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Spike protein-ACE2
receptor
Viral entry into host
Viral protein
replication and
packaging
Cellular Injury
Background and Epidemiology
Pathophysiology
 First detected in Wuhan, China Dec. 2019
 Declared global pandemic on 3/11/2020
 Has affected everyone
 As of___ 2022
o Dominant strain: ___
 As of June__, 2022 in the US:
o ___Deaths
o ___Infected
Monoclonal Antibodies for SARS-CoV-2
Anna Sandler
PharmD Candidate, 2023
2
Cellular injury,
Cytokine release
RAAS dysfunction Pro-inflammatory
Clots, Multi-system
inflammatory
syndrome
Diagnosis and Presentation
Monoclonal Antibodies
 Tests:
o PCR to detect genetic
material (RNA)
o Antigen tests to detect
viral proteins
 Presentation (~4-5 days
following exposure):
o Fever, cough, myalgias
o N/V
o Smell and taste
abnormalities
 Complications:
o ARDS
o Thromboembolic
o Neurologic
o Long-COVID
 Transmission: Respiratory Droplets
 Received EUA from FDA
 Bind to spike protein to block attachment to
ACE2 receptor
 Use: Immunocompromised patients
 Prophylaxis or Treatment
 Adults
 Children ≥ 12 y/o and ≥ 40 kg*
Bebtelovimab
Etesevimab
Casirivinmab
Sotrovimab
Imdevimab
Tixagevimab/cilgavimab
Bamlanivimab/etesevimab
ARDS: Acute Respiratory Distress Syndrome; RAAS: Renin-Angiotensin-Aldosterone System; EUA: Emergency Use Authorization
* With the one exception being bamlanivimab/etesevimab
3
Prophylaxis: As of May 23, 2022
Treatment: As of May 23, 2022
Pre-exposure
 Who: Moderately or severely
immunocompromised patients at increased risk
of inadequate immune response, or those who
cannot get the vaccine
Post-exposure
 Who: Persons exposed to COVID-19 at high risk
of progressing to severe disease
tixagevimab/cilgavimab
casirivimab/imdevimab
balanivimab/etesevimab
Indication:
 Non-hospitalized patients without
supplementary O2 requirements
 Mild-to-moderate disease at risk to progress to
severe disease
 Unable to receive ritonavir-boosted nirmatrelvir
(PaxlovidTM
) or remdesivir
bebtelovimab
sotrovimab
casirivimab/imdevimab
balanivimab/etesevimab
Immunosuppressive
treatments or diseases >/= 65 y/o Chronic organ diseases:
CV, Lung, Kidney
Pregnancy
Immunocompromising conditions
Non-fully vaccinated
individuals
Nursing home or prison
residents
4
Brand/generic
Date EUA
Indication Dosing Adverse Drug
Reactions
Pearls
Tixagevimab/Cilgavimab
(EvusheldTM
)
Dec 2021
Pre-exposure
prophylaxis
300 mg/300 mg IM as
a single dose
administered in 2
separate syringes
consecutively
Dizziness,
fatigue,
headache,
cough,
hypersensitivity,
anaphylaxis
Warnings and Precautions: CV events
Higher reporting of MI and cardiac
failure
Can be used in hospitalized or non-
hospitalized patients
Ineffective against Omicron BA.1 and
BA.1.1
Bebtelovimab
Feb 2022
COVID-19
Treatment
175 mg IV X 1 within 7
days of symptom
onset
Pruritis,
infusion-related
reactions, N/V
Monitor patients after administration
Consider slowing or stopping infusion if
reaction occurs
Effective against all strains
Casirivimab/imdevimab
(REGEN-COVTM
)
Nov 2020
COVID-19
treatment
Post-
exposure
prophylaxis
600 mg/600mg IV or
SubQ once
Within 10 days of
symptom onset
Erythema at
injection site,
pruritis, N/V,
hypersensitivity
Post-exposure prophylaxis for use in
Any patient
DISTRIBUTION PAUSED
Sotrovimab
(XevudyTM
)
May, 2021
COVID-19
treatment
500 mg IV as single
dose as soon as
possible after positive
result and within 7
days of symptom
onset
Skin rash,
diarrhea,
hypersensitivity
reaction,
anaphylaxis
Warnings and precautions:
Hypersensitivity, infusion-related
reactions, resistance
DISTRIBUTION PAUSED
Retains activity against Omicron BA.1
and BA.1.1 subvariants, decreased
activity against BA.2
Balanivimab/etesevimab
Feb 2021
COVID-19
treatment
Post-
exposure
prophylaxis
700 mg/1.4g as a single
dose administered
together as a single IV
infusion, within 10
days of symptom
onset
Pruritis, nausea,
anaphylaxis,
dizziness
Can be used in children and in
neonates
Post-exposure prophylaxis for use in
Any patient
Ineffective against Omicron BA.1 and
BA.1.1
LIMITED USE to susceptible regional
variants
Drug Table
5
References
NIH COVID-19 Treatment Guidelines
IDSA COVID-19 Treatment Guidelines
UpToDate
CDC website
Sriram K, Insel PA. Physiol Rev. 2021;101(2):545-567.
