Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Invivyd, Inc
053217022
Invivyd, Inc
421298354
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
pemgarda
Product Details
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 500 MG/4 ML CARTON
NDC 81960-031-03
Rx-Only
PEMGARDA
(pemivibart) injection
500 mg/4 mL (125 mg/mL)
For use under Emergency Use Authorization (EUA).
For Intravenous Infusion only.
Refer to the FDA-authorized Fact Sheet for detailed instructions on dosage and administration.

DESCRIPTION SECTION
11 DESCRIPTION
Pemivibart is a human IgG1 mAb produced by a Chinese Hamster Ovary cell line and has a molecular weight of 147.51 kDa.
PEMGARDA (pemivibart) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to yellow solution for intravenous infusion after dilution. Each 4 mL of solution contains 500 mg of pemivibart, glycine (33.03 mg), L-arginine hydrochloride (63.2 mg), L‑histidine (3.67 mg), L-histidine hydrochloride monohydrate (3.43 mg), L-methionine (5.97 mg), polysorbate 80 (1.2 mg), sterile water for injection (USP). The pH is 6.2.
INDICATIONS & USAGE SECTION
1 EMERGENCY USE AUTHORIZATION FOR PEMGARDA
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the unapproved product PEMGARDA (pemivibart) for the pre-exposure prophylaxis of coronavirus disease 2019 (COVID-19) in adults and adolescents (12 years of age and older weighing at least 40 kg):
- 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-2and
- Who have moderate-to-severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatmentsand 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:
- 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/mm 3, 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)
Limitations of Authorized Use
- PEMGARDA is not authorized for use:
- For treatment of COVID-19, or
- For post-exposure prophylaxis of COVID-19 in individuals who have been exposed to someone infected with SARS-CoV-2.
- Pre-exposure prophylaxis with PEMGARDA 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 from COVID-19 vaccination, should receive COVID‑19 vaccination.
- In individuals who have recently received a COVID-19 vaccine, PEMGARDA should be administered at least 2 weeks after vaccination.
PEMGARDA may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under State law to prescribe drugs.
PEMGARDA has been authorized by FDA for the emergency use described above. PEMGARDA is not FDA-approved for any use, including use for pre-exposure prophylaxis of COVID-19.
PEMGARDA is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PEMGARDA under section 564(b)(1) of the FD&C Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Justification for Emergency Use of Drugs During the COVID‑19 Pandemic:
There is currently an outbreak of coronavirus disease 2019 (COVID‑19) caused by SARS‑CoV‑2, a novel coronavirus. The Secretary of the U.S. Department of Health and Human Services (HHS) has:
- Determined that there is a public health emergency, or significant potential for a public health emergency [1].
- Declared that circumstances exist justifying the authorization of emergency use of drugs and biological products for the prevention or treatment of COVID-19 [2].
An EUA is an FDA authorization for the emergency use of an unapproved product or unapproved use of an approved product (i.e., drug, biological product, or device) in the United States under certain circumstances including, but not limited to, when the Secretary of HHS declares that there is a public health emergency that affects the national security or the health and security of United States citizens living abroad, and that involves biological agent(s) or a disease or condition that may be attributable to such agent(s). Criteria for issuing an EUA include:
- The biological agent(s) can cause a serious or life-threatening disease or condition.
- Based on the totality of the available scientific evidence (including data from adequate and well controlled clinical trials, if available), it is reasonable to believe that:
- the product may be effective in diagnosing, treating, or preventing the serious or life-threatening disease or condition; and
- the known and potential benefits of the product - when used to diagnose, prevent, or treat such disease or condition - outweigh the known and potential risks of the product, taking into consideration the material threat posed by the biological agent(s).
- There is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating the serious or life-threatening disease or condition.
Information Regarding Available Alternatives for the EUA Authorized Use
There are no adequate, approved, and available alternatives to PEMGARDA for the pre-exposure prophylaxis of COVID-19 in individuals who are unlikely to mount an adequate immune response to COVID-19 vaccination.
For information on clinical studies of PEMGARDA and other therapies for the pre-exposure prophylaxis of COVID-19, see www.clinicaltrials.gov.
