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Ekterly
sebetralstat
Adult Dosing .
Dosage forms: TAB: 300 mg
acute hereditary angioedema attack
- [600 mg PO x1]
- Max: 1200 mg/24h; Info: may give 2nd dose >3h after 1st dose if inadequate response or if sx recur
renal dosing
- [see below]
- eGFR >60: no adjustment; eGFR <60: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class B: decr. usual dose by 50%; Child-Pugh Class C: avoid use
Peds Dosing .
- Dosage forms: TAB: 300 mg
acute hereditary angioedema attack
- [12 yo and older]
- Dose: 600 mg PO x1; Max: 1200 mg/24h; Info: may give 2nd dose >3h after 1st dose if inadequate response or if sx recur
renal dosing
- [see below]
- eGFR >60: no adjustment; eGFR <60: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class B: decr. usual dose by 50%; Child-Pugh Class C: avoid use
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- hepatic impairment, Child-Pugh Class C
- caution: hepatic impairment, Child-Pugh Class B
- caution: electrolyte abnormalities
- caution: long QT syndrome, congenital
- caution: QT prolongation
- caution: QT prolongation family hx
- caution: torsades de pointes hx
- caution: ventricular arrhythmia
- caution: bradycardia
- caution: MI, recent
- caution: CHF
Drug Interactions .
Overview
sebetralstat
kallikrein inhibitor
- CYP3A4 substrate
- prolongs QT interval (conditional)
Contraindicated
- lefamulin
- pimozide
- posaconazole
- thioridazine
Avoid/Use Alternative
- adagrasib
- apalutamide
- arsenic trioxide
- atazanavir
- bedaquiline
- berotralstat
- bosentan
- butalbital
- carbamazepine
- cenobamate
- ceritinib
- chloramphenicol
- cisapride
- clarithromycin
- cobicistat
- crizotinib
- dabrafenib
- domperidone
- dronedarone
- efavirenz
- encorafenib
- enzalutamide
- ephedra
- etravirine
- fexinidazole
- fosphenytoin
- hydroxychloroquine
- idelalisib
- itraconazole
- ivosidenib
- ketoconazole
- levoketoconazole
- lonafarnib
- lopinavir/ritonavir
- lorlatinib
- lumacaftor/ivacaftor
- mavacamten
- mifepristone
- mitapivat
- mitotane
- mobocertinib
- nafcillin
- nefazodone
- nelfinavir
- netupitant
- pacritinib
- pentobarbital
- pexidartinib
- phenobarbital
- phenytoin
- primidone
- quizartinib
- repotrectinib
- ribociclib
- rifabutin
- rifampin
- rifapentine
- ritonavir
- sotalol
- sotorasib
- St. John's wort
- tipranavir
- toremifene
- tucatinib
- vandetanib
- voriconazole
- ziprasidone
Monitor/Modify Tx
- amiodarone
- anagrelide
- apomorphine
- aprepitant
- artemether/lumefantrine
- asenapine
- avacopan
- azithromycin
- cabozantinib
- chloroquine
- ciprofloxacin
- citalopram
- clofazimine
- conivaptan
- cyclosporine
- danazol
- darunavir
- degarelix
- desflurane
- desipramine
- dexmedetomidine
- dexmedetomidine injection
- diltiazem
- disopyramide
- dofetilide
- donepezil
- droperidol
- duvelisib
- epirubicin
- eribulin
- erythromycin
- fedratinib
- flecainide
- fluconazole
- fluorouracil
- fosamprenavir
- gilteritinib
- glasdegib
- goserelin
- grapefruit
- haloperidol
- histrelin
- hydroxyzine
- ibutilide
- imatinib
- inotuzumab ozogamicin
- isavuconazonium
- isoflurane
- lenacapavir
- letermovir
- leuprolide
- levofloxacin
- lofexidine
- macimorelin
- methadone
- moxifloxacin
- nilotinib
- nirogacestat
- oliceridine
- ondansetron
- osimertinib
- paliperidone
- palonosetron
- panobinostat
- pasireotide
- pentamidine
- procainamide
- propafenone
- quinidine (antiarrhythmic)
- quinidine (CYP2D6 inhibitor)
- quinine
- revumenib
- romidepsin
- rucaparib
- selpercatinib
- sevoflurane
- telavancin
- tetrabenazine
- tramadol
- triclabendazole
- trifluridine
- triptorelin
- vemurafenib
- verapamil
Caution Advised
- armodafinil
- belzutifan
- bexarotene
- brigatinib
- clobazam
- danshen
- darolutamide
- dexamethasone
- dicloxacillin
- echinacea
- elafibranor
- elagolix
- enasidenib
- eslicarbazepine acetate
- felbamate
- garlic
- ginkgo
- ginseng, Asian
- glycerol phenylbutyrate
- griseofulvin
- meropenem
- nevirapine
- odevixibat
- olutasidenib
- omaveloxolone
- oxcarbazepine
- perampanel
- pioglitazone
- prednisone
- rufinamide
- sarilumab
- somatropin
- stiripentol
- sunvozertinib
- suzetrigine
- tazemetostat
- tecovirimat
- telotristat ethyl
- tocilizumab
- topiramate
- tovorafenib
- vaborbactam
- vamorolone
- vinblastine
- vorasidenib
- zanubrutinib
Safety/Monitoring .
Monitoring Parameters
ECG, electrolytes incl. Mg if QT prolongation risk
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 11x and 15x MRHD; possible risk of embryofetal loss and fetal malformations at 60x MRHD
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: liver; CYP450: 3A4 (primary), 2C8 substrate
Excretion: feces 63% (12.5% unchanged), urine 32% (8.7% unchanged); Half-life: 5.3-8.9h
Subclass: Hereditary Angioedema
Mechanism of Action
selectively inhibits plasma kallikrein, preventing bradykinin generation
Formulary .
No Formulary Selected
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