Sutter Health Guidance for COVID-19 Antibody Therapy
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Sutter Health Guidance for COVID-19 Antibody Therapy
Version: 7.28.21
The Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) status to
casirivimab/imdevimab, a polyclonal antibody therapy, f or the treatment of non-hospitalized COVID-19 positive
patients who are at high risk for progressing to severe disease, including hospitalization or death.
Casirivimab/imdevimab is not authorized for use in the following populations:
• Patients who are hospitalized due to COVID-19
• Patients who require oxygen therapy due to COVID-19
• Patients 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
The high risk patient criteria are defined in the healthcare provider EUA fact sheet. However, due to resource
constraints, narrower use criteria have been developed to prioritize treatment to patients who are the most likely to
progress to hospitalization and ICU admission. As new data emerges or when a significant change to supply and
demand occurs, the below Sutter Health criteria may change accordingly.
Casirivimab/imdevimab Fact Sheet for Health Care Providers
Per the NIH guidelines (July 8, 2021):
• Casirivimab plus imdevimab is recommended for treatment of outpatients with mild to moderate
COVID-19 who are at high risk of clinical progression as defined by the EUA criteria.
o Medical conditions or other factors that are considered high risk with A level evidence include: age ≥ 65
(AIIa), BMI > 30 (AIIa), diabetes (AIIa), CV disease (including congenital heart disease) or hypertension
(AIIa), chronic lung disease (AIIa), immunocompromising condition or on immunosuppressive treatment
(AIII).
Sutter Health Patient Selection Criteria (start date – on or after August 1, 2021)
Sutter Health has developed guidelines for the use of casirivimab/imdevimab. Since there are insufficient data to
support safety and efficacy in pediatric patients, there will be NO administration in adolescents at this time.
• Non-hospitalized adult patients with mild to moderate COVID-19 who are stable for discharge
o Symptomatic with onset ≤ 5 days AND one of the following risk factors:
▪ Age ≥ 65
▪ BMI ≥ 30
▪ Diabetes
▪ CV disease (including hypertension)
▪ Chronic lung disease
▪ Immunocompromising condition or active immunosuppressive therapy
o Use is restricted to emergency departments and by the FDA EUA limitations of authorized
use.
o Additional exclusion criteria: Patients with recent administration of other COVID-19 EUA
treatments (within 90 days) including convalescent plasma or IVIG; patients who are
hospitalized.
• Patients who received casirivimab/imdevimab should not be given a COVID -19 vaccine within 90
days of administration.
• Individual affiliate sites should address readiness and plan for implementation on or after August 1,based
on local operational, clinical, and training needs.
Prepared by System Pharmacy/FMCP 7-28-2021
1 | Pa ge
Prescriber Ordering
Ordering
Casirivimab/imdevimab
• An order panel “COVID-19 CASIRIVIMAB IMDEVIMAB ANTIBODY EUA ORDER PANEL (813466)” has been
developed to aid with accurate ordering and documenting the requirements f or use. The panel also includes
contingent orders for the management of infusion reaction that are selected by default.
• 600 mg of casirivimab and 600 mg of imdevimab should be administered together as a single intravenous
inf usion over at least 22 minutes. Patients should be monitored f or at least 1 hour af ter completion of
inf usion.
• In order to assist with compliance to FDA EUA requirements, providers will be asked to attest that the
f ollowing tasks were completed and documented in the patient’s medical record:
o Discussion regarding the EUA status and investigational nature of casirivimab/imdevimab with
patient/caregiver including the risks and benefits of casirivimab/imdevimab and alternatives if
available.
o Provision of the required FDA Patient Fact Sheet, available via direct hyperlink within the order.
o A SmartLinks “.COVID19CASIRIVIMABIMDEVIMABEUA” has been created to support proper
documentation in the medical record.
Prepared by System Pharmacy/FMCP 7-28-2021
2 | Pa geCasirivimab/imdevimab Fact Sheet for Patients, Parents, and Caregivers
Adverse Events and Monitoring
• Serious hypersensitivity reactions including anaphylaxis and infusion related reactions have been reported.
• Clinical worsening of COVID-19 has been observed after administration of casirivimab/imdevimab. It is currently
not known if these events were the result of using casirivimab/imdevimab.
Monitoring
• Patient should be monitored f or at least 1 hour after completion of infusion.
