Prescribe Right
Prescribe Right
  • Home
  • About
    • Endorsements
    • Published Articles
    • Consulting
    • Effective Pharmacotherapy
  • Pipeline News
    • Podcast
    • Recent Tweets
  • Pharmaceutical Pipeline Tracker
    • Access Pharmaceutical Pipeline Tracker
    • Pharmaceutical Pipeline Tracker Demo
    • Sample Drug Review
    • Case Studies >
      • Monitoring Drugs With PDUFA Dates
      • Monitoring Drugs By Therapeutic Category
      • Monitoring by Indication
      • Research a Single Drug
    • Sample Searches >
      • Single Drug Report Sample
      • Indication Search Sample
      • Drug Class Search Sample
      • Therapeutic Area Search Sample
      • Company Search Sample
  • COVID-19
    • COVID-19 Updates
    • COVID-19 Vaccines
    • COVID-19 Antivirals
    • COVID-19 Monoclonal Antibodies
    • COVID-19 Plasma Products
    • COVID-19 Anti-Inflammatories
    • Remdesivir
    • Ivermectin
  • Contact Us
  • Home
  • About
    • Endorsements
    • Published Articles
    • Consulting
    • Effective Pharmacotherapy
  • Pipeline News
    • Podcast
    • Recent Tweets
  • Pharmaceutical Pipeline Tracker
    • Access Pharmaceutical Pipeline Tracker
    • Pharmaceutical Pipeline Tracker Demo
    • Sample Drug Review
    • Case Studies >
      • Monitoring Drugs With PDUFA Dates
      • Monitoring Drugs By Therapeutic Category
      • Monitoring by Indication
      • Research a Single Drug
    • Sample Searches >
      • Single Drug Report Sample
      • Indication Search Sample
      • Drug Class Search Sample
      • Therapeutic Area Search Sample
      • Company Search Sample
  • COVID-19
    • COVID-19 Updates
    • COVID-19 Vaccines
    • COVID-19 Antivirals
    • COVID-19 Monoclonal Antibodies
    • COVID-19 Plasma Products
    • COVID-19 Anti-Inflammatories
    • Remdesivir
    • Ivermectin
  • Contact Us

monoclonal antibodies 
​
FOR THE TREATMENT OF COVID-19

Picture
 
Manufacturer
(trade name)
​Route
Indication and Recommendation
Variant Susceptibility
Omicron Susceptibility
Comment
Sotrovimab
GlaxoSmithKline
(Xevudy)
Intravenous infusion
 
Must be Administered by a certified Health Care Provider
The CDC found that sotrovimab is not active against the BA.2 Omicron subvariant.

The FDA no longer authorizes sotrovimab to treat COVID-19 in the U.S. due to the Omicron BA.2 sub-variant becoming the dominant variant. The CDC reports that BA.2 now accounts for 72.2% of all COVID-19 cases with BA.1.1 accounting for most of the remaining cases.
 
Recommended Dose: 500 mg per 8 mL of D5W or NS
Recommend
agent of choice 
 
Variants of concern:

Alpha (S)
Beta (S)
Gama (S)
Delta (S)

Variants of interest:

Epsilon (S)
Theta (I)
iota (S)
Eta (S)
Kappa (S)
Provides intermediate coverage of omicron

​Does not cover the BA.2 sub variant

Sotrovimab provides antibody coverage for most strains of COVID-19 (11)

Dose adjustment is not needed
 (11)

Sotrovimab is not authorized in patients that are hospitalized with COVID-19
 (11)

Patients should be monitored for 24 hrs after infusion for safety concerns (11)

​Refrigerate and allow to come to room temperature prior to administration (11)

Do not shake upon administration (11)

Bamlanivimab + Etesevima
Lilly
Intravenous infusion
 
Must be Administered by a certified HCP
FDA has issued an Emergency Use Authorization of bamlanivimab and etesevimab combination in adults and pediatric individuals, for post-exposure prophylaxis of COVID-19 in individuals at high risk of progression to severe COVID-19, (including hospitalization or death). Usage was also granted for Mild - Moderate COVID-19 in Non Hospitalized patients, including neonates (4) 
 
