Tixagevimab and Cilgavimab Investigational

Tixagevimab and Cilgavimab are combination medications used to prevent Covid-19 in people 12 years and older who weigh at least 88 pounds or 40 kg.

• Tixagevimab and Cilgavimab are available under various brand names: Evusheld

Common side effects of Tixagevimab and Cilgavimab include:

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

Serious side effects of Tixagevimab and Cilgavimab include:

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

Rare side effects of Tixagevimab and Cilgavimab include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injection, solution

• Tixagevimab 150 mg/1.5 mL single-dose vial
• Cilgavimab 150 mg/1.5 mL single-dose vial

COVID-19

Adult and pediatric dosage

• Initial dose: Tixagevimab 300 mg IM and Cilgavimab 300 mg IM administered as separate, consecutive IM injections
• Dosing for individuals who initially received tixagevimab 150 mg and Cilgavimab 150 mg
• Less than 3 months since receiving lower dose: Administer additional 150 mg tixagevimab and 150 mg Cilgavimab
• Above 3 months since receiving lower dose: Administer 300 mg tixagevimab and 300 mg Cilgavimab

Repeat dosing

• 300 mg tixagevimab and 300 mg Cilgavimab IM every 6 months

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Tixagevimab and Cilgavimab have no noted severe interactions with any other drugs.
• Tixagevimab and Cilgavimab have no noted serious interactions with any other drugs.
• Tixagevimab and Cilgavimab have no noted moderate interactions with any other drugs.
• Tixagevimab and Cilgavimab have no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Not currently infected with the SARS-CoV-2 virus
• Not had recent exposure to an individual infected with the SARS-CoV-2 virus
• Immunocompromised or have a weakened immune system due to a medical condition
• Unable to receive a COVID-19 vaccine due to allergy to the COVID-19 vaccine or an ingredient in the vaccine.

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Tixagevimab and Cilgavimab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Tixagevimab and Cilgavimab?”

Cautions

• 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.
• 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

Pregnancy & Lactation

• 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.
• Lactation
  • It is unknown if tixagevimab and Cilgavimab pass into breast milk. Consult your doctor before breastfeeding.