DOSAGE & ADMINISTRATION SECTION
2 DOSAGE AND ADMINISTRATION
2.1 Dosage for Emergency Use of PEMGARDA
Initial Dosing:
The initial dosage of PEMGARDA in adults and adolescents (12 years of age and older weighing at least 40 kg) is 4500 mg administered as a single intravenous (IV) infusion [see Clinical Pharmacology (12.3 )].
Repeat Dose:
The repeat dosage is 4500 mg of PEMGARDA administered as a single IV infusion every 3 months. Repeat dosing should be timed from the date of the most recent PEMGARDA dose.
The recommendations for dosing are based on the totality of the scientific evidence including clinical pharmacology data, antiviral activity data, and clinical study data [see Clinical Pharmacology (12.3), Microbiology (12.4 ), and Clinical Studies (14 )].
2.2 Dosage Adjustment in Specific Populations
No dosage adjustment is recommended in pregnant or lactating individuals, in geriatrics, or in individuals with renal or hepatic impairment [see Use in Specific Populations (8 )].
2.3 Dose Preparation and Administration
General Information:
- PEMGARDA should be prepared and administered by a qualified healthcare provider using aseptic technique .
- Vials of PEMGARDA are for one-time use only.
- Visually inspect the vials for particulate matter and discoloration. PEMGARDA is a clear to slightly opalescent, colorless to yellow solution. Discard the vial if the solution is cloudy, discolored, or if visible particles are observed.
- PEMGARDA should be administered as an IV infusion diluted with 0.9% sodium chloride.
Materials Needed:
- 9 single-dose vials of PEMGARDA (125 mg/mL)
- 50 mL prefilled bag of 0.9% sodium chloride (normal saline) for IV injection
- IV extension set with inline 0.2-micron filter
- Infusion pump or gravity infusion set
- 0.9% sodium chloride injection for flushing
Preparation:
- Remove PEMGARDA vials from refrigerated storage and allow to equilibrate to room temperature (18℃ to 26℃ [64℉ to 79℉]) for 10 minutes before preparation.Do not expose to direct heat. Do not shake vials. Inspect the vials.
- Prepare IV bag by removing and discarding 36 mL from a 50 mL prefilled bag of 0.9% sodium chloride for IV injection.
- Withdraw 36 mL of PEMGARDA from nine (9) vials into appropriately sized polypropylene syringe(s) (e.g., one 40 mL syringe or two 20 mL syringes) and inject into prepared 0.9% sodium chloride IV bag.
- The final product for administration will contain 50 mL: 36 mL of PEMGARDA and 14 mL of 0.9% sodium chloride.
- This product is preservative-free and therefore should be administered immediately.
- If immediate administration is not possible, the diluted solution may be stored at room temperature under ambient light for up to 4 hours. Do not shake the diluted solution.
Administration:
- PEMGARDA should only be administered in settings in which healthcare providers have immediate access to medications to treat a severe hypersensitivity reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary [see Warnings and Precautions (5.1 )].
- Attach infusion set including inline 0.2-micron filter to prepared IV bag, then prime the infusion set.
- Administer the entire 50 mL infusion using infusion pump or gravity infusion set over a minimum of 60 minutes. Due to potential overfill, the entire contents of prepared IV bag should be administered to avoid underdosing.
- Once infusion is complete, flush line with 0.9% sodium chloride.
- Clinically monitor patients during infusion and observe patients for at least 2 hours after infusion is complete [see Warnings and Precautions (5.1)].
DOSAGE FORMS & STRENGTHS SECTION
3 DOSAGE FORMS AND STRENGTHS
PEMGARDA is a sterile, preservative-free, clear to slightly opalescent, colorless to yellow solution available as:
- Injection: 500 mg/4 mL (125 mg/mL) in a single-dose vial
CONTRAINDICATIONS SECTION
4 CONTRAINDICATIONS
PEMGARDA is contraindicated in individuals with previous severe hypersensitivity reactions, including anaphylaxis, to any component of PEMGARDA.
