ﺑﺎﺯﮔﺸﺖ ﺑﻪ ﺻﻔﺤﻪ ﻗﺒﻠﯽ
خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
نسخه الکترونیک
medimedia.ir

Casirivimab and imdevimab (Canada: Authorized; United States: Authorization withdrawn): Drug information

Casirivimab and imdevimab (Canada: Authorized; United States: Authorization withdrawn): Drug information
(For additional information see "Casirivimab and imdevimab (Canada: Authorized; United States: Authorization withdrawn): Pediatric drug information" and see "Casirivimab and imdevimab (Canada: Authorized; United States: Authorization withdrawn): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Special Alerts
Shelf-Life Extension for Casirivimab and Imdevimab June 2022

The FDA has authorized an extension to the shelf-life for specific lots of the Regeneron monoclonal antibodies, casirivimab and imdevimab, administered together (or Regen-COV) from 24 months to 30 months when stored at 2 to 8°C (36 to 46°F) in the original carton protected from light. Because of the high frequency of the Omicron variant and its subvariants, Regen-COV is not currently authorized in any US region. Regen-COV may not be administered for treatment or postexposure prevention of COVID-19 under the Emergency Use Authorization until further notice by the FDA. However, the US government recommends that product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to Regen-COV, emerge and become prevalent in the United States.

Further information, including impacted lot numbers, may be found at https://aspr.hhs.gov/COVID-19/Therapeutics/updates/Pages/important-update-27June2022.aspx.

Casirivimab and Imdevimab Emergency Use Authorization and Distribution Update January 2022

The FDA has amended the Emergency Use Authorization for Regen-COV (casirivimab and imdevimab) to limit its use to when a patient is likely to have been infected with or exposed to a variant that is susceptible to this treatment.

Because data show that Regen-COV is highly unlikely to be active against the Omicron variant of COVID-19, it is not authorized for use in any US states, territories, or jurisdictions at this time. Future use may be authorized in certain regions if patients are likely to be infected or exposed to a variant that is susceptible to Regen-COV.

Further information may be found at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-certain-monoclonal-antibodies-treat-covid-19-due-omicron.

Brand Names: US
  • Regen-COV
Pharmacologic Category
  • Antiviral Agent;
  • Monoclonal Antibody
Dosing: Adult
COVID-19, postexposure prophylaxis

COVID-19, postexposure prophylaxis (off-label use):

Note: Reserve for patients with SARS-CoV-2 exposure, or at high risk for exposure, who are not fully vaccinated or are not expected to mount an adequate immune response to complete vaccination and are at high risk for progression to severe disease or hospitalization (Ref). Refer to the FDA fact sheet for health care providers for more information on patients at high risk for progression to severe disease. Use is not authorized for preexposure prophylaxis (Ref).

IV, SUBQ: Casirivimab 600 mg and imdevimab 600 mg as a single dose; administer as soon as possible following exposure to SARS-CoV-2 (Ref). For individuals in whom repeat dosing is appropriate (eg, ongoing exposure to SARS-CoV-2 for >4 weeks and not expected to mount an adequate immune response to complete vaccination), repeat dosing of casirivimab 300 mg and imdevimab 300 mg may be administered once every 4 weeks for the duration of ongoing exposure (Ref).

COVID-19, mild to moderate; treatment

COVID-19, mild to moderate; treatment (off-label use):

Note: Reserve for patients with positive SARS-CoV-2 direct viral testing who are at high risk for progression to severe disease or hospitalization (Ref). Refer to the FDA fact sheet for health care providers for more information on patients at high risk for progression to severe disease. Use is not authorized for patients who are hospitalized or require new or increased oxygen therapy due to COVID-19 outside of a clinical trial; outcomes may be worse if used in patients requiring high-flow oxygen or mechanical ventilation (Ref).

IV (preferred), SUBQ (alternative): Casirivimab 600 mg and imdevimab 600 mg as a single dose; administer as soon as possible after a positive SARS-CoV-2 test and within 10 days of symptom onset (Ref). Note: Consider local prevalence of SARS-CoV-2 variants when evaluating treatment options (Ref). Further information may be found at: https://covid.cdc.gov/covid-data-tracker/#variant-proportions.

