Xofluza

XOFLUZA is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for:

• Treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications
  .
  (
  1.1 Treatment of Influenza

  XOFLUZA is indicated for treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications¹

  [see Clinical Studies (14.1, 14.2, and 14.3].
  )
• Post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza. (
  1.2 Post-Exposure Prophylaxis of Influenza

  XOFLUZA is indicated for post-exposure prophylaxis of influenza in persons 5 years of age and older following contact with an individual who has influenza

  [see Clinical Studies (14.4)].
  )

Influenza viruses change over time, and factors such as the virus type or subtype, emergence of resistance, or changes in viral virulence could diminish the clinical benefit of antiviral drugs. Consider available information on drug susceptibility patterns for circulating influenza virus strains when deciding whether to use XOFLUZA. (

• Take XOFLUZA as a single dose as soon as possible and within 48 hours of influenza symptom onset for treatment of acute uncomplicated influenza or following contact with an individual who has influenza. XOFLUZA may be taken with or without food. (
  2.1 Dosage and Administration Overview

  XOFLUZA is available in two dosage forms:

  • XOFLUZA tablets (40 mg and 80 mg).
  • XOFLUZA for oral suspension is available in two different presentations: packets (30 mg and 40 mg) and bottles (2 mg/mL). If the patient weighs less than 15 kg, XOFLUZA for oral suspension in bottle is the recommended presentation. Both presentations of the for oral suspension are intended for patients who are unable to or have difficulty swallowing tablets, or those who require enteral administration

    [see Dosage and Administration (2.2, 2.3, 2.4)]

    .

  Take XOFLUZA as soon as possible after influenza symptom onset or exposure to influenza

  [see Dosage and Administration (2.2)]

  .

  XOFLUZA may be taken with or without food. However, concomitant use of XOFLUZA with dairy products, calcium-fortified beverages, polyvalent cation-containing laxatives, antacids, or oral supplements (e.g., calcium, iron, magnesium, selenium, or zinc) should be avoided

  [see Drug Interactions (7.1)and Clinical Pharmacology (12.3)].
  ,
  2.2 Recommended Dosage

  Treatment of Acute Uncomplicated Influenza or Post-Exposure Prophylaxis in Adults, and Pediatric Patients (5 Years of Age and Older)

  Take XOFLUZA as a single dose as soon as possible and within 48 hours of influenza symptom onset for treatment of acute uncomplicated influenza or following contact with an individual who has influenza. The recommended dosage of XOFLUZA in patients 5 years of age or older is a single weight-based dose displayed in Tables 1, 2and 3.

  Table 1 XOFLUZA Tablets: Recommended Dosage in Adults and Pediatric Patients 5 Years of Age and Older

  Patient Body Weight	Recommended Single Oral Dose (Tablets)Recommended XOFLUZA dosage is based on the patient's weight.
  20 kg to less than 80 kg	One 40 mg tablet (blister card contains one 40 mg tablet)
  At least 80 kg	One 80 mg tablet (blister card contains one 80 mg tablet)

  Table 2 XOFLUZA for Oral Suspension (Packets): Recommended Dosage in Adults and Pediatric Patients 5 Years of Age and Older

  Patient Body Weight	Recommended Single Oral Dose (Packets)Recommended XOFLUZA dosage is based on the patient's weight.
  15 kgPatients who weigh less than 15 kg should receive XOFLUZA for oral suspension (bottles).to less than 20 kg	One 30 mg packet
  20 kg to less than 80 kg	One 40 mg packet
  At least 80 kg	80 mg (two 40 mg packets)

  Table 3 XOFLUZA for Oral Suspension (Bottles): Recommended Dosage in Adults and Pediatric Patients 5 Years of Age and Older

  Patient Body Weight	Recommended Single Oral DoseRecommended XOFLUZA dosage is based on the patient's weight.,Use a measuring device (oral syringe) to measure the prescribed dose for use.(For Oral Suspension in Bottles)
  Less than 20 kg	2 mg/kg
  20 kg to less than 80 kg	40 mg (20 mL)
  At least 80 kg	80 mg (40 mLDosage requires two bottles of XOFLUZA for oral suspension.)
  )

Refer to the Full Prescribing Information for additional information on the recommended dosage and preparation of XOFLUZA for oral suspension (bottles) or for oral suspension (packets) for both for oral or enteral use in patients 5 years of age and older. (

• Tablets: 40 mg and 80 mg. (
  3 DOSAGE FORMS AND STRENGTHS

  • Tablets: 40 mg and 80 mg.
  • For oral suspension (packets): 30 mg and 40 mg per packet in about 15-20 mL of drinking water.
  • For oral suspension (bottles): 40 mg/20 mL (2 mg/mL) after reconstitution. .

