TPOXX (tecovirimat)
TPOXX (Tecovirimat) Operational Planning Guide — Information for Providing Therapeutics for Persons with Mpox
Currently there is no FDA-approved treatment for mpox virus infection.
TPOXX (also known as tecovirimat or ST-246) is FDA-approved for the treatment of human smallpox disease caused by variola virus in adults and children. The use of TPOXX for the treatment of other orthopoxvirus infections, including mpox, remains unapproved at this time.
However, the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, is now 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 in people with the disease. Providers are encouraged to inform patients with mpox about STOMP and to recommend they consider enrollment in STOMP. Patients who physically enroll at a STOMP trial site will receive TPOXX onsite. Remote enrollment is also available by which TPOXX is shipped directly to the patient, typically within 24 hours. Patients interested in participating can contact the STOMP call center at 1-855-876-9997.
Providers with patients with mpox who decline enrollment in or are ineligible for STOMP, or who require intravenous TPOXX treatment, and meet treatment eligibility under the
Expanded Access-Investigational New Drug (EA-IND) protocol (e.g., have severe disease or involvement of anatomic areas that might result in serious sequelae, or are at high risk for severe disease), can request TPOXX by calling the CDC Emergency Operations Center (EOC) at (770) 488-7100 or sending an e-mail to
poxvirus@cdc.gov. Providers can also request a clinical consultation regarding management of patients with mpox by contacting the CDC EOC or poxvirus@cdc.gov. (Note: The email box is monitored from 9 a.m. – 4 p.m. U.S. Eastern time on non-holiday weekdays. For urgent issues, contacting the on-call clinician via the EOC is preferred.)
To ensure compliance with FDA requirements and IND regulations, the treating providers are reminded to complete and return the required IND forms to CDC as outlined on
Information for Healthcare Providers: Tecovirimat (TPOXX) for Treatment of Mpox website. For additional information on the use of TPOXX, please see CDC’s
Guidance for Tecovirimat Use.
Formulations
TPOXX is available as oral capsules and vials for injection. 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 insert3 and 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.
Oral dosing can be found in the
EA-IND protocol or below.
Table 1. Recommended Dosage
Weight (kg)
|
Weight (lbs)
|
Recommended Dose (mg)*
|
|
< 3 kg
|
< 7 lbs
|
33.3 mg (⅙ capsule) every 12 hours
|
|
3 kg to < 6 kg
|
7 lbs to < 13 lbs
|
50 mg (¼ capsule) every 12 hours
|
|
6 kg to < 13 kg
|
13 lbs to < 28 lbs
|
100 mg (½ capsule) every 12 hours
|
|
13 kg to < 25 kg
|
28 lbs to < 55 lbs
|
200 mg (1 capsule) every 12 hours
|
|
25 kg to < 40 kg
|
55 lbs to < 88 lbs
|
400 mg (2 capsules) every 12 hours
|
|
40 kg to < 120 kg
|
88 lbs to < 264 lbs
|
600 mg (3 capsules) every 12 hours
|
|
120 kg and above
|
264 lbs and above
|
600 mg (3 capsules) every 8 hours
|
* Tecovirimat capsules should be taken within 30 minutes after a full meal containing moderate or high fat. Drug-Water or Drug-Food Preparation for Patients Who Cannot Swallow Capsules can be found in the EA-IND protocol. The standard treatment duration is 14 days. Based on the risk-benefit assessment of individual patients and depending on the disease progression, tecovirimat treatment may be extended beyond 14 days or shortened due to lack of virologic or clinical response, or occurrence of adverse events. Data on duration other than 14 days are limited.
In cases where intravenous (IV) treatment is needed, conversion from IV to oral TPOXX is recommended as soon as oral treatment can be tolerated. IV TPOXX should not be administered to patients with severe renal impairment (CrCl <30mL/min) and should be used with caution in patients with renal insufficiency or in children aged <2 years.
Dosing for pediatric and adult tecovirimat injection for IV infusion can be found in the
EA-IND protocol.
Note the possibility of resistance to TPOXX has been reported4 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.