Canadian labeling: IV: Casirivimab 1.2 g and imdevimab 1.2 g as a single dose; administer as soon as possible after a positive SARS-CoV-2 test.

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Altered kidney function: No dosage adjustment necessary for any degree of kidney dysfunction (Ref).

Augmented renal clearance (measured urinary CrCl ≥130 mL/minute/1.73 m 2 ): Augmented renal clearance (ARC) is a condition that occurs in certain critically ill patients without organ dysfunction and with normal serum creatinine concentrations. Younger patients (<55 years of age) admitted post trauma or major surgery are at highest risk for ARC, as well as those with sepsis, burns, or hematologic malignancies. An 8- to 24-hour measured urinary CrCl is necessary to identify these patients (Ref):

No dosage adjustment necessary (Ref).

Hemodialysis, intermittent (thrice weekly): Not significantly dialyzed (Ref): No dosage adjustment or supplemental dose necessary (Ref).

Peritoneal dialysis: Unlikely to be significantly dialyzed (Ref): No dosage adjustment necessary (Ref).

CRRT: No dosage adjustment necessary (Ref).

PIRRT (eg, sustained, low-efficiency diafiltration): No dosage adjustment necessary (Ref).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided (has not been studied) (Ref).

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Casirivimab and imdevimab (Canada: Authorized; United States: Authorization withdrawn): Pediatric drug information")

Note: Consider local prevalence of SARS-CoV-2 variants when evaluating treatment options; casirivimab and imdevimab are not authorized for use in geographic regions where infection or exposure are likely to be due to a nonsusceptible variant (Ref). Further information on variants may be found at: https://covid.cdc.gov/covid-data-tracker/#variant-proportions. Casirivimab and imdevimab have not been studied in pediatric patients; emergency use authorization from the FDA is based on likelihood of similar exposures in patients ≥12 years of age weighing ≥40 kg.

COVID-19, postexposure prophylaxis

COVID-19, postexposure prophylaxis :

Note: Only for patients who are at high risk for progressing to severe COVID-19 (including hospitalization or death; refer to the FDA fact sheet for health care providers for more information on patients at high risk for progression to severe disease), who are either not fully vaccinated or not expected to mount an adequate response to SARS-CoV-2 vaccination, and who either meet the CDC's criteria for close contact with an individual infected with SARS-CoV-2 or are at high risk of exposure to an individual infected with SARS-CoV-2 in an institutional setting (eg, nursing home, prison). In clinical trials, casirivimab and imdevimab were administered within 96 hours of the index cases' positive SARS-CoV-2 diagnostic test sample (Ref).

Children ≥12 years and Adolescents weighing ≥40 kg: IV, SUBQ: Casirivimab 600 mg and imdevimab 600 mg as a single dose; administer as soon as possible following exposure to SARS-CoV-2. For individuals in whom repeat dosing is appropriate (eg, ongoing exposure to SARS-CoV-2 for >4 weeks and not expected to mount an adequate immune response to complete vaccination), repeat dosing of casirivimab 300 mg and imdevimab 300 mg may be administered once every 4 weeks for the duration of ongoing exposure (Ref).

COVID-19, mild to moderate; treatment

COVID-19, mild to moderate; treatment:

Note: Only for use in patients with positive SARS-CoV-2 direct viral testing who are at high risk for progression to severe disease, including hospitalization or death. Refer to the FDA fact sheet for health care providers for more information on patients at high risk for progression to severe disease.

Children ≥12 years and Adolescents weighing ≥40 kg: IV (preferred), SUBQ: Casirivimab 600 mg and imdevimab 600 mg as a single dose; administer as soon as possible after a positive SARS-CoV-2 test and within 10 days of symptom onset (Ref).

Canadian labeling:

Children ≥12 years and Adolescents weighing ≥40 kg: IV: Casirivimab 1,200 mg and imdevimab 1,200 mg administered together as a single dose; administer as soon as possible after onset of symptoms and positive SARS-CoV-2 test.

Dosing: Kidney Impairment: Pediatric

Altered kidney function: Children ≥12 years and Adolescents weighing ≥40 kg: IV: No dosage adjustment recommended (Ref).

