Prospect: information for the patient

Xevudy 500 mg concentrate for solution for infusion

Sotrovimab

This medicine is subject to additional monitoring, which will expedite the detection of new information about its safety. You may contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before receiving this medicine.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-If you experience adverse effects, consult your doctor, even if they are not listed in this prospect. See section 4.

1.What is Xevudy and for what it is used

2.What you need to know before Xevudy is administered to you

3.How Xevudy is administered

4.Possible adverse effects

5.Storage of Xevudy

6.Contents of the package and additional information

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

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

You should not receive Xevudy

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

Consult your doctorif you think this applies to you.

Warnings and precautions

Allergic reactions

Xevudy may cause allergic reactions.

?See "Allergic reactions" in Section 4.

Infusion-related reactions

Xevudy may cause infusion-related reactions.

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

Children and adolescents

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

Other medicines and Xevudy

Inform your doctor or pharmacist if you are taking, have recently taken or may need to take any other medicine.

Pregnancy and breastfeeding

If you arepregnant, think you may be pregnantor intend to become pregnant,consult your doctorbefore receiving Xevudy. Your doctor will tell you if the benefits of treatment with Xevudy outweigh the possible risks for you and the baby.

It is unknownwhether the components of Xevudy can pass into breast milk.If you are breastfeeding, you must consult with your doctorbefore receiving Xevudy.

Driving and operating machinery

No effect is expected on your ability to drive or operate machinery.

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

• 500 mg (one vial)

The medication will be prepared as a solution and administered by infusion (infusion) through a vein, by a doctor or nurse. It may take up to 30 minutes to administer the full dose of the medication. You will be monitored during and at least 1 hour after the administration of the treatment.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Allergic reactions

Allergic reactions to Xevudy arefrequentand affect up to 1 in 10 people.

Rarely, these allergic reactions can be severe (anaphylaxis), affecting up to 1 in 1,000 people (rare). If you have any of the following symptoms after receiving Xevudy, you may be having an allergic reaction and shouldseek medical help immediately:

• skin rash, similar to urticaria (hives) or skin redness
• 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).

Reactions related to infusion

It isfrequentfor allergic-type 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 may occur. If you have any of the following symptoms after receiving Xevudy, you may be having a reaction related to the infusion and shouldseek medical help immediately:

• redness
• chills
• fever
• difficulty breathing
• rapid heart rate
• drop in blood pressure

Other side effects

Rare (may affect up to 1 in 100 people)

• shortness of breath (breathlessness).

Reporting side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

The healthcare professionals who are treating you are responsible for storing this medication and disposing of any unused product properly.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the label and packaging after CAD. The expiration date is the last day of the month indicated.

Do not freeze.

Before dilution:

• Store in the refrigerator (between 2°C and 8°C)
• Store in the original packaging to protect it from light.

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

Composition of Xevudy

-The active ingredient is sotrovimab.Each vial contains 500 mg of sotrovimab in 8 ml of concentrate.

-The other components are histidine, histidine hydrochloride, sucrose, polisorbate 80 (E 433), methionine, and water for injection.

Appearance of the product and contents of the pack

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

Marketing authorisation holder

GlaxoSmithKline Trading Services Limited

12 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

Responsible manufacturer

GlaxoSmithKline Manufacturing S.p.A.

Strada Provinciale Asolana, 90,

43056 San Polo di Torrile, Parma

Italy

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of the summary of product characteristics:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agencyhttps://www.ema.europa.eu,and on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

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This information is intended for healthcare professionals only.

For further information, please refer to the SmPC.

The treatment must 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 medicinal product administered must be clearly recorded.

Dilution instructions

1. Remove a vial of sotrovimab from the refrigerator (between 2 °C and 8 °C). Allow the vial to reach room temperature, protected from light, for approximately 15 minutes.
2. Inspect the vial visually to ensure that it is free from particles and that there are no visible damage to the vial. If the vial is identified as unusable, discard it and start the preparation with a new vial.
3. Rotate the vial in circles several times before use without creating air bubbles. Do not move or shake the vial vigorously.

Dilution instructions

1. Remove and discard 8 ml from a 50 ml or 100 ml infusion bag containing sodium chloride 9 mg/ml (0.9%) for infusion or glucose 5% for infusion.
2. Remove 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 forward and backward 3 to 5 times. Do not invert the infusion bag. Avoid the formation of air bubbles.

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

Administration instructions

1. Connect an infusion device to the infusion bag using a standard diameter tube. It is recommended to administer the intravenous solution with a filter in line of 0.2 μm.
2. Prepare the infusion device.
3. Administer as intravenous infusion over15minutes (when using a 50 ml infusion bag) or30 minutes(when using a 100 ml infusion bag)at room temperature.

Elimination

The elimination of unused medicinal product and all materials that have been in contact with it will be carried out in accordance with local regulations.