Evusheld 150 mg / 150 mg solution for injection

• 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. This includes any possible side effects not listed in this leaflet. See section 4.

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

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

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

• If you have low numbers of blood platelets (which help blood clotting), any blood clotting problems or are taking a medicine to prevent blood clots (an anticoagulant).
• have had a heart attack or stroke, have other heart problems, or are at high-risk of cardiac (heart) problems or blood clots.

COVID-19 is caused by different strains (variants) of the SARS-CoV-2 virus that change over time. Evusheld may be less effective at preventing or treating COVID-19 caused by some strains than others. The doctor will take into consideration what is known about the circulating viral variants before prescribing Evusheld. However, do contact your doctor right away if you get symptoms of COVID-19 or if your COVID-19 symptoms worsen. COVID-19 affects different people in different ways:

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

Tell a doctor, pharmacist or nurse or get medical help immediately if you notice any signs of a serious allergic reaction, such as:

• difficulty breathing or swallowing
• swelling of the face, lips, tongue or throat
• severe itching of the skin, with a red rash or raised bumps

See also section 4.

Evusheld should not be given to children.

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines including any medicines that you buy without a prescription from your pharmacy or supermarket.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before receiving this medicine.

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

Allergic reactions may occur during or following administration of monoclonal antibodies. Signs include:

• difficulty breathing or swallowing
• swelling of the face, lips, tongue or throat
• severe itching of the skin, with a red rash or raised bumps

Tell your doctor, pharmacist or nurse or get medical help immediately if you notice any signs of a serious allergic reaction.

Common: may affects up to 1 in 10 people

• hypersensitivity reaction (rash or an itchy red rash or raised bumps) with 300mg dose
• injection site reaction (pain, redness, itching, swelling near where the injection was given)

Uncommon: may affect up to 1 in 100 people

• hypersensitivity reaction (rash or an itchy red rash or raised bumps) with 600mg dose
• injection related reaction (examples of these include headache, chills and redness, discomfort or soreness near where the injection was given)

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Coronavirus Yellow Card Reporting site at https://coronavirus-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 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 (E433) and water for injections.

Evusheld contains two clear glass vials of solution for injection:

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

Each carton of Evusheld contains 2 vials, 1 vial each of tixagevimab and cilgavimab.