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Tpoxx
tecovirimat
Adult Dosing .
Dosage forms: CAP: 200 mg; INJ: various
Restricted Distribution in US
- [distributed directly to CDC and US Dept. of Defense]
smallpox
- [PO route, 40-119 kg]
- Dose: 600 mg PO bid x14 days; Info: give w/in 30min after full moderate-high fat meal
- [PO route, >120 kg]
- Dose: 600 mg PO tid x14 days; Info: give w/in 30min after full moderate-high fat meal
- [IV route, 35-119 kg]
- Dose: 200 mg IV q12h for up to 14 days; Info: switch to PO regimen ASAP to complete course
- [IV route, >120 kg]
- Dose: 300 mg IV q12h for up to 14 days; Info: switch to PO regimen ASAP to complete course
mpox
- [PO route, 40-119 kg]
- Dose: 600 mg PO bid x14 days; Info: for pts w/ severe dz or aberrant infection, or at high risk for severe dz; consider giving w/ cidofovir or brincidofovir; may extend duration based on clinical response; give w/in 30min after full moderate-high fat meal
- [PO route, >120 kg]
- Dose: 600 mg PO tid x14 days; Info: for pts w/ severe dz or aberrant infection, or at high risk for severe dz; consider giving w/ cidofovir or brincidofovir; may extend duration based on clinical response; give w/in 30min after full moderate-high fat meal
- [IV route, 35-119 kg]
- Dose: 200 mg IV q12h x14 days; Info: for pts w/ severe dz or aberrant infection, or at high risk for severe dz; consider giving w/ cidofovir or brincidofovir; switch to PO regimen ASAP to complete course; may extend duration based on clinical response
- [IV route, >120 kg]
- Dose: 300 mg IV q12h x14 days; Info: for pts w/ severe dz or aberrant infection, or at high risk for severe dz; consider giving w/ cidofovir or brincidofovir; switch to PO regimen ASAP to complete course; may extend duration based on clinical response
renal dosing
- [PO route]
- renal impairment: no adjustment
- HD/PD: no adjustment; no supplement
- [IV route]
- CrCl <30: contraindicated; Info: risk of IV vehicle accumulation
- HD/PD: contraindicated
hepatic dosing
- [no adjustment]
Peds Dosing .
- Dosage forms: CAP: 200 mg; INJ: various
Restricted Distribution in US
- [distributed directly to CDC and US Dept. of Defense]
smallpox
- [PO route, 13-24 kg]
- Dose: 200 mg PO bid x14 days; Info: give w/in 30min after full moderate-high fat meal
- [PO route, 25-39 kg]
- Dose: 400 mg PO bid x14 days; Info: give w/in 30min after full moderate-high fat meal
- [PO route, 40-119 kg]
- Dose: 600 mg PO bid x14 days; Info: give w/in 30min after full moderate-high fat meal
- [PO route, >120 kg]
- Dose: 600 mg PO tid x14 days; Info: give w/in 30min after full moderate-high fat meal
- [IV route, 3-34 kg]
- Dose: 6 mg/kg/dose IV q12h for up to 14 days; Info: switch to PO regimen ASAP to complete course
- [IV route, 35-119 kg]
- Dose: 200 mg IV q12h for up to 14 days; Info: switch to PO regimen ASAP to complete course
- [IV route, >120 kg]
- Dose: 300 mg IV q12h for up to 14 days; Info: switch to PO regimen ASAP to complete course
mpox
- [PO route, <6 kg]
- Dose: 50 mg PO bid x14 days; Info: for pts w/ severe dz or aberrant infection, or at high risk for severe dz; consider giving w/ cidofovir or brincidofovir; may extend duration based on clinical response; give w/in 30min after full moderate-high fat meal
- [PO route, 6-12 kg]
- Dose: 100 mg PO bid x14 days; Info: for pts w/ severe dz or aberrant infection, or at high risk for severe dz; consider giving w/ cidofovir or brincidofovir; may extend duration based on clinical response; give w/in 30min after full moderate-high fat meal
- [PO route, 13-24 kg]
