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

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

[PDF-88.34 KB]

English

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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

Tecovirimat ; Tecovirimat Less -
Place as Subject:

United States
Collection(s):

Stephen B. Thacker CDC Library collection
Main Document Checksum:

[+]

urn:sha256:b23055bf80966c2be4f16ebb1cc0d21f0b62f141c02977c581a8d1036a379b8e
Download URL:

https://stacks.cdc.gov/view/cdc/119911/cdc_119911_DS1.pdf
File Type:

Tecovirimat.html

htm

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