Xevudy Drug / Drug Information

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XEVUDY has provisional approval for the treatment of COVID-19 in adults and adolescents (aged 12 years and over and weighing at least 40 kg) with 2019 coronavirus disease (COVID-19) who do not require oxygen initiation by due to COVID-19 and who present an increased risk of progressing to hospitalization or death. This approval was granted on the basis of short-term efficacy and safety data. Evidence of the longer-term efficacy and safety of ongoing trials continues to be gathered and evaluated.

Summary of Consumer Drug Information (MIC)

The full CMI on the next page has more details. If you are concerned about using this medication, talk to your doctor or pharmacist.
This medicine is new or used differently. Please report side effects. See the full CMI for more details.

Why am I being given XEVUDY?

XEVUDY contains the active substance sotrovimab. XEVUDY is used to treat COVID-19.
For more information, see section 1. Why am I being given XEVUDY? in the full CMI.

What should I know before I receive XEVUDY?

Do not use if you have ever had an allergic reaction to sotrovimab or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other health problems, if you are taking other medicines, if you are pregnant or planning to become pregnant, or if you are breast-feeding. For more information, see section 2. What should I know before I receive XEVUDY? in the full CMI.

What if I take other medications?

How is XEVUDY administered?

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

The recommended dose for adults and adolescents 12 years of age and over weighing 40 kg or more is one 500 mg dose of XEVUDY.

It is recommended that you take XEVUDY within 5 days of the onset of symptoms of COVID-19.

It is given as a drip into a vein (intravenous infusion) by a doctor or nurse. It takes 30 minutes to give you the full dose of medicine.

What should I know when taking XEVUDY?

Things you should do

Remind any doctor, dentist or pharmacist you see that you have taken XEVUDY.

See a doctor if you think you are having an allergic reaction.

Things you shouldn’t do

Do not stop until you have taken the full dose of the medicine.

Drive or use machines

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

Take care of your medicine

XEVUDY will be given to you in a healthcare facility and healthcare professionals will be responsible for its storage.

Are there any side effects?

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of the side effects can be serious and you need to know what symptoms to look for. XEVUDY can cause allergic reactions which may be severe. If you develop symptoms of an allergic reaction, you should tell your doctor or nurse as soon as possible. For more information, including what to do if you have side effects, see section 6. Are there any side effects? in the full CMI.
This medicine is subject to additional monitoring. This will allow rapid identification of new security information. You can help by reporting any side effects you may be experiencing. You can report side effects to your doctor or directly to www.tga.gov.au/reporting-problems .

Active ingredient:
sotrovimab

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

This approval was granted on the basis of short-term efficacy and safety data. Evidence of the longer-term efficacy and safety of ongoing trials continues to be gathered and evaluated.

Consumer Medicine Information (CMI)

This leaflet provides important information on the use of XEVUDY. You should also consult your doctor or pharmacist if you want any further information or if you have any concerns or questions regarding the use of XEVUDY.

Where to find information in this brochure:

Why am I being given XEVUDY?

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

XEVUDY is used to treat COVID-19.

XEVUDY prevents the virus from attaching to cells, which prevents the virus from multiplying in the body. This can help your body overcome the infection and prevent you from getting seriously ill.

What should I know before I receive 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.

See your doctor if you:

have other medical conditions

taking medication for any other condition

have allergies to other medicines, foods, preservatives or dyes. XEVUDY can cause allergic reactions.

During treatment you may be at risk for certain side effects. It is important that you understand these risks and how to monitor them. See further information in section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are, think, or intend to become pregnant, and discuss whether you should be given XEVUDY. Your doctor will assess the benefit to you and the risk to your baby of receiving XEVUDY while you are pregnant.

Talk to your doctor if you are breast-feeding or intend to breast-feed. There is insufficient data to determine whether the ingredients in XEVUDY can pass into breast milk. If you are breast-feeding, you should consult your doctor before receiving XEVUDY.

Children

XEVUDY is not intended for use in children under 12 years of age or weighing less than 40 kg.

What if I take other medications?

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

Talk to your doctor or pharmacist if you are not sure which medicines, vitamins or supplements you are taking and whether they affect XEVUDY.

How is XEVUDY administered?

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

How much is given

The recommended dose for adults and adolescents 12 years of age and over who weigh at least 40 kg is a 500 mg dose of XEVUDY.

When XEVUDY is administered

It is recommended that you take XEVUDY within 5 days of the onset of 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 watch for signs of an allergic reaction.

What should I know when taking XEVUDY?

Things you should do

Remind any doctor, dentist or pharmacist you see who has taken XEVUDY.

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines before receiving XEVUDY.

Tell your doctor if you are pregnant, think you might be, or plan to have a baby.

Call your doctor right away if you:

Think you might have an allergic reaction

Things you shouldn’t do

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

Drive or use machines

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

Take care of your medicine

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

XEVUDY should be stored in the refrigerator at 2 ° C to 8 ° C, in the original packaging in order to protect from light.

Do not freeze

Do not use after the expiration date

Keep it where young children cannot reach it.

Getting rid of any unwanted medication

Any unused medicine or waste will be discarded by your healthcare professional.

Are there any side effects?

All medicines can have side effects. If you experience side effects, most are minor and temporary. However, some side effects may require medical attention.

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

Serious side effects

Tell your doctor or pharmacist if you notice anything else that might make you feel bad.

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

Reporting side effects

After receiving medical advice for any side effects you experience, you can report the 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 about the safety of this medicine.

Always be sure to talk to your doctor or pharmacist before deciding to stop taking any of your medications.

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

Nothing

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

What does XEVUDY look like

XEVUDY is supplied as a clear, colorless or yellow to brown concentrated solution for injection in a 10 ml clear glass vial, with a rubber stopper and an aluminum flip-off cap.

(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


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