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the fact sheet for health care providers (has not been studied).

Adverse Reactions

Casirivimab and imdevimab are currently under investigation for use in the treatment of coronavirus disease 2019 (COVID-19). Serious or unexpected adverse reactions not previously reported may occur; refer to emergency use authorization (EUA) for information regarding reporting serious adverse reactions (FDA 2021). Adverse reactions are reported for the authorized dose or unauthorized higher dose.

>10%: Local: Injection site reaction (including ecchymoses, erythema at injection site, injection site pruritus, severe injection site reaction; SUBQ: 4% to 12%)

1% to 10%: Gastrointestinal: Nausea (1%) (Weinreich 2020), vomiting (1%) (Weinreich 2020)

<1%:

Hypersensitivity: Hypersensitivity reaction (including anaphylaxis, angioedema, severe hypersensitivity reaction)

Miscellaneous: Infusion related reaction (including altered mental status, cardiac arrhythmia, chills, dyspnea, syncope, severe infusion related reaction; IV)

Frequency not defined: Miscellaneous: Physical health deterioration (clinical worsening of COVID-19)

Contraindications

Severe hypersensitivity (eg, anaphylaxis) to casirivimab, imdevimab, or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity: Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of casirivimab and imdevimab; hypersensitivity reactions occurring >24 hours after infusion have also been reported. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive care. Infusion-related reactions (eg, fever, difficulty breathing, reduced oxygen saturation, chills, nausea, arrythmia [eg, atrial fibrillation, tachycardia, bradycardia], chest pain or discomfort, weakness, altered mental status, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash [including urticaria], pruritus, myalgia, vasovagal reactions [eg, presyncope, syncope], dizziness, fatigue, diaphoresis) have also been observed and may occur during infusion and up to 24 hours after infusion. 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 (FDA 2021).

Other warnings/precautions:

• Antiviral resistance: Development of SARS-CoV-2 variants with reduced susceptibility to casirivimab and imdevimab may potentially increase risk of treatment failure; consider local prevalence of SARS-CoV-2 variants, if available, when evaluating treatment options (FDA 2021; IDSA [Bhimraj 2021]; NIH 2021).

• Clinical worsening: Clinical worsening of COVID-19, including signs or symptoms of altered mental status, arrhythmia (atrial fibrillation, bradycardia, tachycardia), fatigue, fever, hypoxia, or increased respiratory difficulty, has been reported after administration of casirivimab and imdevimab; some of these events required hospitalization. It is not known if these events were related to casirivimab and imdevimab or were due to COVID-19 progression (FDA 2021).

• Limitations of use: For treatment, casirivimab and imdevimab are not authorized for use in patients who are hospitalized due to COVID-19, require oxygen therapy due to COVID-19, or 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. Benefit of treatment has not been 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. Casirivimab and imdevimab use for postexposure prophylaxis is not a substitute for vaccination against COVID-19. Casirivimab and imdevimab are not authorized for preexposure prophylaxis for prevention of COVID-19 (FDA 2021).

Product Availability

Investigational agent; approved for emergency use authorization by the FDA in November 2020.

Dosage Forms Considerations

Casirivimab and imdevimab is supplied as either a single vial co-formulated in a 1:1 ratio of casirivimab and imdevimab, or in dose packs containing casirivimab and imdevimab in separate vials.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Injection:

Regen-COV: Casirivimab 300 mg and imdevimab 300 mg per 2.5 mL (5 mL [DSC]); Casirivimab 1332 mg and imdevimab 1332 mg per 11.1 mL (22.2 mL [DSC]) [contains polysorbate 80]

Generic: Casirivimab 1332 mg/11.1 mL (11.1 mL [DSC]); Casirivimab 300 mg/2.5 mL (2.5 mL [DSC]); Imdevimab 1332 mg/11.1 mL (11.1 mL [DSC]); Imdevimab 300 mg/2.5 mL (2.5 mL [DSC])

Solution, Injection [preservative free]:

Regen-COV: Casirivimab 600 mg and imdevimab 600 mg/10 mL (10 mL [DSC]); Casirivimab 1332 mg and imdevimab 1332 mg per 11.1 mL (22.2 mL [DSC]) [contains polysorbate 80]

