Pemivibart (Monograph)

Brand name: Pemgarda
Drug class: Monoclonal Antibodies

Medically reviewed by Drugs.com on Apr 10, 2025. Written by ASHP.

Introduction

Recombinant human IgG₁ λ monoclonal antibody that targets the SARS-CoV-2 spike protein receptor binding domain; antiviral agent.

Uses for Pemivibart

Coronavirus Disease 2019 (COVID-19)

Pemivibart is available under an emergency use authorization (EUA) for pre-exposure prophylaxis of coronavirus disease 2019 (COVID-19)^{† [off-label]} in adults and adolescents (12 years of age and older weighing ≥40 kg).

Under conditions of the EUA, can be used only in patients who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2 andwho have moderate-to-severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments and are unlikely to mount an adequate response to COVID-19 vaccination.

Medical conditions or treatments that may result in moderate to severe immune compromise and an inadequate immune response to COVID-19 vaccination include the following: active treatment for solid tumor and hematologic malignancies, hematologic malignancies associated with poor responses to COVID-19 vaccines regardless of current treatment status (e.g., chronic lymphocytic leukemia, non-Hodgkin lymphoma, multiple myeloma, acute leukemia), receipt of solid-organ transplant or an islet transplant and taking immunosuppressive therapy, receipt of chimeric antigen receptor (CAR)-T-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppressive therapy), moderate or severe primary immunodeficiency (e.g., common variable immunodeficiency disease, severe combined immunodeficiency, DiGeorge syndrome, Wiskott-Aldrich syndrome), advanced or untreated HIV infection (people with HIV and CD4⁺ cell counts <200/mm³, history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV), active treatment with high-dose corticosteroids (i.e., ≥20 mg prednisone or equivalent per day when administered for ≥2 weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, and biologic agents that are immunosuppressive or immunomodulatory (e.g., B-cell depleting agents).

Authorized for use only when combined national frequency of variants with substantially reduced susceptibility to pemivibart is ≤90%, based on available information including variant susceptibility to pemivibart and national variant frequencies.

Not authorized for use for treatment of COVID-19 or post-exposure prophylaxis of COVID-19 in individuals who have been exposed to someone infected with SARS-CoV-2.

Pre-exposure prophylaxis with pemivibart is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended. Individuals for whom COVID-19 vaccination is recommended, including individuals with moderate-to-severe immune compromise who may derive benefit, should receive COVID-19 vaccination.

In individuals who have recently received a COVID-19 vaccine, pemivibart should be administered at least 2 weeks after vaccination.

Pemivibart may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants who are licensed or authorized under State law to prescribe drugs.

Consult pemivibart EUA letter of authorization, EUA fact sheet for healthcare providers, and EUA fact sheet for patients and caregivers for additional information.

The 2024 clinical practice guideline update by the Infectious Diseases Society of America (IDSA) suggests pre-exposure prophylaxis with pemivibart in moderately or severely immunocompromised individuals ≥12 years of age at risk for progression to severe COVID-19 when predominant regional variants are susceptible to pemivibart.

Guidelines for prevention and treatment of opportunistic infections in children with and exposed to HIV states pemivibart should be considered for prevention of COVID-19 in children ≥12 years weighing ≥40 kg who have HIV with severe immunosuppression (stage 3 ) regardless of COVID-19 vaccination status. Pemivibart may be considered for the prevention of COVID-19 in children ≥12 years of age weighing ≥40 kg who have HIV with moderate to no immunosuppression (stage 1 or 2 ) in whom COVID-19 vaccines are contraindicated or unavailable.

Pemivibart Dosage and Administration

General

Pretreatment Screening

• Assess timing of most recent COVID-19 vaccination.

• Determine if combined national frequency of variants with reduced susceptibility to pemivibart is ≤90%, based on variant susceptibility to pemivibart and national variant frequencies.

• Assess history of severe allergic reaction to a COVID-19 vaccine. If history of severe allergic reaction to a COVID-19 vaccine is present, consider consultation with an allergist-immunologist prior to pemivibart administration.

