For US Residents and Healthcare Professionals only.
For US Residents and Healthcare Professionals only.
PEMGARDA is contraindicated in individuals with previous severe hypersensitivity reactions, including anaphylaxis, to any component of PEMGARDA.
Serious hypersensitivity reactions, including anaphylaxis, have been observed with PEMGARDA. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive therapy. Clinically monitor individuals during infusion and observe for at least two hours after infusion is complete.
PEMGARDA 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 with a history of severe hypersensitivity reaction to a COVID-19 vaccine, consider consultation with an allergist-immunologist prior to PEMGARDA administration.
Certain SARS-CoV-2 viral variants may emerge that have substantially reduced susceptibility to PEMGARDA. PEMGARDA may not be effective at preventing COVID-19 caused by these SARS-CoV-2 viral variants. Inform individuals of the increased risk, compared to other variants, for COVID-19 due to SARS-CoV-2 viral variants that exhibit significantly reduced susceptibility to PEMGARDA. If signs and symptoms of COVID-19 occur, advise individuals to test for COVID-19 and seek medical attention, including starting treatment for COVID-19 as appropriate.
The most common adverse events (all grades, incidence ≥2%) observed in participants who have moderate-to-severe immune compromise treated with PEMGARDA included systemic and local infusion-related or hypersensitivity reactions, upper respiratory tract infection, viral infection, influenza-like illness, fatigue, headache, and nausea.
There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. PEMGARDA should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus.
There are no available data on the presence of PEMGARDA in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for PEMGARDA and any potential adverse effects on the breastfed infant from PEMGARDA.
PEMGARDA is not authorized for use in pediatrics less than 12 years of age or weighing less than 40 kg. The safety and effectiveness of PEMGARDA has not been established in pediatrics.
See full Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents, and Caregivers for examples of medical conditions or treatments that may result in moderate to severe immune compromise and an inadequate immune response to COVID-19 vaccination, the justification for emergency use of drugs during the COVID-19 pandemic, information on available alternatives, and additional information on COVID-19. The FDA Letter of Authorization is also available for reference.
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:
Submit serious adverse event and medication error reports using FDA Form 3500 to FDA MedWatch using one of the following methods:
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:
You may report side effects related to Invivyd, Inc. products by sending an email to medinfo@invivyd.com.
NOTICE TO ALL: Invivyd, Inc. (Invivyd) does not own or operate any infusion sites. Invivyd's Infusion Center Locator Directory (Locator) is a public resource and the sites displayed are not continuously vetted. This Locator of infusion centers is to be used by website visitors for the purpose of helping patients gain access to appropriate sites of care. It is intended solely for personal and non-commercial use to locate infusion center locations; any other use is strictly prohibited. This is merely a Locator and provided as a courtesy. Invivyd does NOT endorse or recommend any particular infusion center on the basis that it is listed in this Locator. It is the responsibility of the user, patient and/or provider to properly and thoroughly screen all infusion centers prior to receiving treatment and therapy. YOU ARE RESPONSIBLE FOR DETERMINING WHETHER A SITE IS ABLE TO MEET YOUR NEEDS.
No Medical Advice: Invivyd is not a healthcare provider. It does not render medical advice or services. Please contact you physician, other healthcare provider, or the infusion site directly with all medication, referral, facility, and otherwise medical and site-specific questions.
Not Intended for Use by Children: This Locator is not intended for children under the age of eighteen (18). Invivyd will not knowingly collect information from visitors under the age of eighteen (18).
Invivyd is not liable for the accuracy of the information in a site’s profile.
