TPOXX (tecovirimat)
TPOXX (Tecovirimat) Operational Planning Guide — Information for Providing Therapeutics for Persons with Mpox
Currently, there is no FDA-approved treatment for mpox.
TPOXX (also known as tecovirimat or ST-246) is FDA-approved only for the treatment of human smallpox disease cause by variola virus in adults and pediatric patients weighing at least 13kg. TPOXX is not approved for the treatment of other orthopoxvirus infections, including mpox, at this time.
The National Institute of Allergy and Infectious Diseases, part of NIH, is enrolling patients in the Study of Tecovirimat for Human Mpox Virus (STOMP), which is designed to assess whether TPOXX is safe and effective for the treatment of mpox. Providers are strongly encouraged to inform patients who present with symptoms of mpox about STOMP and to recommend that these patients consider enrollment in STOMP. Patients interested in participating in STOMP, including those seeking information on remote enrollment, can contact the STOMP call center at 1-855-876-9997.
Health care providers are encouraged to contact CDC if they attend to patients with mpox who are ineligible for STOMP or require intravenous (IV) TPOXX treatment and meet EA-IND eligibility. Providers should contact their state, local, or territorial health departments to determine if any oral TPOXX remains available within their jurisdiction from prior prepositioned supply. While the large-scale prepositioning of stockpiled oral tecovirimat stopped on February 27, 2023, any remaining supply can be used for EA-IND eligible patients.
For patients who require intravenous TPOXX treatment
and meet treatment eligibility
under the EA-IND protocol, providers, in conjunction with jurisdictional health departments, can contact the CDC EOC (770-488-7100) or
e-mail poxvirus@cdc.gov to make the request; a clinical consultation with a CDC clinical duty officer regarding management of hospitalized patients can also be requested.
To ensure compliance with FDA requirements and IND regulations, the treating providers are reminded to complete and return the required IND forms to CDC.
Formulations
TPOXX is available as oral capsules and vials for dilution for IV use. Each capsule contains 200 mg of tecovirimat active ingredient and comes in bottles containing 42 capsules each. TPOXX for injection comes as a 30 -ml single-dose vial containing 200 mg/20-mL of tecovirimat; instructions for dilution are available in the package insert2 and in the
EA-IND protocol.
Capsules are recommended, but drug absorption of oral formulation is dependent on adequate concurrent intake of a full meal of moderate or high fat (ideally about 600 calories and 25 grams of fat) to improve bioavailability.
Dosage and administration information for oral and IV tecovirimat formulations can be found in the
EA-IND protocol.
In cases where IV treatment is needed, conversion from IV to oral TPOXX is recommended as soon as oral treatment can be tolerated.
Note the possibility of resistance to TPOXX has been reported3 and should be considered in patients who either fail to respond to therapy or who develop recrudescence of disease after an initial period of responsiveness. To improve our understanding of any resistance that may be occurring, it is critical that viral specimens are obtained from patients that do not respond to treatment so that testing can be completed.
2 FDA label for TPOXX
3 Update on Managing Monkeypox in Patients Receiving Therapeutics
