Ordering

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

Oral TPOXX: 

Oral tecovirimat for treatment of mpox is primarily available through the National Institutes of Health’s Study of Tecovirimat for Mpox (STOMP). Healthcare providers should contact the STOMP call center (1-855-876-9997) to enroll eligible patients.

• 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. Note: Eligibility under the EA-IND protocol was updated in June 2024; providers must adhere to the updated protocol.
• 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 consult with providers regarding patient eligibility under the CDC-held EA-IND protocol. Health departments may request a clinical consultation by contacting the CDC EOC at 770-488-7100 or by emailing poxvirus@cdc.gov.
• Access to TPOXX is predicated on receipt of the requisite completed paperwork (see above).
  
• For states that do not have pre-positioned oral TPOXX, health departments may request TPOXX by contacting the CDC EOC at 770-488-7100 or by requesting a clinical consultation by emailing poxvirus@cdc.gov.  
  

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:

IV TPOXX is not available via the STOMP trial. IV TPOXX is only available under the CDC held EA-IND protocol for patients with severe mpox manifestations, at increased risk for severe mpox, or who require IV treatment.

Clinicians with mpox patients requiring IV TPOXX treatment should contact CDC for clinical consultation. During business hours, contact CDC by emailing the CDC Clinical Consultation Team at poxvirus@cdc.gov. If after business hours, requests for consultation can be made by contacting the CDC EOC at 770-488-7100. When appropriate, CDC will notify the SNS that product has been approved for distribution. 

IV TPOXX Product specifications:

• One vial equals one dose for patients weighing 35 kg to < 120 kg
• Store refrigerated at 2-8^o C 
  
• When applicable, the recipient must open shipping containers immediately and follow the enclosed instructions to stop temp-tale and validate sustained shipping temperature range for IV TPOXX. In such cases, this may include:  
  
• sending temp-tale information/picture back to sns.ops@hhs.gov.
  
• SNS evaluating the temp-tale picture (for deviations) and approving the product for use
  
• immediately returning the shipping container/s and the temp-tale/s to SNS using the provided shipping label.
• If there are any issues or concerns with the received product, please notify sns.ops@hhs.gov immediately.
  

Information to include when making TPOXX requests to CDC for current mpox patients:

All requests to CDC for patient treatment 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 (oral) or # vials (IV)
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)