pemgarda (PEMIVIBART)
pemgarda (PEMIVIBART) is one of 8,063 medications in the MedPlain dataset. Key details — Brand name: pemgarda; Generic name: PEMIVIBART; Manufacturer: Invivyd, Inc.
| Brand name | pemgarda |
|---|---|
| Generic name | PEMIVIBART |
| Manufacturer | Invivyd, Inc |
| Used for | 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. Med |
| 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. The recommendation |
| Warnings | 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 a |
| Active ingredient(s) | PEMIVIBART |
| Route | INTRAVENOUS |
| Official label | https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0bdc20a9-791f-9a06-e063-6394a90a84cc |