XEVUDY 500 mg

weight was based on an allometric scaling approach, which accounted for effect of body weight

changes associated with age on clearance annd volume of distribution. This approach is supported by a

population pharmacokinetic analysis, which shows comparable serum exposures of sotrovimab in

adolescents as those observed in adults.t Following intravenous infusion of 500 mg sotrovimab in 7

adolescents, the geometric mean C c was 180 µg/mL (geometric CV% 25.6) and the geometric mean

Day 29 concentration was 47.4 µgu/mL (geometric CV% 17.0).

Data (n=3) in children (aged 6 to less than 12 years and weighing at least 15 kg), are too limited to

establish pharmacokinetics oof sotrovimab in this age group.

Based on population pharmacokinetic analyses, the pharmacokinetics of sotrovimab following

intravenous infusion were not affected by age, sex or BMI. No dose adjustment is warranted based on

these characterisatics. Body weight was a significant covariate, but the magnitude of effect does not

Genotoxicity and carcinogenicity studies have not been conducted with sotrovimab.

Nonclinical reproductive and developmental toxicity studies have not been conducted with

No toxicity with sotrovimab was identified in a cynomolgus monkey 2-week repeat-dose IV infusion

toxicology study with 105-day recovery period at doses up to 500 mg/kg, the no observed adverse

effect level (NOAEL) and highest dose tested. The C and total exposure AUC [sum of AUC

after Dose 1 and AUC after Dose 2 (Day 8)] values at the NOAEL of 500 mg/kg were

13500 µg/mL and 216000 day*µg/mL, respectively.

6. PHARMACEUTICAL PARTICULARS

This medicinal product must not be mixed with other medicinal products except those mentioned in

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 upd to 24 hours from the time of dilution until the end of administration.

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

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

10 mL Tiype I borosilicate clear glass single-use vial, with a grey chlorobutyl elastomer stopper

laminated with fluoropolymer, sealed with an aluminium flip-off cap.

6.6 Special precautions for disposal and other handling

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

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

3. Gently swirl the vial several times before use without creating air bubbles. Do not shake or

1. Withdraw and discard 8 mL from an infusion bag containing 50 mL or 100 mLs 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. r

3. Inject the 8 mL of sotrovimab into the infusion bag via the septum. o

4. Discard any unused portion left in the vial. The vial is single-use onlyh and should only be used

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.

Any unused medicinal product or waste material should be diseposed of in accordance with local

7. MARKETING AUTHORISATION HOLDEoR

8. MARKETING AUTHOdRISATION NUMBER(S)

9. DATE OF FI RST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 17 December 2021

10. DAcTE OF REVISION OF THE TEXT

Detailed information on this medicinal product is available on the website of the European Medicines

A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE

SUBSTANCE AND MANUF ACTURER RESPONSIBLE FOR

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY

C. OTHER CONDITIONS AND REQUIREMENTS OF THE

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL

A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND

MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturers of the biological active substance

Name and address of the manufacturer responsible for batch relearse

B. CONDITIONS OR RESTRICTIONS oREGARDING SUPPLY AND USE

Medicinal product subject to medical prescription.

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING

The requirements for submission of PSURs for this medicinal product are set out in the list of

Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC

and any subsequent u pdates published on the European medicines web-portal.

The marketing authorisation holder (MAH) shall submit the first PSUR for this product within

D. CiONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND

The marketing authorisation holder (MAH) shall perform the required pharmacovigilance

activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the

marketing authorisation and any agreed subsequent updates of the RMP.

• At the request of the European Medicines Agency;

• Whenever the risk management system is modified, especially as the result of new information

being received that may lead to a significant change to the benefit/risk profile or as the result of

an important (pharmacovigilance or risk minimisation) milestone being reached.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

1. NAME OF THE MEDICINAL PRODUCT d

Xevudy 500 mg concentrate for solution for infusion

2. STATEMENT OF ACTIVE SUBSTANCE

Each vial contains 500 mg sotrovimab in 8 mL (62.5 mg/mL). t

3. LIST OF EXCIPIENTS

Also contains: histidine, histidine monohydrochloride, sucrosee, polysorbate 80 (E 433), methionine,