Patient Monitoring

• Monitor for signs and symptoms of hypersensitivity, infusion-related reactions, and anaphylaxis during 60-minute infusion and for at least 2 hours after completion of infusion.

• Monitor for signs and symptoms of hypersensitivity for up to 24 hours after infusion.

Dispensing and Administration Precautions

• Completion of FDA MedWatch forms to report all medication errors and all serious adverse events potentially related to pemivibart is mandatory. The FDA fact sheet for health care providers that is provided with the drug and available at the FDA website should be consulted for requirements and instructions regarding reporting of adverse reactions and medications errors.

Other General Considerations

• In individuals who have received a COVID-19 vaccine, pemivibart should be administered at least 2 weeks after vaccination.

Administration

IV Administration

Administer by IV infusion after dilution.

Administer in settings in which appropriate medical support is available to manage hypersensitivity reactions, including anaphylaxis, and with ability to activate emergency medical system, as necessary.

Remove pemivibart vials from refrigerated storage and allow to equilibrate to room temperature (18–26°C) for 10 minutes before preparation. Do not expose to direct heat. Do not shake vials.

Pemivibart is a clear to slightly opalescent, colorless to yellow solution. Visually inspect vials for particulate matter and discoloration. Discard if solution is cloudy, discolored, or if visible particles observed.

Prior to administration, attach infusion set including in-line 0.2 micron filter to prepared IV bag and prime infusion set.

Once infusion is complete, flush line with 0.9% sodium chloride injection.

Clinically monitor patients during infusion and observe for at least 2 hours after infusion is complete.

Dilution

Prepare IV bag by removing and discarding 36 mL from a 50-mL prefilled bag of 0.9% sodium chloride injection.

Using appropriately sized polypropylene syringe(s) (e.g., one 40 mL syringe or two 20 mL syringes), withdraw 36 mL of pemivibart from 9 vials and inject into prepared 0.9% sodium chloride IV bag.

The final product for administration will contain 36 mL of pemivibart and 14 mL of 0.9% sodium chloride injection for total volume of 50 mL.

Do not shake the diluted solution.

Rate of Administration

Administer entire 50-mL infusion using infusion pump or gravity infusion set over minimum of 60 minutes.

Due to potential overfill, administer entire contents of prepared IV bag to avoid underdosing.

Dosage

Pediatric Patients

Pre-Exposure Prophylaxis of COVID-19 † [off-label]

IV

Adolescents (≥12 years of age weighing ≥40 kg): initial dose is 4500 mg administered as a single IV infusion.

If ongoing protection is necessary, may administer repeat doses of 4500 mg as a single IV infusion every 3 months.

Repeat dosing should be timed from the date of the most recent pemivibart dose.

Adults

Pre-Exposure Prophylaxis of COVID-19† [off-label]

IV

Initial dose is 4500 mg administered as a single IV infusion.

If ongoing protection is necessary, may administer repeat doses of 4500 mg as a single IV infusion every 3 months.

Repeat dosing should be timed from the date of the most recent dose.

Dosage Modification for Toxicity

If mild infusion-related reaction occurs, consider slowing or stopping infusion and administer appropriate medications and/or supportive care.

If signs and symptoms of a clinically significant hypersensitivity reaction, infusion-related reaction, or anaphylaxis occur during administration of pemivibart, immediately discontinue administration and initiate appropriate medications and/or supportive care.

Discontinue pemivibart use permanently in individuals who experience signs and symptoms of anaphylaxis.

Special Populations

Hepatic Impairment

No dosage adjustment is recommended.

Renal Impairment

No dosage adjustment is recommended.

Geriatric Patients

No dosage adjustment is recommended.

Cautions for Pemivibart

Contraindications

• Previous severe hypersensitivity reactions, including anaphylaxis, to any component of pemivibart.

Warnings/Precautions

Warnings

Anaphylaxis

Anaphylaxis reported; can be life-threatening (see Boxed Warning). Manifestations included pruritus, flushing, urticaria, erythema, angioedema, diaphoresis, dizziness, tinnitus, wheezing, dyspnea, chest discomfort, and tachycardia.

