Overview
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.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1Mechanism of Action Pemivibart is a SARS-CoV-2 antiviral drug [see Microbiology ( 12.4 )]. 12.2 Pharmacodynamics Available data suggest a positive relationship between serum neutralizing antibody titers and COVID-19 pre-exposure-prophylactic efficacy using clinical data (completed prior to the emergence of Omicron and Omicron lineage VOCs) and drug concentration data of neutralizing human monoclonal antibodies against SARS-CoV-2. Following single-dose administration of pemivibart 4500 mg IV, calculated geometric mean titer values (pemivibart concentration divided by the pseudotyped virus-like particle neutralization assay EC50 value against JN.1) [ see Microbiology ( 12.4 ) ] range from 2839 (on Day 90) to 20246 (end of infusion on Day 1).
Indications
- 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-2 and Who have moderate-to-severe immune compromise due to a medical condition or receipt of immunosuppressive...
Common Doses
- 4500 mg
- 125 mg
- 50 mL
- 36 mL
Dosage
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 (1 2.3 ) ]. 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.
Black Box Warning
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.
Contraindications
- 4 CONTRAINDICATIONS PEMGARDA is contraindicated in individuals with previous severe hypersensitivity reactions, including anaphylaxis, to any component of PEMGARDA.
Side Effects
- 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.
Interactions
- 7 DRUG INTERACTIONS Drug-drug interaction studies have not been performed. PEMGARDA is not renally excreted or metabolized by cytochrome P450 enzymes; therefore, interactions with concomitant medications that are renally excreted or that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are unlikely [see Clinical Pharmacology (12.3 )] .