Drug Detail:Xofluza (Baloxavir marboxil [ ba-lox-a-vir-mar-box-il ])
Generic Name: BALOXAVIR MARBOXIL 40mg
Dosage Form: tablet, film coated
Drug Class: Miscellaneous antivirals
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)].
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.
| 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) |
| Patient Body Weight (kg) | Recommended Single Oral Dose*, † (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 |
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.
- Gently tap the bottom of the bottle to loosen the granules.
- Constitute XOFLUZA for oral suspension with 20 mL of drinking water or sterile water.
- Gently swirl the suspension to ensure that the granules are evenly suspended. Do not shake.
- 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).
