Baloxavir

Dosage and Administration Overview XOFLUZA 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 ] .

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 and Clinical Pharmacology ].

Preparation of XOFLUZA for Oral Suspension (Packets) by Patient or Caregiver See the XOFLUZA for oral suspension (packets) Instructions for Use for details on the preparation and administration (oral or via enteral feeding tube). 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.

Preparation of XOFLUZA for Oral Suspension (Bottles) by Healthcare Provider 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.

Gently tap the bottom of the bottle to loosen the granules. Reconstitute XOFLUZA for oral suspension (bottles) 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 reconstitution time).

Important Information for the Healthcare Provider Provide caregiver or patient with a measuring device (oral syringe) to deliver the prescribed dose of the for suspension for oral use (bottles). For enteral administration (i.e., feeding tube), draw up for oral suspension (bottles) 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. Instruct the caregiver or patient that the total prescribed dose of XOFLUZA for oral suspension (bottles) 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).