Casirivimab/imdevimab

What is Casirivimab/imdevimab?

• Casirivimab/imdevimab (REGEN-COV), are two recombinant human mAbs which are unmodified in the Fc regions.
• Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture.
• Imdevimab, a human IgG1 mAb, is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture.

REGN-COV2 binding SARS-CoV-2 spike protein

What are the uses of this medicine?

Casirivimab/imdevimab (REGEN-COV), is an investigational medicine used in adults and adolescents (12 years of age and older who weigh at least 88 pounds (40 kg)) who are at high risk for severe COVID-19, including hospitalization or death for:

1. treatment of mild to moderate symptoms of COVID-19
2. post-exposure prevention of COVID-19 in persons who are:

• not fully vaccinated against COVID-19 (Individuals are considered to be fully vaccinated 2 weeks after their second vaccine dose in a 2-dose series [such as the Pfizer or Moderna vaccines], or 2 weeks after a single-dose vaccine [such as Johnson & Johnson's Janssen vaccine]), or,
• are not expected to build up enough of an immune response to the complete COVID-19 vaccination (for example, someone with immunocompromising conditions, including someone who is taking immunosuppressive medications), and
• have been exposed to someone who is infected with SARS-CoV-2. Close contact with someone who is infected with SARS-CoV-2 is defined as being within 6 feet for a total of 15 minutes or more, providing care at home to someone who is sick, having direct physical contact with the person (hugging or kissing, for example), sharing eating or drinking utensils, or being exposed to respiratory droplets from an infected person (sneezing or coughing, for example).
• someone who is at high risk of being exposed to someone who is infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, nursing homes, prisons).

How does this medicine work?

• A combination of two monoclonal antibodies, casirivimab and imdevimab, directed against the spike protein (SP) of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), that can potentially be used for immunization against COVID-19.
• Upon administration, casirivimab and imdevimab specifically target and bind to non-overlapping regions of the receptor-binding domain (RBD) of SP, thereby blocking viral attachment and entry into human cells and may thereby neutralize SARS-CoV-2.
• This may slow the progression of the disease and accelerate recovery, and may potentially provide temporary protection against infection with SARS-CoV-2.
• Binding to two distinct regions of the RBD of SP may decrease the potential for virus escape mutants that occur upon treatment with a single SARS-CoV-2 antibody, and may provide enhanced protection against loss of efficacy.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have had a severe allergic reaction to REGEN-COV.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• Immunosuppressive medications such as cyclosporine (Gengraf, Neoral, Sandimmune), prednisone, and tacrolimus (Astagraf, Envarsus, Prograf).

Is this medicine FDA approved?

• On 21 November 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for casirivimab and imdevimab to be administered together for the treatment of mild to moderate [COVID‑19] in people twelve years of age or older weighing at least 40 kilograms (88 lb) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID‑19.
• In July 2021, the U.S. FDA revised the emergency use authorization (EUA) for REGEN‑COV (casirivimab and imdevimab, administered together) authorizing REGEN‑COV for emergency use as post-exposure prophylaxis (prevention) for COVID‑19 in people aged twelve years of age and older weighing at least 40 kilograms (88 lb) who are at high risk for progression to severe COVID‑19, including hospitalization or death.
• REGEN‑COV remains authorized for the treatment of mild-to-moderate COVID‑19 in people aged twelve years of age and older weighing at least 40 kilograms (88 lb) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID‑19, including hospitalization or death.

How should this medicine be used?

Recommended dosage: Treatment:

• The dosage in adult and pediatric patients (12 years of age and older weighing at least 40 kg) is 600 mg of casirivimab and 600 mg of imdevimab administered together as a single intravenous infusion or by subcutaneous injection.
• Casirivimab and imdevimab should be given together as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 10 days of symptom onset.

Post-Exposure Prophylaxis:

• The dosage in adult and pediatric individuals (12 years of age and older weighing at least 40 kg) is 600 mg of casirivimab and 600 mg of imdevimab administered by subcutaneous injection or together as a single intravenous infusion.
• Casirivimab and imdevimab should be given together as soon as possible following exposure to SARS-CoV-2.

Administration:

• Casirivimab and imdevimab injection comes as a solution (liquid) to be mixed with liquid and infused (injected slowly) into a vein for 20 to 50 minutes or longer by a doctor or nurse.
• It also may be given subcutaneously (under the skin) as multiple separate injections in your abdomen, upper thighs, or the back of your upper arms around the same time.

