pemgarda

WARNING: ANAPHYLAXIS Anaphylaxis has been observed with PEMGARDA in 0.6% (4/623) of participants in a clinical trial. Anaphylaxis was reported during the first and second infusion of PEMGARDA. ( 5.1 , 6.1 ) Anaphylaxis can be life-threatening. Prior to administering PEMGARDA, consider the potential benefit of COVID-19 prevention along with the risk of anaphylaxis. ( 5.1 , 6.1 , 14 ) Administer PEMGARDA 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 individuals during the infusion and for at least two hours after completion of the infusion. Discontinue PEMGARDA use permanently if signs or symptoms of anaphylaxis or any severe systemic reaction are observed and initiate appropriate medications and/or supportive therapy.

5 WARNINGS AND PRECAUTIONS 5.1 Anaphylaxis Anaphylaxis has been observed with PEMGARDA in 4 of 623 (0.6%) participants in a clinical trial [see Adverse Reactions (6.1 )] . Two participants had anaphylaxis during the first infusion, and two participants had anaphylaxis during the second infusion. Anaphylaxis can be life-threatening, and two of the anaphylactic reactions in the clinical trial were reported as life-threatening. Manifestations included pruritus, flushing, urticaria, erythema, angioedema, diaphoresis, dizziness, tinnitus, wheezing, dyspnea, chest discomfort, and tachycardia. In all 4 cases, PEMGARDA was permanently discontinued. Prior to administering PEMGARDA, consider the potential benefit of COVID-19 prevention along with the risk of anaphylaxis [see Adverse Reactions (6.1 ), and Clinical Studies (14 )] . Administer PEMGARDA 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 individuals during the 60-minute infusion and for at least two hours after completion of the infusion. If signs or symptoms of an anaphylactic reaction occur, immediately discontinue administration, and initiate appropriate medications and/or supportive therapy. Discontinue PEMGARDA use permanently in individuals who experience signs or symptoms of anaphylaxis [see Contraindications (4 )] . 5.2 Hypersensitivity and Infusion-Related Reactions Hypersensitivity and infusion-related reactions occurring during the infusion and up to 24 hours after the infusion have been observed with administration of PEMGARDA. Hypersensitivity or infusion-related reactions may be severe or life threatening. If signs or symptoms of a clinically significant hypersensitivity or infusion-related reaction occur, 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., pre-syncope, 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 individuals during infusion and for at least two hours after completion of the 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 Emergency Use Authorization. 5.3 Risk of Cross-Hypersensitivity With COVID-19 Vaccines 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 [see Description (11 ) ] . For individuals with a history of a severe hypersensitivity reaction to a COVID-19 vaccine, consider consultation with an allergist-immunologist prior to PEMGARDA administration. Administration of PEMGARDA should be done 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 during administration of PEMGARDA, immediately discontinue administration and initiate appropriate medications and/or supportive care. Clinically monitor individuals after infusion and observe for at least two hours. 5.4 Risk for COVID-19 Due to SARS-CoV-2 Viral Variants with Substantially Reduced Susceptibility to PEMGARDA 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. The cell culture neutralization activity of PEMGARDA against SARS-CoV-2 viral variants is described in Microbiology ( 12.4 ). Inform individuals of the increased risk, compared to other variants, for COVID-19 due to emergent SARS-CoV-2 viral variants that exhibit substantially reduced susceptibility to PEMGARDA. 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 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. For additional information on the symptoms of COVID-19, please see https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html.

5.1 Anaphylaxis Anaphylaxis has been observed with PEMGARDA in 4 of 623 (0.6%) participants in a clinical trial [see Adverse Reactions (6.1 )] . Two participants had anaphylaxis during the first infusion, and two participants had anaphylaxis during the second infusion. Anaphylaxis can be life-threatening, and two of the anaphylactic reactions in the clinical trial were reported as life-threatening. Manifestations included pruritus, flushing, urticaria, erythema, angioedema, diaphoresis, dizziness, tinnitus, wheezing, dyspnea, chest discomfort, and tachycardia. In all 4 cases, PEMGARDA was permanently discontinued. Prior to administering PEMGARDA, consider the potential benefit of COVID-19 prevention along with the risk of anaphylaxis [see Adverse Reactions (6.1 ), and Clinical Studies (14 )] . Administer PEMGARDA 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 individuals during the 60-minute infusion and for at least two hours after completion of the infusion. If signs or symptoms of an anaphylactic reaction occur, immediately discontinue administration, and initiate appropriate medications and/or supportive therapy. Discontinue PEMGARDA use permanently in individuals who experience signs or symptoms of anaphylaxis [see Contraindications (4 )] .

