Vaccine Information: EVUSHELD (Page 2 of 8)

FULL FACT SHEET FOR HEALTHCARE PROVIDERS

1 EMERGENCY USE AUTHORIZATION

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the unapproved product EVUSHELD (tixagevimab co-packaged with cilgavimab) for the pre-exposure prophylaxis of coronavirus disease 2019 (COVID-19) in adults and pediatric individuals (12 years of age and older weighing at least 40 kg):

Who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2 and
Who have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination 1or
For whom vaccination with any available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended due to a history of severe adverse reaction (e.g., severe allergic reaction) to a COVID-19 vaccine(s) and/or COVID-19 vaccine component(s).

EVUSHELD may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs in the therapeutic class to which EVUSHELD belongs (i.e., anti-infectives).

EVUSHELD has been authorized by FDA for the emergency use described above. EVUSHELD is not FDA-approved for any use, including use for pre-exposure prophylaxis of COVID-19.

EVUSHELD is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of EVUSHELD under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Medical conditions or treatments that may result in moderate to severe immune compromise and an inadequate immune response to COVID-19 vaccination include but are not limited to 1:

Active treatment for solid tumor and hematologic malignancies
Receipt of solid-organ transplant and taking immunosuppressive therapy
Receipt of chimeric antigen receptor (CAR)-T-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppression therapy)
Moderate or severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome)
Advanced or untreated HIV infection (people with HIV and CD4 cell counts <200/mm3 , history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV)
Active treatment with high-dose corticosteroids (i.e., ≥20 mg prednisone or equivalent per day when administered for ≥2 weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor-necrosis (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory (e.g., B-cell depleting agents)

LIMITATIONS OF AUTHORIZED USE

EVUSHELD is not authorized for use in individuals:
For treatment of COVID-19, or
For post-exposure prophylaxis of COVID-19 in individuals who have been exposed to someone infected with SARS-CoV-2.
Pre-exposure prophylaxis with EVUSHELD is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended. Individuals for whom COVID-19 vaccination is recommended, including individuals with moderate to severe immune compromise who may derive benefit from COVID-19 vaccination, should receive COVID-19 vaccination.
In individuals who have received a COVID-19 vaccine, EVUSHELD should be administered at least two weeks after vaccination.

Justification for Emergency Use of Drugs During the COVID-19 Pandemic

There is currently an outbreak of COVID-19 caused by SARS-CoV-2, a novel coronavirus. The Secretary of HHS has declared that:

A public health emergency related to COVID-19 has existed since January 27, 2020.
Circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic (March 27, 2020 declaration).

An EUA is a FDA authorization for the emergency use of an unapproved product or unapproved use of an approved product (i.e., drug, biological product, or device) in the United States under certain circumstances including, but not limited to, when the Secretary of HHS declares that there is a public health emergency that affects the national security or the health and security of United States citizens living abroad, and that involves biological agent(s) or a disease or condition that may be attributable to such agent(s). Criteria for issuing an EUA include:

The biological agent(s) can cause a serious or life-threatening disease or condition;
Based on the totality of the available scientific evidence (including data from adequate and well-controlled clinical trials, if available), it is reasonable to believe that
The product may be effective in diagnosing, treating, or preventing the serious or life-threatening disease or condition; and
The known and potential benefits of the product — when used to diagnose, prevent, or treat such disease or condition — outweigh the known and potential risks of the product, taking into consideration the material threat posed by the biological agent(s);
There is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating the serious or life-threatening disease or condition.

Information Regarding Available Alternatives for the EUA Authorized Use

There are no adequate, approved and available alternatives to EVUSHELD for the pre-exposure prophylaxis of COVID-19 in individuals who may not mount an adequate immune response to COVID-19 vaccination or for whom COVID-19 vaccination is not recommended due to a history of severe adverse reaction to a COVID-19 vaccine or its components.

For information on clinical studies of EVUSHELD and other therapies for the prophylaxis of COVID-19, see www.clinicaltrials.gov.


1
For additional information please see https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html.Healthcare providers should consider the benefit-risk for an individual patient.

