The Centers for Disease Control and Prevention (CDC) has updated its Guidance for Tecovirimat (TPOXX) Use Under Expanded Access Investigational New Drug Protocol, based on data from the published literature and recently released data from the Food and Drug Administration, which suggest that broad use of the antiviral drug TPOXX could promote resistance and render the drug ineffective for some patients.

All patients with monkeypox benefit from supportive care and pain control that is started early in the illness. For most patients with healthy immune systems, supportive care and pain control may be enough. However, there are some instances where TPOXX could be beneficial, and CDC has updated guidance to reflect this. 

Specifically, TPOXX should be considered for use in people who have—

• Severe disease—meaning someone has a condition such as hemorrhagic disease, confluent lesions (i.e., individual sores have joined into one larger sore), sepsis, encephalitis, eye infections, or other infections that require hospitalization
• Involvement of anatomic areas which might result in serious disease including scarring

TPOXX should also be considered for use in people who are at high risk for severe disease, including—

• People with immunocompromising conditions
• Children, particularly patients younger than 8 years of age
• People who are pregnant or breastfeeding
• People with certain skin infections

However, for those patients for whom TPOXX is recommended, early administration is best. Patients can begin treatment as soon they have provided informed consent to their healthcare provider and the provider is enrolled in the Expanded Access Investigational New Drug protocol.

Additional Resources (updated September 15, 2022)

• Treatment Information for Healthcare Professionals
• Patient's Guide to Monkeypox Treatment with TPOXX
• Study of Tecovirimat for Human Monkeypox Virus (STOMP) Clinical Trial