- Dose: 200 mg PO bid x14 days; Info: for pts w/ severe dz or aberrant infection, or at high risk for severe dz; consider giving w/ cidofovir or brincidofovir; may extend duration based on clinical response; give w/in 30min after full moderate-high fat meal
- [PO route, 25-39 kg]
- Dose: 400 mg PO bid x14 days; Info: for pts w/ severe dz or aberrant infection, or at high risk for severe dz; consider giving w/ cidofovir or brincidofovir; may extend duration based on clinical response; give w/in 30min after full moderate-high fat meal
- [PO route, 40-119 kg]
- Dose: 600 mg PO bid x14 days; Info: for pts w/ severe dz or aberrant infection, or at high risk for severe dz; consider giving w/ cidofovir or brincidofovir; may extend duration based on clinical response; give w/in 30min after full moderate-high fat meal
- [PO route, >120 kg]
- Dose: 600 mg PO tid x14 days; Info: for pts w/ severe dz or aberrant infection, or at high risk for severe dz; consider giving w/ cidofovir or brincidofovir; may extend duration based on clinical response; give w/in 30min after full moderate-high fat meal
- [IV route, <35 kg]
- Dose: 6 mg/kg/dose IV q12h x14 days; Info: for pts w/ severe dz or aberrant infection, or at high risk for severe dz; consider giving w/ cidofovir or brincidofovir; switch to PO regimen ASAP to complete course; may extend duration based on clinical response
- [IV route, 35-119 kg]
- Dose: 200 mg IV q12h x14 days; Info: for pts w/ severe dz or aberrant infection, or at high risk for severe dz; consider giving w/ cidofovir or brincidofovir; switch to PO regimen ASAP to complete course; may extend duration based on clinical response
- [IV route, >120 kg]
- Dose: 300 mg IV q12h x14 days; Info: for pts w/ severe dz or aberrant infection, or at high risk for severe dz; consider giving w/ cidofovir or brincidofovir; switch to PO regimen ASAP to complete course; may extend duration based on clinical response
renal dosing
- [PO route]
- renal impairment: no adjustment
- HD/PD: no adjustment; no supplement
- [IV route]
- CrCl <30: contraindicated; Info: risk of IV vehicle accumulation
- HD/PD: contraindicated
hepatic dosing
- [no adjustment]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- CrCl <30 (INJ form)
- avoid: breastfeeding (smallpox use)
- avoid: breastfeeding (pts w/ active mpox lesion)
- caution: pts <2 yo (IV use)
- caution: immunocompromised pts
Drug Interactions .
Overview
tecovirimat
viral envelope wrapping protein inhibitor
Interaction Characteristics:
- CYP2C8 inhibitor, weak
- CYP2C19 inhibitor, weak
- CYP3A4 inducer, minor
Avoid/Use Alternative
- atazanavir
- atogepant
- desogestrel (contraceptive)
- dienogest (contraceptive)
- dolutegravir
- drospirenone (contraceptive)
- estradiol (contraceptive)
- ethinyl estradiol (contraceptive)
- ethynodiol (contraceptive)
- etonogestrel (contraceptive)
- fosamprenavir
- levonorgestrel (contraceptive)
- levonorgestrel (post-coital contraceptive)
- lopinavir/ritonavir
- lumateperone
- mavacamten
- medroxyprogesterone (contraceptive)
- meperidine
- methadone
- norelgestromin (contraceptive)
- norethindrone (contraceptive)
- norgestimate (contraceptive)
- norgestrel (contraceptive)
- ranolazine
- rilpivirine
- segesterone (contraceptive)
- ulipristal (post-coital contraceptive)
- zuranolone
Monitor/Modify Tx
- amiodarone
- amlodipine
- buprenorphine
- carbamazepine
- citalopram
- cyclophosphamide
- cyclosporine
- diazepam
- diltiazem
- disopyramide
- everolimus
- fedratinib
- flibanserin
- fosphenytoin
- ifosfamide
- isradipine
- ketoconazole
- mitapivat
- nicardipine
- nimodipine
- nisoldipine
- oliceridine
- paclitaxel
- perampanel
- phenytoin
- quetiapine
- quinidine (antiarrhythmic)
- repaglinide
- sirolimus
- tacrolimus
- tiagabine
- ubrogepant
- voriconazole
- warfarin
Caution Advised