By continuing you agree to our Terms of Use
Invivyd, Inc. Infusion Center Locator Website Directory Terms and Conditions of Use Agreement
THIS CLICK-THROUGH AGREEMENT (THIS “AGREEMENT”) IS BETWEEN INVIVYD, INC. (INVIVYD) AND YOU. IF YOU ARE ENTERING INTO THIS AGREEMENT ON BEHALF OF A PHYSICIAN(S), PROFESSIONAL ORGANIZATION, COMPANY OR OTHER ENTITY, YOU REPRESENT THAT YOU ARE THE EMPLOYEE OR AGENT OF SUCH PHYSICIAN(S), PROFESSIONAL ORGANIZATION, COMPANY (OR OTHER ENTITY) AND YOU HAVE THE AUTHORITY TO ENTER INTO THIS AGREEMENT ON BEHALF OF SUCH PHYSICIAN(S), PROFESSIONAL ORGANIZATION, COMPANY (OR OTHER ENTITY). BY CLICKING ON THE “ACCEPT” BUTTON BELOW OR BY CHECKING THE BOX INDICATING YOUR ACCEPTANCE, YOU ACKNOWLEDGE THAT YOU HAVE READ ALL OF THE TERMS AND CONDITIONS SET FORTH BELOW, UNDERSTAND ALL OF THE TERMS AND CONDITIONS OF THIS AGREEMENT, AND AGREE TO BE BOUND BY ALL OF THE TERMS AND CONDITIONS OF THIS AGREEMENT. BY USING THE Invivyd, Inc. Infusion Center Locator website Directory (the "LOCATOR" hereafter), you are acknowledging your consent to these Terms and Conditions of Use. Do not use the Locator if you do not agree to the following Terms and Conditions of Use. Invivyd reserves the right to modify these Terms and Conditions of Use from time to time.
IF YOU DO NOT AGREE TO ANY OF THE TERMS AND CONDITIONS OF THIS AGREEMENT, INVIVYD IS UNWILLING TO ALLOW YOU TO USE OR SEARCH THE LOCATOR.
THE “EFFECTIVE DATE” OF THIS AGREEMENT IS THE DATE UPON WHICH YOU CLICK THE “ACCEPT” BUTTON. FOR THE PURPOSE OF THIS AGREEMENT, YOU AND, IF APPLICABLE, SUCH PHYSICIAN(S), PROFESSIONAL ORGANIZATION, COMPANY (OR OTHER ENTITY) CONSTITUTES “USER”.
Terms of Service. Invivyd, Inc. (INVIVYD) maintains an infusion center website directory (the “Locator”) to help patients, providers, organizations and other interested parties find access to appropriate sites of care for infusion therapy of PEMGARDA (pemivibart) injection for intravenous use (Please see the Fact Sheet for Patients, Parents, and Caregivers). Upon acceptance of the terms herein, User may search the Locator. User desires to use the Locator only in accordance with the terms set forth herein.
License. INVIVYD grants to User a nonexclusive, nontransferable, nonsublicensable, revocable and limited license to access and use its Locator solely for the specific purpose of searching the Locator to locate infusions sites of care for patients.
License Restrictions. Unless expressly otherwise set forth in this Agreement, User will not use the Locator to (a) solicit, attempt to solicit, or contact with the intent to solicit any product or service, (b) modify, rent, reverse engineer, copy, replicate, create derivative works of, disseminate, or disassemble the Locator, (c) engage in or support commercial activities or enterprise of the user or user’s affiliates, or (d) cause or permit any other party to do any of the foregoing.
Ownership. As between the parties, INVIVYD owns all right, title and interest in and to the Locator. No implied licenses are granted or exist in this Agreement, and INVIVYD reserves all rights not expressly granted under this Agreement.
Possible Errors and Omissions. The information in the Locator may contain inaccuracies or typographical errors. Invivyd reserves the right to make additions, deletions or modification to the information within the Locator at any time without prior notice. Invivyd also reserves the right to withdraw any site or other information contained in the Locator. USER ASSUMES FULL RESPONSIBILITY OF ANY AND ALL RISKS ARISING FROM OR RELATED TO THE USE OF THE LOCATOR OR THE INFORMATION CONTAINED THEREIN.