2 DOSAGE AND ADMINISTRATION

2.1 Dosage for Emergency Use of EVUSHELD

Initial Dosing

Due to decreased neutralization activity of EVUSHELD against the Omicron subvariants BA.1 and BA.1.1 (BA.1+R346K), 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 [see Clinical Pharmacology (12.3)]. Refer to Table 1 below.

Dosing for Individuals Who Initially Received 150 mg of Tixagevimab and 150 mg of Cilgavimab

Individuals who have already received the previously authorized initial 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 below.
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 below.

Repeat Dosing

EVUSHELD has only been studied in single-dose studies. There are no safety and efficacy data available with repeat dosing. Longer term data from the study PROVENT indicated that EVUSHELD may be effective for pre-exposure prophylaxis for 6 months post-administration for pre-Omicron SARS-CoV-2 variants [see Clinical Studies (14)]. However, the neutralization activity of EVUSHELD against the Omicron subvariants (BA.1, and BA.1.1 [BA.1+R346K]) versus the reference strain decreases 12- to 424-fold [see Microbiology (12.4)] , and consequently the duration of protection is not known and is likely reduced. Conversely, the neutralization activity of EVUSHELD against the Omicron BA.2 subvariant versus the reference strain is minimally impacted [see Microbiology (12.4)].

Because it is unclear which SARS-CoV-2 variant or Omicron subvariant will become dominant in the United States over the next few months, the recommended timing for repeat dosing cannot be provided at this time. The Fact Sheets will be revised with repeat dosing recommendations in the near future when more data are available to determine the appropriate timing of redosing (e.g., a repeat dose with 150 mg of tixagevimab and 150 mg of cilgavimab 3 months or 6 months after the prior dose). Any repeat dosing will be timed from the date of the most recent EVUSHELD dose.

To access the most recent EVUSHELD Fact Sheets, please visit http://www.evusheld.com or scan the QR code:

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The recommendations for dosing are based on the totality of the scientific evidence including clinical pharmacology data, antiviral activity data, and clinical trial data [see Clinical Pharmacology (12.3) , Microbiology (12.4), and Clinical Studies (14)]. EVUSHELD has only been studied for the prophylaxis of COVID-19 at the EVUSHELD (150 mg of tixagevimab and 150 mg of cilgavimab) dose. There are no data available in a prophylaxis setting for the EVUSHELD (300 mg of tixagevimab and 300 mg of cilgavimab) dose. The clinical safety of the EVUSHELD (300 mg of tixagevimab and 300 mg of cilgavimab) dose is supported by safety data from a treatment study in subjects with mild to moderate COVID-19 [see Adverse Reactions (6.1)].

2.2 Dosage Adjustment in Specific Populations

No dosage adjustment is recommended in pregnant or lactating individuals, in geriatrics, and in individuals with renal impairment [see Use in Specific Populations (8)].

2.3 Dose Preparation and Administration

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).

Table 1 Initial 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

EVUSHELD *

(tixagevimab co-packaged with cilgavimab)

Antibody dose

Number of vials needed

Volume to withdraw from vial(s)

tixagevimab

300 mg

2 vials

3 mL

cilgavimab

300 mg

2 vials

3 mL

Table 2Dosage 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

EVUSHELD *

(tixagevimab co-packaged with cilgavimab)

Antibody dose

Number of vials needed

Volume to withdraw from vial(s)

tixagevimab

150 mg

1 vial

1.5 mL

cilgavimab

150 mg

1 vial

1.5 mL

Preparation

Tixagevimab and cilgavimab must be prepared by a qualified healthcare provider.
Tixagevimab and cilgavimab are each supplied in individual single-dose vials. Do not shake the vials.
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.
Administer EVUSHELD as TWO separate, consecutive intramuscular (IM) injections, 1 injection of tixagevimab and 1 injection of cilgavimab.
Withdraw the appropriate amount of tixagevimab solution and the appropriate amount of cilgavimab solution into TWO separate syringes (see Table 1 and Table 2). Discard unused portion in vials.
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 25ºC (77ºF).

Administration

Tixagevimab and cilgavimab must be administered by a qualified healthcare provider.
Administer the two components of EVUSHELD consecutively.
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 [see Warnings and Precautions (5.1)].

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