Consumer medicine information

XEVUDY Concentrated injection 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. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.

XEVUDY Concentrated injection solution for infusion

Active ingredient: sotrovimab

XEVUDY has provisional approval for treatment of COVID-19 in adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require initiation of oxygen due to COVID-19 and who are at increased risk of progression to hospitalisation or death.

This approval has been granted on the basis of short term efficacy and safety data. Evidence of longer term efficacy and safety from ongoing trials continues to be gathered and assessed.


Consumer Medicine Information (CMI)

This leaflet provides important information about using XEVUDY. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using XEVUDY.

Where to find information in this leaflet:

1. Why am I being given XEVUDY?
2. What should I know before I am given XEVUDY?
3. What if I am taking other medicines?
4. How XEVUDY is given?
5. What should I know when being given XEVUDY?
6. Are there any side effects?
7. Product details

1. Why am I being given XEVUDY?

XEVUDY contains the active ingredient sotrovimab, a monoclonal antibody which is 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.

XEVUDY stops the virus from attaching to cells and this blocks the virus from multiplying in the body. This can help your body to overcome the infection and prevent you from getting seriously ill.

2. What should I know before I am given XEVUDY?

Warnings

Do not take XEVUDY if:

  • you are allergic to sotrovimab, or any of the ingredients listed at the end of this leaflet.
  • Always check the ingredients to make sure you can use this medicine.

Check with your doctor if you:

  • have any other medical conditions
  • take any medicines for any other condition
  • have allergies to any other medicines, foods, preservatives or dyes. XEVUDY can cause allergic reactions.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or think you could be pregnant or intend to become pregnant and discuss if you should receive XEVUDY. Your doctor will consider the benefit to you and the risk to your baby of receiving XEVUDY while you’re pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed. There is insufficient data on 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.

Children

XEVUDY is not intended to be given to children younger than 12 years old or weighing less than 40 kg.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect XEVUDY.

4. How XEVUDY is given?

XEVUDY should not be given to you if you have been hospitalised due to COVID-19.

How much is given

The recommended dose for adults and adolescents aged 12 years and older and weighing at least 40 kg is one 500 mg dose of XEVUDY.

When XEVUDY is given

  • XEVUDY is recommended to be given to you within 5 days of showing symptoms of COVID-19.
  • XEVUDY will be given to you in a healthcare facility under the supervision of a healthcare professional.
  • It will be given to you as a drip into a vein (intravenous infusion).
  • It takes 30 minutes to give you the full dose of medicine.
  • After the infusion, your doctor or nurse will observe you for 1 hour to monitor for signs of an allergic reaction.

5. What should I know when being given XEVUDY?

Things you should do

  • Remind any doctor, dentist or pharmacist you visit that have taken XEVUDY.
  • Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines before you receive XEVUDY.
  • Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.

Call your doctor straight away if you:

Things you should not do

  • Do not stop your medicine before the full dose has been taken.

Driving or using machines

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

Looking after your medicine

XEVUDY will be given to you in a healthcare facility and the healthcare professionals caring for you will be responsible for storing this medicine.

XEVUDY should be stored in a refrigerator between 2°C to 8°C, in the original carton to protect from light.

  • Do not freeze
  • Do not use after the expiry date

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

Unused medicine or waste material will be discarded by your healthcare professional.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Serious side effects

Serious side effects What to do
Allergic reactions
These reactions may be severe (for example anaphylaxis) with the following symptoms:

  • skin rash (hives) or redness
  • 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)
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.
These side effects can have a delayed onset after you leave the infusion site or clinic.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What XEVUDY contains

Active ingredient
(main ingredient)
Sotrovimab
Other ingredients
(inactive ingredients)
Histidine
Histidine hydrochloride monohydrate
Sucrose
Methionine
Polysorbate 80
Water for injections
Potential allergens None

Do not be given this medicine if you are allergic to any of these ingredients.

What XEVUDY looks like

XEVUDY is supplied as a clear, colourless or yellow to brown concentrated injection solution, in a 10 mL clear glass vial, with a rubber stopper and flip-off aluminium over-seal.

(Aust R 364110).

Who distributes XEVUDY

XEVUDY is supplied in Australia by:

GlaxoSmithKline Australia Pty Ltd
Level 4, 436 Johnston Street
Abbotsford, VIC 3067
Australia

Trademarks are owned by or licensed to the GSK group of companies.

© 2021 GSK group of companies or its licensor.

This leaflet was prepared in August 2021.

Version 1.0