5.2 Hypersensitivity and Infusion-Related Reactions Hypersensitivity and infusion-related reactions occurring during the infusion and up to 24 hours after the infusion have been observed with administration of PEMGARDA. Hypersensitivity or infusion-related reactions may be severe or life threatening. If signs or symptoms of a clinically significant hypersensitivity or infusion-related reaction occur, 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., pre-syncope, 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 individuals during infusion and for at least two hours after completion of the 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 Emergency Use Authorization.

5.3 Risk of Cross-Hypersensitivity With COVID-19 Vaccines 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 [see Description (11 ) ] . For individuals with a history of a severe hypersensitivity reaction to a COVID-19 vaccine, consider consultation with an allergist-immunologist prior to PEMGARDA administration. Administration of PEMGARDA should be done 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 during administration of PEMGARDA, immediately discontinue administration and initiate appropriate medications and/or supportive care. Clinically monitor individuals after infusion and observe for at least two hours.

6 ADVERSE REACTIONS To report SERIOUS ADVERSE REACTIONS or MEDICATION ERRORS potentially related to PEMGARDA (1) do so by submitting FDA Form 3500 online, (2) by downloading this form, and then submitting it by mail or fax, or (3) by contacting the FDA at 1-800-332-1088 to request this form. To report suspected adverse reactions, please also provide a copy of this form to Invivyd, Inc. by email at: pv@invivyd.com or call 1-800-890-3385 to report adverse events. 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, 297 participants received a second dose of PEMGARDA 4500 mg IV three months after the initial dose. In Cohort B, 296 participants received a second dose of PEMGARDA 4500 mg IV and 154 received a second dose of placebo three months after the initial dose. 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, 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 Cumulatively, infusion-related reactions and hypersensitivity reactions were observed in 6% (38/623) of participants across cohorts, including: 9% (27/306) of participants who have moderate-to-severe immune compromise (Cohort A). 3% (11/317) of participants who received PEMGARDA in Cohort B. The severity of the reactions was generally mild (24/38) or moderate (12/38), but two reactions, both in Cohort A, 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 1% (10/623) of participants who received PEMGARDA across cohorts, including: 2% (7/306) of participants who have moderate-to-severe immune compromise (Cohort A). 1% (3/317) of participants who received PEMGARDA in Cohort B. Cumulatively, infusion-related reactions and hypersensitivity reactions were observed following both the first and second dose of PEMGARDA in 1% (7/623) of participants who received PEMGARDA across cohorts, including: 2% (6/306) of participants who have moderate-to-severe immune compromise (Cohort A). <1% (1/317) of participants who received PEMGARDA in Cohort B. 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 of PEMGARDA. No local infusion site reactions were observed in Cohort B. Local reactions were reported as infusion site bruising, infusion site erythema, and injection site reaction. All local reactions were mild, and none led to treatment discontinuation. Cumulatively, infusion site infiltration or extravasation was noted in 5% (15/306) of participants who have moderate-to-severe immune compromise (Cohort A) and in 1% (3/317) of participants in Cohort B with either the first or second dose of PEMGARDA. Other Common Adverse Events First and Second Dose, Cumulative 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 through Month 6 were as follows: In participants who have moderate-to-severe immune compromise in Cohort A: viral infection (7%), upper respiratory tract infection (7%), influenza-like illness (4%), urinary tract infection (4%), fatigue (3%), headache (3%), sinusitis (3%), nasopharyngitis (2%), influenza (2%), and pneumonia (2%). In Cohort B: upper respiratory tract infection (8%), viral infection (6%), influenza-like illness (5%), enterovirus infection (3%), and viral upper respiratory tract infection (2%). These adverse events were observed at a similar or higher rate with placebo. Cumulatively, infusion site infiltration or extravasation was noted in 5% (15/306) of participants who have moderate-to-severe immune compromise (Cohort A) and in 1% (3/317) of participants in Cohort B with either the first or second dose of PEMGARDA. To report SERIOUS ADVERSE REACTIONS or MEDICATION ERRORS potentially related to PEMGARDA (1) by submitting FDA Form 3500 online, (2) by downloading this form, and then submitting it by mail or fax, or (3) by contacting the FDA at 1-800-332-1088 to request this form. To report suspected adverse reactions, please also provide a copy of this form to Invivyd, Inc. by email at: pv@invivyd.com or call 1-800-890-3385 to report adverse events. 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 To report SERIOUS ADVERSE REACTIONS or MEDICATION ERRORS potentially related to PEMGARDA (1) do so by submitting FDA Form 3500 online, (2) by downloading this form, and then submitting it by mail or fax, or (3) by contacting the FDA at 1-800-332-1088 to request this form. To report suspected adverse reactions, please also provide a copy of this form to Invivyd, Inc. by email at: pv@invivyd.com or call 1-800-890-3385 to report adverse events.