Solution, Intravenous [preservative free]:

Regen-COV: Casirivimab 1332 mg/11.1 mL and imdevimab 4 x 300 mg/2.5 mL (21.1 mL); Casirivimab 4 x 300 mg/2.5 mL and imdevimab 1332 mg/11.1 mL (21.1 mL); Casirivimab 4 x 300 mg/2.5 mL and imdevimab 4 x 300 mg/2.5 mL (20 mL) [contains polysorbate 80]

Generic Equivalent Available: US

Yes

Pricing: US

Solution (Casirivimab Injection)

300 mg/2.5 mL (per mL): $0.00

1332MG/11.1ML (per mL): $0.00

Solution (Imdevimab Injection)

300 mg/2.5 mL (per mL): $0.00

1332MG/11.1ML (per mL): $0.00

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Injection:

Generic: Casirivimab 1332 mg and imdevimab 1332 mg per 11.1 mL (22.2 mL); Casirivimab 300 mg and imdevimab 300 mg per 2.5 mL (5 mL)

Prescribing and Access Restrictions

Casirivimab and imdevimab are not commercially available; they are available as part of ongoing clinical trials and through an emergency use authorization (EUA) from the FDA. The Department of Health and Human Services will determine weekly distribution amounts for each state/territory based on weekly reports of new COVID-19 cases and hospitalizations, in addition to data on inventories and use submitted to the federal government. State and territorial health departments will identify which sites in their respective jurisdictions receive product as well as the amount they will receive.

As part of the EUA, fact sheets pertaining to emergency use of casirivimab and imdevimab are required to be available for health care providers and patients/caregivers, and certain mandatory requirements for casirivimab and imdevimab administration under the EUA must be met as outlined in the FDA EUA letter; the fact sheets and EUA letter may be accessed at https://www.regeneroneua.com/. Additionally, health care providers must track and report all medication errors and serious adverse events potentially associated with casirivimab and imdevimab use by either submitting a MedWatch form (www.fda.gov/medwatch/report.htm), FDA Form 3500 (health professional; available at: https://www.fda.gov/safety/medwatch-forms-fda-safety-reporting/instructions-completing-form-fda-3500) by mail (MedWatch, 5600 Fishers Lane, Rockville MD 20852-9787) or fax (1-800-FDA-0178), or by calling 1-800-FDA-1088 to request a reporting form; a copy of all MedWatch forms should also be provided to Regeneron Pharmaceuticals, Inc (phone: 1-844-734-6643; fax: 1-888-876-2736, or email: [email protected]).

Administration: Adult

IV (preferred route for treatment): If diluted solution is refrigerated prior to administration, allow solution to come to room temperature for ~30 minutes prior to administration. Administer as an IV infusion at a rate ≤310 mL/hour for doses prepared in 100, 150, or 250 mL prefilled NS or D5W infusion bags. For doses prepared in 50 mL prefilled NS or D5W infusion bags, administer the casirivimab 600 mg and imdevimab 600 mg dose at a rate of ≤180 mL/hour, and the casirivimab 300 mg and imdevimab 300 mg dose at a rate of ≤165 mL/hour. Administer through a PVC, polyethylene-lined PVC, or polyurethane infusion set containing a 0.2-micron polyethersulfone filter. Due to potential overfill of prefilled bags, the entire infusion solution in the bag should be administered to avoid underdosage. Slow or stop infusion and treat as appropriate if an infusion-related reaction occurs. Flush infusion line with NS or D5W following completion of the infusion (Ref).

Canadian labeling: Administer as an IV infusion over ≥1 hour; do not administer as an IV push or bolus.

SUBQ: If prepared syringes are refrigerated prior to administration, allow to come to room temperature for ~20 minutes prior to administration. Administer SUBQ using a 25- or 27-gauge needle; administer the syringes consecutively (2 or 4 syringes, depending on dose), each at a different quadrant in the thigh, back of the upper arm, or abdomen (except for 2 inches around the navel; avoid the waistline). Do not inject into skin that is tender, damaged, bruised, or scarred (Ref).