• Signs and symptoms of infusion related reactions include: fever, difficulty breathing, reduced oxygen
saturation, chills, fatigue, arrhythmia (e.g., atrial fibrillation, tachycardia, bradycardia), chest pain or
discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension,
angioedema, throat irritation, rash including urticaria, pruritus, myalgia, dizziness, and diaphoresis.
• If hypersensitivity or infusion related reactions occur, immediately stop the infusion and notify the provider.
The provider should immediately assess the patient and consider providing medications and supportive care
as necessary.
Prepared by System Pharmacy/FMCP 7-28-2021
3 | Pa geError and Adverse Event Reporting
As part of the EUA, health care providers will be required to report all medication errors and serious adverse events
potentially associated with casirivimab/imdevimab within 7 calendar days f rom event onset. Reports can be submitted
online via http://www.fda.gov/medwatch/report.htm
Casirivimab/imdevimab
The report needs to include unique identifiers and the words ““REGEN-COV use for COVID-19 under Emergency Use
Authorization (EUA)” in the description section. A copy of the submitted FDA MedWatch forms should also be sent to
medical.information@regeneron.com
Prepared by System Pharmacy/FMCP 7-28-2021
4 | Pa geFor Pharmacists:
Order Verification
Prior to verifying a COVID-19 antibody therapy order, confirm that the ordering provider has completed the appropriate
documentation described above.
Product Availability and Admixing
Casirivimab/imdevimab
• One f ormulation contains both casirivimab and imdevimab in a single-dosed vial. Also available as separate individual
components in preservative free vials.
o Co-f ormulation: Casirivimab 600mg / imdevimab 600mg in 10mL vial
o Casirivimab (REGN10933): 300mg/2.5mL or 1,332mg/11.1mL single-dose vials
o Imdevimab (REGN10987): 300mg/2.5mL or 1,332mg/11.1ml single dose vials
o Note that some packaging may only have the REGN number without a drug name listed.
• Remove casirivimab and imdevimab vials f rom ref rigerated storage and allow the vials to equilibrate to room
temperature f or approximately 20 minutes before preparation. Do not expose to direct heat or shake the vials.
Inspect the vials visually for particulate matter and discoloration.
• Withdraw 10 mL of casirivimab/imdevimab (600 mg / 600 mg) from the co-f ormulated vial or 5 mL of
casirivimab (600 mg) and 5 mL of imdevimab (600 mg) f rom the respective vials using two different
syringes.
• Transf er the content of the syringe(s) into the 0.9% Sodium Chloride infusion bag (final volume of 110 mL)
• Gently invert IV bag by hand approximately 10 times to mix. Do not shake. Discard any product remaining
in the vials.
Product Storage and Documentation
Casirivimab/imdevimab
• Store unopened vials in the original carton to protect the vials from light and at a temperature of 2°C to 8°C
(36°F to 46°F). Do not freeze, or shake the vials.
• The admixed infusion bag can be stored between 2°C to 8°C (36°F to 46°F) for up to 36 hours and at
room temperature for up to 4 hours. If ref rigerated, let the solution equilibrate to room temperature for
approximately 30 minutes prior to infusion.
• Individual pharmacies may require staff to confirm completion of all required steps prior to
dispensing casirivimab/imdevimab, either via electronic I-Vent or paper documentation.
Prepared by System Pharmacy/FMCP 7-28-2021
5 | Pa geTABLE 1: Polyclonal Antibody Therapy At A Glance
CASIRIVIMAB/IMDEVIMAB (REGEN-COV)
ANTIBODY Polyclonal
(Two monoclonal antibodies prepared and administered together)
DOSE Casirivimab - 600 mg (5 mL), PLUS
Imdevimab – 600 mg (5 mL)
VOLUME/ DURATION • Final volume of 110 mL
• Infuse over 22 minutes
POTENTIAL BENEFIT • Phase 3 results in high risk patients showed a reduction in COVID-19 related
hospitalization or death (1% in the treatment group vs. 3.2% in the placebo
group)
STABILITY OF 36 hours refrigerated or 4 hours at room temperature
ADMIXED INFUSION
BAG
ADVERSE EVENTS • Infusion related events and hypersensitivity reactions.
• Observe patient for 1 hour post infusion
SMARTLINKS .COVID19CASIRIVIMABIMDEVIMABEUA
Prepared by System Pharmacy/FMCP 7-28-2021
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