doi:10.1152/physrev.00035.2020
Image Links
Globe
COVID life cycle
RNA
Rapid Test
COVID and Organ Systems
Evusheld
N/V: Nausea and Vomiting; CV: Cardiovascular
6

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Final mab DI question presentation.docx

  • 1. 1 Spike protein-ACE2 receptor Viral entry into host Viral protein replication and packaging Cellular Injury Background and Epidemiology Pathophysiology  First detected in Wuhan, China Dec. 2019  Declared global pandemic on 3/11/2020  Has affected everyone  As of___ 2022 o Dominant strain: ___  As of June__, 2022 in the US: o ___Deaths o ___Infected Monoclonal Antibodies for SARS-CoV-2 Anna Sandler PharmD Candidate, 2023
  • 2. 2 Cellular injury, Cytokine release RAAS dysfunction Pro-inflammatory Clots, Multi-system inflammatory syndrome Diagnosis and Presentation Monoclonal Antibodies  Tests: o PCR to detect genetic material (RNA) o Antigen tests to detect viral proteins  Presentation (~4-5 days following exposure): o Fever, cough, myalgias o N/V o Smell and taste abnormalities  Complications: o ARDS o Thromboembolic o Neurologic o Long-COVID  Transmission: Respiratory Droplets  Received EUA from FDA  Bind to spike protein to block attachment to ACE2 receptor  Use: Immunocompromised patients  Prophylaxis or Treatment  Adults  Children ≥ 12 y/o and ≥ 40 kg* Bebtelovimab Etesevimab Casirivinmab Sotrovimab Imdevimab Tixagevimab/cilgavimab Bamlanivimab/etesevimab ARDS: Acute Respiratory Distress Syndrome; RAAS: Renin-Angiotensin-Aldosterone System; EUA: Emergency Use Authorization * With the one exception being bamlanivimab/etesevimab
  • 3. 3 Prophylaxis: As of May 23, 2022 Treatment: As of May 23, 2022 Pre-exposure  Who: Moderately or severely immunocompromised patients at increased risk of inadequate immune response, or those who cannot get the vaccine Post-exposure  Who: Persons exposed to COVID-19 at high risk of progressing to severe disease tixagevimab/cilgavimab casirivimab/imdevimab balanivimab/etesevimab Indication:  Non-hospitalized patients without supplementary O2 requirements  Mild-to-moderate disease at risk to progress to severe disease  Unable to receive ritonavir-boosted nirmatrelvir (PaxlovidTM ) or remdesivir bebtelovimab sotrovimab casirivimab/imdevimab balanivimab/etesevimab Immunosuppressive treatments or diseases >/= 65 y/o Chronic organ diseases: CV, Lung, Kidney Pregnancy Immunocompromising conditions Non-fully vaccinated individuals Nursing home or prison residents
  • 4. 4 Brand/generic Date EUA Indication Dosing Adverse Drug Reactions Pearls Tixagevimab/Cilgavimab (EvusheldTM ) Dec 2021 Pre-exposure prophylaxis 300 mg/300 mg IM as a single dose administered in 2 separate syringes consecutively Dizziness, fatigue, headache, cough, hypersensitivity, anaphylaxis Warnings and Precautions: CV events Higher reporting of MI and cardiac failure Can be used in hospitalized or non- hospitalized patients Ineffective against Omicron BA.1 and BA.1.1 Bebtelovimab Feb 2022 COVID-19 Treatment 175 mg IV X 1 within 7 days of symptom onset Pruritis, infusion-related reactions, N/V Monitor patients after administration Consider slowing or stopping infusion if reaction occurs Effective against all strains Casirivimab/imdevimab (REGEN-COVTM ) Nov 2020 COVID-19 treatment Post- exposure prophylaxis 600 mg/600mg IV or SubQ once Within 10 days of symptom onset Erythema at injection site, pruritis, N/V, hypersensitivity Post-exposure prophylaxis for use in Any patient DISTRIBUTION PAUSED Sotrovimab (XevudyTM ) May, 2021 COVID-19 treatment 500 mg IV as single dose as soon as possible after positive result and within 7 days of symptom onset Skin rash, diarrhea, hypersensitivity reaction, anaphylaxis Warnings and precautions: Hypersensitivity, infusion-related reactions, resistance DISTRIBUTION PAUSED Retains activity against Omicron BA.1 and BA.1.1 subvariants, decreased activity against BA.2 Balanivimab/etesevimab Feb 2021 COVID-19 treatment Post- exposure prophylaxis 700 mg/1.4g as a single dose administered together as a single IV infusion, within 10 days of symptom onset Pruritis, nausea, anaphylaxis, dizziness Can be used in children and in neonates Post-exposure prophylaxis for use in Any patient Ineffective against Omicron BA.1 and BA.1.1 LIMITED USE to susceptible regional variants Drug Table
  • 5. 5 References NIH COVID-19 Treatment Guidelines IDSA COVID-19 Treatment Guidelines UpToDate CDC website Sriram K, Insel PA. Physiol Rev. 2021;101(2):545-567. doi:10.1152/physrev.00035.2020 Image Links Globe COVID life cycle RNA Rapid Test COVID and Organ Systems Evusheld N/V: Nausea and Vomiting; CV: Cardiovascular
  • 6. 6