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 1. Home
 2. Drugs
 3. Drug Safety and Availability
 4. FDA authorizes revisions to Evusheld dosing

 1. Drug Safety and Availability


FDA AUTHORIZES REVISIONS TO EVUSHELD DOSING

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[2/24/2022] The U.S. Food and Drug Administration has revised the emergency use
authorization for Evusheld (tixagevimab co-packaged with cilgavimab) to change
the initial dose for the authorized use as pre-exposure prophylaxis (prevention)
of COVID-19 in certain adults and pediatric patients.

Based on the most recent information and data available, Evusheld may be less
active against certain Omicron subvariants. The dosing regimen was revised
because available data indicate that a higher dose of Evusheld may be more
likely to prevent infection by the COVID-19 Omicron subvariants BA.1 and BA.1.1
than the originally authorized Evusheld dose.

Previously, the authorized Evusheld dosage was 150 mg of tixagevimab and 150 mg
of cilgavimab administered as two separate consecutive intramuscular injections,
with repeat doses every six months while SARS-CoV-2 remains in circulation. With
this EUA revision, FDA has increased the initial authorized dose to 300 mg of
tixagevimab and 300 mg of cilgavimab. Patients who have already received the
previously authorized dose (150 mg of tixagevimab and 150 mg of cilgavimab)
should receive an additional dose of 150 mg of tixagevimab and 150 mg of
cilgavimab as soon as possible to raise their monoclonal antibody levels to
those expected for patients receiving the higher dose.

Evusheld is authorized for the emergency use as pre-exposure prophylaxis (PrEP)
for prevention of COVID-19 in certain adults and pediatric patients (12 years of
age and older weighing at least 40 kg). Health care providers should only
administer it to individuals who are not currently infected with SARS-CoV-2 and
who have not had a known recent exposure to someone infected with SARS-CoV-2.
Evusheld is only authorized for those:

 * who have moderate-to-severe immune compromise due to a medical condition or
   who have received immunosuppressive medications or treatments and may not
   mount an adequate immune response to COVID-19 vaccination or
 * for whom vaccination with any available approved or authorized COVID-19
   vaccine 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).

The duration of protection provided by Evusheld against symptomatic SARS-CoV-2
infection may not be as long as was shown in the clinical trial supporting the
initial authorization because the clinical trial data came from a time period
before the emergence of the BA.1 and BA.1.1 subvariants. However, it is not
known whether BA.1 and BA1.1 will still be circulating in the coming months or
whether another Omicron subvariant, BA.2, for which Evusheld is expected to have
greater neutralizing activity, will become dominant. 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. We will continue to monitor the situation closely and
will provide updates with redosing recommendations in the near future when more
data are available to determine the appropriate timing of redosing (e.g., 3
months or 6 months after the prior dose).

WHAT SHOULD PATIENTS KNOW:

 * Patients who previously received an initial lower dose of Evusheld (150 mg of
   tixagevimab and 150 mg of cilgavimab) should contact their health care
   provider and return for an additional 150 mg of tixagevimab and 150 mg of
   cilgavimab dose as soon as possible. Any subsequent repeat dosing will be
   timed from the date of this additional Evusheld dose.
   
   
 * Patients who have not received any doses of Evusheld should talk to their
   health care provider to determine whether, based on their individual
   circumstances, they are eligible to receive it. If they are eligible, they
   should receive the 300 mg of tixagevimab and 300 mg of cilgavimab dose.
   
   
 * Patients with any additional questions should contact their health care
   provider.

WHAT HEALTH CARE PROFESSIONALS SHOULD KNOW:

 * Health care professionals should contact patients who received the previously
   authorized Evusheld dose to return for an additional 150 mg tixagevimab and
   150 mg cilgavimab dose as soon as possible.
 * The volume of each injection for the new, higher dose will be larger, 3 mL
   instead of 1.5 mL. This means that the injections should be limited to large
   muscles on the body that can accommodate this volume (e.g., the gluteal
   muscles).
 * Health care professionals should review the updated Fact Sheets and Dear
   Health Provider Letter for Evusheld.
 * As part of the EUA, FDA requires health care providers who prescribe Evusheld
   to report all medication errors and serious adverse events considered to be
   potentially related to Evusheld through FDA’s MedWatch Adverse Event
   Reporting program. Providers can complete and submit the report online; or
   download and complete the form, then submit it via fax at 1-800-FDA-0178.


   CONTENT CURRENT AS OF:
   
   02/24/2022


 * REGULATED PRODUCT(S)
   
    * Drugs
   
   
   TOPIC(S)
   
    * Safety - Issues, Errors, and Problems

 * Drug Safety and Availability
    * Information about Nitrosamine Impurities in Medications
    * Drug Alerts and Statements
    * Medication Guides
    * Drug Safety Communications
   
    * Drug Shortages
    * FDA Drug Safety Podcasts
    * Information by Drug Class
    * Medication Errors Related to CDER-Regulated Drug Products
    * Postmarket Drug Safety Information for Patients and Providers
    * Risk Evaluation and Mitigation Strategies | REMS
    * Safe Use Initiative
    * Drug Recalls
    * Drug Supply Chain Integrity
    * Multistate outbreak of fungal meningitis and other infections




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