Dosing & Uses
Dosage Forms & Strengths
tablet
- 40mg
- 80mg
granules for oral suspension
- 40mg/20mL
- Reconstituted solution 2mg/mL
Influenza
Indications
-
Acute uncomplicated influenza (symptomatic ≤48 hr)
- Otherwise healthy individuals, or
- Individuals at high-risk of developing influenza-related complications
-
Postexposure prophylaxis
- Following contact with individual who has influenza
Tablet
- 20 kg to <80 kg: 40 mg PO as a single dose
- ≥80 kg: 80 mg PO as a single dose
Oral suspension
- 20 kg to <80 kg: 40 mg (20 mL) PO as a single dose
- ≥80 kg: 80 mg (40 mL) PO as a single dose
Dosage Modifications
Coadministration with polyvalent cation-containing products
- Avoid coadministration with dairy products, calcium-fortified beverages, polyvalent cation-containing laxatives or antacids, or oral supplements (eg, calcium, iron, magnesium, selenium, zinc)
Renal impairment
- CrCl ≥50 mL/min: Pharmacokinetic analysis did not identify a clinically meaningful effect
- Severe: Not studied
Hepatic impairment
- Moderate (Child-Pugh B) to normal: No clinically meaningful pharmacokinetic differences were observed
- Severe: Not studied
Dosing Considerations
Limitations of use
- Influenza viruses change over time, and factors (eg, virus type or subtype, emergence of resistance, changes in viral virulence) could diminish drug’s clinical benefit
- Check drug susceptibility patterns for circulating influenza virus strains
Dosage Forms & Strengths
tablet
- 40mg
- 80mg
granules for oral suspension
- 40mg/20mL
- Reconstituted solution 2mg/mL
Influenza
Indications
-
Acute uncomplicated influenza (symptomatic ≤48 hr)
- Otherwise healthy children aged ≥5 years, or
- Adolescents aged ≥12 years who are at high risk of developing influenza-related complications
-
Postexposure prophylaxis
- Children aged ≥5 years following contact with individual who has influenza
Tablet
- 20 kg to <80 kg: 40 mg PO as a single dose
- ≥80 kg: 80 mg PO as a single dose
Oral suspension
- <20 kg: 2 mg/kg PO as a single dose
- 20 kg to <80 kg: 40 mg (20 mL) PO as a single dose
- ≥80 kg: 80 mg (40 mL) PO as a single dose
Dosage Modifications
Coadministration with polyvalent cation-containing products
- Avoid coadministration with dairy products, calcium-fortified beverages, polyvalent cation-containing laxatives or antacids, or oral supplements (eg, calcium, iron, magnesium, selenium, zinc)
Renal impairment
- CrCl ≥50 mL/min: Pharmacokinetic analysis did not identify a clinically meaningful effect
- Severe: Not studied
Hepatic impairment
- Moderate (Child-Pugh B) to normal: No clinically meaningful pharmacokinetic differences were observed
- Severe: Not studied
Dosing Considerations
Limitations of use
- Influenza viruses change over time, and factors (eg, virus type or subtype, emergence of resistance, changes in viral virulence) could diminish drug’s clinical benefit
- Check drug susceptibility patterns for circulating influenza virus strains
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (1)
- magnesium supplement
magnesium supplement will decrease the level or effect of baloxavir marboxil by Other (see comment). Contraindicated. Drug may form a chelate with polyvalent cations; may decrease absorption by the intestinal tract; applies to oral forms
Serious - Use Alternative (49)
- aluminum hydroxide
aluminum hydroxide will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- aluminum hydroxide/magnesium carbonate
aluminum hydroxide/magnesium carbonate will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- aluminum hydroxide/magnesium trisilicate
aluminum hydroxide/magnesium trisilicate will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- aspirin/citric acid/sodium bicarbonate
aspirin/citric acid/sodium bicarbonate will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- calcium acetate
calcium acetate will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- calcium carbonate
calcium carbonate will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- calcium chloride
calcium chloride will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- calcium citrate
calcium citrate will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- calcium gluconate
calcium gluconate will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- calcium/vitamin D
calcium/vitamin D will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- carbonyl iron
carbonyl iron will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- chromium
chromium will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- citric acid/sodium bicarbonate
citric acid/sodium bicarbonate will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- copper
