Each EVUSHELD carton contains two vials; one of each antibody. Each vial contains an overfill to allow the withdrawal of 150 mg (1.5 mL)
EVUSHELD contains polysorbate 80, which is in some COVID-19 vaccines and is structurally similar to polyethylene glycol (PEG), an ingredient in other COVID-19 vaccines. For individuals with a history of a severe hypersensitivity reaction to a COVID-19 vaccine, consider consultation with an allergist-immunologist prior to EVUSHELD administration.
The initial dosage of EVUSHELD in adults and pediatric individuals (12 years of age and older weighing at least 40 kg) is 300 mg of tixagevimab and 300 mg of cilgavimab administered as two separate consecutive intramuscular (IM) injections.
300 mg/3 mL
300 mg/3 mL
The repeat dosage of EVUSHELD in adults and pediatric individuals (12 years of age and older weighing at least 40 kg) is 300 mg of tixagevimab and 300 mg of cilgavimab administered every 6 months. Repeat dosing should be timed from the date of the most recent EVUSHELD dose.
Table 1: Dosage of 300 mg of Tixagevimab and 300 mg of Cilgavimab
*300 mg of tixagevimab and 300 mg of cilgavimab are to be administered as separate, consecutive intramuscular injections
Dosing for Individuals Who Initially Received 150 mg of Tixagevimab and 150 mg of Cilgavimab
Individuals who have already received the previously authorized dose (150 mg of tixagevimab and 150 mg of cilgavimab) should receive an additional EVUSHELD dose as soon as possible, with the dose based on the following criteria:
If the patient received their initial dose ≤ 3 months ago, the patient should receive a dose of 150 mg of tixagevimab and 150 mg of cilgavimab, refer to Table 2.
If the patient received their initial dose > 3 months ago, the patient should receive a dose of 300 mg of tixagevimab and 300 mg of cilgavimab, refer to Table 1.
1 VIAL: tixagevimab solution 150 mg/1.5 mL
1 VIAL: cilgavimab solution 150 mg/1.5 mL
1 VIAL: tixagevimab solution (150 mg/1.5 mL)
150 mg/1.5 mL
1 VIAL: cilgavimab solution (150 mg/1.5 mL)
150 mg/1.5 mL
Table 2: Dosage of 150 mg of Tixagevimab and 150 mg of Cilgavimab
*150 mg of tixagevimab and 150 mg of cilgavimab are to be administered as separate, consecutive intramuscular injections
Tixagevimab and cilgavimab are each supplied in individual single-dose vials. Do not shake the vials.
There are limited clinical data available for EVUSHELD. Serious and unexpected adverse events may occur that have not been previously reported with EVUSHELD use.
EVUSHELD is contraindicated in individuals with previous hypersensitivity reactions, including anaphylaxis to EVUSHELD.
As with any intramuscular injection, EVUSHELD should be given with caution to individuals with thrombocytopenia or any coagulation disorder.
Consider the risks and benefits prior to initiating EVUSHELD in individuals at high risk for cardiovascular events, and advise individuals to seek immediate medical attention if they experience any signs or symptoms suggestive of a cardiovascular event.
As a prescribing healthcare practitioner, you must communicate to the patient, parent and caregiver information consistent with the Fact Sheet for Patients, Parents and Caregivers and provide them with a copy of this Fact Sheet prior to administration of EVUSHELD.
EVUSHELD must be prepared by a qualified healthcare provider.
Visually inspect the vials for particulate matter and discoloration.
Tixagevimab and cilgavimab are clear to opalescent, colorless to slightly yellow solutions. Discard the vials if the solution is cloudy, discolored, or visible particles are observed.
Withdraw the appropriate amount of tixagevimab solution and the appropriate amount of cilgavimab solution into TWO separate syringes. Discard unused portion in vials.
Administer the IM injections at different injection sites, preferably one in each of the gluteal muscles, one after the other.
For the 300 mg tixagevimab and 300 mg cilgavimab dose, ensure that the administration sites are appropriate for the volume (3 mL per injection).
Clinically monitor individuals after injections and observe for at least 1 hour.
Administration of EVUSHELD should be done under the supervision of a healthcare provider with appropriate medical support to manage severe hypersensitivity reactions. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur while taking EVUSHELD, immediately discontinue administration and initiate appropriate medications and/or supportive care.
Refrigerate unopened vials at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light
Do not freeze. Do not shake
This product is preservative-free and therefore, the prepared syringes should be administered immediately
If immediate administration is not possible, and the prepared tixagevimab and cilgavimab syringes need to be stored, the total time from vial puncture to administration must not exceed 4 hours:
in a refrigerator at 2ºC to 8ºC (36ºF to 46ºF), or
at room temperature up to 25°C (77°F)
DOSAGE ADJUSTMENT IN SPECIFIC POPULATIONS
No dosage adjustment is recommended in pregnant or lactating individuals, in geriatrics, and in individuals with renal impairment.
Please see Fact Sheet for Healthcare Providers for complete dosing and administration instructions.