BOXED WARNING SECTION
WARNING: ANAPHYLAXIS
ADVERSE REACTIONS SECTION
6 ADVERSE REACTIONS
6.1 Adverse Reactions from Clinical Studies
The following adverse reactions have been observed in the clinical study of PEMGARDA that supported the EUA [see Clinical Studies (14)]. The adverse reaction rates observed in the clinical study cannot be directly compared to rates in the clinical studies of other products and may not reflect the rates observed in clinical practice. Additional adverse reactions associated with PEMGARDA may become apparent with more widespread use.
The safety of PEMGARDA is based on exposure of 623 participants who received at least one dose of PEMGARDA 4500 mg IV in one of two cohorts in the ongoing CANOPY trial. Cohort A is a single-arm, open-label trial in adults who have moderate-to-severe immune compromise (n=306), while Cohort B is a randomized, placebo-controlled trial in which adults who do not have moderate-to-severe immune compromise received PEMGARDA (n=317) or placebo (n=162). In Cohort A, 296 participants received a second dose of PEMGARDA 4500 mg IV three months after the initial dose. In Cohort B, 450 participants received a second dose of PEMGARDA 4500 mg IV or placebo three months after the initial dose. Cumulative safety with the first two doses of PEMGARDA is assessed only in Cohort A because unblinded safety data in Cohort B were not available after Day 28.
Anaphylaxis
Anaphylaxis was observed in 4 of 623 (0.6%) participants in CANOPY, all in Cohort A.
Two participants had anaphylaxis during the first infusion, and two participants had anaphylaxis during the second infusion. All four reactions led to permanent discontinuation of PEMGARDA. Three participants had complete resolution, and one participant had acute resolution with sequelae related to a flare of an underlying condition.
Symptoms of anaphylaxis during the first dose included dyspnea, diaphoresis, erythema (face), chest discomfort, and tachycardia in one participant, and flushing, dizziness, tinnitus, and wheezing in one participant. Treatment for both included diphenhydramine.
Both instances of anaphylaxis with the second dose were reported as life- threatening. Symptoms during the second infusion and following discontinuation of the infusion in both participants included pruritus, urticaria, angioedema, dyspnea, and either erythema or flushing. One participant also experienced headache, dizziness, and chest pain; additionally, pruritus, erythema, and urticaria reoccurred in this participant within 24 hours of the initial onset of anaphylaxis. Both participants were treated with diphenhydramine and epinephrine, and one participant also received oral prednisone and metoprolol for an associated flare of an underlying condition.
Systemic Infusion-Related Reactions and Hypersensitivity Reactions
First Dose
Systemic infusion-related reactions and hypersensitivity reactions (i.e., adverse events assessed as causally related) were observed with the first dose in CANOPY in 4% (24/623) of participants who received PEMGARDA across cohorts, including:
- 7% (20/306) of participants who have moderate-to-severe immune compromise (Cohort A), and
- 1% (4/317) of participants who received PEMGARDA in Cohort B
Infusion-related reactions and hypersensitivity reactions were not observed in any participants who received placebo in Cohort B.
Systemic infusion-related or hypersensitivity reactions that started within 24 hours of the first dose of PEMGARDA treatment were reported as infusion- related reaction, infusion-related hypersensitivity, hypersensitivity, fatigue, headache, tachycardia, brain fog, dermatitis, diarrhea, myalgia, nausea, paresthesia, presyncope, and tremor. All reactions were mild or moderate, but two reactions were anaphylaxis [see Box Warnings, and Warnings and Precautions (5.1, 5.2)]. Infusion-related reactions or hypersensitivity reactions led to discontinuation of the first infusion in 1% (6/623) of participants who received PEMGARDA.
First and Second Dose, Cumulative – Moderately to Severely Immunocompromised Population
Cumulatively, infusion-related reactions and hypersensitivity reactions were observed in 9% (27/306) of participants who have moderate-to-severe immune compromise, who received PEMGARDA in Cohort A of CANOPY. The severity of the reactions was generally mild (17/27) or moderate (8/27), but two reactions were life-threatening [see Boxed Warnings and Warnings and Precautions (5.1, 5.2)]. Infusion-related reactions or hypersensitivity reactions led to discontinuation of the first or second infusion in 2% (7/306) of Cohort A participants.