Prior to administration, consider potential benefit of COVID-19 prevention along with risk of anaphylaxis.

Administer only in settings in which healthcare providers have immediate access to medications to treat anaphylaxis and the ability to activate the emergency medical system (EMS), as necessary.

Clinically monitor patients during the 60-minute infusion and for at least 2 hours after completion of infusion.

If signs or symptoms of an anaphylactic reaction occur, immediately discontinue and initiate appropriate medications and/or supportive therapy. Permanently discontinue in patients who experience signs or symptoms of anaphylaxis.

Other Warnings and Precautions

Hypersensitivity and Infusion-Related Reactions

Hypersensitivity and infusion-related reactions during the infusion and up to 24 hours after infusion observed. May be severe or life threatening.

If a clinically significant hypersensitivity or infusion-related reaction occurs, immediately discontinue administration and initiate appropriate medications and/or supportive therapy. Signs and symptoms of hypersensitivity or infusion-related reactions may include fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g., atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, vasovagal reactions (e.g., presyncope, syncope), dizziness, and diaphoresis.

If a mild infusion-related reaction occurs, consider slowing or stopping the infusion and administer appropriate medications and/or supportive care.

Clinically monitor patients during infusion and for at least 2 hours after completion of infusion for signs and symptoms of hypersensitivity. Hypersensitivity reactions occurring more than 24 hours after the infusion have also been reported with the use of SARS-CoV-2 monoclonal antibodies under EUA.

Risk of Cross-Hypersensitivity with COVID-19 Vaccines

Pemivibart 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 patients with a history of a severe hypersensitivity reaction to a COVID-19 vaccine, consider consultation with an allergist-immunologist prior to pemivibart administration.

Administer pemivibart under the supervision of a healthcare provider with appropriate medical support to manage severe hypersensitivity reactions.

If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive care. Clinically monitor patients after infusion and observe for at least 2 hours.

Risk for COVID-19 Due to SARS-CoV-2 Viral Variants Not Neutralized by Pemivibart

Certain SARS-CoV-2 viral variants may emerge that are not neutralized by monoclonal antibodies such as pemivibart. Pemivibart may not be effective at preventing COVID-19 caused by these SARS-CoV-2 viral variants.

Inform patients of the increased risk for COVID-19 due to emergent SARS-CoV-2 viral variants not neutralized by pemivibart.

If signs or symptoms of COVID-19 occur, advise individuals to test for COVID-19 and seek medical attention, including starting treatment for COVID-19 as appropriate. Symptoms 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.

Immunogenicity

No immunogenicity data available.

EUA Requirements for Patient Monitoring and Mandatory FDA MedWatch Reporting

Safety and efficacy of pemivibart not established. FDA EUA that permits use of pemivibart for pre-exposure prophylaxis of COVID-19 in certain adults and adolescents requires that the drug be administered using the dosages recommended in the EUA.

Completion of FDA MedWatch forms to report all medication errors and all serious adverse events potentially related to pemivibart is mandatory. The EUA fact sheet for health care providers that is provided with the drug should be consulted for requirements and instructions regarding reporting of adverse reactions and medications errors.

Specific Populations

Pregnancy

Insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Only use during pregnancy if potential benefit outweighs potential risk.

Human IgG₁ antibodies are known to cross placental barrier; therefore, pemivibart has potential to be transferred from the mother to developing fetus. It is unknown whether this provides any treatment benefit or risk to the developing fetus.

Lactation

No data on presence of pemivibart in human or animal milk, effects on the breast-fed infant, or effects on milk production. Consider developmental and health benefits of breastfeeding along with the mother’s clinical need for pemivibart and any potential adverse effects on the breast-fed infant from the drug.

Pediatric Use

Not authorized for use in pediatric patients <12 years of age or weighing <40 kg. Safety and effectiveness not established in pediatric patients.

Recommended dosing regimen is expected to result in comparable serum exposures in adolescents ≥12 years of age weighing ≥40 kg as in adults.

