Xofluza

XOFLUZA- baloxavir marboxil tablet, film coated
XOFLUZA- baloxavir marboxil granule, for solution
Genentech, Inc.

1 INDICATIONS AND USAGE

1.1 Treatment of Influenza

​ XOFLUZA is indicated for treatment of acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours and who are:

–

otherwise healthy adults and pediatric patients 5 years of age and older [see Clinical Studies (14.1)],

OR

–

adults and pediatric patients 12 years of age and older who are at high-risk of developing influenza-related complications¹ [see Clinical Studies (14.2)].

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 (14.3)].

1.3 Limitations of Use

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 [see Warnings and Precautions (5.2), Microbiology (12.4) and Clinical Studies (14)].

2 DOSAGE AND ADMINISTRATION

2.1 Dosage and Administration Overview

XOFLUZA is available in two dosage forms:

• ​ XOFLUZA tablets (40 mg and 80 mg).
• ​ XOFLUZA for oral suspension (2 mg/mL). This granule formulation is intended for patients who are unable to or have difficulty swallowing tablets, or those who require enteral administration [see Dosage and Administration (2.3)].

​ XOFLUZA should be taken as soon as possible after influenza symptom onset or exposure to influenza and may be taken with or without food. However, coadministration 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)

​ XOFLUZA should be taken 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 and 2.

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

​ Patient Body Weight (kg)	Recommended Single Oral Dose (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)

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

​ Patient Body Weight (kg)	Recommended Single Oral Dose *, † (For Oral Suspension)
* Recommended XOFLUZA dosage is based on the patient’s weight. † Use a measuring device (oral syringe) to measure the prescribed dose for use. ‡ Dosage requires two bottles of XOFLUZA for oral suspension.
​ Less than 20 kg	2 mg/kg taken as a single dose
​ 20 kg to less than 80 kg	40 mg (20 mL) taken as a single dose
​ At least 80 kg	80 mg (40 mL ‡) taken as a single dose

2.3 Preparation of XOFLUZA for Oral Suspension by Healthcare Provider

​ Prior to dispensing to the patient, constitute XOFLUZA for oral suspension with 20 mL of drinking water or sterile water. After constitution, each bottle of XOFLUZA for oral suspension contains 40 mg of baloxavir marboxil per 20 mL of volume for a final concentration of 2 mg/mL. This dosage form can be used for oral or enteral use. The contents of the full bottle(s) of XOFLUZA for oral suspension should not be taken without use of measuring device (oral syringe). Ensure the caregiver or patient uses an oral syringe to measure the prescribed dose of XOFLUZA for oral suspension. Patients may need to draw up XOFLUZA for oral suspension multiple times using the oral syringe to receive the full dose.

Constituting XOFLUZA for Oral Suspension

Prepare the suspension at the time of dispensing. Administration must occur within 10 hours after constitution because the product does not contain a preservative.

1. Gently tap the bottom of the bottle to loosen the granules.
2. Constitute XOFLUZA for oral suspension with 20 mL of drinking water or sterile water.
3. Gently swirl the suspension to ensure that the granules are evenly suspended. Do not shake.
4. Write the expiration time and date on the bottle label in the space provided (10 hours from constitution time).

Important Information for the Healthcare Provider

• Provide caregiver or patient with a measuring device (oral syringe) to deliver the prescribed dose of the suspension for oral use. For enteral administration (i.e., feeding tube), draw up suspension with an enteral syringe. Flush with 1 mL of water before and after enteral administration.
• Instruct the caregiver or patient that the total prescribed dose of XOFLUZA for oral suspension may require:
  • ​less than one bottle (e.g., for pediatric patients 5 years of age and older who weigh less than 20 kg)
  • ​one bottle (e.g., for adults and adolescents weighing 20 kg to less than 80 kg), or
  • ​two bottles (e.g., for adults and adolescents weighing at least 80 kg).