Medically reviewed by Drugs.com. Last updated on Oct 15, 2021.
Generic name: BALOXAVIR MARBOXIL 20mg
Dosage form: tablet, film coated
Dosage and Administration Overview
XOFLUZA is available in two dosage forms:
- XOFLUZA tablets
- XOFLUZA for oral suspension. 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)].
Treatment of Acute Uncomplicated Influenza or Post-Exposure Prophylaxis in Adults and Adolescents (12 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 12 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)|
|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 (Suspension)|
|Less than 80 kg||40 mg/20 mL (1 bottle) taken as a single dose|
|At least 80 kg||80 mg/40 mL (2 bottles) 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 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.
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 (e.g., oral syringe, measuring cup) 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 more than one bottle (e.g., for adults and adolescents weighing at least 80 kg).
Frequently asked questions
More about Xofluza (baloxavir marboxil)
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- During Pregnancy
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- 22 Reviews
- Drug class: miscellaneous antivirals
- FDA Approval History
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.