Warranty and Disclaimer. INVIVYD expressly disclaims responsibility for any consequences or liability attributable to or related to any use, non-use, or interpretation of information contained or not contained in the Locator. User represents warrants and covenants that: (a) User and, as applicable, all of User’s employees and consultants will abide by the terms of this Agreement; and (b) User and, as applicable, all of User’s employees and consultants will comply with all applicable laws, regulations, rules, orders and other requirements, now or hereafter in effect, of any applicable regulatory or governmental authority, in its performance of this Agreement. Notwithstanding any terms to the contrary in this Agreement, User will remain responsible for acts or omissions of all employees or consultants of User to the same extent as if such acts or omissions were undertaken by User. THE LOCATOR IS PROVIDED ON AN “AS IS” OR “AS AVAILABLE” BASIS WITHOUT ANY REPRESENTATIONS, WARRANTIES, COVENANTS OR CONDITIONS OF ANY KIND. INVIVYD DOES NOT WARRANT OR REPRESENT THAT ANY PART OF THE LOCATOR WILL BE FREE FROM ALL ERRORS, OR OMISSIONS. INVIVYD DISCLAIMS ANY AND ALL OTHER WARRANTIES AND REPRESENTATIONS (EXPRESS OR IMPLIED, ORAL OR WRITTEN, CREATED BY CONTRACT, OR OTHERWISE) WITH RESPECT TO THE LOCATOR WHETHER ALLEGED TO ARISE BY OPERATION OF LAW, BY REASON OF CUSTOM OR USAGE IN THE TRADE, BY COURSE OF DEALING OR OTHERWISE INCLUDING, WITHOUT LIMITATION ANY AND ALL (I) WARRANTIES OF MERCHANTABILITY, (II) WARRANTIES OF FITNESS OR SUITABILITY FOR ANY PURPOSE (WHETHER OR NOT INVIVYD KNOWS, HAS REASON TO KNOW, HAS BEEN ADVISED, OR IS OTHERWISE AWARE OF ANY SUCH PURPOSE), AND (III) WARRANTIES OF NONINFRINGEMENT OR CONDITION OF TITLE. USER ACKNOWLEDGES AND AGREES THAT USER HAS RELIED ON NO WARRANTIES OR REPRESENTATIONS. IN NO EVENT SHALL INVIVYD BE LIABLE FOR ANY DAMAGES, INCLUDING BUT NOT LIMITED TO DIRECT, INDIRECT, SPECIAL, PUNITIVE, INCIDENTAL OR CONSEQUENTIAL DAMAGES (INCLUDING LOSS OF PROFIT) ARISING FROM OR IN CONNECTION WITH THE USE OR EXISTENCE OF THE LOCATOR, THE INABILITY TO USE THE LOCATOR, AND/OR THE INFORMATION THAT THE LOCATOR CONTAINS, REGARDLESS OF WHETHER INVIVYD HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. INVIVYD DOES NOT WARRANT THAT THE LOCATOR OR THE SERVERS THAT MAKE IT AVAILABLE ARE FREE FROM ERRORS OF ANY SORT OR FREE FROM COMPUTER VIRUSES.
INVIVYD ALSO DISCLAIMS RESPONSIBILITY FOR ANY DAMAGES WHATSOEVER THAT RESULT FROM MISTAKES, OMISSIONS, INTERRUPTIONS, DELETION OF FILES, ERRORS, DEFECTS, DELAYS IN OPERATION OR TRANSMISSION, OR ANY FAILURE OF PERFORMANCE RELATING TO THE LOCATOR WHETHER OR NOT CAUSED BY EVENTS BEYOND OUR REASONABLE CONTROL INCLUDING, WITHOUT LIMITATION, ACTS OF ANY OF OUR THIRD-PARTY VENDORS, ACTS OF GOD, COMMUNICATION LINE FAILURE, THEFT, DESTRUCTION OR UNAUTHORIZED ACCESS TO THE WEBSITES’ RECORDS, PROGRAMS OR SERVICES. IN NO EVENT SHALL INVIVYD’S TOTAL LIABILITY FOR ALL DAMAGES, LOSSES AND CAUSES OF ACTION EXCEED FIVE DOLLARS ($5.00).
