Information for Healthcare Providers on Obtaining and Using TPOXX (Tecovirimat) for Treatment of Monkeypox

Summary of Recent Changes

CDC, in partnership with FDA, has made it easier for healthcare providers to provide tecovirimat (TPOXX) treatment to patients with monkeypox under EA-IND. The streamlined process reduces the number of required forms and gives patients the option to see their doctor virtually. Demographics of patients receiving TPOXX under the EA-IND are available on CDC’s website.

How to obtain TPOXX

  • TPOXX is available through the Strategic National Stockpile, and multiple state and territorial health departments are pre-positioning supplies of TPOXX within their jurisdictions. Clinicians and care facility pharmacists requesting TPOXX should contact their state/territorial health department. Pre-positioned supply may be the fastest route to obtain TPOXX.
  • For urgent clinical situations after hours, providers may contact the CDC Emergency Operations Center (770-488-7100) for clinical consultation on patient cases.
  • Treatment with TPOXX can begin upon receipt of the medication and after obtaining informed consent.
  • Forms requested under the EA-IND can be returned to CDC after treatment begins. Please return completed forms to CDC via encrypted email (regaffairs@cdc.gov) or uploading to secure ShareFile (please zip multiple files and use filenames with patient initials, patient age, hospital/facility name, state, tecovirimat start date, and file contents [e.g., 1572, CV, Patient Intake Form]). Personally identifiable information should not be emailed without encryption.

Protocol

Required

  1. Informed Consent Form: English [238 KB, 6 pages] Obtain prior to treatment.
    1. Other languages: Spanish [263 KB, 7 pages] | Arabic [308 KB, 6 pages] | Korean [431 KB, 7 pages] | Russian [245 KB, 7 pages] | Simplified Chinese [316 KB, 6 pages] | Tagalog [243 KB, 7 pages] | Vietnamese [338 KB, 7 pages]
    2. Alternative Consent Forms that can be used to obtain informed consent:
  2. Patient Intake Form [385 KB, 2 pages]: Baseline assessment.
  3. FDA Form 1572 [1 MB, 2 pages]: One signed 1572 and treating clinician’s CV per facility suffices for all TPOXX treatments administered under the EA-IND at the same facility.
  4. Serious Adverse Events: Per FDA requirement, report life-threatening or serious adverse events associated with TPOXX by completing a PDF MedWatch Form [956 KB, 5 pages] and returning it to CDC via email (regaffairs@cdc.gov) or uploading to ShareFile within 72 hours of awareness or sooner, if possible. The PDF MedWatch Form can also be downloaded from the FDA website. (Note: The MedWatch Form can only be viewed on the Adobe desktop app. Please save or download the form for viewing.)

Optional

  • Patient diary [180 KB, 2 pages]: Ideally, give the diary to the patients during baseline assessment. Patient can use this form to record how they feel and any side effects to TPOXX.
  • Clinical Outcome Form [383 KB, 2 pages]: Progress and outcome information post treatment.
  • Photos of lesions: If feasible, take lesion photos at baseline prior to TPOXX treatment, and post-treatment to follow lesion progression and healing during treatment.
  • Lesions samples for resistance testing: Ideally, a sample from at least 1 lesion prior to TPOXX treatment but only if baseline diagnostic testing wasn’t performed, as well as samples from any new lesions that develop during and after TPOXX treatment to assess for development of antiviral resistance mutations. Optional Lesion Samples for Resistance Testing [106 KB, 1 page] has instructions on collection, storage, and submission of samples.
  • Pharmacokinetic samples for testing: During TPOXX treatment, plasma samples may be collected to monitor TPOXX levels for adequate drug exposure in patients. Optional Pharmacokinetic Samples for Testing [375 KB, 4 pages] has instructions on collection, storage, and submission of samples.

Institutional Review Board (IRB) Approval

  • CDC IRB serves as the central IRB for review and approval. Facilities may elect to rely on the CDC IRB for centralized review and approval by submitting a request to the CDC’s Human Research Protection Office within 7 calendar days of tecovirimat treatment at your facility. CDC will promptly document an agreement in writing using the CDC IRB Authorization Agreement (Sample Template) [4 MB, 2 pages] which must be signed by both parties.
  • Facilities that elect to obtain their own IRB review must ensure compliance with applicable FDA regulations related to the TPOXX EA-IND protocol. Note that the posted TPOXX EA-IND protocol and the attachments must be used without any changes being made by the IRB.
  • Since this TPOXX EA-IND protocol is solely for treatment use, CDC determined that its use does not constitute research involving human subjects as defined by 45 CFR 46.102, therefore, the federal-wide assurance requirements do not apply.