MONOCLONAL COCKTAIL-

THE GAME CHANGER

DR.KANNAN NAIR
CONSULTANT-ER
SREECHAND HOSPITAL,KANNUR
 THE TRUMB EFFECT
 Used for covid treatment for donald trumb on
“compassionate grounds!!!!!”

 Oct 2020
 What is it?????
 Casirivimab+imdevimab
 Casirivimab (IgG1-kappa) and imdevimab
(IgG1-lambda) are recombinant human mAbs,
which are unmodified in the Fc regions
 The mAbs bind to nonoverlapping epitopes of
the spike protein receptor binding domain
(RBD) of SARS-CoV-2, and thereby block
binding to the human ACE2 receptor
 What is it????
 Dosage Forms & Strengths
 IV solution
 Casirivimab 1200mg/10mL vial
 Imdevimab 1200mg/10mL vial
 HOW TO
ADMINISTER????
Casirivimab 1200 mg and imdevimab 1200
administered together as a single IV
infusion.
IV Compatibilities
0.9% NaCl
Remove vials from refrigerated storage and
allow to equilibrate to room temperature for
~20 minutes before preparation
Do not expose to direct heat; do not shake
vials
 HOW TO
ADMINISTER????
Casirivimab and imdevimab IV solution are
each supplied in individual single-dose vials
and must be diluted before administration
Add casirivimab 1200 mg (10 mL) and
imdevimab 1200 mg (10 mL) from each
respective vial using 2 separate syringes and
inject all 20 mL into the infusion bag
containing
0.9%NaCl(50ML/100ML/150ML/250 ML)
Maximum infusion rate
50-mL bag: 210 mL/hr (minimum time: 20
min)
100-mL bag: 310 mL/hr (minimum time: 23
min)
 WHATS NEXT?

Monitor during infusion and observe patients

for at least 1 hr after infusion completed
No evidence for pretreatment for allergy
STORAGE
PRESERVATIVE-FREE PRODUCT

UNOPENED VIALS

REFRIGERATE UNOPENED VIALS AT 2-8ºC (36-46ºF) IN ORIGINAL

CARTON TO PROTECT FROM LIGHT
DO NOT FREEZE, SHAKE, OR EXPOSE TO DIRECT LIGHT

DILUTED SOLUTION

REFRIGERATE AT 2-8ºC (36-46ºF) FOR NO MORE THAN 36 HR OR

STORE AT ROOM TEMPERATURE UP TO 25ºC (77ºF) FOR NO
MORE THAN 4 HR
THESE STORAGE TIMES INCLUDE INFUSION TIME
 Patient selection…
 mild-to-moderate coronavirus disease 2019
(COVID-19) in adults and pediatric patients
aged ≥12 years weighing at least 40 kg with
positive results of direct SARS-CoV-2 viral
testing, and who are at high risk for
progressing to severe COVID-19 and/or
hospitalization
 Patient selection…
 Older age (eg, ≥65 yr)
 Obesity/overweight (BMI ≥25 kg/m2 [adults]; BMI ≥85th percentile for
age/gender based on CDC growth charts [if aged 12-17 yr])
 Pregnancy
 Chronic kidney disease
 Diabetes
 Immunosuppressive disease or immunosuppressive treatment
 Cardiovascular disease (including congenital heart disease) or
hypertension
 Chronic lung diseases (eg, COPD, moderate-to-severe asthma, interstitial
lung disease, cystic fibrosis, pulmonary hypertension)
 Sickle cell disease
 Neurodevelopmental disorders (eg, cerebral palsy) or other conditions that
confer medical complexity (eg, genetic or metabolic syndromes, severe
congenital anomalies)
 Not authorized for use in patients
 who are hospitalized due to COVID-19, OR
 who require oxygen therapy due to COVID-19, OR
 who require an increase in baseline oxygen flow rate
due to COVID-19 in those on long-term oxygen
therapy due to underlying non-COVID-19-related
comorbidity
 Dosage Modifications

Renal impairment
 Not eliminated intact in urine, thus renal

impairment is not expected to affect systemic

exposure
Hepatic impairment
Unknown
 Drug interaction overview

 Not renally excreted or metabolized by CYP450

enzymes
 Interactions with concomitant renally excreted
drugs or drugs that are CYP450 substrates,
inducers, or inhibitors are unlikely
 Adverse Effects

 1-10%
Infusion-related reactions (1.5%)

Hyperglycemia
Nausea
Vomiting
Intestinal obstruction
Dyspnea
 CAUTIONS

Hypersensitivity
 Potential for serious hypersensitivity reaction, including

anaphylaxis
 If signs and symptoms occur, immediately discontinue IV infusion

and initiate appropriate medications and/or supportive care

 Infusion-related reactions reported, including fever, chills, nausea,

headache, bronchospasm, hypotension, angioedema, throat

irritation, rash including urticaria, pruritus, myalgia, dizziness
 Severe COVID-19

 Treatment benefit not observed in patients hospitalized due to

COVID-19
 Monoclonal antibodies may be associated with worse clinical

outcomes when administered to hospitalized patients with COVID-

19 requiring high-flow oxygen or mechanical ventilation
 Pregnancy & Lactation

Pregnancy
 Insufficient data to evaluate drug-associated risk of

major birth defects, miscarriage, or adverse

maternal or fetal outcomes
 Use during pregnancy only if the potential benefit

outweighs the potential risk for the mother and

fetus
Lactation
 Data are unknown regarding presence in human or

animal milk, effects on breastfed infants, or effects

on milk production
 HURDLES…..

C -COST (Rs.65000+)

A -ADMINISTRATIVE ISSUES ON PATIENT

SELECTION

P -PERMISSIONS
THANK YOU