Pemivibart Dosage

Medically reviewed by Drugs.com. Last updated on Apr 9, 2024.

Applies to the following strengths: 500 mg/4 mL

Usual Adult Dose for Pre-Exposure Prophylaxis

For investigational use only

Initial dose: 4500 mg IV once
Repeat dose: 4500 mg IV every 3 months

Comments:

The US FDA issued an Emergency Use Authorization (EUA) to allow the emergency use of this unapproved drug for the preexposure prophylaxis of coronavirus disease 2019 (COVID-19) in patients who are not currently infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and have not had a known recent exposure to someone infected with SARS-CoV-2 AND who have moderate to severe immune compromise due to a medical condition or use of immunosuppressive agents/treatments and are unlikely to mount an adequate response to COVID-19 vaccination; this drug is not approved by the US FDA for this or any use.
This drug should be administered as a single IV infusion over at least 60 minutes.
Repeat dosing should be timed from the date of the most recent dose of this drug.
No dose adjustment is recommended in pregnant, lactating, or older adult patients.
For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs

Use: For the preexposure prophylaxis of COVID-19 in patients:

Who are not currently infected with SARS-CoV-2 and have not had a known recent exposure to someone infected with SARS-CoV-2 AND
Who have moderate to severe immune compromise due to a medical condition or use of immunosuppressive agents/treatments and are unlikely to mount an adequate response to COVID-19 vaccination

Usual Pediatric Dose for Pre-Exposure Prophylaxis

For investigational use only

12 years or older, at least 40 kg:

Initial dose: 4500 mg IV once
Repeat dose: 4500 mg IV every 3 months

Comments:

The US FDA issued an EUA to allow the emergency use of this unapproved drug for the preexposure prophylaxis of COVID-19 in patients who are not currently infected with SARS-CoV-2 and have not had a known recent exposure to someone infected with SARS-CoV-2 AND who have moderate to severe immune compromise due to a medical condition or use of immunosuppressive agents/treatments and are unlikely to mount an adequate response to COVID-19 vaccination; this drug is not approved by the US FDA for this or any use.
This drug should be administered as a single IV infusion over at least 60 minutes.
Repeat dosing should be timed from the date of the most recent dose of this drug.
No dose adjustment recommended in pregnant or lactating patients.
For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs

Use: For the preexposure prophylaxis of COVID-19 in patients:

Who are not currently infected with SARS-CoV-2 and have not had a known recent exposure to someone infected with SARS-CoV-2 AND
Who have moderate to severe immune compromise due to a medical condition or use of immunosuppressive agents/treatments and are unlikely to mount an adequate response to COVID-19 vaccination

Renal Dose Adjustments

Renal dysfunction: No adjustment recommended

Liver Dose Adjustments

Liver dysfunction: No adjustment recommended

Precautions

US BOXED WARNING:

ANAPHYLAXIS: In a clinical trial, anaphylaxis was observed with this drug in 4 of 623 patients; anaphylaxis (which can be life-threatening) was reported during the first and second infusion of this drug. Before administration, potential benefit of COVID-19 prevention should be considered as well as the risk of anaphylaxis. This drug should be administered only in settings in which health care providers have immediate access to medications to treat anaphylaxis and the ability to activate the emergency medical system (EMS), as needed. Patients should be clinically monitored during the infusion and for at least 2 hours after infusion is complete. This drug should be discontinued immediately if signs/symptoms of anaphylaxis or any severe systemic reaction are observed and appropriate medications and/or supportive therapy should be started.

CONTRAINDICATIONS:

Previous severe hypersensitivity reactions (including anaphylaxis) to the active component or any of the ingredients

Safety and efficacy have not been established in patients younger than 18 years; this drug is not authorized for use in pediatric patients weighing less than 40 kg or younger than 12 years.

Dialysis

Data not available

Other Comments

Administration advice:

This drug should be administered by a qualified health care provider, only in settings which have immediate access to medications to treat a severe hypersensitivity reaction (e.g., anaphylaxis) and the ability to activate the EMS, as needed.
Administer as an IV infusion using an infusion pump or gravity infusion set.
Use an IV extension set with inline 0.2-micron filter.
Administer the entire infusion over at least 60 minutes.
Due to potential overfill, administer the entire contents of the prepared IV bag to avoid underdosing.
After infusion is complete, flush the line with 0.9% sodium chloride.
Clinically monitor patients during infusion and observe patients for at least 2 hours after infusion is complete.

Storage requirements:

Unopened vials: Store in refrigerator at 2C to 8C (36F to 46F) in original carton; protect from light and do not freeze or shake.
Remove vial from refrigerated storage and allow to equilibrate to room temperature (18C to 26C [64F to 79F]) for 10 minutes before preparation; do not expose to direct heat. Do not shake vials.
Diluted solution: Should administer immediately; if immediate administration is not possible, store at room temperature under ambient light for up to 4 hours. Do not shake.

Reconstitution/preparation techniques:

This drug should be prepared by a qualified health care provider.
The Fact Sheet for Health Care Providers should be consulted.

IV compatibility:

Compatible: 0.9% Sodium chloride

General:

The Fact Sheet for Health Care Providers should be consulted.
This drug may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants licensed/authorized under state law to prescribe drugs.
The recommendations for dosing are based on the totality of the scientific evidence (including clinical pharmacology, antiviral activity, and clinical trial data).
There are no adequate, approved, and available alternatives to this drug for the preexposure prophylaxis of COVID-19 in patients who are unlikely to mount an adequate immune response to COVID-19 vaccination.
ClinicalTrials.gov should be consulted for information on clinical studies of this and other therapies for the preexposure prophylaxis of COVID-19.
LIMITATIONS OF AUTHORIZED USE:
This drug is not authorized for the treatment of COVID-19.
This drug is not authorized for postexposure prophylaxis of COVID-19 in patients exposed to someone infected with SARS-CoV-2.
Preexposure prophylaxis with this drug is not a substitute for vaccination in patients for whom COVID-19 vaccination is recommended; such patients (including those with moderate to severe immune compromise who may derive benefit from COVID-19 vaccination), should receive COVID-19 vaccination.
In patients who have received a COVID-19 vaccine, this drug should be administered at least 2 weeks after vaccination.
Medical Conditions or Treatments That May Result in Moderate to Severe Immune Compromise and an Inadequate Immune Response to COVID-19 Vaccination Include:
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 (patients with HIV and CD4 counts less than 200/mm3, history of AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV)
Active treatment with high-dose corticosteroids (i.e., at least 20 mg prednisone or equivalent per day when administered for at least 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)

Patient advice:

Read the Fact Sheet for Patients, Parents, and Caregivers.
You may need to receive additional doses of this drug 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 this drug); therefore, this drug may not prevent COVID-19 due to these SARS-CoV-2 viral variants. If signs/symptoms of COVID-19 occur, test for COVID-19 and seek medical attention, including starting COVID-19 therapy as appropriate.