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Blujepa
gepotidacin
Adult Dosing .
Dosage forms: TAB: 750 mg
UTI, uncomplicated
- [female pts, >40 kg]
- Dose: 1500 mg PO bid x5 days; give after meals
renal dosing
- [see below]
- eGFR <30: avoid use
- HD: avoid use; PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class C: avoid use
Peds Dosing .
- Dosage forms: TAB: 750 mg
UTI, uncomplicated
- [female pts, 12 yo and older, >40 kg]
- Dose: 1500 mg PO bid x5 days; give after meals
renal dosing
- [see below]
- eGFR <30: avoid use
- HD: avoid use; PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class C: avoid use
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- eGFR <30
- hepatic impairment, Child-Pugh Class C
- 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
- caution: abx-associated colitis hx, recent
Drug Interactions .
Overview
gepotidacin
bacterial topoisomerase II inhibitor
- CYP3A4 substrate
- CYP3A4 inhibitor, weak
- P-gp inhibitor, weak
- affected by altered gastrointestinal motility
- alters GI flora
- cholinergic effects
- impairs immunomodulatory bacterial infective agent
- neuromuscular blocking effects
- prolongs QT interval (conditional)
Contraindicated
- cisapride
- colchicine
- eliglustat
- pimozide
- posaconazole
- thioridazine
Avoid/Use Alternative
- adagrasib
- alprazolam
- amikacin
- amikacin inhaled
- amiodarone
- anagrelide
- apalutamide
- apixaban
- apomorphine
- arsenic trioxide
- artemether/lumefantrine
- asenapine
- atazanavir
- azithromycin
- BCG live intravesical
- bedaquiline
- bremelanotide
- butalbital
- cabozantinib
- carbamazepine
- ceritinib
- chloramphenicol
- chloroquine
- cholera vaccine, live
- citalopram
- clarithromycin
- clofazimine
- cobicistat
- codeine
- colistimethate
- crizotinib
- dabigatran
- degarelix
- desflurane
- desipramine
- dexmedetomidine
- dexmedetomidine injection
- disopyramide
- dofetilide
- domperidone
- donepezil
- dronedarone
- droperidol
- encorafenib
- enzalutamide
- ephedra
- epirubicin
- eribulin
- erythromycin
- fecal microbiota, live
- fexinidazole
- flecainide
- fluorouracil
- fosphenytoin
- gentamicin
- gilteritinib
- glasdegib
- goserelin
- haloperidol
- histrelin
- hydrocodone
- hydroxychloroquine
- hydroxyzine
- ibutilide
- idelalisib
- inotuzumab ozogamicin
- isoflurane
- itraconazole
- ivosidenib
- ketoconazole
- lefamulin
- leuprolide
- levofloxacin
- levoketoconazole
- lofexidine
- lonafarnib
- lopinavir/ritonavir
- lumacaftor/ivacaftor
- macimorelin
- meperidine
- methadone
- methotrexate
- mifepristone
- mitotane
- mobocertinib
- moxifloxacin
- nefazodone
- nelfinavir
- neomycin
- nilotinib
- oliceridine
- ondansetron
- osimertinib
- oxycodone
- pacritinib
- paliperidone
- palonosetron
- panobinostat
- paromomycin
- pasireotide
- pentamidine
- pentobarbital
- phenobarbital
- phenytoin
- plazomicin
- polymyxin B
- pralsetinib
- primidone
- procainamide
- propafenone
- quinidine (antiarrhythmic)
- quinidine (CYP2D6 inhibitor)
- quinine
- quizartinib
- revumenib
- ribociclib
- rifabutin
- rifampin
- ritonavir
- rivastigmine
- romidepsin
- rucaparib
- selpercatinib
- sevoflurane
- simvastatin
- sirolimus albumin-bound
- sotalol
- St. John's wort
- streptomycin
- telavancin
