Tixagevimab and Cilgavimab

As of January 26, 2023, the FDA is no longer recommending use of tixagevimab and cilgavimab in any region in the United States due to the increasing circulation of COVID-19 variants that tixagevimab and cilgavimab is not effective against.

Tixagevimab and cilgavimab injection is currently being studied for the prevention of coronavirus disease 2019 (COVID-19) caused by the SARS-CoV-2 virus.

Only limited clinical trial information is available at this time to support the use of tixagevimab and cilgavimab injection for the prevention of COVID-19. More information is needed to know how well the combination of tixagevimab and cilgavimab work for the prevention of COVID-19 and the possible adverse events from it.

Tixagevimab and cilgavimab injection has not undergone the standard review to be approved by the FDA for use. However, the FDA has approved an Emergency Use Authorization (EUA) to allow certain adults and children 12 years of age and older to receive tixagevimab and cilgavimab injection for prevention of COVID-19.

Tixagevimab and cilgavimab is used to prevent COVID-19 in people 12 years of age and older who weigh at least 88 pounds (40 kg) and who are not currently infected with the SARS-CoV-2 virus and who have not had recent exposure to an individual infected with the SARS-CoV-2 virus and

• are immunocompromised (have a weakened immune system) due to a medical condition or being on certain medicines which may cause them not to respond to a COVID-19 vaccine; or
• are unable to receive a COVID-19 vaccine due to a history of reaction to COVID-19 vaccine or an ingredient in the vaccine.

Tixagevimab and cilgavimab is in a class of medications called monoclonal antibodies. It works by preventing the virus from entering and infecting human cells.

Tixagevimab and cilgavimab comes as a solution (liquid) to be injected intramuscularly (into the muscle), usually in the buttocks, by a doctor or a nurse in a medical clinic or in an office. It is given one time as two shots (one after another) into the buttocks. Your doctor will decide if you need to receive additional doses every 6 months.

Tixagevimab and cilgavimab may cause severe or life-threatening reactions when you receive the medication. Your doctor will monitor you carefully for at least 1 hour after you receive the injection. Tell your doctor if you experience any of these symptoms: fever; chills; nausea; headache; shortness of breath; rapid or slow heart beat; chest discomfort or pain; weaknes; confusion; feeling tired; wheezing; swelling of your lips, face, or throat; rash including hives or itching; muscle aches, dizziness and sweating.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking tixagevimab and cilgavimab,

• tell your doctor and pharmacist if you are allergic to tixagevimab and cilgavimab, any other medications, or any of the ingredients in tixagevimab and cilgavimab. Ask your pharmacist or doctor for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention following: anticoagulants ('blood thinners') such as warfarin (Coumadin). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had any bleeding disorders or have or have had a heart attack, stroke, or heart disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while you are receiving tixagevimab and cilgavimab, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Tixagevimab and cilgavimab may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• tiredness or weakness
• swelling in the ankles or lower legs
• headache
• cough

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• chest pain
• pain or discomfort in one or both arms, the back, neck, jaw or stomach
• shortness of breath
• cold sweat
• nausea
• lightheadedness

Tixagevimab and cilgavimab may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep all appointments with your doctor.

Ask your pharmacist any questions you have about tixagevimab and cilgavimab.

You should continue to isolate as directed by your doctor and follow public health practices such as wearing a mask, social distancing, and frequent hand washing.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

The American Society of Health-System Pharmacists, Inc. represents that this information about tixagevimab and cilgavimab was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are cautioned that tixagevimab and cilgavimab are not approved for prevention of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, but rather, are being investigated for and are currently available under, an FDA emergency use authorization (EUA) for the prevention of COVID-19 in certain adults and children 12 years of age and older. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to the information, and specifically disclaims all such warranties. Readers of the information about tixagevimab and cilgavimab are advised that ASHP is not responsible for the continued currency of the information, for any errors or omissions, and/or for any consequences arising from the use of this information. Readers are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information contained in this information is provided for informational purposes only. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. This information about tixagevimab and cilgavimab are not to be considered individual patient advice. Because of the changing nature of drug information, you are advised to consult with your physician or pharmacist about specific clinical use of any and all medications.

• Evusheld^®