Evusheld (EUA)

tixagevimab/cilgavimabMed Info

The FDA is allowing the emergency use of the combination of tixagevimab and cilgavimab to prevent COVID-19. It is used by people 12 years of age and older who should not receive a COVID-19 vaccine due to a history of a serious allergic reaction to a COVID-19 vaccine or who may not develop an adequate response to a COVID-19 vaccine due to certain immune system disorders. This product is not for use by people who are infected with COVID-19 or who had a recent exposure to someone infected with COVID-19. Talk to your doctor about the risks and benefits of treatment with tixagevimab and cilgavimab.

Tixagevimab and cilgavimab are antibodies that can neutralize the coronavirus and may prevent COVID-19. More information about tixagevimab and cilgavimab is available from the FDA Fact Sheet for Patients, Parents, and Caregivers for Emergency Use. If you are enrolled in a study, information should be provided by the doctor via the Informed Consent Form.

There is limited information about how safe and effective the combination of tixagevimab and cilgavimab is for preventing COVID-19. Study results show that the combination of tixagevimab and cilgavimab may help protect some people against COVID-19. Continue to wear a mask, practice social distancing (physical distancing), and follow other safety guidelines to protect yourself and those around you until otherwise directed by your health care professional and public health officials.

The information in this document reflects emerging data, which is evolving and subject to reassessment. Users should be aware of these considerations in their review of tixagevimab and cilgavimab, and it is always the responsibility of treating practitioners to exercise independent judgment in making care decisions.

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150 mg/1.5 ml- 150 mg/1.5 ml, 30 milliliters, Solution

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About Evusheld (EUA)

Overview

The FDA is allowing the emergency use of the combination of tixagevimab and cilgavimab to prevent COVID-19. It is used by people 12 years of age and older who should not receive a COVID-19 vaccine due to a history of a serious allergic reaction to a COVID-19 vaccine or who may not develop an adequate response to a COVID-19 vaccine due to certain immune system disorders. This product is not for use by people who are infected with COVID-19 or who had a recent exposure to someone infected with COVID-19. Talk to your doctor about the risks and benefits of treatment with tixagevimab and cilgavimab.

Tixagevimab and cilgavimab are antibodies that can neutralize the coronavirus and may prevent COVID-19. More information about tixagevimab and cilgavimab is available from the FDA Fact Sheet for Patients, Parents, and Caregivers for Emergency Use. If you are enrolled in a study, information should be provided by the doctor via the Informed Consent Form.

There is limited information about how safe and effective the combination of tixagevimab and cilgavimab is for preventing COVID-19. Study results show that the combination of tixagevimab and cilgavimab may help protect some people against COVID-19. Continue to wear a mask, practice social distancing (physical distancing), and follow other safety guidelines to protect yourself and those around you until otherwise directed by your health care professional and public health officials.

The information in this document reflects emerging data, which is evolving and subject to reassessment. Users should be aware of these considerations in their review of tixagevimab and cilgavimab, and it is always the responsibility of treating practitioners to exercise independent judgment in making care decisions.

How to use

This medication is given by injection into a muscle by a healthcare professional. The medication is given as a series of 2 injections. Each injection should be given in a different area of the body. A healthcare professional will observe you for at least 1 hour after your injections in case you have serious side effects.

Another dose of tixagevimab and cilgavimab may be given 6 months after your first injection. Ask your healthcare professional for more details.

Side effects

Pain, soreness, swelling, or bruising of the skin at the injection site may occur. If you notice any of these effects, tell your health care professional promptly.

There have been rare reports of heart problems (including heart attack, heart failure), especially in people who have a history of heart disease, heart attack, stroke, or other risk factors for heart disease. If you notice any of the following symptoms, get medical help right away symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), symptoms of heart failure (such as swelling ankles/feet, unusual tiredness, unusual/sudden weight gain), fast/irregular heartbeat.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Information is limited and it is unknown at this time if tixagevimab and cilgavimab cause other serious side effects. This is not necessarily a complete list of possible side effects.

Contact your doctor for medical advice about side effects.

Warnings & Precautions

Before using this medication, tell your doctor if you have any allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems.

Limited information is known at this time about other medical conditions that may affect how tixagevimab and cilgavimab work, or how tixagevimab and cilgavimab may affect other medical conditions.

Before using this medication, tell your doctor your medical history.

Tell your doctor if you are pregnant or think you are pregnant. The combination of tixagevimab and cilgavimab should be used during pregnancy only if the possible benefits are greater than the possible risks.

It is unknown if tixagevimab and cilgavimab pass into breast milk. Consult your doctor before breast-feeding.

Storage

Not applicable. This product is not stored at home.

Drug interactions

Drug interactions may change how medications work or increase your risk for serious side effects. Information is limited and it is unknown at this time if tixagevimab and cilgavimab have drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

Overdose information is not available at this time.

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Missed Doses:

Not applicable.

Notes:

Not applicable.

Selected from the Licensed Solutions data included with permission and copyrighted by FDB, inc., 2014. This copyrighted material has been downloaded and Licensed data provider and is not for distribution in professional healthcare settings. This information is generalized and not intended as specific medical advice. Consult your healthcare professional before taking any drug or commencing or discontinuing any course of treatment. 

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