- tetrabenazine
- tipranavir
- tobramycin
- tobramycin inhaled
- toremifene
- tramadol
- triclabendazole
- trifluridine
- triptorelin
- tucatinib
- typhoid vaccine, live
- vandetanib
- vemurafenib
- voriconazole
- ziprasidone
Monitor/Modify Tx
- abemaciclib
- acalabrutinib
- alfentanil
- atorvastatin
- avanafil
- avapritinib
- botulinum toxin
- brigatinib
- capivasertib
- clozapine
- cyclosporine
- digoxin
- docetaxel
- entrectinib
- everolimus
- exenatide
- fedratinib
- felodipine
- fentanyl
- finerenone
- flibanserin
- gepirone
- ibrutinib
- infigratinib
- ivabradine
- ixabepilone
- lemborexant
- lomitapide
- lovastatin
- lumateperone
- lurasidone
- lurbinectedin
- mavacamten
- midazolam
- morphine
- nifedipine
- nimodipine
- nisoldipine
- pemigatinib
- pramlintide
- red yeast rice
- selumetinib
- sirolimus
- succinylcholine
- sufentanil
- tacrolimus
- tadalafil
- temsirolimus
- tolvaptan
- triazolam
- ubrogepant
- vardenafil
- venetoclax
- vinblastine
- vincristine
- vinorelbine
- warfarin
- zanubrutinib
Caution Advised
- aclidinium inhaled
- amantadine
- amifampridine
- atracurium
- atropine
- belladonna alkaloids
- benztropine
- bethanechol
- bosentan
- cariprazine
- cenobamate
- cevimeline
- cisatracurium
- clidinium
- cobimetinib
- conivaptan
- cyclophosphamide
- dabrafenib
- daridorexant
- darifenacin
- dicyclomine
- dihydroergotamine
- dulaglutide
- efavirenz
- eplerenone
- ergotamine
- etravirine
- fesoterodine
- flavoxate
- galantamine
- glycopyrrolate
- glycopyrrolate inhaled
- glycopyrronium topical
- homatropine
- hyoscyamine
- ipratropium inhaled
- lactulose
- liraglutide
- lorlatinib
- methacholine inhaled
- methscopolamine
- methylergonovine
- mitapivat
- modafinil
- nafcillin
- neostigmine
- oxybutynin
- palovarotene
- pancuronium
- pexidartinib
- pilocarpine
- pyridostigmine
- repotrectinib
- revefenacin inhaled
- rifapentine
- rocuronium
- roflumilast
- roflumilast topical
- scopolamine
- sirolimus topical
- sodium picosulfate
- sofpironium topical
- solifenacin
- sotorasib
- tiotropium inhaled
- tirzepatide
- tolterodine
- trihexyphenidyl
- trospium
- umeclidinium inhaled
- vecuronium
- verapamil
Adverse Reactions .
Serious Reactions
- hypersensitivity rxn
- anaphylaxis
- AV block
- bradycardia
- bronchospasm
- seizures
- syncope
- C. difficile-assoc. diarrhea
Common Reactions
- diarrhea
- nausea
- abdominal pain
- flatulence
- dizziness
- vomiting
- muscle spasms
- dysarthria
- presyncope
- hyperhidrosis
Safety/Monitoring .
Monitoring Parameters
Cr at baseline; ECG, electrolytes incl. Mg if QT prolongation risk
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; possible risk of decr. fetal wt and incr. late fetal resorption based on conflicting animal data at 0.8x and 3x MRHD
Pregnancy Registry
enroll pts or encourage pts to enroll in Blujepa Pregnancy Registry at 1-888-825-5249
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 substrate
Excretion: feces 52% (30% unchanged), urine 31% (20% unchanged); Half-life: 9.3h
Subclass: Antiseptics, Urinary ; Triazaacenaphthylenes
Mechanism of Action
inhibits DNA gyrase and topoisomerase IV, blocking bacterial DNA replication
Formulary .
No Formulary Selected
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