baloxavir marboxil (Rx)

Brand and Other Names:Xofluza
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 20mg
  • 40mg

granules for oral suspension

  • 40mg/20mL
  • Reconstituted solution 2mg/mL

Influenza

Treatment

  • Indicated for treatment of acute uncomplicated influenza in patients who have been symptomatic for ≤48 hr and who are otherwise healthy or at high risk of developing influenza-related complications
  • <80 kg: 40 mg PO as a single dose
  • ≥80 kg: 80 mg PO as a single dose

Prophylaxis

  • Indicated for postexposure prophylaxis of influenza in patients following contact with an individual who has influenza
  • <80 kg: 40 mg PO as a single dose
  • ≥80 kg: 80 mg 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

  • 20mg
  • 40mg

granules for oral suspension

  • 40mg/20mL
  • Reconstituted solution 2mg/mL

Influenza

Treatment

  • Indicated for treatment of acute uncomplicated influenza in patients aged ≥12 years who have been symptomatic for ≤48 hr and otherwise healthy, or at high risk of developing influenza-related complications
  • <12 years: Safety and efficacy not established
  • ≥12 years
    • <80 kg: 40 mg PO as a single dose
    • ≥80 kg: 80 mg PO as a single dose

Prophylaxis

  • Indicated for postexposure prophylaxis of influenza in patients aged ≥12 years following contact with an individual who has influenza
  • <12 years: Safety and efficacy not established
  • ≥12 years
    • <80 kg: 40 mg PO as a single dose
    • ≥80 kg: 80 mg 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
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Interactions

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            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 (1)

            • 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.

            Minor (0)

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              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

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              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

              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
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              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.

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              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%)

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              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)

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              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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              Formulary

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              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.