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, 297 participants received a second dose of PEMGARDA 4500 mg IV three months after the initial dose. In Cohort B, 296 participants received a second dose of PEMGARDA 4500 mg IV and 154 received a second dose of placebo three months after the initial dose. 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, 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 Cumulatively, infusion-related reactions and hypersensitivity reactions were observed in 6% (38/623) of participants across cohorts, including: 9% (27/306) of participants who have moderate-to-severe immune compromise (Cohort A). 3% (11/317) of participants who received PEMGARDA in Cohort B. The severity of the reactions was generally mild (24/38) or moderate (12/38), but two reactions, both in Cohort A, 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 1% (10/623) of participants who received PEMGARDA across cohorts, including: 2% (7/306) of participants who have moderate-to-severe immune compromise (Cohort A). 1% (3/317) of participants who received PEMGARDA in Cohort B. Cumulatively, infusion-related reactions and hypersensitivity reactions were observed following both the first and second dose of PEMGARDA in 1% (7/623) of participants who received PEMGARDA across cohorts, including: 2% (6/306) of participants who have moderate-to-severe immune compromise (Cohort A). <1% (1/317) of participants who received PEMGARDA in Cohort B. 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 of PEMGARDA. No local infusion site reactions were observed in Cohort B. Local reactions were reported as infusion site bruising, infusion site erythema, and injection site reaction. All local reactions were mild, and none led to treatment discontinuation. Cumulatively, infusion site infiltration or extravasation was noted in 5% (15/306) of participants who have moderate-to-severe immune compromise (Cohort A) and in 1% (3/317) of participants in Cohort B with either the first or second dose of PEMGARDA. Other Common Adverse Events First and Second Dose, Cumulative 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 through Month 6 were as follows: In participants who have moderate-to-severe immune compromise in Cohort A: viral infection (7%), upper respiratory tract infection (7%), influenza-like illness (4%), urinary tract infection (4%), fatigue (3%), headache (3%), sinusitis (3%), nasopharyngitis (2%), influenza (2%), and pneumonia (2%). In Cohort B: upper respiratory tract infection (8%), viral infection (6%), influenza-like illness (5%), enterovirus infection (3%), and viral upper respiratory tract infection (2%). These adverse events were observed at a similar or higher rate with placebo. Cumulatively, infusion site infiltration or extravasation was noted in 5% (15/306) of participants who have moderate-to-severe immune compromise (Cohort A) and in 1% (3/317) of participants in Cohort B with either the first or second dose of PEMGARDA. To report SERIOUS ADVERSE REACTIONS or MEDICATION ERRORS potentially related to PEMGARDA (1) by submitting FDA Form 3500 online, (2) by downloading this form, and then submitting it by mail or fax, or (3) by contacting the FDA at 1-800-332-1088 to request this form. To report suspected adverse reactions, please also provide a copy of this form to Invivyd, Inc. by email at: pv@invivyd.com or call 1-800-890-3385 to report adverse events.

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 To report SERIOUS ADVERSE REACTIONS or MEDICATION ERRORS potentially related to PEMGARDA (1) do so by submitting FDA Form 3500 online, (2) by downloading this form, and then submitting it by mail or fax, or (3) by contacting the FDA at 1-800-332-1088 to request this form. To report suspected adverse reactions, please also provide a copy of this form to Invivyd, Inc. by email at: pv@invivyd.com or call 1-800-890-3385 to report adverse events.