XEVUDY 500 MG CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the Patient

Xevudy 500 mg concentrate for solution for infusion

sotrovimab

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you how to report side effects.

Read all of this leaflet carefully before you are given this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Xevudy and what is it used for
2. What you need to know before you are given Xevudy
3. How Xevudy is given
4. Possible side effects
5. Storage of Xevudy
6. Contents of the pack and other information

1. What is Xevudy and what is it used for

Xevudy contains the active substance sotrovimab. Sotrovimab is a monoclonal antibody, a type of protein modified to recognize a specific target on the SARS-CoV-2 virus, the virus that causes COVID-19.

Xevudy is used to treat COVID-19 in adults and adolescents (from 12 years of age and weighing at least 40 kg). It targets the spike protein that the virus uses to attach to cells, preventing the virus from entering the cell and producing new viruses. By preventing the virus from multiplying in the body, Xevudy can help your body overcome the infection and prevent serious illness.

2. What you need to know before you are given Xevudy

You must not be given Xevudy

• if you are allergic to sotrovimab or any of the other ingredients of this medicine (listed in section 6).

• Tell your doctorif you think this applies to you.

Warnings and precautions

Allergic reactions

Xevudy can cause allergic reactions.

• See "Allergic reactions" in Section 4.

Infusion-related reactions

Xevudy can cause infusion-related reactions.

• See "Infusion-related reactions" in Section 4.

Children and adolescents

Xevudy must not be given to children or adolescents under 12 years of age or weighing less than 40 kg.

Other medicines and Xevudy

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnantor are planning to have a baby, ask your doctorfor advice before being given Xevudy. Your doctor will decide if the benefits of treatment with Xevudy outweigh the potential risks to you and your baby.

It is not knownif the components of Xevudy can pass into breast milk. If you are breastfeeding, ask your doctorfor advice before being given Xevudy.

Driving and using machines

Xevudy is not expected to affect your ability to drive or use machines.

Xevudy contains polysorbate

This medicine contains 4.8 mg of polysorbate 80 in each 500 mg dose. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergy.

3. How Xevudy is given

The recommended dose for adults and adolescents (12 years of age or older and weighing at least 40 kg) is:

• 500 mg (one vial)

The medicine will be prepared in a solution and given to you by drip (infusion) into a vein by a doctor or nurse. It takes up to 30 minutes to give you the full dose of the medicine. You will be monitored during and for at least 1 hour after the treatment.

The "Instructions for healthcare professionals" below provide details for your doctor, pharmacist or nurse on how to prepare and administer the infusion of Xevudy.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reactions

Allergic reactions to Xevudy are commonand affect up to 1 in 10 people.

Rarely, these allergic reactions can be serious (anaphylaxis), affecting up to 1 in 1,000 people (rare). If you get any of the following symptoms after being given Xevudy, you may be having an allergic reaction and should seek medical help immediately:

• skin rash, like hives or redness of the skin
• itching
• swelling, sometimes of the face or mouth (angioedema)
• increased wheezing (high-pitched sound when breathing), cough or difficulty breathing
• sudden feeling of weakness or dizziness (which can cause loss of consciousness or falls)

Infusion-related reactions

It is commonfor infusion-related reactions to occur when receiving an infusion, affecting up to 1 in 10 people. These reactions usually develop within minutes or hours but can appear up to 24 hours after treatment or later. The following symptoms are possible. If you get any of these symptoms after being given Xevudy, you may be having an infusion-related reaction and should seek medical help immediately:

• redness of the skin (flushing)
• chills
• fever
• difficulty breathing
• fast heart rate
• low blood pressure

Other side effects

Uncommon (may affect up to 1 in 100 people)

• shortness of breath (dyspnoea).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Xevudy

Healthcare professionals are responsible for storing this medicine and disposing of any unused product correctly.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of the month shown.

Do not freeze.

Before dilution:

• store in a refrigerator (2°C to 8°C)
• store in the original package to protect from light.

Once diluted, this medicine should be used immediately. If immediate administration is not possible after dilution, the diluted solution can be stored at room temperature (up to 25°C) for up to 6 hours or in a refrigerator (2°C to 8°C) for up to 24 hours from the time of dilution until administration is complete.

6. Contents of the pack and other information

What Xevudy contains

• The active substance is sotrovimab. Each vial contains 500 mg of sotrovimab in 8 ml of concentrate.
• The other ingredients are histidine, histidine hydrochloride, sucrose, polysorbate 80 (E 433) (see section 2 "Xevudy contains polysorbate"), methionine and water for injections.

Appearance and pack

Xevudy is a clear, colourless or yellow to brown liquid presented in a single-use glass vial with a rubber stopper and a removable aluminium seal. Each pack contains one vial.

Marketing authorisation holder

GlaxoSmithKline Trading Services Limited

12 Riverwalk

Citywest Business Campus

Dublin 24

D24 YK11

Ireland

Manufacturer

GlaxoSmithKline Manufacturing S.p.A.

Strada Provinciale Asolana, 90,

43056 San Polo di Torrile, Parma

Italy

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu, and on the Spanish Agency of Medicines and Health Products (AEMPS) web site (http://www.aemps.gob.es/).

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This information is intended only for healthcare professionals.

For more information, see the Summary of Product Characteristics.

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

Traceability

In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.

Preparation of the dilution

1. Remove a vial of sotrovimab from the refrigerator (2°C to 8°C). Allow the vial to reach room temperature, protected from light, for approximately 15 minutes.
2. Visually inspect the vial to ensure it is free from particles and that there is no visible damage to the vial. If the vial is identified as unusable, discard it and restart preparation with a new vial.
3. Gently rotate the vial in circles 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 a 50 ml or 100 ml infusion bag containing 9 mg/ml (0.9%) sodium chloride solution for infusion or 5% glucose solution for infusion.
2. Withdraw 8 ml of sotrovimab from the vial.
3. Inject the 8 ml of sotrovimab into the infusion bag through the septum.
4. Discard any unused solution remaining in the vial. The vial is for single use only and should only be used for one patient.
5. Before infusion, gently move the infusion bag back and forth 3 to 5 times. Do not invert the infusion bag. Avoid the formation of air bubbles.

The diluted sotrovimab solution should be used immediately. If immediate administration is not possible after dilution, the diluted solution can be stored at room temperature (up to 25°C) for up to 6 hours or in a refrigerator (2°C to 8°C) for up to 24 hours from the time of dilution until administration is complete.

Administration instructions

1. Connect an infusion set to the infusion bag using a standard diameter tube. It is recommended to administer the dosing solution intravenously with an in-line filter of 0.2 μm.
2. Prepare the infusion set.
3. Administer as an intravenous infusion over 15 minutes (when using a 50 ml infusion bag) or 30 minutes (when using a 100 ml infusion bag) at room temperature.

Disposal

Disposal of unused medicinal product and all materials that have come into contact with it should be done in accordance with local regulations.