Evusheld

Evusheld was an investigational medication that packages together in one carton two separate monoclonal antibodies - tixagevimab and cilgavimab.

Tixagevimb and cilgavimab are human immunoglobulin G1 (IgG1κ) monoclonal antibodies produced in Chinese hamster ovary (CHO) cells using recombinant DNA technology. They are SARS-CoV-2 spike protein-directed attachment inhibitors.

The monoclonal antibodies in Evusheld worked by binding to the spike protein on SARS-CoV-2, the virus that causes COVID-19. This blocks the virus from being able to bind to ACE2 receptors, which is what enables the virus to invade your cells.

Evusheld was authorisorized by the US Food and Drug Administration (FDA) under the Emergency Use Authorization (EUA) program. It was first authorized for use in the US in December 2021.

Evusheld was prescribed for pre-exposure prophylaxis for prevention of COVID-19 in adults and adolescents 12 years of age and older who weigh at least 88 pounds (40 kg).

It was used in people who are not currently infected with SARS-CoV-2 and who have not had recent close contact with someone who is infected with the virus and:

• Who had moderate-to-severe immune compromise due to a medical condition, or have received immunosuppressive medicines or treatments and may not mount an adequate immune response to a COVID-19 vaccine, or
• For whom vaccination with any available COVID-19 vaccines was not recommended due to a history of severe adverse reaction to such vaccines or their ingredients.

Medical conditions or treatments that may result in moderate-to-severe immune system compromise and an inadequate immune response to a COVID-19 vaccine include but are not limited to:

• Active treatment for solid tumor and hematologic malignancies
• Receipt of solid-organ transplant and taking immunosuppressive therapy
• Receipt of chimeric antigen receptor (CAR)-T-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppression therapy)
• Moderate or severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome)
• Advanced or untreated HIV infection (people with HIV and CD4 cell counts <200/mm3, history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV)
• Active treatment with high-dose corticosteroids (i.e., ≥20 mg prednisone or equivalent per day when administered for ≥2 weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor-necrosis (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory (e.g., B-cell depleting agents)

Evusheld was not authorized for use in individuals:

• To treat COVID-19, or
• For post-exposure prophylaxis in people who have been exposed to someone with COVID-19.

Pre-exposure prophylaxis with this medication was not a substitute for vaccination for those who were recommended to get vaccinated.

• Evuheld will be administered by a healthcare professional.
• You will receive one dose of Evusheld, which consists of two separate injections - one containing tixagevimab and one containing cilgavimab - which are administered one after the other.
• The two separate injections, which are given consecutively, will be given at two different injection sites.
• Evusheld is given via intramuscular injection, usually into the gluteal or buttocks muscles.
• You will need to receive additional doses of this medication every six months if ongoing protection is needed. Talk to your healthcare provider for more information.

It is possible that Evusheld may reduce your body’s immune response to a COVID-19 vaccine. If you have received a COVID-19 vaccine, you should wait at least 2 weeks to receive Evusheld.

Do not receive Evusheld if you have a severe allergic reaction to tixagevimab or cilgavimab or any of the other ingredients in this medication. See below for a complete list of ingredients.

• Have any allergies, including if you have had a severe allergic reaction to a COVID-19 vaccine
• Have low numbers of blood platelets (which help blood clotting), a bleeding disorder, or are taking anticoagulants (to prevent blood clots)
• Have had a heart attack or stroke, have other heart problems, or are at high risk of cardiac (heart) events
• Have any serious illness

Possible side effects of Evusheld include:

• Allergic reactions. These can happen during and after receiving this medication. They can sometimes be serious or life-threatening. You may be at increased risk if you have had a severe allergic reaction to a COVID-19 vaccine. Evusheld contains polysorbate 80, which is also similar to polyethylene glycol (PEG), an ingredient in some COVID-19 vaccines that some people react to. Your healthcare provider may consult with an allergy and immunology specialist before giving you this medication if you have had a serious allergic reaction to a COVID-19 vaccine.Your healthcare provider will monitor you for allergic reactions during and for at least one hour after you receive Evusheld. Tell your healthcare provider right away if you get any of the following signs and symptoms of an allergic reaction during or after you receive this medication: trouble breathing or shortness of breath, hives, wheezing, chills, itching, tiredness or weakness, skin flushing, fast heart rate, sweating, chest pain or discomfort, muscle aches, nausea and vomiting, you feel lightheaded or faint, swelling of your face, lips, mouth and tongue, and throat tightness.
• Cardiac (heart) events: Serious cardiac adverse events have happened, but were not common, in people who received Evusheld in clinical trials. In clinical trials, more people with cardiac risk factors (including a history of heart attack) who received Evusheld experienced serious cardiac events than people who did not receive it. It's not known if these events are related to Evusheld or underlying medical conditions. Contact your healthcare provider or get medical help right away if you get any symptoms of cardiac events, including pain, pressure, or discomfort in the chest, arms, neck, back, stomach or jaw, as well as shortness of breath, feeling tired or weak (fatigue), feeling sick (nausea), or swelling in your ankles or lower legs.

The side effects of getting any medicine by intramuscular injection may include:

• pain
• bruising of the skin
• soreness
• swelling
• bleeding or infection at the injection site

These are not all the possible side effects of this medication, which has not been given to a lot of people. Evusheld is still being studied so it is possible that all of the risks are not known at this time. Serious and unexpected side effects may happen.

Contact your healthcare provider if you have any side effects that bother you or do not go away. Report side effects to FDA MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088 or call AstraZeneca at 1-800-236-9933.

Evusheld is no longer authorized for Emergency Use for COVID-19.

The dosage of Evusheld for emergency use was:

• Initial dose: 300 mg of tixagevimab and 300 mg of cilgavimab administered as two separate consecutive intramuscular injections.
• Dosing for individuals who initially received 150 mg of tixagevimab and 150 mg cilgavimab.For individuals who initially received 150 mg tixagevimab and 150 mg cilgavimab: Initial dose ≤3 months prior: 150 mg tixagevimab and 150 mg cilgavimab. Initial dose >3 months prior: 300 mg tixagevimab and 300 mg cilgavimab.
• Repeat dose: 300 mg of tixagevimab and 300 mg of cilgavimab every 6 months. Repeat dosing should be timed from the date of the most recent Evusheld dose.

See the Full Prescribing Information for further information about Evusheld dosing.

It is recommended to receive Evusheld every six months if ongoing protection is required. Talk to your healthcare provider if you are due for another dose of Evusheld.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if Evusheld will affect your unborn baby. Evusheld should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not know whether this medication passes into breastmilk or affects breastfed babies. Talk to your healthcare provider about the best way to feed your baby if you receive Evusheld.

• Store unopened vials of Evusheld in a refrigerator at 2°C to 8°C (36°F to 46°F)
• Store in the original carton to protect from light
• Discard any unused portion
• Do not freeze
• Do not shake

Active ingredients: tixagevimab is the active ingredient in one vial and cilgavimab is the active ingredient in the other.

Inactive ingredients: Each vial contains L- histidine, L- histidine hydrochloride monohydrate, polysorbate 80, sucrose, water.