Two percent (5/306) of participants who have moderate-to-severe immune compromise (Cohort A) had an infusion-related reaction or hypersensitivity reaction with both the first and second dose of PEMGARDA.
Local Infusion Site Reactions
First and Second Dose, Cumulative
Cumulatively, local infusion site reactions were observed in 2% (6/306) of participants who have moderate-to-severe immune compromise (Cohort A) with either the first or second dose. No local infusion site reactions were observed in Cohort B. Local reactions were reported as infusion site bruising, infusion site erythema, infusion site rash, and injection site reaction. All local reactions were mild, and none led to treatment discontinuation.
Cumulatively, infusion site infiltration, extravasation, or vein rupture was noted in 5% (14/306) of participants who have moderate-to-severe immune compromise (Cohort A) with either the first or second dose.
Other Common Adverse Events
First and Second Dose, Cumulative – Moderately to Severely Immunocompromised Population
In addition to systemic and local infusion-related/hypersensitivity reactions described above, the most common (≥2%) treatment-emergent adverse events, irrespective of causality, observed with PEMGARDA in participants who have moderate-to-severe immune compromise (Cohort A) in CANOPY were upper respiratory tract infection (6%), viral infection (4%), influenza-like illness (3%), fatigue (3%), headache (2%), and nausea (2%).
6.4 Required Reporting for Serious Adverse Events and Medication Errors
The prescribing healthcare provider and/or the provider’s designee is/are responsible for mandatory reporting of all serious adverse events* and medication errors potentially related to PEMGARDA within 7 calendar days from the healthcare provider’s awareness of the event, using FDA Form 3500 (for information on how to access this form, see below). The FDA requires that such reports, using FDA Form 3500, include the following:
- Patient demographics and baseline characteristics (e.g., patient identifier, age or date of birth, sex, weight, ethnicity, and race).
- A statement “PEMGARDA use for the pre-exposure prophylaxis of COVID-19 under Emergency Use Authorization (EUA)” under the**“Describe Event, Problem, or Product Use/Medication Error”** heading.
- Information about the serious adverse event or medication error (e.g., signs and symptoms, test/laboratory data, complications, timing of drug initiation in relation to the occurrence of the event, duration of the event, treatment required to mitigate the event, evidence of event improvement/disappearance after stopping or reducing the dosage, evidence of event reappearance after reintroduction, clinical outcomes).
- Patient’s preexisting medical conditions and use of concomitant products.
- Information about the product (e.g., dosage, route of administration, NDC #).
Submit serious adverse event and medication error reports using FDA Form 3500 to FDA MedWatch using one of the following methods:
-
Complete and submit the report online: www.fda.gov/medwatch/report.htm.
-
Complete and submit a postage-paid FDA Form 3500
( https://www.fda.gov/media/76299/download) and return by:- Mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787, or
- Fax to 1-800-FDA (332)-0178, or
-
Call 1-800-FDA (332)-1088 to request a reporting form.
In addition, please provide a copy of all FDA MedWatch forms to:
Invivyd, Inc.
Email: pv@invivyd.com
Or call Invivyd, Inc. at 1-800-890-3385 to report serious adverse events.
The prescribing healthcare provider and/or the provider’s designee is/are responsible for mandatory responses to requests from FDA for information about serious adverse events and medication errors following receipt of PEMGARDA.
*Serious adverse events are defined as:
- Death
- A life-threatening adverse event
- Inpatient hospitalization or prolongation of existing hospitalization
- A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
- A congenital anomaly/birth defect
- Other important medical events, which may require a medical or surgical intervention to prevent death, a life-threatening event, hospitalization, disability, or congenital anomaly
OVERDOSAGE SECTION
10 OVERDOSAGE
Doses above 4500 mg PEMGARDA (the authorized dose of pemivibart) were not administered in clinical studies. There is no specific treatment for overdose with PEMGARDA.
SPL PATIENT PACKAGE INSERT SECTION
FACT SHEET FOR PATIENTS, PARENTS, AND CAREGIVERS
What is the most important information I should know about PEMGARDA?
