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Pemivibart
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NOTE: Pemivibart is authorized for use in persons who:
NOTE: Pemivibart is NOT authorized for:
4,500 mg IV once. For people requiring ongoing protection, may repeat doses of 4,500 mg IV once every 3 months. Repeat dosing should be timed from the date of the most recent dose.[70471]
4,500 mg IV once. For people requiring ongoing protection, may repeat doses of 4,500 mg IV once every 3 months. Repeat dosing should be timed from the date of the most recent dose.[70471]
40 kg or more: 4,500 mg IV.
less than 40 kg: Use not authorized.
40 kg or more: 4,500 mg IV.
less than 40 kg: Use not authorized.
40 kg or more: 4,500 mg IV.
less than 40 kg: Use not authorized.
12 years and weighing 40 kg or more: 4,500 mg IV.
12 years and weighing less than 40 kg: Use not authorized.
1 to 11 years: Use not authorized.
Use not authorized.
Use not authorized.
No dosage adjustments are needed.
No dosage adjustments are needed.
† Off-label indicationPemivibart is a recombinant human immunoglobulin G1 (IgG1) monoclonal antibody with activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is not FDA-approved for any indication; however, it has been issued an Emergency use Authorization (EUA) by the FDA for pre-exposure prophylaxis of coronavirus disease 2019 (COVID-19) in certain adult and pediatric individuals (12 years of age and older weighing at least 40 kg). Specifically, pemivibart is authorized for use in persons who:
Circumstances in which the drug is NOT authorized for use include:
Cases of anaphylaxis have been observed following the use of pemivibart. Therefore, the drug must be administered in a setting in which the health care provider has immediate access to medications used to treat anaphylaxis and the ability to activate the emergency medical system (EMS), as necessary. Prior to administering pemivibart, consider the potential benefits of COVID-19 prevention along with the risk of anaphylaxis.[70471] The Infectious Diseases Society of America (IDSA) conditionally recommends the use of pemivibart for pre-exposure prophylaxis in moderately or severely immunocompromised individuals aged 12 years and older who are at risk for progression to severe COVID-19.[71675]
For storage information, see the specific product information within the How Supplied section.
NOTE: Pemivibart is not an FDA-approved medication; however, it has been authorized for emergency use as pre-exposure prophylaxis of COVID-19 in certain persons who may not mount an adequate immune response to COVID-19 vaccination. Under the Emergency Use Authorization (EUA), health care providers are required to communicate to the patient, parent, or caregiver information consistent with the "Fact Sheet for Patients, Parents or Caregivers" and provide them with a copy of this Fact Sheet prior to the patient receiving treatment.
NOTE: Inform patients that certain severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants may have substantially reduced susceptibility to pemivibart, and thus, pemivibart may not be effective at preventing COVID-19 caused by these variants. Instruct patients to undergo viral testing and seek medical attention if they develop signs or symptoms of COVID-19 after receiving pemivibart. Symptoms of COVID-19 may include fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea. Pemivibart will remain authorized for use so long as the combined national frequency of SARS-CoV-2 variants with substantially reduced susceptibility to pemivibart does not exceed 90%. The FDA will continue to monitor variant susceptibility and frequency data.
NOTE: Under the EUA, health care providers are required to report all medication errors and serious adverse events potentially related to pemivibart therapy within 7 calendar days from the health care provider's awareness of the event.[70471]
Preparation
Intravenous infusion
The most common treatment-emergent adverse events reported by moderate-to-severely immunocompromised recipients of pemivibart (Cohort A) through Month 6 of clinical trials (n = 306) included upper respiratory tract infection (7%), viral infection (7%), influenza-like illness (4%), urinary tract infection (4%), fatigue (3%), headache (3%), sinusitis (3%), naso-pharyngitis (2%), influenza (2%), and pneumonia (2%). In non-immunocompromised drug recipients (Cohort B), the most common treatment-emergent adverse events were upper respiratory tract infection (8%), viral infection (6%), influenza-like illness (5%), enterovirus infection (3%), and viral upper respiratory tract infection (2%).[70471]
During clinical trials, 2% (n = 6 of 306) of moderate-to-severely immunocompromised patients experienced a local injection site reaction during either the first or second pemivibart dose; no local injection site reactions were noted in immunocompetent drug recipients. Local reactions were reported as bruising or hematoma, erythema, rash, and injection site reaction. All local reactions were mild, and none resulted in treatment discontinuation. Additionally, 5% (n = 15 of 306) of the moderate-to-severely immunocompromised patients in Cohort A and 1% (n = 3 of 317) non-immunocompromised patients in Cohort B experienced an infusion site infiltration or extravasation during either the first or second pemivibart dose.[70471]
During clinical trials, systemic infusion-related reactions and hypersensitivity reactions were observed during the first pemivibart dose in 4% (n = 24 of 623) of all drug recipients. These reactions started within 24 hours of the first dose and were reported as infusion-related reactions, infusion-related hypersensitivity, hypersensitivity, fatigue, headache, sinus tachycardia, dermatitis, diarrhea, myalgia, nausea, paresthesias, pre-syncope, and tremor. All reactions were mild or moderate in severity, but 2 reactions were classified as anaphylaxis. Infusion-related or hypersensitivity reactions resulted in discontinuation of the first dose in 1% (n = 6 of 623) of all drug recipients. In Cohort A of patients who were moderate-to-severely immunocompromised, 9% (n = 27 of 306) developed infusion-related or hypersensitivity reactions during either the first or second pemivibart dose, while these reactions were observed in 3% (n = 11 of 317) of non-immunocompromised patients in Cohort B during either the first or second dose. The severity of these reactions were generally mild (n = 24 of 38) or moderate (n = 12 of 38); however, 2 of the reactions that occurred in Cohort A were classified as life-threatening. Infusion-related or hypersensitivity reactions resulted in discontinuation of the first or second dose in 1% (n = 10 of 623) of patients who received pemivibart across cohorts, including 2% (n = 7 of 306) in Cohort A and 1% (n = 3 of 317) in Cohort B. Clinically monitor patients during the infusion and for at least 2 hours after completion of the infusion. If a mild infusion-related reaction occurs, consider slowing or stopping the infusion and administering appropriate supportive care.[70471]
