cilgavimab and tixagevimab

What is the most important information I should know about cilgavimab and tixagevimab?

Cilgavimab and tixagevimab is not currently authorized for use until further notice by the US Food and Drug Administration (FDA).

What is cilgavimab and tixagevimab?

Cilgavimab and tixagevimab is not currently authorized for use until further notice by the US Food and Drug Administration (FDA).

Cilgavimab in combination with tixagevimab is an experimental medicine being studied for the prevention before exposure of COVID-19. It is not yet known if this medicine is safe and effective.

The US Food and Drug Administration (FDA) has not authorized emergency use of cilgavimab in combination with another medicine called tixagevimab for the prevention before exposure of COVID-19 in adults and people 12 years of age and older (weighing at least 40 kg or 88 lbs) who are not currently infected with COVID-19 and:

• who have not had a known recent exposure to someone infected with COVID-19;
• who are moderately to severely immunocompromised and may not get an adequate immune response to COVID-19 vaccination; or
• for whom vaccination with any COVID-19 vaccine is not recommended due to a history of severe adverse reaction to a COVID-19 vaccine.

Cilgavimab and tixagevimab is not authorized for use in people:

• for treatment of COVID-19; or
• for prevention after exposure of COVID-19 in people who have been exposed to someone infected with COVID-19.

Cilgavimab and tixagevimab is not a substitute for vaccination in people for whom COVID-19 vaccine is recommended. People who may benefit from COVID-19 vaccination should get vaccinated.

In people who have received a COVID-19 vaccine, cilgavimab and tixagevimab is not currently authorized to be given at least 2 weeks after vaccination.

Cilgavimab and tixagevimab may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving cilgavimab and tixagevimab?

Tell your doctor if:

• you had a COVID-19 vaccine;
• you have heart problems;
• you have a coagulation disorder or thrombocytopenia (low levels of platelets in the blood);
• you are pregnant or breastfeeding; or
• you have any serious or chronic disease.

COVID-19 is more likely to cause serious illness or death in a pregnant woman. Not all risks are known yet, but being treated with cilgavimab and tixagevimab is likely to be less harmful than being infected with COVID-19 during pregnancy.

How are cilgavimab and tixagevimab given?

Cilgavimab and tixagevimab are injected into a muscle by a healthcare provider as two separate consecutive injections.

Cilgavimab and tixagevimab can be given after 6 months of the initial consecutive injections. Follow your doctor's instructions about receiving a repeat dose if needed.

You will be watched for at least 1 hour to make sure you do not have an allergic reaction.

Cilgavimab and tixagevimab are still being studied and all of the risks are not yet known.

What happens if I miss a dose?

Cilgavimab is given with tixagevimab in two separate consecutive injections and does not have a daily dosing schedule.

What happens if I overdose?

In a medical setting an overdose would be treated quickly.

What should I avoid while receiving cilgavimab and tixagevimab?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of cilgavimab and tixagevimab?

• throat irritation, swelling in your face or throat;
• dizziness, a light-headed feeling (like you might pass out);
• chest pain, wheezing, shortness of breath;
• fever, chills, sweating, nausea;
• fast or slow heartbeats, headache, pounding in your neck or ears;
• weakness, tiredness;
• a rash or itching; or
• muscle pain.

• confusion;
• weakness; or
• fast or slow heartbeats.

Also call your doctor at once, and get tested for COVID-19, if you develop any symptoms of COVID-19:

• fever, chills;
• cough, shortness of breath;
• tiredness;
• muscle or body aches;
• headache;
• sore throat;
• altered sense of taste or smell;
• stuffy or runny nose; or
• nausea, vomiting, or diarrhea.

Common side effects may include:

• headache;
• tiredness; or
• cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect cilgavimab and tixagevimab?

Other drugs may affect cilgavimab and tixagevimab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Where can I get more information?

Your doctor or pharmacist can provide more information about cilgavimab and tixagevimab.