Administration: Pediatric

Parenteral:

IV (preferred for treatment of COVID-19):

Must be diluted prior to administration. If diluted solution is refrigerated following preparation, allow solution to come to room temperature (~30 minutes) prior to administration. Administer as an IV infusion through a PVC, polyethylene-lined PVC, or polyurethane infusion set containing a 0.2 micron polyethersulfone filter.

Rate of infusion is dependent upon size of infusion bag:

50 mL bag: ≤180 mL/hour.

100, 150, or 250 mL bag: ≤310 mL/hour.

Canadian labeling: Administer as an IV infusion over ≥1 hour.

Infuse the entire contents of the bag to avoid underdosage; flush line with NS or D5W following completion of infusion. Slow or interrupt infusion and treat as appropriate if the patient develops any signs of infusion-associated events (eg, fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia, chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, dizziness, diaphoresis); if severe or life-threatening hypersensitivity reactions occur, immediately discontinue infusion and provide emergency care (Ref).

SUBQ: Note: For treatment of COVID-19, SUBQ route should only be used when IV is not feasible and will result in treatment delay. For postexposure prophylaxis, either route is appropriate.

If syringes are refrigerated following preparation, allow to come to room temperature (~20 minutes) prior to administration. Administer SUBQ using a 25- or 27-gauge needle; administer the syringes (2 or 4 syringes, depending on dose) consecutively, each at a different injection site; space each injection apart by administering in different quadrants of the thigh, back of upper arm, or abdomen, except for the 2 inches (5 cm) around the navel. Avoid injecting at the waistline; do not inject into skin that is tender, damaged, bruised, or scarred (Ref).

Use: Labeled Indications

See "Use: Off-Label."

Use: Off-Label: Adult

COVID-19, postexposure prophylaxis; COVID-19, treatment, mild to moderate

Medication Safety Issues
Packaging issues:

Formulations: Two different formulations are available; casirivimab and imdevimab co-formulated solution in a 1:1 ratio in the same vial (casirivimab 60 mg/mL and imdevimab 60 mg/mL; available in 10 mL single dose vials) or casirivimab and imdevimab as individual solutions in separate vials (casirivimab 120 mg/mL and imdevimab 120 mg/mL; available as 2.5 single dose or 11.1 mL 2-dose vials). Even when packaged separately, both components, casirivimab and imdevimab, must be administered together. Store both components together in inventory to reduce the risk for potential errors. Of note, there are multiple versions of casirivimab and imdevimab packaging (FDA 2021).

Labeling: Some cartons and vials of casirivimab and imdevimab are alternately labeled as REGN10933 and REGN10987, respectively (FDA 2021). Although vials may be labeled for IV administration only, they may also be used to prepare SUBQ injections (Regeneron 2021).

Further information is available at https://www.regeneron.com/sites/default/files/treatment-covid19-eua-preventing-medication-errors.pdf.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Reproductive Considerations

Reproductive toxicity studies have not been conducted (FDA 2022).

Pregnancy Considerations

Casirivimab and imdevimab (administered in combination) are under FDA emergency use authorization (EUA) for the treatment and postexposure prophylaxis of COVID-19. Reproductive toxicity studies have not been conducted (FDA 2022).

Casirivimab and imdevimab are humanized monoclonal antibodies (IgG1). Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).

Outcome data following maternal use of casirivimab in combination with imdevimab during pregnancy are available (Crispino 2023, Eid 2022; Folkman 2023; Hirshberg 2021; Levey 2022; Magawa 2022; Mayer 2021; McCreary 2022; Richley 2022; Williams 2023). The potential benefits or risks of in utero exposure to casirivimab/imdevimab to the fetus are not known (FDA 2022).

The risk of severe morbidity and mortality from COVID-19 infection is increased in symptomatic pregnant patients compared to nonpregnant patients. Pregnant and recently pregnant patients with moderate or severe infection are at increased risk of complications, such as hypertensive disorders of pregnancy, postpartum hemorrhage, or other infections, compared to pregnant patients without COVID-19. Symptomatic pregnant patients may require ICU admission, mechanical ventilation, or ventilatory support (ECMO). Other adverse pregnancy outcomes include preterm birth and stillbirth. The risk of coagulopathy, cesarean delivery, and maternal death may be increased; neonates have an increased risk for NICU admission. Maternal age and comorbidities such as diabetes, hypertension, lung disease, and obesity may also increase the risk of severe illness in pregnant and recently pregnant patients (ACOG 2023; NIH 2022).

