XEVUDY Concentrate for solution for infusion Ref.[28113] Active ingredients: Sotrovimab

Xevudy should be administered under conditions where management of severe hypersensitivity reactions, such as anaphylaxis, is possible and patients can be monitored during and for at least one hour after administration (see section 4.4).

It is recommended that Xevudy is administered within 5 days of onset of symptoms of COVID-19 (see section 5.1).

Posology

Adults and adolescents (from 12 years and 40 kg body weight)

The recommended dose is a single 500 mg intravenous infusion administered following dilution (see sections 4.4 and 6.6).

Special populations

Elderly

No dose adjustment is required in elderly patients (see section 5.2).

Renal impairment

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

Hepatic impairment

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

Paediatric population

The safety and efficacy of Xevudy in children under 12 years old or weighing less than 40 kg have not yet been established. Currently available data are described in sections 4.8 and 5.2 but no recommendation on posology can be made.

Method of administration

For intravenous use.

This medicinal product must be diluted prior to administration.

Once diluted, it is recommended that the solution is administered over 15 minutes (when using a 50 mL infusion bag) or over 30 minutes (when using a 100 mL infusion bag) with a 0.2-μm in-line filter.

Xevudy must not be administered as an intravenous push or bolus injection.

For instructions on dilution of the medicinal product, see section 6.6.

There is no specific treatment for an overdose of sotrovimab. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.

A single 2000 mg dose of sotrovimab (4 times the recommended dose) administered by intravenous infusion over 60 minutes has been evaluated in a clinical trial (N=81) without evidence of dose-limiting toxicity.

Unopened vial:

4 years.

Diluted solution for infusion:

The diluted solution is intended to be used immediately. If after dilution, immediate administration is not possible, the diluted solution may be stored at room temperature (up to 25°C) for up to 6 hours or refrigerated (2°C to 8°C) for up to 24 hours from the time of dilution until the end of administration.

Store in a refrigerator (2°C to 8°C).

Do not freeze.

Store in the original carton in order to protect from light.

For storage conditions after dilution of the medicinal product, see section 6.3.

10 mL Type I borosilicate clear glass single-use vial, with a grey chlorobutyl elastomer stopper laminated with fluoropolymer, sealed with an aluminium flip-off cap.

Pack size: 1 vial.

Treatment should be prepared by a qualified healthcare professional using aseptic technique.

Preparation for dilution:

1. Remove one vial of sotrovimab from the refrigerator (2°C to 8°C). Allow the vial to equilibrate to ambient room temperature, protected from light, for approximately 15 minutes.
2. Visually inspect the vial to ensure it is free from particulate matter and that there is no visible damage to the vial. If the vial is identified to be unusable, discard and restart the preparation with a new vial.
3. Gently swirl the vial several times before use without creating air bubbles. Do not shake or vigorously agitate the vial.

Dilution instructions:

1. Withdraw and discard 8 mL from an infusion bag containing 50 mL or 100 mL of sodium chloride 9 mg/mL (0.9%) solution for infusion or 5% glucose for infusion.
2. Withdraw 8 mL from the vial of sotrovimab.
3. Inject the 8 mL of sotrovimab into the infusion bag via the septum.
4. Discard any unused portion left in the vial. The vial is single-use only and should only be used for one patient.
5. Prior to the infusion, gently rock the infusion bag back and forth 3 to 5 times. Do not invert the infusion bag. Avoid forming air bubbles.

Disposal:

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