Tecovirimat (TPOXX) is an antiviral medication that is available for use to treat monkeypox under an expanded access investigational new drug (EA-IND) protocol (sometimes called “compassionate use”). It is the first-line medication to treat monkeypox in adults and children weighing 13kg or more. 

The CDC IRB serves as the central IRB for the tecovirimat protocol; they have determined that its use dose not constitute research involving human subjects as defined by 45 CFR 46.102.

Studies have shown it to be effective in treating orthopox virus infection in a variety of animal species. Based on limited available data, it is felt that tecovirimat may shorten the duration of patients’ illness and viral shedding. 

Clinical safety trials in people have found only minor side effects. There was a small increase in headache (12%) and nausea (5%) for patients taking tecovirimat compared to placebo (8% and 4% respectively). Significant side effects have not been reported with its use during the current outbreak.

Tecovirimat is available as a pill or IV injection, and is given as a 14 day course. Specific dosing information can be found in the package insert.

If an Orange County healthcare provider identifies a case that may require treatment, they can submit a request for tecovirimat to IAP@ochca.com mailbox or call 714-834-8180. For after office hours, please call 714-834-8180, and ask to speak to the HCA nurse on-call.

Medical providers have discretion as to when to use tecovirimat in treating monkeypox. In general, its use should be considered for treatment of persons who have severe disease or are at high risk of developing severe disease. CDC’s clinical considerations for the use of tecovirimat can be found here.

A confirmatory laboratory test result is not mandated prior to starting treatment; the medication can be started if a patient has disease consistent with monkeypox infection. Providers should obtain confirmatory clinical testing in all suspect cases, even if treatment is begun empirically.  

The CDC documentation that is required for each treated patient can be found here. Clinicians can start treatment upon completion of the informed medical consent document, which should be retained in the patient medical record. It does not need to be submitted. All other paperwork can be completed and submitted after starting treatment.

A Patient Intake Form and a Clinical Outcome Form both must be completed for each patient treated. An FDA Form 1572 must be submitted one time per facility offering treatment.  These forms must be completed and submitted to the CDC within 3 days of dispensing medication via email at regaffairs@cdc.gov.  To complete the Clinical Outcome Form, patients must be assessed three times: prior to treatment, once during the 14-day therapy, and once after completion of treatment. Patient assessments can be done in-person or virtually (via telemedicine).

Required safety reporting by clinicians and healthcare facilities focuses on serious adverse events only and should be reported by filling out a PDF MedWatch Form and returning it to CDC via email (regaffairs@cdc.gov) or uploading to ShareFile within 72 hours of awareness or sooner, if possible. Safety reporting is only required if a serious adverse event should occur. 

Providers with questions about tecovirimat can contact the Communicable Disease Control Division at (714) 834-8180.

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