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

CDC, in partnership with FDA, has made it easier for healthcare providers to provide tecovirimat (TPOXX) treatment to patients with monkeypox under the expanded access investigational new drug (EA-IND).

The streamlined process allows healthcare providers to start treatment before the paperwork is submitted, and reduces the number of required forms, patient samples, photos, and gives patients the option to see their doctor virtually.

How to obtain TPOXX

  • TPOXX is available through the Strategic National Stockpile. To request TPOXX, clinicians and care facility pharmacists can contact their state/territorial health department or CDC (Emergency Operations Center 770-488-7100; Poxvirus@cdc.gov)
  • Treatment with TPOXX can begin upon receipt of the medication and after obtaining informed consent. No pre-registration is required for clinicians or facilities.
  • Forms requested under the EA-IND can all be returned to CDC after treatment begins.

Protocol

  • CDC holds an intermediate-size patient population EA-IND(IND 116,039/Protocol 6402) to allow access to and use of TPOXX for treatment of orthopoxvirus infections, including monkeypox. The EA-IND provides an umbrella regulatory coverage so that clinicians and facilities do not need to request and obtain their own INDs. The EA-IND also provides liability coverage under the PREP Act for compensation to patients if injured via the Countermeasure Injury Compensation Program (CICP).
  • On July 21, 2022, CDC IRB approved an amendment [123KB, 1 page] and continuation [105KB, 1 page] of Protocol 6402 [430KB, 21 pages]. Clinicians, care facilities, hospitals providing TPOXX can immediately transition to the revised protocol and forms.
  • CDC IRB serves as the central IRB for review and approval of the TPOXX EA-IND protocol and determined that its use does not constitute research involving human subjects as defined by 45 CFR 46.102. Since this EA-IND protocol for TPOXX is solely for treatment use and not considered human subjects research, federal-wide assurance requirements do not apply.
  • For facilities requiring a reliance agreement, CDC IRB will provide a pre-signed reliance agreement for facilities to sign documenting reliance on CDC IRB (huma@cdc.gov).
  • Healthcare providers should complete the following forms:

Required

  1. Informed Consent Form [214KB, 5 pages]: Obtain prior to treatment.
  2. Patient Intake Form [321KB, 3 pages]: Baseline assessment.
  3. FDA Form 1572 [1MB, 2 pages]: One signed 1572 per facility suffices for all TPOXX treatments administered under the EA-IND at the same facility.
  4. Clinical Outcome Form [279KB, 4 pages]: Progress information during and post treatment.
  5. Serious Adverse Events : Report life-threatening or serious adverse events associated with TPOXX by completing a PDF MedWatch Form [226KB, 3 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 Photos and Samples

  • 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. See Optional Lesion Samples for Resistance Testing [117KB, 1 page] for 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. See Optional Pharmacokinetic Samples for Testing [253KB, 5 pages] for instructions on collection, storage, and submission of samples.

Optional Patient Diary and Instructions