- abemaciclib
- abrocitinib
- acalabrutinib
- alfentanil
- alprazolam
- aluminum hydroxide
- aprepitant
- artemether/lumefantrine
- atorvastatin
- avacopan
- avapritinib
- axitinib
- bictegravir
- bosutinib
- brigatinib
- budesonide
- buspirone
- cabozantinib
- calcium acetate
- capivasertib
- capmatinib
- carisoprodol
- clarithromycin
- clobazam
- clopidogrel
- cobicistat
- cobimetinib
- codeine
- crizotinib
- daridorexant
- darunavir
- dasatinib
- deflazacort
- doravirine
- dronedarone
- elacestrant
- elbasvir
- elexacaftor/tezacaftor/ivacaftor
- eliglustat
- elvitegravir
- entrectinib
- erdafitinib
- erlotinib
- felodipine
- fentanyl
- ferric citrate
- finerenone
- fosaprepitant
- fostamatinib
- fruquintinib
- ganaxolone
- gepirone
- gilteritinib
- glasdegib
- glecaprevir
- grazoprevir
- guanfacine
- haloperidol
- hydrocortisone
- ibrutinib
- idelalisib
- imatinib
- infigratinib
- irinotecan
- isavuconazonium
- istradefylline
- itraconazole
- ivacaftor
- ixazomib
- lanthanum
- lapatinib
- larotrectinib
- lazertinib
- lefamulin
- lenacapavir
- leniolisib
- letermovir
- levoketoconazole
- levonorgestrel intrauterine device (contraceptive)
- lonafarnib
- lorlatinib
- lurasidone
- macitentan
- maraviroc
- midazolam
- midostaurin
- mobocertinib
- naldemedine
- naloxegol
- nefazodone
- nelfinavir
- neratinib
- netupitant
- nevirapine
- nifedipine
- nilotinib
- nirmatrelvir
- nirogacestat
- olaparib
- olutasidenib
- oxycodone
- palbociclib
- pemigatinib
- pimavanserin
- pirtobrutinib
- ponatinib
- praziquantel
- pretomanid
- proguanil
- quinine
- quizartinib
- repotrectinib
- ribociclib
- ripretinib
- ritonavir
- roflumilast
- rolapitant
- samidorphan
- selpercatinib
- selumetinib
- sevelamer
- sildenafil
- simvastatin
- sirolimus albumin-bound
- sonidegib
- sucroferric oxyhydroxide
- suzetrigine
- tadalafil
- tamoxifen
- tazemetostat
- temsirolimus
- tezacaftor/ivacaftor
- ticagrelor
- tipranavir
- tofacitinib
- tolvaptan
- toremifene
- tramadol
- vanzacaftor/tezacaftor/deutivacaftor
- velpatasvir
- venetoclax
- verapamil
- vinblastine
- vincristine
- vinorelbine
- voclosporin
- vonoprazan
- voxelotor
- voxilaprevir
- zanubrutinib
Adverse Reactions .
Serious Reactions
may occur but none reported
Common Reactions
- infusion site rxn (IV use)
- headache
- nausea (PO use)
- abdominal pain (PO use)
- vomiting (PO use)
- dry mouth (PO use)
- impaired concentration (PO use)
- dysphoria (PO use)
- fever (PO use)
- diarrhea
- facial edema (PO use)
- purpura, palpable (PO use)
- abnormal EEG
- myalgia (IV use)
- arthritis (IV use)
- photophobia (IV use)
Safety/Monitoring .
Monitoring Parameters
Cr at baseline and during tx if using IV
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; no known risk of fetal harm based on animal data at 0.4x, 23x, and 24x recommended human dose
Lactation
Clinical Summary
Smallpox Use: avoid breastfeeding; no human data available, though possible risk of postnatal smallpox virus transmission; no human data available to assess effects on milk production
Mpox Use: avoid breastfeeding if active lesions, otherwise weigh risk/benefit while breastfeeding; no human data available, though possible risk of postnatal mpox virus transmission; no human data available to assess effects on milk production
Pharmacology .
Metabolism: liver; CYP450: none; UGT: 1A1, 1A4 substrate
Excretion: urine 73%, feces 23% (primarily unchanged); Half-life: 20h
Mechanism of Action
inhibits orthopoxvirus envelope wrapping protein, preventing extracellular enveloped virus production and cell-to-cell dissemination of variola (smallpox) virus
Formulary .
No Formulary Selected
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