Drug updated on 12/11/2024
| Dosage Form | Capsule (oral; 200 mg); Injection (intravenous; 200 mg/20 mL [10 mg/mL]) |
| Drug Class | Inhibitors of the orthopoxvirus VP37 envelope wrapping protein |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of human smallpox disease caused by variola virus in adults and pediatric patients weighing at least 3 kg.
Latest News
Summary
- This summary is based on the review of one randomized controlled trial. [1]
- Tecovirimat demonstrated over 90% survival in monkeypox models at a minimum dose of 10 mg/kg for 14 days, while achieving similar efficacy at a higher dose of 40 mg/kg in rabbitpox models.
- The effective dose per kilogram was higher in rabbits compared to nonhuman primates, with lower exposure levels (Cmax, Cmin, Cavg, and AUC0-24hr) observed in rabbits, indicating nonhuman primates as a more conservative model for estimating human drug exposure.
- In a human trial involving 449 adult volunteers, a selected dose of 600 mg twice daily for 14 days provided exposures exceeding those seen in nonhuman primates, with no pattern of troubling adverse events reported.
- No significant safety concerns or adverse effects were noted in the provided study.
- There is no information available on population types or subgroups in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| TPOXX (tecovirimat) Prescribing Information. | 2024 | SIGA Technologies, Inc., New York, NY |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Oral Tecovirimat for the Treatment of Smallpox | 449Subjects F: 59% M: 41% | 2018 | The New England Journal of Medicine |
Document Title
Sex Distribution:
F:59%
M:41%
449Subjects
Year:
2018
Source:The New England Journal of Medicine