In general, the treatment of COVID-19 infection during pregnancy is the same as in nonpregnant patients. However, because data for most therapeutic agents in pregnant patients are limited, treatment options should be evaluated as part of a shared decision-making process (NIH 2022). Pregnancy is one of the medical conditions listed in the EUA eligibility criteria for casirivimab in combination with imdevimab. According to the EUA, dose adjustments are not recommended for patients who are pregnant (FDA 2022). Information related to the treatment of COVID-19 during pregnancy continues to emerge; refer to current guidelines for the treatment of pregnant patients.

Data collection to monitor maternal and infant outcomes following exposure to COVID-19 during pregnancy is ongoing. Health care providers are encouraged to enroll patients exposed to COVID-19 during pregnancy in the Organization of Teratology Information Specialists pregnancy registry (877-311-8972; https://mothertobaby.org/join-study/).

Breastfeeding Considerations

It is not known if casirivimab or imdevimab are present in breast milk.

Casirivimab and imdevimab are humanized monoclonal antibodies (IgG1). Human IgG is present in breast milk; concentrations are dependent upon IgG subclass and postpartum age (Anderson 2021).

Casirivimab and imdevimab (administered in combination) are under FDA emergency use authorization (EUA) for the treatment and postexposure prophylaxis of COVID-19. Dose adjustments are not recommended for lactating patients. According to the EUA, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother (FDA 2022).

Lactating patients with one or more risk factors for severe illness from COVID-19 infection may be treated with monoclonal antibodies. Breast milk has not been found to be a source of COVID-19 infection and maternal infection is not a contraindication to breastfeeding. The decision to breastfeed during treatment for COVID-19 should be evaluated as part of a shared decision-making process. However, lactating patients with COVID-19 infection can transmit the virus through respiratory droplets and all precautions should be taken to avoid spreading the virus to the infant (eg, hand hygiene, mask wearing); alternatively, breast milk can be expressed and fed to the infant by someone without confirmed or suspected COVID-19 (ACOG 2023; NIH 2023).

Information related to COVID-19 and breastfeeding is available from the World Health Organization (https://www.who.int/news/item/28-04-2020-new-faqs-address-healthcare-workers-questions-on-breastfeeding-and-covid-19).

Monitoring Parameters

Monitor for infusion-related reactions (eg, fever, chills, hypotension, rash, pruritus) and hypersensitivity/anaphylaxis during infusion and for ≥1 hour following infusion completion (FDA 2021).

Mechanism of Action

Casirivimab and imdevimab are recombinant human (IgG1κ and IgG1λ, respectively) monoclonal antibodies to the spike protein of SARS-CoV-2. Casirivimab and imdevimab bind to nonoverlapping epitopes of the spike protein receptor binding domain, blocking attachment to the human ACE2 receptor (FDA 2021).

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Vd: Casirivimab: 7.16 L; Imdevimab: 7.43 L (Deeks 2021).

Half-life elimination: Casirivimab: 31.8 ± 8.35 days; Imdevimab: 26.9 ± 6.8 days (FDA 2021).

Time to peak: Casirivimab: 8 days (range: 4 to 87 days); Imdevimab: 7 days (range: 4 to 15 days) (FDA 2021).