Treatment:

• If you are receiving an intravenous infusion, the infusion will take 20 to 50 minutes or longer.
• Your healthcare provider will determine the duration of your infusion.
• If your healthcare provider determines that you are unable to receive REGEN-COV as an intravenous infusion which would lead to a delay in treatment, then as an alternative, REGEN-COV can be given in the form of subcutaneous injections.
• If you are receiving subcutaneous injections, your dose will be provided as multiple injections given in separate locations around the same time.

Post-exposure prevention:

• If you are receiving subcutaneous injections, your dose will be provided as multiple injections given in separate locations around the same time.
• If you are receiving an intravenous infusion, the infusion will take 20 to 50 minutes or longer.
• After the initial dose, if your healthcare provider determines that you need to receive additional doses of REGEN-COV for ongoing protection, the additional intravenous or subcutaneous doses would be administered monthly.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As:

• A single vial which contains two antibodies co-formulated in a 1:1 ratio of casirivimab and imdevimab or
• Individual antibody solutions in separate vials, which may be supplied in separate cartons or together in a single carton (also referred to as a co-packaged carton), or in a dose pack.

This medicine is available in fallowing brand namesː

• REGEN-COV

What side effects can this medication cause?

The most common side effects of this medicine include:

• pain, bleeding, bruising of the skin, soreness, swelling, and possible infection at the infusion site

Less common,but serious side effects may include:

• Allergic reactions
• Worsening symptoms after treatment

What special precautions should I follow?

• Patients treated with REGEN-COV (casirivimab and imdevimab) should continue to self-isolate and use infection control measures (e.g., wear mask, isolate, social distance, avoid sharing personal items, clean and disinfect "high touch" surfaces, and frequent handwashing) according to CDC guidelines.
• Serious hypersensitivity reactions, including anaphylaxis, have been reported with administration of REGEN-COV (casirivimab and imdevimab). If signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive care.
• Infusion-related reactions, occurring during the infusion and up to 24 hours after the infusion, have been observed with administration of REGEN-COV. These reactions may be severe or life threatening. If an infusion-related reaction occurs, consider slowing or stopping the infusion and administer appropriate medications and/or supportive care.
• Clinical worsening of COVID-19 after administration of REGEN-COV has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia (e.g., atrial fibrillation, tachycardia, bradycardia), fatigue, and altered mental status. Some of these events required hospitalization.
• REGEN-COV is 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 chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.
• There are no available data on the presence of casirivimab and/or imdevimab in human milk or animal milk, the effects on the breastfed infant, or the effects of the drug on milk production.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Treatment of overdose should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
• There is no specific antidote for overdose with REGEN-COV (casirivimab and imdevimab).

Can this medicine be used in pregnancy?

• There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
• REGEN-COV (casirivimab and imdevimab) should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus.

Can this medicine be used in children?

• REGEN-COV is not authorized for use in pediatric patients under 12 years of age or weighing less than 40 kg.

What are the active and inactive ingredients in this medicine?

Active Ingredient:

• Casirivimab

Inactive Ingredients:

• Histidine
• Histidine Monohydrochloride Monohydrate
• polysorbate 80
• sucrose
• Water

Who manufactures and distributes this medicine?

Manufactured by:

• Regeneron Pharmaceuticals, Inc.
• 777 Old Saw Mill River Road
• Tarrytown, NY

What should I know about storage and disposal of this medication?

• Casirivimab is preservative-free.
• Discard any unused portion.
• Imdevimab is preservative-free. Discard any unused portion.
• Store unopened casirivimab and imdevimab vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
• Unopened vials may be stored in the original carton at room temperature [up to 25°C (77°F)] and must be used within 30 days.
• If not used in the 30 days, discard vials.
• DO NOT FREEZE.
• DO NOT SHAKE.
• DO NOT EXPOSE TO DIRECT LIGHT.
• Solution in vial requires dilution prior to intravenous administration.
• The prepared infusion solution is intended to be used immediately.
• If immediate administration is not possible, store diluted casirivimab and imdevimab infusion solution in the refrigerator at 2°C to 8°C (36°F to 46°F) for no more than 36 hours or at room temperature up to 25°C (77°F) for no more than 4 hours.
• If refrigerated, allow the infusion solution to equilibrate to room temperature for approximately 30 minutes prior to administration.

• Dailymed label info on Casirivimab/imdevimab
• FDA Casirivimab/imdevimab

Casirivimab/imdevimab Resources
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