PEMGARDA may cause serious side effects, including:
*A serious allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and can happen during or after your infusion of PEMGARDA. In case you have a severe allergic reaction to PEMGARDA and need medical help right away, you will receive PEMGARDA in a healthcare setting. Your healthcare provider will monitor you for allergic reactions during your infusion and for at least 2 hours after you are finished receiving PEMGARDA. Your healthcare provider will stop PEMGARDA right away if you develop signs or symptoms of anaphylaxis or severe allergic reaction.Tell your healthcare provider right away if you get any of the following signs or symptoms of anaphylaxis during or after your infusion of PEMGARDA:
itching |
dizziness |
flushing |
ringing in ears |
hives |
wheezing |
skin redness |
trouble breathing |
swelling of your face, lips, mouth, tongue, throat, hands, or feet |
chest discomfort |
sweating |
fast heartbeat |
See**“What are the important possible side effects of PEMGARDA?”**for more information about side effects.
You are being given this Fact Sheet because your healthcare provider believes it is necessary to provide you or your child with PEMGARDA for pre-exposure prophylaxis to help prevent coronavirus disease 2019 (COVID‑19) caused by the SARS-CoV-2 virus.
This Fact Sheet contains information to help you understand the potential risks and the potential benefits of receiving PEMGARDA, which you, or your child, have received or may receive.
The United States (US) Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to make PEMGARDA available during the COVID-19 pandemic (for more details about an EUA please see “What is an Emergency Use Authorization (EUA)?” at the end of this document). PEMGARDA is not an FDA-approved medicine in the US.
Read this Fact Sheet for information about PEMGARDA. Talk to your healthcare provider about your options or if you have any questions. It is your choice for you or your child to receive PEMGARDA or stop at any time.
What is COVID-19?
COVID-19 is caused by a virus called a coronavirus (SARS-CoV-2). You can get COVID-19 through contact with another person who has the virus.
COVID-19 illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in death. While information so far suggests that most COVID‑19 illnesses are mild, serious illness can happen and may cause some of your other medical conditions to become worse. Older people and people of all ages with severe, long lasting (chronic) medical conditions like immune compromise, heart disease, lung disease, diabetes, and obesity, for example, seem to be at higher risk of being hospitalized for COVID‑19.
What is PEMGARDA?
PEMGARDA is an investigational medicine that is authorized for use for pre- exposure prophylaxis to help prevent COVID-19 in adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) who:
- arenotcurrently infected with SARS-CoV-2 and who havenotbeen known to be exposed to someone who is infected with SARS-CoV-2and
- have moderate-to-severe immune compromise because of a medical condition or because they receive medicines or treatments that suppress the immune systemandthey are unlikely to have an adequate response to COVID-19 vaccination.
PEMGARDA is investigational because it is still being studied. There is limited information about the safety and effectiveness of using PEMGARDA for prevention of COVID-19. The FDA has authorized the emergency use of PEMGARDA for pre-exposure prophylaxis to help prevent COVID-19 under an EUA. For more information on EUA, see the**“What is an Emergency Use Authorization (EUA)?**” section at the end of this Fact Sheet.
PEMGARDA isnotauthorized:
- to treat COVID-19
- to prevent COVID-19 after being around someone infected with SARS-CoV-2 (post-exposure prophylaxis)
- for use in children under 12 years of age or weighing less than 88 pounds (40 kg)
Pre-exposure prophylaxis to help prevent COVID-19 with PEMGARDA does not take
the place of receiving COVID-19 vaccination in people who can be vaccinated for
COVID-19. If your healthcare provider recommends it, you should receive a COVID-19
vaccination.
If you have received a COVID-19 vaccine, you should wait at least 2 weeks after vaccination to receive PEMGARDA.
What should I tell my healthcare provider before I receive PEMGARDA?
Tell your healthcare provider about all of your medical conditions, including if you:
- have any allergies, including if you have had a severe allergic reaction to a COVID‑19 vaccine or to PEMGARDA.
- are pregnant or plan to become pregnant. It is not known if PEMGARDA can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if PEMGARDA can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive PEMGARDA.