Pediatric patients that are >12 kg are authorized to receive a treatment dose of 150/350 mg  
Bamlanivimab and etesevimab are not authorized for use in patients 2 years and older who are hospitalized due to COVID-19 (4)
 
Bamlanivimab and etesevimab are not authorized for post-exposure prophylaxis of COVID-19 in geographic regions where exposure is likely to have been to a nonsusceptible SARS-CoV-2 variant (4)
 
Recommended Dose: 
(700 mg/700 mg) per 20 mL NS or D5W

Variants of concern:

Alpha (S)
Beta (I)
Gama (I)
Delta (I)
 
Variants of Interest

​Kappa (S)
Epsilon (S)
Theta ( R )
Iota (P)
Eta ( R )
Not recommended:
 
Omicron is Not susceptible to Bamlanivimab + Etesevimab.
The combination of Bamlanivimab & Etesevimab is essential for its efficacy (13)

Must be administered as soon as possible or within 10 days of a positive diagnosis
 (13) 

Refrigerate and allow to come to room temperature prior to administration
 (13)

Do not shake upon administration
 (13)

Patients should be monitored for 24 hrs after infusion for safety concerns
 (13)
Casirivimab + Imdevimab
Regeneron
(Regen-COV)

Intravenous infusion
(Preferred)
 
Subcutaneous 
injection
 
Must be Administered by a certified HCP
The FDA has granted emergency use authorization (EUA) for casirivimab and imdevimab (Regen-COV) to be administered together for the treatment of mild to moderate COVID-19 in outpatients 12 years of age or older weighing at least 40 kilograms, who are at high risk to progress to more severe disease. (12)
 
Prophylaxis for 
Post exposure 
600 mg / 600 mg then
300 mg /300 mg once every 4 weeks. in Normal Saline mL (12)
 
Casirivimab and imdevimab are not authorized for patients who are hospitalized or require supplemental oxygen (12)
 
600 mg / 600 mg in normal NS
Varients of concern:
Alpha (S)
Beta (S)
gamma (I)
Delta (I)
 
Variants of interest:
Kappa (P)
Epsilon (I)
Mu (S)
Iota (S)
Not recommended by FDA due to reduced efficacy against omicron. (12)
Combination of Casirivimab & Imdevimab is needed for efficacy (12)

Should not be used if patient has hypertension. 
(12)

No dose adjustments for Kidney function needed 
(12)

Must be administered as soon as possible or within 10 days of a positive diagnosis 
(12)

Must be refrigerated when not in use 
(12)

Do not shake upon administration 
(12)

Do not expose to light 
(12)

Patients should be monitored for 24 hrs after infusion for safety concerns. 
(12)

Tixagevimab + Cilgavimab
AstraZeneca
(Evusheld)
Intramuscular injection (1)
 
(Gluteal muscle preferred site) (1)
 
Must be Administered by a certified HCP
The FDA has issued an Emergency Use Authorization for tixagevimab and cilgavimab (Evusheld) for pre-exposure prophylaxis of COVID-19 in patients 12 years old or older & who weigh ≥40 kg. (9)
 
Use of Evusheld is also authorized for patients that have a history of severe allergy that prevents their vaccination against COVID-19 or moderate or severe immune compromise. (9)
 

Evusheld is not approved for use in hospitalized patients (1)
 
Recommended Dose:
300 mg / 300 mg 
Variants of concern:

​Alpha (S)

Beta (S)
gamma (S)
Delta (I)

Variants of interest
:

Kappa: (P)

Epsilon: (S)
300 mg/ 300 mg provides better coverage for Omicron (1)

Trials are currently evaluating higher doses of tixagevimab plus cilgavimab (1)

​
Omicron subvariant BA.4.6 is not susceptible (1)
An additional 150 mg / 150 mg for patients that have already received an initial dose) should be considered (1)
 
Must be refrigerated and protected from light (1)
 
Should not be used if patient has hypersensitivity (1)
 
Bring to room temperature upon administration (1)
 
Do not shake upon administration (1)
 
Evusheld is well tolerated and has shown no safety issues (1)

Bebtelovimab
Lilly
Intravenous infusion
 
Must be Administered by a certified HCP
The FDA removed the EUA for bebtelovimab to treat COVID-19 because the antibody is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1.
  
