Guidance for Tecovirimat use under expanded access investigational new drug protocol during 2022 U.S. monkeypox cases

Details

• Corporate Authors:
  National Center for Emerging and Zoonotic Infectious Diseases (U.S.). Division of High-Consequence Pathogens and Pathology.
• Description:
  Updated August 3, 2022
  
  Tecovirimat (also known as TPOXX or ST-246) is FDA-approved for the treatment of human smallpox disease caused by Variola virus in adults and children. However, its use for other orthopoxvirus infections, including monkeypox, is not approved by the FDA. Therefore, CDC holds a non-research expanded access Investigational New Drug (EA-IND) protocol that allows for the use of tecovirimat for primary or early empiric treatment of non-variola orthopoxvirus infections, including monkeypox, in adults and children of all ages.
  
  
• Content Notes:
  Treatment Consideration -- Efficacy -- Available Formulations -- Adverse Reactions -- Drug-Drug Interactions -- Special Populations -- Cost -- How to Request.
• Subjects:
  Antiviral Agents Drugs, Investigational Mpox (monkeypox) Poxviridae Infections/drug Therapy Smallpox/drug Therapy
• Document Type:
  Webpage
• Name as Subject:
  Tecovirimat ; Tecovirimat
• Place as Subject:
  United States
• Collection(s):
  Stephen B. Thacker CDC Library
• Main Document Checksum:
  urn:sha256:b23055bf80966c2be4f16ebb1cc0d21f0b62f141c02977c581a8d1036a379b8e
• Download URL:
  https://stacks.cdc.gov/view/cdc/119911/cdc_119911_DS1.pdf
• File Type:
  [PDF - 88.34 KB ]