Xofluza

XOFLUZA- baloxavir marboxil tablet, film coated
A-S Medication Solutions

1 INDICATIONS AND USAGE

1.1 Treatment of Influenza

XOFLUZA is indicated for the treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours and who are:

1.2 Post-Exposure Prophylaxis of Influenza

XOFLUZA is indicated for post-exposure prophylaxis of influenza in persons 12 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 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
  • 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)].

2.2 Recommended Dosage

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.

Table 1 Recommended XOFLUZA Tablet Dosage in Adults and Adolescents (12 Years of Age and Older)
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)
Table 2 Recommended XOFLUZA Oral Suspension Dosage in Adults and Adolescents (12 Years of Age and Older)
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

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 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.

  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 (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).

3 DOSAGE FORMS AND STRENGTHS

XOFLUZA Tablets:

XOFLUZA 40 mg tablets are white to light yellow, oblong-shaped, film-coated tablets debossed with “BXM40” on one side.

XOFLUZA 80 mg tablets are white to light yellow, oblong shaped, film-coated tablets debossed with “BXM80” on one side.

XOFLUZA for Oral Suspension:

XOFLUZA for oral suspension contains 40 mg/20 mL or 2 mg/mL baloxavir marboxil after constitution with 20 mL of drinking water or sterile water. The granules are white to light yellow. The constituted product is a white to light yellow opaque suspension with strawberry flavor.

4 CONTRAINDICATIONS

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 [see Warnings and Precautions (5.1)].

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity

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 [see Contraindications (4) and Adverse Reactions (6.2)].

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