Tecovirimat (TPOXX): Information for healthcare providers

Tecovirimat (TPOXX): Information for healthcare providers

While there is no FDA approved treatment for monkeypox, Tecovirimat (TPOXX) is available for use as an investigational new drug (IND). This process allows healthcare providers to start treatment before the CDC paperwork is submitted, and recently, the CDC has reduced the number of required forms, patient samples, and photos to treat your patient with Tecovirimat. All required forms for administering Tecovirimat (TPOXX) can be found on the CDCs EA-IND.

Providers who provide this drug are responsible for the paperwork related to giving this medication. This includes an initial patient evaluation, follow-up, monitoring, and reporting collected information to CDC. An initial evaluation is required and a 3-14 day post treatment evaluation is now optional. These can be done by telemedicine.

While most cases do not require treatment, Tecovirimat (TPOXX) may be considered for treatment in people infected with Monkeypox virus:

  • With severe disease (e.g., hemorrhagic disease, confluent lesions, sepsis, encephalitis, or other conditions requiring hospitalization)
  • Who are at high risk of severe disease:
    • People with immunocompromising conditions (e.g., HIV/AIDS, leukemia, lymphoma, generalized malignancy, solid organ transplantation, therapy with alkylating agents, antimetabolites, radiation, tumor necrosis factor inhibitors, high-dose corticosteroids, being a recipient with hematopoietic stem cell transplant <24 months post-transplant or ≥24 months but with graft-versus-host disease or disease relapse, or having autoimmune disease with immunodeficiency as a clinical component)
    • Pediatric populations, particularly patients younger than 8 years of age
    • Pregnant or breastfeeding women
    • People with a history or presence of atopic dermatitis, people with other active exfoliative skin conditions (e.g., eczema, burns, impetigo, varicella zoster virus infection, herpes simplex virus infection, severe acne, severe diaper dermatitis with extensive areas of denuded skin, psoriasis, or Darier disease [keratosis follicularis])
    • People with one or more complication (e.g., secondary bacterial skin infection; gastroenteritis with severe nausea/vomiting, diarrhea, or dehydration; bronchopneumonia; concurrent disease or other comorbidities)
  • With infections involving accidental implantation in eyes, mouth, or other anatomic areas where Monkeypox virus infection might constitute a special hazard (e.g., the genitals or anus)

Full guidance can be found online on the CDC website.

Begin treatment if there is clinical suspicion of severe monkeypox before test results are available. Patients with an initial negative test, but for whom both epidemiologic and clinical evidence suggests monkeypox disease (particularly if clinical progression is worsening), should be re-tested but be treated with TPOXX while results are pending. If results from re-testing confirm monkeypox, patients should continue TPOXX treatment. If results from re-testing are in agreement with the initial negative test results, TPOXX should be suspended in those patients.

Utah DHHS has identified some specific providers who are able to provide this medication. For help locating treatment or if you are interested in providing this medication please contact mpxtreatment@utah.gov