TPOXX Thresholds by Jurisdiction
On August 22, 2022, ASPR made 50,000 patient courses of TPOXX (100,000 bottles) available to jurisdictions to make the treatment more readily accessible for providers and patients. ASPR has distributed approximately 40,000 patient courses of TPOXX to help states and jurisdictions respond to the mpox outbreak.
TPOXX is not FDA-approved for mpox but is available under the Expanded Access Investigational New Drug (EA-IND) for treatment of people infected with mpox, particularly those with severe disease, or at risk for severe disease such as immunocompromised, and pediatric cases. A list of considerations can be found under
Interim Clinical Guidance for the Treatment of Mpox.
Equitable distribution remains a priority, ensuring jurisdictions have the ability to access TPOXX when and where needed for eligible patients.
Jurisdiction health departments ordering TPOXX capsules from thresholds was paused on February 27, 2023. With the current pause on the large-scale pre-positioning program, there are a limited number of jurisdictions where the previously pre-positioned on hand supply of oral TPOXX has been exhausted or has expired. As contingency to the paths to obtain oral TPOXX for patients in the
TPOXX Operational Planning Guide (i.e., enrollment in STOMP or
ordering from the SNS via the CDC EOC), jurisdictions may wish to hold a limited supply oral TPOXX so that they can be prepared for instances in which rapid deployment of product from within a given jurisdiction is the most effective way to avoid delaying treatment for critically ill patients with mpox who are eligible for treatment under the EA-IND. To ensure that all jurisdictions have this response capability, any jurisdiction without a current supply of oral TPOXX can place a one-time order for up to 20 bottles of oral TPOXX using the HPOP ordering system for pre-positioning (see “Ordering" for additional information on how to place an order using HPOP).
For the intravenous (IV) formulation of TPOXX, jurisdiction health departments should continue to contact the CDC directly. The IV formulation should only be considered when oral route is not possible, and patients should be converted to oral TPOXX as soon as they can tolerate swallowing capsules.
CDC holds the EA-IND protocol which allows access to and use of TPOXX for treatment of mpox. The EA-IND provides umbrella regulatory coverage to clinicians, so that facilities do not need to request and obtain their own INDs. The EA-IND also provides liability coverage under the PREP Act only when appropriate documentation is filed for each patient receiving treatment, and the drug is administered in accordance with the EA-IND.
Appropriate monitoring of patient safety and clinical outcomes for anyone receiving TPOXX is required. Healthcare providers are required to complete the specific forms when initiating TPOXX treatment for a patient and return the forms to CDC. TPOXX distribution will be tracked by the number of bottles.
For additional ordering details, jurisdiction health departments and healthcare providers should see the TPOXX ordering in the operational planning guide. For pre-positioning purposes, we are estimating 2 bottles per patient course and will be tracking bottles for inventory purposes.
