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| ID | Type | Description | Link |
|---|---|---|---|
| M-10922 | Other Identifier | USAMRDC |
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| Name | Class |
|---|---|
| SIGA Technologies | INDUSTRY |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TPOXX IV (Tecovirimat Injection, 10 mg/mL) | Drug | IV solution (10 mg/mL) must be diluted with 2 parts 0.9% normal saline or 5% dextrose solution prior to dosing. Once diluted, the drug product should be stored at 2-8°C (36-46°F) and used as soon as possible (i.e., not more than 24 hours after dilution). Given via an IV infusion pump over a 6 hour period, twice daily, and for up to 7 days, or until the physician determines oral TPOXX may be given |
Inclusion Criteria:
Have a confirmed or suspected (based on clinical signs and symptoms with known or suspected exposure and/or positive or pending laboratory confirmation) orthopox virus infection.
Note: Patients with a negative orthopox virus diagnostic test but with epidemiological and clinical evidence of an orthopox viral infection, especially those with evidence of clinical disease progression, may be included. Primary/Treating physician may consult with sponsor's Subject Matter Expert; OR Have developed a significant vaccinia adverse reaction (e.g., eczema vaccinatum, progressive vaccinia, generalized vaccinia that is severe or persistent, and select cases of inadvertent inoculation due to severe pain related to mucosal involvement, ocular involvement) resulting from vaccination, secondary transmission, or other exposure;
Be DoD-affiliated personnel (including active and reserve component service members, US civilian employees, contractors, other US personnel, and dependents, as well as allied military forces and local nationals) who have been granted access to the medical facility;
Unable to take the oral formulation of TPOXX (e.g., unable to swallow capsules or take medication powder dissolved in soft food or liquid, vomiting);
Is available for clinical follow-up for duration of the treatment and follow-up period;
Females of childbearing potential must use a highly effective method of contraception during treatment and for 30 days after the last dose of drug. Male patients with a female partner of childbearing potential must use an acceptable method of contraception and refrain from donating sperm during treatment and for 30 days after the last dose.
Exclusion Criteria:
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| ID | Term |
|---|---|
| C505045 | tecovirimat |
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