Baloxavir marboxil
بالوکساویر
🦠 Antiinfectives For Systemic UseAnti-influenza (endonuclease inhibitor)
Market / country: 🇺🇸 USA
Xofluza (US)
🧮 Dose calculator
Influenza (flu) · Regimen source: FDA Xofluza · 2.2, Tables 1–3
- • Single dose, as soon as possible and within 48 h of symptom onset or contact. Not with dairy, calcium-fortified drinks, antacids, laxatives or calcium, iron, magnesium, selenium or zinc supplements. FDA Xofluza · 2.2FDA Xofluza · 2.1
Enter age and weight.
🛡️ Safety & information
Contraindications
- ⛔ History of hypersensitivity to baloxavir (anaphylaxis, angioedema, urticaria, erythema multiforme). FDA Xofluza · 4
Important interactions
- • Dairy, antacids and calcium, iron, magnesium, selenium and zinc supplements reduce absorption. FDA Xofluza · 2.1
Formulations
- 40 mg tablet — tablet 🇺🇸 USA FDA Xofluza · 3
- 80 mg tablet — tablet 🇺🇸 USA FDA Xofluza · 3
- 2 mg/mL suspension (40 mg/20 mL bottle after reconstitution) — suspension 🇺🇸 USA FDA Xofluza · 3FDA Xofluza · 2.4
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Xofluza · 8.1
“Risk Summary There are no adequate and well-controlled studies with XOFLUZA in pregnant women to inform a drug-associated risk of adverse developmental outcomes.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Xofluza · 8.2
“Risk Summary There are no data on the presence of baloxavir marboxil in human milk, the effects on the breastfed infant, or the effects on milk production.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Xofluza · 8.4
“Pediatric Subjects (< 5 Years of Age) The safety and effectiveness of XOFLUZA for treatment and post-exposure prophylaxis of influenza in pediatric subjects less than 5 years of age, including neonates, have not been established [see Warnings and Precautions (5.2) and Microbiology (12.4) ].”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Xofluza · 8.5
“The safety and effectiveness of XOFLUZA in subjects 65 years of age and older has been established and is supported by one randomized, double-blind, controlled trial [see Clinical Studies (14.2) ] .”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA210854
- DailyMed (FDA label)FDA Xofluza
- MedlinePlus (NIH)Baloxavir Marboxil
- WHO ATC/DDDJ05AX25
- Darooyab (Iran)❌ None
🇮🇷 Not found in Iran list Darooyab · search
Darooyab lists no registered dosage form or brand for this drug. This does not prove it is unavailable.
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Xofluza · 3FDA Xofluza · 2.4FDA Xofluza · 2.2, Tables 1–3FDA Xofluza · 2.2FDA Xofluza · 2.1FDA Xofluza · 4FDA Xofluza · 8.1FDA Xofluza · 8.2FDA Xofluza · 8.4FDA Xofluza · 8.5FDA Xofluza · SPL approval / marketing category
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · search
- Clinical review⚠ Unverified