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Xofluza
baloxavir marboxil
Adult Dosing .
Dosage forms: TAB: 40 mg, 80 mg; GRANULE: 40 mg per packet; SUSPENSION: 40 mg per 20 mL
influenza A and B (seasonal flu) tx, uncomplicated
- [20-79 kg]
- Dose: 40 mg PO x1; Start: within 48h of symptom onset; Info: includes high-risk patients
- [>80 kg]
- Dose: 80 mg PO x1; Start: within 48h of symptom onset; Info: includes high-risk patients
influenza A and B (seasonal flu) prophylaxis, post-exposure
- [20-79 kg]
- Dose: 40 mg PO x1; Start: within 48h of exposure
- [>80 kg]
- Dose: 80 mg PO x1; Start: within 48h of exposure
novel influenza A tx (off-label)
- [20-79 kg]
- Dose: 40 mg PO x1; Start: ASAP after symptom onset; Info: for immunocompromised pts; give with oseltamivir
- [>80 kg]
- Dose: 80 mg PO x1; Start: ASAP after symptom onset; Info: for immunocompromised pts; give with oseltamivir
renal dosing
- [see below]
- CrCl >50: no adjustment; CrCl <50: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined
Peds Dosing .
- Dosage forms: TAB: 40 mg, 80 mg; GRANULE: 30 mg per packet, 40 mg per packet; SUSPENSION: 40 mg per 20 mL
influenza A and B (seasonal flu) tx, uncomplicated
- [5 yo and older, <20 kg]
- Dose: 2 mg/kg/dose PO x1; Start: within 48h of symptom onset
- [5 yo and older, 20-79 kg]
- Dose: 40 mg PO x1; Start: within 48h of symptom onset
- [5 yo and older, >80 kg]
- Dose: 80 mg PO x1; Start: within 48h of symptom onset
influenza A and B (seasonal flu) prophylaxis, post-exposure
- [5 yo and older, <20 kg]
- Dose: 2 mg/kg/dose PO x1; Start: within 48h of symptom onset
- [5 yo and older, 20-79 kg]
- Dose: 40 mg PO x1; Start: within 48h of symptom onset
- [5 yo and older, >80 kg]
- Dose: 80 mg PO x1; Start: within 48h of exposure
novel influenza A tx (off-label)
- [5 yo and older, <20 kg]
- Dose: 2 mg/kg/dose PO x1; Start: ASAP after symptom onset; Info: for immunocompromised pts; give with oseltamivir
- [5 yo and older, 20-79 kg]
- Dose: 40 mg PO x1; Start: ASAP after symptom onset; Info: for immunocompromised pts; give with oseltamivir
- [5 yo and older, >80 kg]
- Dose: 80 mg PO x1; Start: ASAP after symptom onset; Info: for immunocompromised pts; give with oseltamivir
renal dosing
- [see below]
- CrCl >50: no adjustment; CrCl <50: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- pregnancy
- breastfeeding
Drug Interactions .
Overview
baloxavir marboxil
viral polymerase acidic endonuclease inhibitor
- binds to polyvalent cations
- impairs immunomodulatory viral infective agent
Avoid/Use Alternative
- aluminum hydroxide
- calcium acetate
- calcium carbonate
- calcium citrate
- calcium gluconate
- ferric citrate
- ferrous fumarate
- ferrous gluconate
- ferrous sulfate
- magnesium citrate
- magnesium supplement
- sucralfate
- zinc oral
Monitor/Modify Tx
- chromium
- ferric maltol
- influenza nasal vaccine, live
- lanthanum
- magnesium carbonate
- magnesium hydroxide
- magnesium oxide
- molindone
- quinapril
- sucroferric oxyhydroxide
- sulfate bowel prep
Adverse Reactions .
Serious Reactions
- anaphylaxis
- anaphylactoid reaction
- angioedema
- erythema multiforme
- urticaria
Common Reactions
- nausea (patients >65 yo)
- diarrhea (peds patients)
Safety/Monitoring .
Monitoring Parameters
no routine tests recommended
Pregnancy/Lactation .
Pregnancy
Clinical Summary
avoid use during pregnancy; no human data available; no known risk of fetal harm based on animal data at 5x and 7x MRHD
Lactation
Clinical Summary
avoid use while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for baloxavir marboxil: liver; CYP450: 3A4 substrate (minor); UGT: 1A3 substrate (primary)
Excretion: for baloxavir marboxil: feces 80.1%, urine 14.7%; Half-life: 79.1h
Subclass: Influenza (Flu)
Mechanism of Action
for baloxavir marboxil: prodrug converted to baloxavir, which inhibits viral polymerase acidic protein endonuclease activity, inhibiting viral replication
Formulary .
No Formulary Selected
Manufacturer/Pricing .
Manufacturer: Genentech, Inc.
DEA/FDA: Rx
Retail Price
Estimated prices only. For current pricing, visit GoodRx.
oral tablet:
- 20 mg (1 dose pack, 2 tablets): $166.00
- 40 mg (1 dose pack, 2 tablets): $166.00
oral tablet:
- 40 mg (1 dose pack, 1 tablet): $166.00
- 80 mg (1 dose pack, 1 tablet): $166.00
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