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Pediatric: Clinical trials have not been performed; serum exposures in patients ≥12 years of age and weighing ≥40 kg are expected to be similar to those observed in adults (FDA 2022).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Casirivimab and imdevimab;
  • (BG) Bulgaria: Ronapreve;
  • (DE) Germany: Ronapreve;
  • (FR) France: Ronapreve;
  • (JP) Japan: Ronapreve;
  • (NL) Netherlands: Ronapreve;
  • (NO) Norway: Ronapreve;
  • (PR) Puerto Rico: Regen cov;
  • (QA) Qatar: Ronapreve;
  • (SE) Sweden: Ronapreve;
  • (TW) Taiwan: Casirivimab and imdevimab;
  • (ZA) South Africa: Ronapreve
  1. American College of Obstetricians and Gynecologists (ACOG). COVID-19 FAQs for obstetrician-gynecologists, obstetric. https://www.acog.org/clinical-information/physician-faqs/covid-19-faqs-for-ob-gyns-obstetrics. Accessed December 4, 2023.
  2. Anderson PO. Monoclonal antibodies during breastfeeding. Breastfeed Med. 2021;16(8):591-593. doi:10.1089/bfm.2021.0110 [PubMed 33956488]
  3. Bhimraj A, Morgan RL, Shumaker AH, et al. Infectious Diseases Society of America (IDSA) guidelines on the treatment and management of patients with COVID-19. https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/. Updated August 17, 2021. Accessed August 30, 2021.
  4. Bilbao-Meseguer I, Rodríguez-Gascón A, Barrasa H, Isla A, Solinís MÁ. Augmented renal clearance in critically ill patients: a systematic review. Clin Pharmacokinet. 2018;57(9):1107-1121. doi:10.1007/s40262-018-0636-7 [PubMed 29441476]
  5. Casirivimab and imdevimab [prescribing information]. Welwyn Garden City, England, United Kingdom: Roche Products Limited; received September 2023.
  6. Casirivimab and Imdevimab [product monograph]. Mississauga, Ontario, Canada: Hoffmann-La Roche Ltd; June 2022.
  7. Clements T, Rice TF, Vamvakas G, et al. Update on transplacental transfer of IgG subclasses: impact of maternal and fetal factors. Front Immunol. 2020;11:1920. doi:10.3389/fimmu.2020.01920 [PubMed 33013843]
  8. Crispino P, Marocco R, Di Trento D, et al. Use of monoclonal antibodies in pregnant women infected by COVID-19: a case series. Microorganisms. 2023;11(8):1953. doi:10.3390/microorganisms11081953 [PubMed 37630512]
  9. Deeks ED. Casirivimab/Imdevimab: first approval. Drugs. 2021;81(17):2047-2055. doi:10.1007/s40265-021-01620-z [PubMed 34716907]
  10. Eid J, Abdelwahab M, Williams H, et al. Outpatient use of monoclonal antibodies in pregnant individuals with mild or moderate coronavirus disease 2019 (COVID-19). Obstet Gynecol. 2022;140(1):74-76. doi:10.1097/AOG.0000000000004826 [PubMed 35849458]
  11. Expert opinion. Senior Renal Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
  12. Folkman R, Blennow O, Tovatt T, Pettersson K, Nowak P. Treatment of COVID-19 with monoclonal antibodies casirivimab and imdevimab in pregnancy. Infection. 2023;51(1):261-263. doi:10.1007/s15010-022-01829-4 [PubMed 35482208]
  13. Hirshberg JS, Cooke E, Oakes MC, Odibo AO, Raghuraman N, Kelly JC. Monoclonal antibody treatment of symptomatic COVID-19 in pregnancy: initial report. Am J Obstet Gynecol. 2021;225(6):688-689. doi:10.1016/j.ajog.2021.08.025 [PubMed 34453934]
  14. Lancaster J. New name and packaging for Regeneron COVID-19 monoclonal antibodies (casirivimab with imdevimab) to be administer together: REGEN-COV™. Tarrytown, NY: Regeneron; February 3, 2021.
  15. Lancaster J. Preventing medication errors with casirivimab and imdevimab. Tarrytown, NY: Regeneron; December 8, 2020.
  16. Levey NH, Forrest AD, Spielman DW, Easley KA, Dude CM, Badell ML. Outcomes of pregnant patients treated with REGEN-COV during the COVID-19 pandemic. Am J Obstet Gynecol MFM. 2022;4(5):100673. doi:10.1016/j.ajogmf.2022.100673 [PubMed 35671984]
