Xevudy - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Xevudy 500 mg concentrate for solution for infusion

This medicine is subject to additional monitoring. This will allow quick identification of new safetyinformation. You canhelp by reporting any side effects, you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you receive this medicine.

• – Keep this leaflet. You may need to read it again.

• – If you have any questions, ask your doctor or pharmacist.

• – If you get any side effects, talk to your doctor.This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Xevudy is and what it is used for

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

• 3. How Xevudy is given

• 4. Possible side effects

• 5. How to store Xevudy

• 6. Contents of the pack and other information

1. What Xevudy is and what it is used for

Xevudy contains the active substance sotrovimab. Sotrovimab is a monoclonal antibody , a type of protein designed to recognise 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 and weighing at least 40 kg). It targets the spike protein that the virus uses to attach to cells, blocking the virus from entering the cell and making new viruses. By preventing the virus from multiplying in the body, Xevudy can help your body overcome the infection and prevent you from getting seriously ill.

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

You must not receive Xevudy

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

• ■ ^ Check with your doctor if 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 should not be given to children or adolescents younger than 12 years old 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 breast-feeding

If you are pregnant , think you may be pregnant , or are planning to have a baby, ask your doctor for advice before receiving Xevudy. Your doctor will advise you whether the benefits of treatment with Xevudy are greater than any likely risks for you and your baby.

It is not known whether the ingredients of Xevudy can pass into breast milk. If you are breast-feeding, you must check with your doctor before you receive Xevudy.

Driving and using machines

Xevudy is not expected to have any effect on your ability to drive or use machines.

• 3. How Xevudy is given

• The recommended dose for adults and adolescents (aged 12 years and older and weighing at least 40 kg) is: 500 mg (one vial)

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

The ‘Instructions for healthcare professionals’ below give details for your doctor, pharmacist or nurse on how the Xevudy infusion is made up and given.

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 common , affecting up to 1 in 10 people.

• Rarely, these allergic reactions may 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 should get medical help immediately: skin rash, similar to nettle rash (hives) or redness itching
• swelling, sometimes of the face or mouth (angioedema)
• becoming very wheezy, coughing or having difficulty in breathing
• suddenly feeling weak or light-headed (may lead to loss of consciousness or falls).

Infusion-related reactions

• chills
• fever
• difficulty in breathing
• rapid heartbeat
• drop in blood pressure

Other side effects

Uncommon

Reporting of side effects

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

5. How to store Xevudy

The healthcare professionals caring for you 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.

Do not freeze.

Before diluting:

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

Once diluted, this medicine 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 – 8°C) for up to 24 hours from the time of dilution until the end of administration.

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 concentrate.

• – The other ingredients are histidine, histidine monohydrochloride, sucrose, polysorbate 80, methionine and water for injections.

What Xevudy looks like and contents of the pack

Xevudy is a clear, colourless or yellow to brown liquid supplied in a single-use glass vial with a rubber stopper and flip-off aluminium over-seal. Each carton contains one vial.

Marketing Authorisation Holder

GlaxoSmithKline Trading Services Limited

12 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

Manufacturer

GlaxoSmithKline Manufacturing S.p.A.

Strada Provinciale Asolana, 90,

43056 San Polo di Torrile, Parma

Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency website:.

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

Scan the code below with a mobile device to get this information in different languages or visit.

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The following information is intended for healthcare professionals only.

Please refer to the Summary of Product Characteristics for further information.

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 the batch number of the administered product should be clearly recorded.

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 8 mL from an infusion bag containing 50 mL or 100 mL of sodium chloride 9 mg/mL

(0.9%) solution for injection or 5% dextrose for injection.

• 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.

The diluted solution of sotrovimab 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) up to 24 hours from the time of dilution until the end of administration.

Administration instructions

• 1. Attach an infusion set to the infusion bag using standard bore tubing. The intravenous dosing solution is recommended to be administered with a 0.2-gm in-line filter.

• 2. Prime the infusion set.

• 3. Administer as an IV infusion for 30 minutes at room temperature.