baloxavir marboxil is an antiviral medication used for the treatment of influenza (flu) virus. It inhibits viral replication by blocking the cap-dependent endonuclease activity of the viral polymerase.

Indications
  • Acute uncomplicated influenza in patients 12 years and older who have been symptomatic for no more than 48 hours
  • Otherwise healthy patients or those at high risk of developing influenza-related complications
  • Post-exposure prophylaxis (PEP) of influenza in patients 12 years and older following contact with an individual who has influenza
Pharmacology

Baloxavir marboxil is an antiviral polymerase endonuclease inhibitor. It is a film-coated tablet for oral administration. Baloxavir marboxil is a prodrug that is converted by hydrolysis to baloxavir, the active form that exerts anti-influenza virus activity.

Baloxavir inhibits the endonuclease activity of the polymerase acidic (PA) protein, an influenza virus-specific enzyme in the viral RNA polymerase complex required for viral gene transcription, resulting in inhibition of influenza virus replication.

Dosage

Adults and Adolescents (12 years and older):

  • Weight 40 to <80 kg: 40 mg (two 20 mg tablets) as a single dose
  • Weight ≥80 kg: 80 mg (two 40 mg tablets) as a single dose

Hepatic Impairment: Moderate (Child-Pugh B) to normal: No clinically meaningful pharmacokinetic differences observed; Severe: Not studied.

Renal Impairment (CrCl >50 mL/min): No clinically meaningful effect identified; Severe: Not studied.

Side effects
  • Diarrhea (3%)
  • Bronchitis (3%)
  • Nausea (2%)
  • Sinusitis (2%)
  • Headache (1%)

Rare: Anaphylaxis, angioedema, urticaria, erythema multiforme

Use in pregnancy

[CONSULT YOUR DOCTOR] Pregnant women are at higher risk of severe complications from influenza. There are no adequate well-controlled studies in pregnant women. Animal studies showed no adverse developmental effects. Use only if clearly needed.

Pregnancy Category: C — always consult a doctor before taking during pregnancy.

Precautions & warnings
  • No evidence of efficacy in illnesses caused by pathogens other than influenza viruses
  • Serious bacterial infections may begin with influenza-like symptoms or may occur as a complication of influenza
  • If allergic reactions (anaphylaxis, angioedema) occur, initiate appropriate treatment
  • Monitor for secondary bacterial infections and treat appropriately
Overdose effects

There is no specific antidote for baloxavir overdose. Treatment should consist of general supportive measures including monitoring of vital signs and observation of the patient's clinical status.

Storage conditions

Store below 30°C, away from light and moisture. Keep out of reach of children.

Baloxavir marboxil — see the full informationPharmacology, precautions, pregnancy, overdose and the rest on the generic page
⚠️ This information is for educational purposes only — not a substitute for medical advice. Consult a registered physician before taking any medicine.