copper will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- ferric carboxymaltose
ferric carboxymaltose will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- ferric citrate
ferric citrate will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- ferric gluconate
ferric gluconate will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- ferric maltol
ferric maltol will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- ferric pyrophosphate DIALYSATE
ferric pyrophosphate DIALYSATE will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- ferrous fumarate
ferrous fumarate will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- ferrous gluconate
ferrous gluconate will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- ferrous sulfate
ferrous sulfate will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- ferumoxytol
ferumoxytol will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- iodine
iodine will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- iron dextran complex
iron dextran complex will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- iron sucrose
iron sucrose will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- magnesium chloride
magnesium chloride will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- magnesium citrate
magnesium citrate will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- magnesium gluconate
magnesium gluconate will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- magnesium hydroxide
magnesium hydroxide will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- magnesium oxide
magnesium oxide will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- magnesium sulfate
magnesium sulfate will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- manganese
manganese will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- molybdenum
molybdenum will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- multivitamins
multivitamins will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- multivitamins, vision
multivitamins, vision will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- polyethylene glycol & electrolytes
polyethylene glycol & electrolytes will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- polyethylene glycol/electrolytes/sodium ascorbate/ascorbic acid
polyethylene glycol/electrolytes/sodium ascorbate/ascorbic acid will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- polysaccharide iron
polysaccharide iron will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- potassium chloride
potassium chloride will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- selenium
selenium will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- sodium acid phosphate
sodium acid phosphate will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- sodium phosphate rectal
sodium phosphate rectal will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- sodium phosphates, IV
sodium phosphates, IV will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- sodium picosulfate/magnesium oxide/anhydrous citric acid
sodium picosulfate/magnesium oxide/anhydrous citric acid will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- sodium sulfate/?magnesium sulfate/potassium chloride
sodium sulfate/?magnesium sulfate/potassium chloride decreases levels of baloxavir marboxil by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- sodium sulfate/potassium sulfate/magnesium sulfate
sodium sulfate/potassium sulfate/magnesium sulfate decreases levels of baloxavir marboxil by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- trimagnesium citrate anhydrous
trimagnesium citrate anhydrous will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
- zinc
zinc will decrease the level or effect of baloxavir marboxil by cation binding in GI tract. Avoid or Use Alternate Drug. Baloxavir may bind to polyvalent cations resulting in decreased absorption. Studies in monkeys showed concurrent use with calcium, aluminum, or iron caused significantly decreased plasma levels. Human studies not conducted.
Monitor Closely (2)
- influenza virus vaccine quadrivalent, intranasal
baloxavir marboxil will decrease the level or effect of influenza virus vaccine quadrivalent, intranasal by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Use of baloxavir with intranasal live attenuated influenza vaccine (LAIV) has not been evaluated. Antivirals may inhibit LAIV viral replication, causing decreased vaccine effectiveness.
- ublituximab
ublituximab decreases effects of baloxavir marboxil by immunosuppressive effects; risk of infection. Use Caution/Monitor.