  XOFLUZA Tablets:

  • 40 mg: white to light yellow, oblong-shaped, film-coated, debossed with "BXM40" on one side.
  • 80 mg: white to light yellow, oblong shaped, film-coated, debossed with "BXM80" on one side.

  XOFLUZA for Oral Suspension (Packets):

  • 30 mg: white to light yellow granules with strawberry flavor (each packet contains 30 mg baloxavir marboxil).
  • 40 mg: white to light yellow granules with strawberry flavor (each packet contains 40 mg baloxavir marboxil).

  XOFLUZA for Oral Suspension (Bottles):

  • 40 mg/20 mL (2 mg/mL) of baloxavir marboxil after reconstitution with 20 mL of drinking water or sterile water. The granules are white to light yellow. The reconstituted product is a greyish white, white to light yellow opaque suspension with strawberry flavor.
  )
• For oral suspension (packets): 30 mg and 40 mg per packet in about 15-20 mL of drinking water. (
  3 DOSAGE FORMS AND STRENGTHS

  • Tablets: 40 mg and 80 mg.
  • For oral suspension (packets): 30 mg and 40 mg per packet in about 15-20 mL of drinking water.
  • For oral suspension (bottles): 40 mg/20 mL (2 mg/mL) after reconstitution. .

  XOFLUZA Tablets:

  • 40 mg: white to light yellow, oblong-shaped, film-coated, debossed with "BXM40" on one side.
  • 80 mg: white to light yellow, oblong shaped, film-coated, debossed with "BXM80" on one side.

  XOFLUZA for Oral Suspension (Packets):

  • 30 mg: white to light yellow granules with strawberry flavor (each packet contains 30 mg baloxavir marboxil).
  • 40 mg: white to light yellow granules with strawberry flavor (each packet contains 40 mg baloxavir marboxil).

  XOFLUZA for Oral Suspension (Bottles):

  • 40 mg/20 mL (2 mg/mL) of baloxavir marboxil after reconstitution with 20 mL of drinking water or sterile water. The granules are white to light yellow. The reconstituted product is a greyish white, white to light yellow opaque suspension with strawberry flavor.
  )
• For oral suspension (bottles): 40 mg/20 mL (2 mg/mL) after reconstitution. (
  3 DOSAGE FORMS AND STRENGTHS

  • Tablets: 40 mg and 80 mg.
  • For oral suspension (packets): 30 mg and 40 mg per packet in about 15-20 mL of drinking water.
  • For oral suspension (bottles): 40 mg/20 mL (2 mg/mL) after reconstitution. .

  XOFLUZA Tablets:

  • 40 mg: white to light yellow, oblong-shaped, film-coated, debossed with "BXM40" on one side.
  • 80 mg: white to light yellow, oblong shaped, film-coated, debossed with "BXM80" on one side.

  XOFLUZA for Oral Suspension (Packets):

  • 30 mg: white to light yellow granules with strawberry flavor (each packet contains 30 mg baloxavir marboxil).
  • 40 mg: white to light yellow granules with strawberry flavor (each packet contains 40 mg baloxavir marboxil).

  XOFLUZA for Oral Suspension (Bottles):

  • 40 mg/20 mL (2 mg/mL) of baloxavir marboxil after reconstitution with 20 mL of drinking water or sterile water. The granules are white to light yellow. The reconstituted product is a greyish white, white to light yellow opaque suspension with strawberry flavor.
  ).

There are no adequate and well-controlled studies with XOFLUZA in pregnant women to inform a drug-associated risk of adverse developmental outcomes. There are risks to the mother and fetus associated with influenza virus infection in pregnancy

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%–4% and 15%–20%, respectively.