Tecovirimat
Tecovirimat is an antiviral medication specifically developed to treat infections caused by orthopoxviruses, including smallpox (variola virus). It is the first antiviral approved specifically for smallpox treatment. The drug works by inhibiting a protein essential for viral replication and spread, helping the body's immune system fight the infection more effectively.
Tecovirimat is an antiviral drug used to treat smallpox and other orthopoxvirus infections by blocking viral spread.
Key facts at a glance
- ATC
- J05AX24
- RxNorm
- 2055104
- Generic
- Tecovirimat
- Class
- atc-j05
- Brands
- Tpoxx
- Availability
- rx
- Lactation
- unknown
- Routes
- oral
- Forms
- injection, capsule
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 600mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 5mg/kg twice daily (max 600mg)
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 600mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
13 groupspregnancy
first trimesteravoid if possible
use only if benefits outweigh potential risks to fetus; tecovirimat should not be withheld if clinically indicated
regular prenatal monitoring
Use with caution and monitor for adverse effects.
pregnancy
second trimesterstandard dosing
use only if benefits outweigh potential risks; tecovirimat should not be withheld if clinically indicated for severe infection
regular prenatal monitoring
Use with caution and monitor for adverse effects.
pregnancy
third trimesterstandard dosing
use if benefits outweigh risks; consider timing of delivery
fetal monitoring and assessment of maternal condition
Use with caution and monitor for adverse effects.
lactation
breastfeedinguse with caution
breastfeeding mothers should decide with healthcare provider; consider pumping and discarding milk during treatment
monitor infant for adverse effects
pediatric_age
children under 12weight-based dosing required
approved for pediatric use; dosing based on weight; oral suspension available for young children
monitor weight, growth, and development during extended treatment
pediatric_age
adolescents 12 17adult dosing or weight-based
approved for adolescent use; follow adult dosing guidelines
standard monitoring
geriatric
elderly over 65standard dosing
use standard adult dosing; monitor renal and hepatic function
monitor renal function, liver enzymes, and overall clinical status
Use with caution and monitor for adverse effects.
renal_impairment
mildno adjustment needed
standard dosing; no dose modification required
standard monitoring
renal_impairment
moderateno adjustment needed
standard dosing; monitor renal function
monitor renal function periodically
Use with caution and monitor for adverse effects.
renal_impairment
severeuse with caution
use with caution; consider monitoring drug levels if available
close monitoring of renal function and clinical response
Use with caution and monitor for adverse effects.
hepatic_impairment
mildno adjustment needed
standard dosing
standard monitoring
hepatic_impairment
moderateno adjustment needed
use with caution; monitor liver function
monitor liver enzymes
Use with caution and monitor for adverse effects.
hepatic_impairment
severeuse with caution
use only if benefits outweigh risks; limited data available
close monitoring of liver function and clinical response
Use with caution and monitor for adverse effects.
Statistics and clinical data
Drug class
Tecovirimat is classified as an antiviral agent targeting orthopoxviruses
FDA approval year
FDA approval for treatment of smallpox
Primary indications
Primary therapeutic uses for orthopoxvirus infections
Mechanism of action
Molecular mechanism of antiviral action
Tecovirimat is indicated for the treatment of smallpox in adults and children. Due to the eradication of smallpox, its efficacy was established using animal models (animal rule), as human trials were not feasible. It may also be used for other orthopoxvirus infections, including mpox (monkeypox) and cowpox, when clinically appropriate.
Tecovirimat targets the VP37 protein (encoded by the F13L gene), which is essential for the formation and release of enveloped virions from infected cells. By inhibiting this protein, the drug prevents the virus from spreading to other cells, allowing the immune system to clear the infection more effectively.
Tecovirimat is available as oral capsules. Safety and effectiveness have been evaluated primarily through animal studies and limited human trials, as controlled trials for smallpox are not possible. The drug is generally well-tolerated, with headache, nausea, and abdominal pain being the most commonly reported side effects. It should be used as part of a comprehensive treatment approach, and patients should consult their healthcare provider for specific dosing and suitability information.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy