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Tecovirimat

Medically reviewed by Drugs.com. Last updated on Aug 27, 2019.

Pronunciation

(TEK oh VIR i mat)

Index Terms

  • Tpoxx

Pharmacologic Category

  • Antiviral Agent

Pharmacology

Tecovirimat inhibits the activity of the orthopoxvirus VP37 protein and blocks its interaction with cellular Rab9 GTPase and TIP47, preventing formation of egress-competent enveloped virions (necessary for dissemination of virus).

Distribution

Vd (Vz/F): 1,030 L

Metabolism

Hydrolysis of the amide bond and glucuronidation (UGT1A1, UGT1A4)

Excretion

Urine (73%, predominantly metabolites); feces (23%, predominantly as unchanged drug)

Time to Peak

4 to 6 hours

Half-Life Elimination

20 hours

Protein Binding

77% to 82%

Use: Labeled Indications

Smallpox: Treatment of human smallpox disease caused by variola virus in adults and pediatric patients weighing ≥13 kg.

Limitations of use: Treatment of smallpox disease has not been determined in humans because adequate and well-controlled field trials have not been feasible, and inducing smallpox disease in humans to study the drug's efficacy is not ethical.

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Dosing: Adult

Smallpox: Oral: 600 mg twice daily for 14 days

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Smallpox disease: Children and Adolescents: Oral:

13 to <25 kg: 200 mg twice daily for 14 days

25 to <40 kg: 400 mg twice daily for 14 days

≥40 kg: 600 mg twice daily for 14 days

Administration

Oral: Administer ≤30 minutes after a full meal of moderate or high fat (about 25 g of fat). For patients who cannot swallow capsules, capsules may be opened and entire contents mixed with 30 mL of liquid (eg, milk, chocolate milk, infant formula) or soft food (eg, applesauce, yogurt); powder may not dissolve completely. Administer entire mixture within 30 minutes after preparation.

Dietary Considerations

Take ≤30 minutes after a full meal of moderate or high fat (about 25 g of fat).

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted 15°C to 30°C (59°F to 86°F).

Drug Interactions

CloZAPine: CYP3A4 Inducers (Weak) may decrease the serum concentration of CloZAPine. Monitor therapy

Midazolam: Tecovirimat may decrease the serum concentration of Midazolam. Monitor therapy

NiMODipine: CYP3A4 Inducers (Weak) may decrease the serum concentration of NiMODipine. Monitor therapy

Repaglinide: Tecovirimat may increase the serum concentration of Repaglinide. Monitor therapy

Smallpox Vaccine Live: Tecovirimat may diminish the therapeutic effect of Smallpox Vaccine Live. Monitor therapy

Adverse Reactions

>10%: Central nervous system: Headache (12%)

1% to 10%:

Cardiovascular: Increased heart rate (<2%)

Central nervous system: Abnormal electroencephalogram (<2%), chills (<2%), depression (<2%), disturbance in attention (<2%), dysphoria (<2%), irritability (<2%), malaise (<2%), migraine (<2%), pain (<2%), panic attack (<2%), paresthesia (<2%)

Dermatologic: Cheilosis (<2%), facial erythema (<2%), facial swelling (<2%), pruritic rash (<2%), pruritus (<2%), skin rash (<2%)

Endocrine & metabolic: Increased thirst (<2%)

Gastrointestinal: Nausea (5%), abdominal pain (2%), vomiting (2%), dysgeusia (<2%), dyspepsia (<2%), eructation (<2%), oral paresthesia (<2%), xerostomia (<2%)

Hematologic & oncologic: Decreased hematocrit (<2%), decreased hemoglobin (<2%), purpuric rash (palpable: <2%)

Neuromuscular & skeletal: Arthralgia (<2%), osteoarthritis (<2%)

Respiratory: Oropharyngeal pain (<2%)

Miscellaneous: Fever (<2%)

Frequency not defined: Gastrointestinal: Diarrhea, mild gastric distress

Warnings/Precautions

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Immunocompromised patients: Efficacy may be reduced (based on studies in immunocompromised animal models).

Monitoring Parameters

Blood glucose, symptoms of hypoglycemia (when coadministered with repaglinide)

Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies. Pregnant patients were not included in pharmacokinetic studies (Grosenbach 2018).

Smallpox infection is more severe in pregnant patients; transmission to the fetus may occur (Fenner 1988).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, nausea, vomiting, or abdominal pain (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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