Minor (0)
Adverse Effects
1-10%
Diarrhea (3%)
Bronchitis (2%)
Nausea (1%)
Nasopharyngitis (1%)
Headache (1%)
Postmarketing Reports
Body as a whole: Swelling of face, eyelids or tongue, dysphonia, angioedema, anaphylactic reactions, anaphylactic shock, anaphylactoid reactions
Skin and SC tissue disorders: Rash, urticaria, erythema multiforme
Gastrointestinal disorders: Vomiting, bloody diarrhea, melena, colitis
Psychiatric: Delirium, abnormal behavior, hallucinations
Warnings
Contraindications
Hypersensitivity
Cautions
There is no evidence of efficacy in any illness caused by pathogens other than influenza viruses; serious bacterial infections may begin with influenzalike symptoms, may coexist with, or may occur as a complication of influenza; monitor for secondary bacterial infections and treat appropriately
Cases of anaphylaxis, urticaria, angioedema, and erythema multiforme have been reported in postmarketing experience; institute appropriate treatment if an allergic-like reaction occurs or is suspected
Not indicated in patients <5 years of age due to increased incidence of treatment-emergent resistance in this age group; potential for transmission of resistant strains in the community has not been determined
Drug interaction overview
-
Polyvalent cations
- Baloxavir (active metabolite) may form a chelate with polyvalent cations, such as calcium, aluminum, or magnesium, in food or medications
- Avoid coadministration with dairy products, calcium-fortified beverages, polyvalent cation-containing laxatives, antacids, or oral supplements (eg, calcium, iron, magnesium, selenium, zinc)
-
Vaccines
- Concurrent use with intranasal live attenuated influenza vaccine (LAIV) not evaluated
- Coadministration may inhibit viral replication of LAIV, resulting in decreased LAIV vaccine effectiveness
Pregnancy
Pregnancy
Data are not available
Animal studies
- No adverse developmental effects observed in rats or rabbits with PO administration at exposures approximately 5 (rats) and 7 (rabbits) times the systemic baloxavir exposure at the maximum recommended human dose (MRHD)
Clinical considerations
- Pregnant women are at higher risk of severe complications from influenza, which may lead to adverse pregnancy and/or fetal outcomes, including maternal death, stillbirth, birth defects, preterm delivery, low birth weight, and small for gestational age
Lactation
Data are not available for excretion in human milk
Baloxavir and its related metabolites were present in milk of lactating rats
Consider developmental and health benefits of breastfeeding along with the mother’s clinical need the drug and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Inhibits cap-dependent endonuclease; it is thought to inhibit viral replication activity of the viral polymerase
Inhibition accomplished by a method called cap snatching, where viruses hijack the host mRNA transcription system to allow viral RNA synthesis
Absorption
Effect of food: Decreased peak plasma concentration by 48% and AUC by 36%
Peak plasma time: 4 hr
Peak plasma concentration: 96.4 ng/mL (40-mg dose); 107 ng/mL (80-mg dose)
AUC: 6,160 ng·hr/mL (40-mg dose); 8,009 ng·hr/mL (80-mg dose)
Distribution
Protein bound: 92.9-93.9%
Vd: 1180 L
Metabolism
Metabolized by UGT1A3 (major) and CYP3A4 (minor)
Metabolites: Baloxavir marboxil is a prodrug and is almost completely converted to baloxavir (active metabolite)
Elimination
Half-life: 79.1 hr
Clearance: 10.3 L/hr
Excretion: Feces (80.1%), urine (14.7%)
Administration
Oral Suspension Preparation
Gently tap bottom of bottle to loosen granules
Reconstitute with 20 mL of drinking water or sterile water
After constitution, each bottle of suspension contains 40 mg of baloxavir marboxil per 20 mL (final concentration: 2 mg/mL)
Gently swirl suspension to ensure that granules are evenly suspended; do not shake
Write expiration time and date on bottle label (10 hr from reconstitution time)
Oral Administration
Initiate treatment within 48 hr of influenza symptom onset
Take orally as a single dose
May be taken with or without food
Oral suspension
- Administer with measuring device (eg, oral syringe, measuring cup) to deliver prescribed dose
- For enteral administration (ie, feeding tube), draw up suspension with an enteral syringe
- Flush with 1 mL of water before and after enteral administration
- May require more than 1 bottle (eg, for adults and adolescents weighing at least 80 kg)
Storage
Store at controlled room temperature of 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)
Granules: Store at room temperature 20-25ºC (68-77ºF) and keep in original bottle; excursions permitted to 15-30ºC (59-86ºF)
Reconstituted suspension: Store at room temperature 20-25ºC (68-77ºF) no longer than 10 hr once reconstituted; discard suspension if not used within 10 hr of preparation or if suspension has been stored at >25ºC (77ºF)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Xofluza oral - | 40 mg tablet |  | |
| Xofluza oral - | 20 mg tablet |  |
Copyright © 2010 First DataBank, Inc.
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