Ordering

TPOXX (Tecovirimat) Operational Planning Guide — Information for Providing Therapeutics for Persons with Mpox 

Oral TPOXX: 

For patients: For patients who decline enrollment in or are ineligible for STOMP, oral TPOXX remains available under the CDC-held EA-IND protocol. 

• State and local health departments who have pre-positioned supplies can provide oral TPOXX upon request from providers whose patients are eligible through the EA-IND. 
• 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.
• State and local health departments are also encouraged to have providers consult with CDC regarding patient eligibility under the CDC-held EA-IND protocol by contacting the CDC Emergency Operations Center (770-488-7100) or by requesting a clinical consultation at CDC by emailing poxvirus@cdc.gov.
• For states that do not have pre-positioned oral TPOXX, providers may request TPOXX from CDC by contacting the CDC Emergency Operations Center (770-488-7100) or by requesting a clinical consultation at CDC by emailing poxvirus@cdc.gov.  
  

One-time order for contingency supplies: As stated in the Distribution section above, jurisdictions where the previously pre-positioned on-hand supply of oral TPOXX has been exhausted or has expired may request a one-time contingency order of up to 20 bottles (not for immediate patient care) of oral TPOXX through HPOP. ASPR will follow up with jurisdiction partners to review each request.

Oral TPOXX Product specifications:

• Each bottle of capsules contains 42 capsules; one 14-day course equals 2 bottles for adults weighing < 120 kg
• Minimum order quantity (MOQ) is 2 bottles, all orders need to be placed in multiples of 2 bottles
• Store at controlled room temperature

IV TPOXX:

Clinicians with mpox patients requiring intravenous (IV) TPOXX treatment should reach out for clinical consultation with CDC; requests for consultation can be made by contacting the CDC Emergency Operations Center 770-488-7100.

IV TPOXX Product specifications:

• One vial equals one dose for patients weighing 35 kg to < 120 kg
• Store refrigerated at 2-8^o C 

All requests, both to CDC for patient treatment and via HPOP for pre-positioned oral TPOXX, should provide the following information, unless otherwise noted:

1. Jurisdiction/requestor
2. Formulation of TPOXX being requested: oral and/or IV (for patient treatment only)
3. Date by which TPOXX needs to be received
4. Name of receiving site
5. Shipping address of receiving site
6. Receiving POC #1 at the shipping address (name, email, 24/7 monitored phone #)
7. Receiving POC #2 at the shipping address (name, email, 24/7 monitored phone #)
8. State Health Department POC (name, email, 24/7 monitored phone #)
9. Quantity requested – in # bottles or # vials
10. Hours available to receive:
    
1. Monday-Friday hours to receive SNS shipments
2. Weekend/Holiday/hours to receive SNS shipments
3. Notes: (i.e., special delivery instructions)