Bebetlovimab also is not approved for hospitalized patients. (3)
 
Recommended dose: 175 mg / 2 mL of D5W or NS
Recommended agent of choice
Variants of concern:

Alpha (S)
Beta (S)
gamma (S)
Delta (S)

Variants of interest:
​

Kappa: (S)
Epsilon: (S)
Iota: (S)
Recommended against all 3 variants of omicron (6)
Bebtelovimab is not authorized in patients that are hospitalized with COVID-19 (6)
 
Bebtelovimab demonstrated potent activity across a broad spectrum of variants of concern (6)
 
Bebelovimab should be refrigerated when not in use. Allow Bebelovimab to come to room temperature upon use (6)
 
Bebelovimab should not be frozen or exposed to light (6)
 
Patients should be monitored for 1 hour after treatment. for adverse effects (6)

Variant Susceptibility:
S- Susceptible; is effective on variant of Concern / Interest 
I - Intermittent susceptibility. has reduced efficacy rate   
P - Potential Sensitivity 
R - Resistance or severely reduced efficacy towards variant of concern / interest
References:
  1. Fact Sheet for Health Care providers for Evusheld (tixagevimab plus cilgavimab)
  2. Elesdoudy A. Sotrovimab: is it effective in early treatment of mild and moderate COVID-19 infections? A retrospective study. The Egyptian Journal of Bronchology. 2021;15(1):56. doi:10.1186/s43168-021-00104-8
  3. Food and Drug Administration. Fact sheet for healthcare providers: emergency use authorization for bebtelovimab. 2022. Available at: https://www.fda.gov/media/156152/download.
  4. Liang KH, Chiang PY, Ko SH, et al. Antibody cocktail effective against variants of SARS-CoV-2. J Biomed Sci. 2021;28(1):80. Published 2021 Nov 23. doi:10.1186/s12929-021-00777-9
  5. Public Health Emergency. Bamlanivimab/etesevimab. 2022. Available at: https://www.phe.gov/emergency/events/COVID19/investigation-MCM/Bamlanivimab-etesevimab/Pages/default.aspx. Accessed March 3, 2022.
  6. Shrestha J, Sherchan R. Bamlanivimab. [Updated 2022 Feb 6]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK576376/
  7. Singh DD, Sharma A, Lee H-J and Yadav DK (2022) SARS-CoV-2: Recent Variants and Clinical Efficacy of Antibody-Based Therapy. Front. Cell. Infect. Microbiol. 12:839170. doi: 10.3389/fcimb.2022.839170
  8. Sotrovimab for COVID-19. Aust Prescr. 2021;44(5):175. doi:10.18773/austprescr.2021.051
  9. .Tixagevimab and Cilgavimab (Evusheld) for Pre-Exposure Prophylaxis of COVID-19. JAMA.2022;327(4):384–385. doi:10.1001/jama.2021.24931
  10. Translational Medicine Department, Institut de Recherches Internationales Servier, Suresnes, Franceb St. John’s Institute of Dermatology, School of Basic & Medical Biosciences, King’s College London, London, UKc The Antibody Society, Inc, Framingham, MA, USA
  11. US Food and Drug Administration (FDA). Fact sheet for healthcare providers emergency use authorization (EUA) of sotrovimab. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Sotrovimab/pdf/SOTROVIMAB-EUA.PDF. Updated February 2022. Accessed March 1, 2022.
  12. US Food and Drug Administration (FDA). Fact sheet for healthcare providers: emergency use authorization (EUA) of REGEN-COV (casirivimab and imdevimab). https://www.regeneron.com/downloads/treatment-covid19-eua-fact-sheet-for-hcp.pdf. Published December 2021. Accessed December 28, 2021.
  13. US Food and Drug Administration (FDA). Fact sheet for healthcare providers emergency use authorization (EUA) of bamlanivimab and etesevimab. https://pi.lilly.com/eua/bam-and-ete-eua-factsheet-hcp.pdf Updated January 2022. Accessed March 9, 2022.

Services

Pharmaceutical Pipeline Tracker​
Consulting

Company

About
Blog
Tweets

Support

Contact
© COPYRIGHT 2015. ALL RIGHTS RESERVED.