Serious hypersensitivity reactions or anaphylaxis were observed in 4 of 623 (0.6%) patients who received pemivibart during clinical trials, all 4 occurring in the cohort of patients who were moderate-to-severely immunocompromised (n = 306). Two of the patients developed anaphylaxis during the first infusion, and 2 had anaphylaxis during the second infusion. Symptoms of anaphylaxis that occurred during the first pemivibart dose included dyspnea, diaphoresis, facial erythema, chest pain (unspecified), and sinus tachycardia in 1 patient, and flushing, dizziness, tinnitus, and wheezing in the other. Both of these patients received treatment with diphenhydramine. The cases of anaphylaxis that occurred during the second pemivibart dose were both reported as life-threatening. In both of these patients, the symptoms included pruritus, urticaria, angioedema, dyspnea, erythema, and flushing. One of the patients also experienced headache, dizziness, and chest pain during the infusion, with additional symptoms of pruritus, erythema, and urticaria reoccurring within 24 hours of the initial anaphylaxis onset. Both patients were treated with diphenhydramine and epinephrine, and 1 patient also received oral prednisone and metoprolol for an associated flare of an underlying condition. In all 4 patients, pemivibart was permanently discontinued. Administer pemivibart in a setting with immediate access to medications to treat anaphylaxis and the ability to activate the emergency medical system (EMS), as necessary. Permanently discontinue use of the drug if signs or symptoms of anaphylaxis or any severe systemic reaction are observed and initiate appropriate medication or supportive therapy.[70471]
The coadministration of certain medications may lead to harm and require avoidance or therapy modification; review all drug interactions prior to concomitant use of other medications.
This medication is contraindicated in patients with a history of hypersensitivity to it or any of its components. Additionally, the drug contains polysorbate 80, which is in some COVID-19 vaccines and is structurally similar to polyethylene glycol (PEG), an ingredient in other COVID-19 vaccines. For individuals who have previously experienced a severe hypersensitivity reaction to a COVID-19 vaccine, consider consultation with an allergist-immunologist prior to administering pemivibart.[70471]
Certain severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants may have substantially reduced susceptibility to pemivibart, and pemivibart may not be effective at preventing COVID-19 caused by these variants. Instruct patients to undergo viral testing and seek medical attention if they develop signs or symptoms of COVID-19 after receiving pemivibart. Symptoms of COVID-19 may include fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea. Pemivibart will remain authorized for use so long as the combined national frequency of SARS-CoV-2 variants with substantially reduced susceptibility to pemivibart does not exceed 90%. The FDA will continue to monitor variant susceptibility and frequency data.[70471]
Administer pemivibart during pregnancy only if the potential benefit outweighs the potential risk for the mother and fetus. There are insufficient data regarding the use of pemivibart during pregnancy to determine a drug-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. Human immunoglobulin G1 (IgG1) antibodies are known to cross the placental barrier; therefore, pemivibart has the potential to be transferred from the mother to the developing fetus. It is unknown if this potential in utero transfer provides any therapeutic benefit or risk to the fetus.[70471]
There are no data regarding the presence of pemivibart in human milk, the effects on the breast-fed infant, or the effects on milk production; however, maternal immunoglobulin G (IgG) is known to be present in human milk. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the mother's clinical need for pemivibart. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.[70471]
Pemivibart is a recombinant human immunoglobulin G1 (IgG1) monoclonal antibody used as a preventative antiviral medication against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The antibody binds to the spike protein receptor binding domain (RBD) of SARS-CoV-2, thereby preventing the virus from interacting with the human ACE2 receptor and blocking viral attachment. For the ancestral SARS-CoV-2 and Omicron BA.2.86 variant, pemivibart blocks attachment of the RBD proteins to the human ACE2 receptor with half-maximal inhibitory concentrations (IC50) of 10 ng/mL and 3,370 ng/mL, respectively. For the Omicron variants, the 50% effective concentrations (EC50) are 14.2 ng/mL against BA.1, 5.8 ng/mL against BA.2, 25.8 ng/mL against BA.4.1, 118 to 661.2 ng/mL against XBB.1.16, 290 to 479.9 ng/mL against XBB.1.5, 1,445 ng/mL against EG.5.1, and 529.4 ng/mL against HV.1 (last authentic virus variant tested). Pemivibart exhibits Fc receptor and C1q binding and Fc-mediated effector activity, including antibody-dependent cellular cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and antibody-dependent complement deposition (ADCD). Cell-based complement-dependent cytolysis (CDC) was not observed with pemivibart in cell culture. Pemivibart has not been directly evaluated for antibody-dependent enhancement (ADE) of infection. The parent antibody of pemivibart, which contains an identical Fc region and targets an overlapping epitope, failed to exhibit detectable ADE in cell culture.
