XOFLUZA Granules for oral suspension Ref.[115516] Active ingredients: Baloxavir marboxil

Posology

Treatment of influenza

A single dose of baloxavir marboxil should be taken as soon as possible within 48 hours of symptom(s) onset.

Post-exposure prophylaxis of influenza

A single dose of baloxavir marboxil should be taken as soon as possible within 48 hours following close contact with an individual known or suspected to have influenza (see section 5.1).

Adults, adolescents, children and infants (≥3 weeks of age)

The recommended single oral dose of baloxavir marboxil is determined by body weight (see Table 1).

Adults, adolescents and children weighing ≥20 kg who are able to swallow tablets may instead receive treatment with Xofluza tablets at a dose of 40 mg or 80 mg depending on the patient's body weight. Refer to the Xofluza tablet SmPC for dose information.

Table 1. Baloxavir marboxil dosing by patient body weight (≥3 weeks of age):

^* The volume of the suspension in the bottle after reconstitution is 22 mL. The exact volume to be administered should be measured using the oral dispenser(s) included in the carton. e.g., 20 mL of suspension provides the recommended single dose of 40 mg.
^** Dose requires 2 bottles of Xofluza granules for oral suspension.

There are no clinical data on the use of a repeat dose of baloxavir marboxil for the treatment of uncomplicated influenza or for post-exposure prophylaxis in any one influenza season.

Special populations

Elderly

No dose adjustment is required (see section 5.2).

Hepatic impairment

No dose adjustment is required for patients with mild or moderate hepatic impairment (Child-Pugh class A or B). The safety and efficacy of baloxavir marboxil have not been established in patients with severe hepatic impairment (Child-Pugh class C).

Renal impairment

No dose adjustment is required in patients with renal impairment (see section 5.2).

Paediatric population

The safety and efficacy of baloxavir marboxil in preterm neonates and children aged <3 weeks have not been established. No data are available.

Method of administration

Oral or enteral use.

Xofluza may be taken with or without food (see section 5.2). Granules for oral suspension and final oral suspension should not be mixed with food. Any mixing outside the recommendations is the responsibility of the healthcare professional or the user.

Xofluza should not be taken with products that contain polyvalent cations such as laxatives, antacids or oral supplements containing iron, zinc, selenium, calcium or magnesium (see section 4.5).

It is recommended that Xofluza granules for oral suspension be reconstituted by a healthcare professional prior to dispensing. If the patient or caregiver is reconstituting the oral suspension, they must be advised to read the instructions for use before preparing and administering.

For instructions on reconstitution of Xofluza granules before administration, see section 6.6.

The appearance after reconstitution is a greyish white, white to light yellow opaque suspension.

The recommended dose can be administered via an enteral feeding tube. The tube should be flushed with water before and after delivering Xofluza. Follow the manufacturer's instructions for the feeding tube to administer the medicine, see section 6.6.

Reports of overdoses with baloxavir marboxil have been received from clinical trials and during postmarketing experience. In the majority of cases reporting overdose, no adverse reactions were reported. Data are insufficient to determine what symptoms may be anticipated as a result of an overdose.

Management

No known specific antidote exists for Xofluza. In the event of overdose, standard supportive medical care should be initiated based on the patient's signs and symptoms.

Baloxavir is unlikely to be significantly removed by dialysis due to high serum protein binding.

5 years.

After reconstitution, use within 10 hours.

Before reconstitution: This medicinal product does not require any special temperature storage conditions. Keep the bottle tightly closed in order to protect from moisture.

After reconstitution: Do not store above 30°C.

Amber glass bottle with a tamper-evident child-resistant screw cap.

Each carton contains: 1 bottle, 1 press-in bottle adapter, 1 measuring cup, a 3 mL oral syringe with orange plunger and a 10 mL oral syringe with transparent plunger.

Do not shake the bottle.

Avoid skin contact.

It is recommended that Xofluza granules for oral suspension should be reconstituted by a healthcare professional prior to dispensing. If necessary, the patient or caregiver may also reconstitute the oral suspension. The healthcare professional must counsel the individual or caregiver on how to reconstitute the suspension and must advise them to read the instructions for use before preparing and administering.

Xofluza granules for oral suspension should be taken immediately or within 10 hours of reconstitution. Discard the suspension if not used within 10 hours of reconstitution.

Preparation of oral suspension:

1 Gently tap the bottom of the bottle to loosen the granules.

2 Add a measured 20 mL of drinking water to the granules, using a measuring cup.

3 Do not shake the bottle.

4 Gently swirl the suspension to ensure that the granules are evenly suspended.

5 Write the 'Discard after' time (10 hours from reconstitution time) on the bottle label.

6 Indicate the volume of oral suspension (2 mg/mL) to withdraw, based on body weight (see Table 1).

The appearance after reconstitution is a greyish white, white to light yellow opaque suspension.

Refer to the Instructions for Use included within the carton for full details on preparation and administration of Xofluza granules for oral suspension.

Check the manufacturer's instructions for the size and dimensions of the enteral feeding tube.

For administration through enteral feeding tubes, draw up suspension with an enteral syringe. Flush with 1 mL of water before and after enteral administration.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.