pemgarda 125 mg/mL
pemivibart · INJECTION · Invivyd, Inc
pemgarda is a injection containing pemivibart at 125 mg/mL, taken intravenous. Manufactured by Invivyd, Inc.
Key Facts
- Brand Name
- pemgarda
- Generic Name
- pemivibart
- NDC Code (Product)
81960-031- Manufacturer
- Invivyd, Inc
- Strength
- 125 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- EUA000122
- Marketing Start
- 03/22/2024
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
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 medications or treatments and 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 immunosu…
Dosage & Administration
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. 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 ) ] . 2.3Dose 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 inspe…
Contraindications
4 CONTRAINDICATIONS PEMGARDA is contraindicated in individuals with previous severe hypersensitivity reactions, including anaphylaxis, to any component of PEMGARDA.
Drug 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 )] .
Adverse Reactions
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 imm…
Frequently Asked Questions
What is pemgarda used for?
pemgarda contains pemivibart. It is a injection taken intravenous. Consult your doctor for specific uses.
Is pemgarda a controlled substance?
pemgarda is not classified as a controlled substance by the DEA.
What is the generic name for pemgarda?
The generic name for pemgarda is pemivibart. There are no other listed brand versions of pemivibart.
What is the NDC code for pemgarda 125 mg/mL?
The NDC (National Drug Code) for pemgarda 125 mg/mL is 81960-031, listed by Invivyd, Inc.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)