  17. Magawa S, Nii M, Maki S, et al. Evaluation of the tolerability of monoclonal antibody therapy for pregnant patients with COVID-19. J Obstet Gynaecol Res. Published online June 24, 2022. doi:10.1111/jog.15338 [PubMed 35748316]
  18. Mayer C, VanHise K, Caskey R, Naqvi M, Burwick RM. Monoclonal antibodies casirivimab and imdevimab in pregnancy for coronavirus disease 2019 (COVID-19). Obstet Gynecol. 2021;138(6):937-939. doi:10.1097/AOG.0000000000004603 [PubMed 34583385]
  19. McCreary EK, Lemon L, Megli C, Oakes A, Seymour CW; UPMC Magee Monoclonal Antibody Treatment Group. Monoclonal antibodies for treatment of SARS-CoV-2 infection during pregnancy: a cohort study. Ann Intern Med. 2022;175(12):1707-1715. doi:10.7326/M22-1329 [PubMed 36375150]
  20. National Institutes of Health (NIH). COVID-19 Treatment Guidelines Panel. Coronavirus disease 2019 (COVID-19) treatment guidelines. https://www.covid19treatmentguidelines.nih.gov/. Updated May 31, 2022. Accessed August 4, 2022.
  21. National Institutes of Health (NIH). COVID-19 Treatment Guidelines Panel. Coronavirus disease 2019 (COVID-19) treatment guidelines. https://www.covid19treatmentguidelines.nih.gov/. Updated November 2, 2023. Accessed December 12, 2023.
  22. National Institutes of Health (NIH). COVID-19 Treatment Guidelines Panel. Coronavirus disease 2019 (COVID-19) treatment guidelines. https://www.covid19treatmentguidelines.nih.gov/. Updated October 19, 2021. Accessed October 22, 2021.
  23. O'Brien MP, Forleo-Neto E, Musser BJ, et al; Covid-19 Phase 3 Prevention Trial Team. Subcutaneous REGEN-COV antibody combination to prevent covid-19. N Engl J Med. 2021:NEJMoa2109682. doi:10.1056/NEJMoa2109682 [PubMed 34347950]
  24. Palmeira P, Quinello C, Silveira-Lessa AL, Zago CA, Carneiro-Sampaio M. IgG placental transfer in healthy and pathological pregnancies. Clin Dev Immunol. 2012;2012:985646. doi:10.1155/2012/985646 [PubMed 22235228]
  25. Pentsuk N, van der Laan JW. An interspecies comparison of placental antibody transfer: new insights into developmental toxicity testing of monoclonal antibodies. Birth Defects Res B Dev Reprod Toxicol. 2009;86(4):328-344. doi:10.1002/bdrb.20201 [PubMed 19626656]
  26. Regeneron Pharmaceuticals Inc. Important information regarding packaging, labeling and storage of COVID-19 monoclonal antibody therapeutic: REGEN-COV. Published October 8, 2021.
  27. Richley M, Rao RR, Afshar Y, et al. Neutralizing monoclonal antibodies for coronavirus disease 2019 (COVID-19) in pregnancy: a case series. Obstet Gynecol. 2022;139(3):368-372. doi:10.1097/AOG.0000000000004689 [PubMed 35115451]
  28. Udy AA, Roberts JA, Boots RJ, Paterson DL, Lipman J. Augmented renal clearance: implications for antibacterial dosing in the critically ill. Clin Pharmacokinet. 2010;49(1):1-16. doi:10.2165/11318140-000000000-00000 [PubMed 20000886]
  29. 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.
  30. 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. Revised January 2022. Accessed February 2, 2022.
  31. Weinreich DM, Sivapalasingam S, Norton T, et al; Trial Investigators. REGN-COV2, a neutralizing antibody cocktail, in outpatients with COVID-19. N Engl J Med. 2021;384(3):238-251. doi:10.1056/NEJMoa2035002 [PubMed 33332778]
  32. Williams FB, Morgan JA, Elmayan A, Martin JK, Mussarat N, Biggio JR. Effectiveness of REGEN-COV combination monoclonal antibody infusion to reduce the risk of COVID-19 hospitalization in pregnancy: a retrospective cohort study. Am J Obstet Gynecol. 2023;228(1):102-103. doi:10.1016/j.ajog.2022.09.017 [PubMed 36108732]
Topic 130225 Version 115.0

آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