Distribution from the Strategic National Stockpile, Pre-Positioning, and Contingency Supplies
TPOXX (Tecovirimat) Operational Planning Guide — Information for Providing Therapeutics for Persons with Mpox
Distribution of TPOXX through Enrollment in STOMP
Providers are encouraged to inform eligible patients with mpox about
Study of Tecovirimat for Human Mpox Virus (STOMP). Patients who physically enroll at a STOMP trial site will receive TPOXX onsite. Remote enrollment is also available by which TPOXX is shipped directly to the patient, typically within 24 hours. Interested participants can contact the STOMP call center at 1-855-876-9997. For patients who do not qualify or decline participation in STOMP, TPOXX remains available through the CDC-held
Expanded Access-Investigational New Drug (EA-IND) protocol.
Orders for immediate patient use
Approved order requests initiated through the CDC Emergency Operations Center (EOC) are fulfilled by the Strategic National Stockpile (SNS). Typically, TPOXX from the SNS is delivered within 24 hours of order placement; however, some orders may arrive within 48 hours due to the time the order was placed, shipping routes and/or other logistical factors. Requests for consultation can be made by contacting the CDC EOC at 770-488-7100 or
poxvirus@cdc.gov. (Note: The email box is monitored from 9 a.m. – 4 p.m. U.S. Eastern time on non-holiday weekdays. For urgent issues, contacting the on-call clinician via the EOC is preferred.)
Pre-positioning and continued availability of pre-positioned TPOXX
As part of the U.S. government's response to the mpox outbreak, nearly 40,000 treatment courses of oral TPOXX were pre-positioned throughout the country. While some of this product has since expired, there are an estimated 25,000 treatment courses that are still on hand within jurisdictions. This inventory can continue to be used for the treatment of patients in accordance with the
CDC-held EA-IND protocol and in concert with CDC's
Guidance for Tecovirimat Use.
Based on several epidemiological factors and the current outbreak trajectory, including significant declines in the rolling 7-day average for new cases, pre-positioning of oral TPOXX was paused on February 27, 2023. ASPR, in consultation with its federal partners, continues to assess the need for pre-positioning and will notify jurisdictions if the program resumes.
Contingency planning / limited pre-positioned supply
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 aforementioned paths to obtain oral TPOXX for patients (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).
Data Reporting
The data reporting requirements are not impacted by the PHE and therefore remain unchanged.
- Health departments, serving as the central depot responsible for TPOXX distribution within their jurisdictions, are responsible for communicating the reporting requirements on TPOXX use under the EA-IND with the appropriate end-user.
- Treating facilities, hospitals, medical centers, and providers (private or affiliated with these facilities) need to ensure EA-IND paperwork is completed and submitted for each patient treated in accordance with FDA and HHS guidance (as noted below).
- For jurisdictions with pre-positioned oral TPOXX, jurisdictions will be required to attest to reporting doses on-hand and doses dispensed or administered, on a weekly cadence or as directed by HHS.
CDC holds an EA-IND protocol to allow access to and use of TPOXX for treatment of mpox. The EA-IND provides umbrella regulatory coverage to clinicians and facilities so that they do not need to request and obtain their own INDs. The EA-IND also provides liability coverage under the Public Readiness and Emergency Preparedness (PREP) Act for healthcare providers prescribing, administering, or dispending the drug, and the ability for patients to seek compensation if they are seriously injured by the medication (Countermeasures Injury Compensation Program). If patients meet the EA-IND eligibility criteria and there are no contraindications to treatment, treatment may begin once informed consent is obtained, with completion of the remaining required EA-IND paperwork soon after treatment starts.
TPOXX use under the EA-IND must comply with the following:
-
Register online – All providers must register as participating providers by completing the
Tecovirimat (TPOXX) IND Online Registry for Providers/Facilities prior to providing tecovirimat treatment to the extent feasible and no later than within 7 calendar days of first prescribing or administering tecovirimat.5,6
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Obtain Informed Consent – prior to initiating tecovirimat treatment; provide a copy to the patient and
retain a copy at the treating facility/institution.
- Complete the electronic Patient Intake Form for each patient who is prescribed tecovirimat as soon as possible and no later than 7 days of starting treatment.
Access the electronic form through theTecovirimat IND Online Registry.
- Report life-threatening or serious adverse events associated with TPOXX by completing a
PDF MedWatch Form and returning it to CDC via encrypted email (regaffairs@cdc.gov) within 72 hours of awareness or sooner, if possible. A fillable-PDF MedWatch Form can also be downloaded from the FDA Website.
- Complete the electronic Clinical Outcome Form within 3-7 days after completion of tecovirimat treatment.
Access the electronic form through theTecovirimat IND Online Registry.
Refer to
Information for Healthcare Providers: Tecovirimat (TPOXX) for Treatment of Mpox website for up-to-date tecovirimat EA-IND protocol and requirements.
5 Information for Healthcare Providers: Tecovirimat (TPOXX) for Treatment of Monkeypox | Monkeypox | Poxvirus | CDC
6 Online TPOXX registry
