Patient Information Leaflet for Xevudy

Updated 28 March 2022

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This publication is available at https://www.gov.uk/government/publications/regulatory-approval-of-xevudy-sotrovimab/patient-information-leaflet-for-xevudy

Sotrovimab

Xevudy 500 mg concentrate for solution for infusion

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

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 acute covid-19 infection.

Xevudy is used to treat symptomatic acute covid-19 infection 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. Xevudy can help your body overcome the infection and prevent you from getting seriously ill.

You must not receive Xevudy:

You should self-isolate for a period of time after being given Xevudy in accordance with national covid-19 guidelines because you can still pass on the virus to others for some days after treatment.

Xevudy can cause allergic reactions (see section 4).

Xevudy should not be given to children or adolescents younger than 12 years old or weighing less than 40 kg.

Tell your healthcare professional if you are taking, have recently taken or might take any other medicines. Also tell your healthcare professional if you have been vaccinated against the covid virus or are about to be administered a vaccine.

Ask your healthcare professional for advice before receiving Xevudy if you are pregnant, think you may be pregnant, or are planning to have a baby.

It is not known whether the ingredients of Xevudy can pass into breast milk. Tell your healthcare professional if you are breast-feeding before you receive Xevudy.

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

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

The medicine will be made up into a solution and given to you by a drip (infusion) into a vein by a healthcare professional. It takes 30 minutes to give you the full dose of medicine. You will be monitored during and after your treatment is given.

The ‘Instructions for healthcare professionals’ below give details for your healthcare professional on how the Xevudy infusion is made up and given.

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

Get urgent medical attention if you get symptoms of a severe allergic reaction (anaphylaxis) after receiving Xevudy. Such reactions may include a combination of any of the following symptoms:

Other side effects that may occur after receiving Xevudy:

Common (may affect up to 1 in 10 people)

If you get any side effects, talk to your healthcare professional. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website: www.yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The healthcare professionals caring for you are responsible for storing this medicine and disposing of any unused product correctly.

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.

GlaxoSmithKline UK Limited980 Great West RoadBrentfordMiddlesexTW8 9GSUK

GlaxoSmithKline Manufacturing S.P.AStrada Provinciale Asolana, No 9043056 San Polo di Torrile, ParmaItaly

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This leaflet was last revised in December 2021.

This medicine has been given ‘conditional approval’. This means that there is more evidence to come about this medicine. The Medicines and Healthcare products Regulatory Agency (MHRA) will review new information on this medicine at least every year and this leaflet will be updated as necessary.

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

Treatment should be prepared by a qualified healthcare provider. Administration should be under conditions where management of severe hypersensitivity reactions, such as anaphylaxis, is possible. Individuals should be monitored during and post intravenous infusion.

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

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.

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