There is a potential for prophylaxis failure due to the development of viral variants that are resistant to pemivibart. Health care providers are advised to consider the prevalence of SARS-CoV-2 variants in their area when considering prophylactic treatment options. Data are limited regarding spike substitutions in Omicron-lineage variants that may confer significantly reduced susceptibility to pemivibart. However, escape variants were identified after serial passage of Omicron XBB.1.5.6 in cell culture in the presence of pemivibart that contained a T500N spike substitution or a combination of R498Q, Y501N, and H505Y spike substitutions. In clinical studies, resistance-associated substitutions were identified in spike sequences from 3 moderately to severely immunocompromised drug recipients: T500A in a JN.1 variant and in a KP.3.1.1 variant, and T500N in a KP.3.1.1 variant. The RBD amino acid substitutions were associated with a 22-fold increase in EC50 value (JN.1 with T500A), or no measurable neutralization (KP.3.11 with T500N), when spike variants carrying these substitutions were evaluated for susceptibility to pemivibart. Evaluations of pemivibart neutralization susceptibility of variants that have been identified through global surveillance are ongoing.[70471]
Revision Date: 07/30/2025, 01:15:09 PMPemivibart is administered via intravenous infusion. Once in systemic circulation, the steady state volume of distribution is 5.62 L. Pemivibart is metabolized in the same manner as endogenous IgG via catabolic pathways. It is unlikely to undergo renal elimination and has clearance of 0.0862 L/day. The half-life is 49 days.[70471]
Affected cytochrome P450 isoenzymes: none
After a single 4,500 mg intravenous infusion of pemivibart in adults, the maximum plasma concentration (Cmax) is 1,820 mcg/mL and the systemic exposure (AUC0-3 months) is 40,500 days x mcg/mL. At post-dose Days 28 and 90, drug concentrations fall to 468 mcg/mL and 188 mcg/mL, respectively.[70471]
Hepatic impairment is not expected to impact the pharmacokinetics of pemivibart.[70471]
Monoclonal antibodies with molecular weights greater than 69 kDa are known not to undergo renal elimination; therefore, neither renal impairment nor dialysis are expected to impact the pharmacokinetics of pemivibart (molecular weight: 147.51 kDa).[70471]
The pharmacokinetics of pemivibart have not been evaluated in pediatric patients; however, the recommended dosing regimen is expected to result in pemivibart plasma exposures in pediatric patients (12 years and older weighing at least 40 kg) that are comparable to those observed in adult drug recipients.[70471]
The pharmacokinetics of pemivibart are not substantially affected by age.[70471]
The pharmacokinetics of pemivibart are not substantially affected by gender.[70471]
The pharmacokinetics of pemivibart are not substantially affected by ethnicity.[70471]
Body weight is not expected to have a clinically relevant effect on the pharmacokinetics of pemivibart in patients weighing between 43 and 190 kg.[70471]
Administer pemivibart during pregnancy only if the potential benefit outweighs the potential risk for the mother and fetus. There are insufficient data regarding the use of pemivibart during pregnancy to determine a drug-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. Human immunoglobulin G1 (IgG1) antibodies are known to cross the placental barrier; therefore, pemivibart has the potential to be transferred from the mother to the developing fetus. It is unknown if this potential in utero transfer provides any therapeutic benefit or risk to the fetus.[70471]
There are no data regarding the presence of pemivibart in human milk, the effects on the breast-fed infant, or the effects on milk production; however, maternal immunoglobulin G (IgG) is known to be present in human milk. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the mother's clinical need for pemivibart. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.[70471]
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