Dosage & administration
| Patient Body Weight | Recommended Single Oral Dose in Patients 5 Years of Age and Older (Tablets) |
|---|---|
| 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) |
| Patient Body Weight | Recommended Single Oral Dose in Patients 5 Years of Age and Older For Oral Suspension (Packets) |
|---|---|
| 15 kg 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) |
| Patient Body Weight | Recommended Single Oral Dose in Patients 5 Years of Age and Older For Oral Suspension (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 mL) |
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. (
| 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) |
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) |
| 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.) |
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Xofluza prescribing information
Dosage and Administration (XOFLUZA is available in two dosage forms:
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)]. 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.
See the XOFLUZA for oral suspension (packets) Instructions for Use for details on the preparation and administration (oral or via enteral feeding tube).
Prior to dispensing to the patient, reconstitute XOFLUZA for oral suspension (bottles) with 20 mL of drinking water or sterile water. After reconstitution, each bottle of XOFLUZA for oral suspension (bottles) contains 40 mg of baloxavir marboxil per 20 mL of volume for a final concentration of 2 mg/mL. The for oral suspension (bottles) can be used for oral or enteral use. Only take the contents of the full bottle(s) of XOFLUZA for oral suspension (bottles) with the use of a measuring device (oral syringe). Ensure the caregiver or patient uses an oral syringe to measure the prescribed dose of XOFLUZA for oral suspension (bottles). Patients may need to draw up XOFLUZA for oral suspension (bottles) multiple times using the oral syringe to receive the full dose. Reconstituting XOFLUZA for Oral Suspension (Bottles) Prepare the for oral suspension (bottles) at the time of dispensing. Administration must occur within 10 hours after reconstitution because this product does not contain a preservative.
Important Information for the Healthcare Provider
| 05/2025 |
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 InfluenzaXOFLUZA 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 InfluenzaXOFLUZA 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. (
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 OverviewXOFLUZA 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 DosageTreatment 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 WeightRecommended 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 kgOne 30 mg packet 20 kg to less than 80 kgOne 40 mg packet At least 80 kg80 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.)
| Patient Body Weight | Recommended Single Oral Dose in Patients 5 Years of Age and Older (Tablets) |
|---|---|
| 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) |
| Patient Body Weight | Recommended Single Oral Dose in Patients 5 Years of Age and Older For Oral Suspension (Packets) |
|---|---|
| 15 kg 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) |
| Patient Body Weight | Recommended Single Oral Dose in Patients 5 Years of Age and Older For Oral Suspension (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 mL) |
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. (
| 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) |
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) |
| 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.) |
- For the 30 mg or 40 mg dose, mix in a small container with 1 tablespoon (about 15-20 mL) of room temperature drinking water. Once the supplied XOFLUZA for oral suspension (packets) have fully dispersed in the drinking water, take the entire mixture immediately.
- For the 80 mg dose, use two 40 mg packets. Prepare each packet as described above for the 40 mg dose and take the packets separately.
- For enteral administration (i.e., feeding tube), draw up the entire contents with an enteral syringe and administer through a tube that is 4 French or larger. Flush with 1 mL of water before and after enteral administration.
- 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
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.
Baloxavir marboxil was administered orally to pregnant rats (20, 200, or 1,000 mg/kg/day from gestation day 6 to 17) and rabbits (30, 100, or 1,000 mg/kg/day from gestation day 7 to 19). No adverse embryo-fetal effects were observed in rats up to the highest dose of baloxavir marboxil (1,000 mg/kg/day), resulting in systemic baloxavir exposure (AUC) of approximately 5 times the exposure at the MRHD. In rabbits, fetal skeletal variations occurred at a maternally toxic dose (1,000 mg/kg/day) resulting in 2 abortions out of 19 pregnancies. No adverse maternal or embryo-fetal effects were observed in rabbits at the middle dose (100 mg/kg/day) resulting in systemic baloxavir exposure (AUC) approximately 7 times the exposure at the MRHD.
In the prenatal and postnatal development study in rats, baloxavir marboxil was administered orally at 20, 200, or 1,000 mg/kg/day from gestation day 6 to postpartum/lactation day 20. No significant effects were observed in the offspring at maternal systemic baloxavir exposure (AUC) approximately 5 times the exposure at the MRHD.
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.
XOFLUZA is contraindicated in patients with a history of hypersensitivity to baloxavir marboxil or any of its ingredients. Serious allergic reactions have included anaphylaxis, angioedema, urticaria, and erythema multiforme
Cases of anaphylaxis, urticaria, angioedema, and erythema multiforme have been reported in postmarketing experience with XOFLUZA. Appropriate treatment should be instituted if an allergic-like reaction occurs or is suspected. The use of XOFLUZA is contraindicated in patients with known hypersensitivity to XOFLUZA