***Clinical/Expanded Use of an Investigational Product (Non-Research)***

Tecovirimat Eligibility:

All patient populations, who meet eligibility criteria, can receive tecovirimat treatment under this IND program (e.g., children and all adults including pregnant and nursing individuals, and prisoners). Clinical considerations of tecovirimat therapy during an outbreak may evolve depending on the duration and nature of the outbreak and event-based information that may become available during the outbreak. For up-to-date interim clinical guidance for treatment of monkeypox during the current 2022 monkeypox outbreak, please refer to CDC website at: https://www.cdc.gov/poxvirus/monkeypox/clinicians/treatment.html#anchor_1655488137245.

• People with severe disease (e.g., hemorrhagic disease, confluent lesions, sepsis, encephalitis, or other conditions requiring hospitalization).
• People who may be at high risk of severe disease:
  • People with immunocompromise (e.g., human immunodeficiency virus/acquired immune deficiency syndrome infection, 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;
  • People with a history or presence of atopic dermatitis, persons 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]);
  • Pregnant or breastfeeding women;
  • People with one or more complications (e.g., secondary bacterial skin infection; gastroenteritis with severe nausea/vomiting, diarrhea, or dehydration; bronchopneumonia; concurrent disease or other comorbidities).
• People with monkeypox virus aberrant infections that include accidental implantation in eyes, mouth, or other anatomical areas where monkeypox virus infection might constitute a special hazard (e.g., the genitals or anus).

Tecovirimat Ineligibility:

• Patient or legally authorized representative unwilling to sign an informed consent and refuse tecovirimat treatment.
• Known allergy to tecovirimat and/or inactive ingredients in tecovirimat.
• For IV tecovirimat only: patients with severe renal impairment (creatinine clearance < 30mL/min). Oral tecovirimat is an option for patients with severe renal impairment.