EVUSHELD 150 MG +150 MG INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

EVUSHELD 150 mg + 150 mg solution for injection

tixagevimab + cilgavimab

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

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the pack

1. What is EVUSHELD and what is it used for
2. What you need to know before you are given EVUSHELD
3. How to use EVUSHELD
4. Possible side effects
5. Storage of EVUSHELD
6. Contents of the pack and other information

1. What is EVUSHELD and what is it used for

EVUSHELD is made up of two active substances, tixagevimab and cilgavimab. Both are medicines called monoclonal antibodies. These antibodies are proteins that bind to a specific protein of the SARS-CoV-2 virus, the virus that causes COVID-19. By binding to this protein, they prevent the virus from entering human cells.

EVUSHELD is used for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents from 12 years of age and weighing at least 40 kg.

EVUSHELD is used to treat adults and adolescents, from 12 years of age and weighing at least 40 kg, with COVID-19 who:

• do not require supplemental oxygen to treat COVID-19, and
• are at higher risk of the disease becoming severe according to their doctor's assessment

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

This medicine must not be given

• if you are allergicto tixagevimab, cilgavimab, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you are given EVUSHELD

• if you have a low number of platelets in your blood (which help your blood to clot), any bleeding problems, or are taking any medicine to prevent blood clots (an anticoagulant).
• if you have ever had a severe allergic reaction or breathing problems after being given EVUSHELD in the past.

COVID-19 is caused by different variants of the SARS-CoV-2 virus that change over time. EVUSHELD may be less effective at preventing COVID-19 caused by some variants than others. Contact your doctor immediately if you have symptoms of COVID-19. COVID-19 affects different people in different ways:

• the most common symptoms include fever, cough, tiredness, and loss of taste or smell;
• the most severe symptoms include difficulty breathing or shortness of breath, loss of speech or mobility, or confusion and chest pain.

Contact a doctor, pharmacist, or nurse, or seek medical attention immediately:

• if you notice any symptoms of a heart attack, such as:
• • chest pain;
  • shortness of breath;
  • a general feeling of discomfort, illness, or unease;
  • a feeling of dizziness or fainting.
• if you notice any signs of a severe allergic reaction, such as:
• • difficulty breathing or swallowing;
  • swelling of the face, lips, tongue, or throat;
  • severe itching of the skin, with rash.

Children and adolescents

EVUSHELD must not be given to children under 12 years of age or weighing less than 40 kg.

Other medicines and EVUSHELD

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This is because it is not yet known if this medicine affects other medicines, or if it is affected by them.

Pregnancy and breastfeeding

Talk to your doctor or nurse if you are pregnant, think you may be pregnant, or plan to become pregnant.

• This is because there is not enough information to ensure that the medicine is safe to use during pregnancy.
• This medicine will only be given if the potential benefits of treatment outweigh the potential risks to the mother or unborn child.

Tell your doctor or nurse if you are breastfeeding.

• This is because it is not known if this medicine passes into breast milk, or what effects it may have on the baby or milk production.
• Your doctor will help you decide whether to continue breastfeeding or start treatment with this medicine.

Driving and using machines

It is unlikely that EVUSHELD will affect your ability to drive or use machines.

EVUSHELD contains polysorbate 80

This medicine contains 0.6 mg of polysorbate 80 in each vial of tixagevimab and in each vial of cilgavimab. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

3. How EVUSHELD is given

The recommended dose for pre-exposure prophylaxis (prevention) is 300 milligrams (mg), given as two injections:

• 150 mg of tixagevimab
• 150 mg of cilgavimab

The recommended dose for the treatment of mild to moderate COVID-19 is 600 milligrams (mg), given as two injections:

• 300 mg of tixagevimab
• 300 mg of cilgavimab

EVUSHELD consists of two separate solutions, one containing tixagevimab and one containing cilgavimab. Your doctor or nurse will give you each injection into a different muscle, usually one into each gluteal muscle. The two injections will be given one after the other.

Your doctor or nurse will decide how long you should be clinically monitored after being given the medicine. This is in case you experience any side effects.

4. Possible side effects

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

Side effects

Common(may affect up to 1 in 10 people)

• hypersensitivity reaction (rash or redness with itching or hives)
• injection site reaction (pain, redness, itching, inflammation near the injection site)

Uncommon(may affect up to 1 in 100 people)

• injection-related reaction (examples include headache, chills, and redness, discomfort, or pain near the injection site)

Rare(may affect up to 1 in 1,000 people)

• severe allergic reaction with difficulty breathing, swelling, dizziness, rapid heartbeat, sweating, and loss of consciousness (anaphylaxis)

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of EVUSHELD

Keep this medicine out of the sight and reach of children.

Your doctor, pharmacist, or nurse is responsible for the storage of this medicine and for disposing of any unused product. The following information is intended for healthcare professionals.

Do not use this medicine after the expiry date which is stated on the carton and on the label of the vial after EXP. The expiry date is the last day of the month stated.

Unopened vials:

• Store in a refrigerator (between 2 °C and 8 °C).
• Do not freeze.
• Do not shake.
• Keep in the original packaging to protect from light.

Prepared syringes should be used immediately. If necessary, prepared syringes can be stored for no more than 4 hours between 2 °C and 25 °C.

6. Contents of the pack and other information

Composition of EVUSHELD

The active substances are:

• tixagevimab – 150 mg in 1.5 ml of solution.
• cilgavimab – 150 mg in 1.5 ml of solution.

The other ingredients are histidine, histidine hydrochloride monohydrate, sucrose, polysorbate 80 (E 433), and water for injections.

Appearance and packaging

EVUSHELD contains two glass vials of solution for injection:

• Tixagevimab solution for injection (dark grey cap) is a clear to opalescent, colorless to slightly yellow solution.
• Cilgavimab solution for injection (white cap) is a clear to opalescent, colorless to slightly yellow solution.

Each pack of EVUSHELD contains 2 vials: 1 vial of tixagevimab and 1 vial of cilgavimab.

Marketing authorisation holder

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Manufacturer

AstraZeneca AB

Gärtunavägen

SE-152 57 Södertälje

Sweden

You can ask for more information about this medicine from your local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu

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This information is intended for healthcare professionals only:

Administration

• This medicine should be handled by a healthcare professional using aseptic technique to ensure the sterility of each dose.
• Tixagevimab and cilgavimab should be inspected visually for particles and discoloration before administration. Both tixagevimab and cilgavimab are clear to opalescent, colorless to slightly yellow solutions. Discard the vials if the solution is cloudy, discolored, or visible particles are observed.
• Do not shake the vials.
• After initial puncture, if not used immediately, the medicine in the vial may be stored for 4 hours between 2 °C and 25 °C. In-use storage times and conditions are the responsibility of the user.
• Withdraw the required dose of tixagevimab into a syringe and withdraw the required dose of cilgavimab into a separate syringe. The two separate syringes should be administered by intramuscular injection into two different muscles, preferably into the gluteal muscles.
• An overfill is included in each vial to allow for the withdrawal of 1.5 ml. Discard any unused portion remaining in the vial.
• Prepared syringes should be administered immediately.
• If immediate administration is not possible, in-use storage times and conditions are the responsibility of the user and normally should not exceed 4 hours between 2 °C and 25 °C.

Disposal of unused medicine and all materials that have come into contact with it should be done in accordance with local regulations.