- have any serious illnesses.
- take any medicines including prescription, over-the-counter, vitamins, and herbal products.
How will I receive PEMGARDA?
- You will receive 1 dose of PEMGARDA.
- PEMGARDA will be given to you through an infusion in a vein (intravenous [IV] infusion). It will take about 60 minutes to finish the infusion.
- You will receive PEMGARDA in a healthcare setting.
- You will be observed by a healthcare provider during your infusion and for at least 2 hours after your infusion is finished.
You may need to receive additional doses of PEMGARDA for ongoing protection from COVID-19. Viruses can change over time (mutate) and develop into a slightly different form of the virus, called a variant. Based on what we know about current SARS-CoV-2 variants, you may need to receive additional doses of PEMGARDA every 3 months.
Who should generally not take PEMGARDA?
Do not take PEMGARDA if you have had a severe allergic reaction to PEMGARDA or any ingredient in PEMGARDA. See the end of this Fact Sheet for a complete list of ingredients in PEMGARDA.
What are the important possible side effects of PEMGARDA?
- See “What is the most important information I should know about PEMGARDA?” ***Allergic and infusion-related reactions.**Allergic and infusion-related reactions are common and can sometimes be severe or life-threatening. Allergic and infusion-related reactions can happen during and after your infusion of PEMGARDA. You may have an increased risk of allergic reaction with PEMGARDA if you have had a severe allergic reaction to a COVID‑19 vaccine. PEMGARDA contains polysorbate 80, an ingredient in some COVID‑19 vaccines. Also, polysorbate 80 is similar to polyethylene glycol (PEG), an ingredient in other COVID‑19 vaccines. Your healthcare provider may consult with a healthcare provider who specializes in allergy and immunology before giving you PEMGARDA if you have had a serious allergic reaction to a COVID-19 vaccine. Your healthcare provider will monitor you for allergic reactions during the infusion and for at least 2 hours after you receive PEMGARDA.Tell your healthcare provider right away if you get any of the following signs or symptoms of an allergic or infusion-related reaction during or after your infusion of PEMGARDA:
fever |
headache |
trouble breathing or shortness of breath |
throat tightness or irritation |
chills |
high or low blood pressure |
tiredness |
swelling of your face, lips, mouth, tongue, throat, hands, or feet |
fast or slow heart rate |
rash, including hives |
chest pain or discomfort |
itching |
weakness |
muscle aches |
confusion |
feeling lightheaded, faint, or dizzy |
nausea |
sweating |
The side effects of receiving any medicine by vein (IV) may include pain, redness, bleeding, bruising of the skin, soreness, swelling, and possible infection at the infusion site.
The most common side effects in people treated with PEMGARDAwho have moderate-to-severe immune compromise include allergic and infusion-related reactions, infusion site reactions, common cold, viral infection, flu-like illness, tiredness, headache and nausea.
These are not all the possible side effects of PEMGARDA. Not a lot of people have been given PEMGARDA. Serious and unexpected side effects may happen. PEMGARDA is still being studied, so it is possible that all of the risks are not known at this time.
What other important information do I need to know when receiving PEMGARDA?
Risk of COVID-19 caused by certain SARS-CoV-2 variants: Viruses can change over time (mutate) and develop into a slightly different form of the virus, called a variant. PEMGARDA may not be effective at preventing COVID-19 caused by certain SARS‑CoV-2 variants. If you are exposed to these variants, your chance of developing COVID-19 is higher than from other variants. Tell your healthcare provider right away, and test for COVID-19, if you develop any symptoms of COVID-19, including:
fever or chills |
headache |
cough |
sore throat |
shortness of breath or difficulty breathing |
new loss of taste or smell |
congestion or runny nose |
feeling tired (fatigue) |
nausea or vomiting |
muscle or body aches |
diarrhea |
For more information about the symptoms of COVID-19, go to https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html.
If you develop COVID-19, your healthcare provider may recommend one of the available COVID-19 treatments.
What other prevention choices are there?