Indemnification. YOU AGREE TO DEFEND, INDEMNIFY, AND HOLD HARMLESS INVIVYD, ITS OFFICERS, DIRECTORS, EMPLOYEES AND THIRD-PARTY VENDORS FROM AND AGAINST ANY LOSSES, DAMAGES, CLAIMS, ACTIONS, DEMANDS OR EXPENSES, INCLUDING REASONABLE ATTORNEY’S FEES, OF ANY PERSON OR ENTITY, INCLUDING PERSONAL INJURY AND DEATH, REGARDLESS OF WHETHER THEY ARISE OUT OF OR ARE ATTRIBUTABLE TO ANY ACT OR OMISSION, NEGLIGENT OR OTHERWISE, OF INVIVYD, ARISING OUT OF OR IN CONNECTION WITH: (i) YOUR USE OF ANY OF THE LOCATOR, (ii) YOUR BREACH OF THESE TERMS AND CONDITIONS OF USE, INCLUDING ANY ABUSIVE OR UNLAWFUL BEHAVIOR ON THE PART OF YOU OR YOUR DEPENDENTS, OR (iii) YOUR INFRINGEMENT OF ANY INTELLECTUAL PROPERTY OR PRIVACY RIGHT OF ANY PERSON. THIS INDEMNIFICATION PROVISION SHALL APPLY TO THIRD-PARTY CLAIMS AS WELL AS CLAIMS BETWEEN THE PARTIES TO THESE TERMS AND CONDITIONS OF USE.
Use of Data. In compliance with applicable privacy rules, regulations and laws, (i) INVIVYD hereby expressly reserves the right to process and (2) User hereby grants INVIVYD the right to process, including without limitation, collect, use, analyze, record, organize, structure, store, adapt or alter, retrieve, consult, use, disclose by transmission, disseminate or otherwise make available, align or combine, restrict, erase or destroy and disseminate any and all User information and data including, but not limited to, your search queries, search results, search patterns, geography and demographic information, Locator usage date and time of search session(s), geographic location, how you navigated the Locator site, and how you interacted with the Locator site. This information is collected for our legitimate business purposes and will be saved for the period of time needed to fulfill legitimate and lawful business purposes in accordance with INVIVYD’s policies and applicable laws and regulations. User accepts that their personal information is treated in accordance with Invivyd's online Privacy Policy.
Limitation of Liability. EXCEPT FOR ANY ACTS OF FRAUD, GROSS NEGLIGENCE, OR WILLFUL MISCONDUCT, IN NO EVENT WILL INVIVYD BE LIABLE TO USER OR ANY THIRD PARTY FOR ANY LOSS OF PROFITS, LOSS OF USE, LOSS OF REVENUE, LOSS OF GOODWILL, ANY INTERRUPTION OF BUSINESS, OR FOR ANY INDIRECT, SPECIAL, INCIDENTAL, EXEMPLARY, PUNITIVE OR CONSEQUENTIAL DAMAGES OF ANY KIND ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT OR THE LOCATOR, REGARDLESS OF THE TYPE OF ACTION, WHETHER IN CONTRACT, TORT, STRICT LIABILITY OR OTHERWISE, EVEN IF INVIVYD HAS BEEN ADVISED OR IS OTHERWISE AWARE OF THE POSSIBILITY OF SUCH DAMAGES.
Termination. The term of this Agreement will commence on the Effective Date and will remain in effect in perpetuity, unless otherwise terminated in accordance with this Agreement. User may voluntarily terminate this Agreement at any time by deleting and destroying all physical and/or electronic copies of any part of the Locator. Without prejudice to any other rights, in the event of a breach of this Agreement by you, INVIVYD may immediately terminate this Agreement. Upon expiration or termination of this Agreement, all rights granted to User under this Agreement will immediately cease. In addition to all definitions and this sentence, the following sections will survive any termination or expiration of this Agreement: Warranty and Disclaimer, Indemnification, Use of Data, and Limitation of Liability.
Miscellaneous. This Agreement is the entire agreement of the parties regarding the subject matter hereof, superseding all other agreements between them, whether oral or written, regarding the subject matter hereof. This Agreement will be governed by and construed in accordance with the laws of Massachusetts applicable to agreements made and to be entirely performed within the State of Massachusetts, without resort to its conflict of law provisions. User may not transfer User’s rights under this Agreement to any third party. If any provision of this Agreement is invalid, illegal, or incapable of being enforced by any rule of law or public policy, all other provisions of this Agreement will nonetheless remain in full force and effect.
If any of the above exclusions of warranties is unenforceable in your jurisdiction, the other exclusions listed above will still be given effect to the full extent permitted by that jurisdiction's law.
The information provided on www.pemgarda.com is intended for U.S. Healthcare Professionals and Residents only. Please confirm you are a U.S. Healthcare Professional or Patient/Caregiver.