baloxavir marboxil (Rx)

Brand and Other Names:Xofluza
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 40mg
  • 80mg

Influenza

Indicated for treatment of acute uncomplicated influenza in patients who have been symptomatic for ≤48 hr

40 to <80 kg: 40 mg PO as a single dose

≥80 kg: 80 mg PO as a single dose

Dosage Modifications

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

Influenza

Indicated for treatment of acute uncomplicated influenza in patients who have been symptomatic for ≤48 hr

<12 years: Safety and efficacy not established

≥12 years and weight ≥40 kg

  • 40 to <80 kg: 40 mg PO as a single dose
  • ≥80 kg: 80 mg PO as a single dose

Dosage Modifications

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

Interaction Checker

and baloxavir marboxil

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    Contraindicated

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            Adverse Effects

            1-10%

            Frequency of adverse effects listed below are less than or equal to those reported with placebo

            Diarrhea (3%)

            Bronchitis (2%)

            Nausea (1%)

            Nasopharyngitis (1%)

            Headache (1%)

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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

            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 Administration

            Initiate treatment within 48 hr of influenza symptom onset

            Take orally as a single dose

            May be taken with or without food

            Storage

            Store at controlled room temperature of 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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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.