Vaccines to help prevent COVID-19 are approved or available under Emergency Use Authorization. Use of PEMGARDA does not replace vaccination against COVID-19. For information on clinical studies of PEMGARDA and other therapies for the pre-exposure prophylaxis of COVID-19, see www.clinicaltrials.gov.
It is your choice to receive or not receive PEMGARDA for pre-exposure prophylaxis to help prevent COVID-19. Should you decide not to receive PEMGARDA, it will not change your standard medical care.
PEMGARDA is not authorized to treat COVID-19 or for post-exposure prophylaxis of COVID-19.
What if I am pregnant or breastfeeding?
There is no experience using PEMGARDA in women who are pregnant or breastfeeding. For a mother and unborn baby, the benefit of receiving PEMGARDA may be greater than the risk of using the product. If you are pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider.
How do I report side effects with PEMGARDA?
Tell your healthcare provider right away if you have any side effect that bothers you or does not go away. Report side effects to FDA MedWatch at www.fda.gov/medwatch, or call 1‑800‑FDA‑1088, or call Invivyd at 1-800-890-3385.
How can I learn more about PEMGARDA?
If you have questions, visit the website, or call the telephone number provided below. To access the most recent PEMGARDA Fact Sheet, please scan the QR code provided below.
Website |
Telephone Number |
1-800-890-3385 |
How can I learn more about COVID-19?
- Ask your healthcare provider.
- Visit https://www.cdc.gov/COVID19.
- Contact your local or state public health department.
What is an Emergency Use Authorization?
The United States FDA has made PEMGARDA available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by a Secretary of Health and Human Services (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic.
PEMGARDA for pre-exposure prophylaxis to help prevent COVID-19 has not undergone the same type of review as an FDA-approved product. In issuing an EUA under the relevant COVID-19 declaration, the FDA has determined, among other things, that based on the total amount of scientific evidence available, including data from adequate and well-controlled clinical trials, it is reasonable to believe that the product may be effective for diagnosing, treating, or preventing COVID 19; that the known and potential benefits of the product, when used to diagnose, treat, or prevent such disease or condition, outweigh the known and potential risks of such product; and that there are no adequate, approved, and available alternatives.
All of these criteria must be met to allow the product to be used during the COVID-19 pandemic. The EUA for PEMGARDA is in effect for the duration of the COVID-19 declaration justifying emergency use of PEMGARDA, unless terminated or revoked (after which PEMGARDA may no longer be used under the EUA).
What are the ingredients in PEMGARDA?
Active ingredient: pemivibart
Inactive ingredients: glycine, L-arginine hydrochloride, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 80, and sterile water for injection.
Manufactured and distributed by: Invivyd, Inc., 1601 Trapelo Road, Suite 178, Waltham, MA 02451
INVIVYD™, PEMGARDA™, and the Ribbon logos are trademarks of Invivyd, Inc.
©2024 Invivyd, Inc. All rights reserved.
Issued: March 2024
Emergency Use Authorization (EUA) of PEMGARDA (pemivibart) for Coronavirus Disease 2019 (COVID-19)
HOW SUPPLIED SECTION
16 HOW SUPPLIED/STORAGE AND HANDLING
PEMGARDA injection is a sterile, preservative-free, clear to slightly opalescent, colorless to yellow solution supplied in a single-dose 6R vial intended for intravenous infusion only.
Antibody |
Concentration |
Package Size |
NDC |
---|---|---|---|
Pemivibart |
500 mg/4 mL vial (125 mg/mL) |
Nine vials per carton |
81960-031-03 |
Refrigerate unopened vials at 2 ℃ to 8 °C (36 ℉ to 46 °F) in the original carton to protect from light.
Do not freeze or shake. Do not use if seal is broken or missing.
SPL UNCLASSIFIED SECTION
18 MANUFACTURER INFORMATION
For additional information, visit: http://www.pemgarda.com/or scan the code below:

Manufactured and distributed by:
Invivyd, Inc.
1601 Trapelo Road, Suite 178
Waltham, MA 02451
INVIVYD™, PEMGARDA™, and the Ribbon logos are trademarks of Invivyd, Inc.
©2024 Invivyd, Inc. All rights reserved.