Geriatric Use

No clinically meaningful effects of age on pharmacokinetics of pemivibart.

Hepatic Impairment

Effect of hepatic impairment on pharmacokinetics of pemivibart is unknown.

Renal Impairment

Pemivibart is not eliminated in the urine; therefore, mild, moderate, or severe renal impairment not expected to affect exposure. Dialysis not expected to impact pharmacokinetics of pemivibart.

Common Adverse Effects

Most common adverse events (≥2%) in patients with moderate-to-severe immune compromise: systemic and local infusion-related or hypersensitivity reactions, upper respiratory tract infection, viral infection, influenza-like illness, fatigue, headache, and nausea.

Drug Interactions

Drug-drug interaction studies not performed. Pemivibart is not renally excreted or metabolized by CYP enzymes; therefore, interactions with concomitant medications that are renally excreted or that are substrates, inducers, or inhibitors of CYP enzymes are unlikely.

Pemivibart Pharmacokinetics

Elimination

Metabolism

Metabolized by catabolic pathways.

Elimination Route

Not likely to undergo renal excretion.

Half-life

Half-life: 44.8 days.

Special Populations

Pharmacokinetics not affected by age, sex, race, or immune compromise status.

Pharmacokinetics not expected to be affected by renal or hepatic impairment.

Stability

Storage

Parenteral

Injection, for IV Infusion

Store unopened vials in refrigerator at 2–8ºC in original carton to protect from light. Do not freeze or shake. Do not use if seal is broken or missing. After dilution, if immediate administration is not possible, may store diluted solution at room temperature under ambient light for up to 4 hours.

Actions

• Recombinant human monoclonal IgG₁ λ antibody that targets the SARS-CoV-2 spike protein receptor binding domain (RBD); inhibits virus attachment to the human angiotensin-converting enzyme (ACE) 2 receptor on host cells.

• Neutralizes authentic SARS-CoV-2 isolates in Vero E6 or Vero E6-TMPRSS2 cells with half maximal effective concentration (EC₅₀) values of 0.165—0.230 nM (24.3—34 ng/mL) against B.1, and 0.075 nM (11 ng/mL) against B.1.617.2 (Delta).

• Potential risk of prophylaxis failure due to the emergence of a pemivibart-resistant SARS-CoV-2 variant.

• Cross-resistance is not expected with other COVID-19 therapies.

Advice to Patients

• Provide the EUA Fact Sheet for Patients, Parents, or Caregivers and communicate information contained on this Fact Sheet to the patient, parent, and caregiver prior to administration of pemivibart.

• Inform patients and caregivers that anaphylaxis has been observed with pemivibart. Advise patients and caregivers that they will be monitored during and for at least 2 hours after completion of the infusion. In those who experience signs or symptoms of anaphylaxis, pemivibart use will be discontinued permanently.

• Inform patients and caregivers that hypersensitivity and infusion-related reactions have occurred during the infusion and up to 24 hours after the infusion with pemivibart. These hypersensitivity or infusion-related reactions may be severe or life threatening.

• Inform patients and caregivers that they may need to receive additional doses of pemivibart every 3 months if ongoing protection is needed.

• Certain SARS-CoV-2 viral variants may emerge that are not neutralized by monoclonal antibodies such as pemivibart. Pemivibart may not be effective at preventing COVID-19 caused by these SARS-CoV-2 viral variants. Inform patients and caregivers of the increased risk, compared to other variants, for COVID-19 due to SARS-CoV-2 viral variants not neutralized by pemivibart. If signs or symptoms of COVID-19 occur, advise patients and caregivers to test for COVID-19 and seek medical attention, including starting treatment for COVID-19 as appropriate.

• Advise patients to inform their clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.

• Advise patients to inform their clinician if they are or plan to become pregnant or plan to breast-feed.

• Inform patients of other important precautionary information.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Pemivibart is not commercially available. FDA issued an EUA for pemivibart that allows use of the drug for pre-exposure prophylaxis of COVID-19 in certain adults and adolescents. Contact manufacturer for information on how to obtain pemivibart for use under the EUA ([Web]).

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