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Nuzolvence
zoliflodacin
Adult Dosing .
Dosage forms: SUSP: 3 g
gonorrhea, uncomplicated
- [35-49 kg]
- Dose: 3 g PO x1; Info: give 1h before or 2h after food
- [>50 kg]
- Dose: 3 g PO x1; Info: give w/ food
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: SUSP: 3 g
gonorrhea, uncomplicated
- [12 yo and older, 35-49 kg]
- Dose: 3 g PO x1; Info: give 1h before or 2h after food
- [12 yo and older, >50 kg]
- Dose: 3 g PO x1; Info: give w/ food
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- pregnancy
- caution: patients of childbearing potential
- caution: male patients of reproductive potential
- caution: abx-associated colitis history, recent
Drug Interactions .
Overview
zoliflodacin
bacterial topoisomerase II inhibitor
- CYP3A4 substrate
- affected by altered gastrointestinal motility
- alters GI flora
- impairs immunomodulatory bacterial infective agent
Contraindicated
- apalutamide
- bosentan
- butalbital
- carbamazepine
- cenobamate
- dabrafenib
- efavirenz
- encorafenib
- enzalutamide
- etravirine
- fexinidazole
- fosphenytoin
- ivosidenib
- lorlatinib
- lumacaftor/ivacaftor
- mavacamten
- mitapivat
- mitotane
- modafinil
- nafcillin
- pacritinib
- pentobarbital
- pexidartinib
- phenobarbital
- phenytoin
- primidone
- repotrectinib
- rifabutin
- rifampin
- rifapentine
- sotorasib
- St. John's wort
Avoid/Use Alternative
- BCG live intravesical
- bremelanotide
- cholera vaccine, live
- fecal microbiota, live
- methotrexate
- typhoid vaccine, live
Monitor/Modify Tx
- exenatide
- lixisenatide
- pramlintide
- warfarin
Caution Advised
- dulaglutide
- lactulose
- liraglutide
- sodium picosulfate
- tirzepatide
Adverse Reactions .
Serious Reactions
- hypersensitivity reaction
- C. difficile-associated diarrhea
- male infertility (animal studies)
Common Reactions
- neutropenia
- headache
- leukopenia
- dizziness
- nausea
- diarrhea
Safety/Monitoring .
Monitoring Parameters
pregnancy test before tx start
Pregnancy/Lactation .
Pregnancy
Clinical Summary
avoid use during pregnancy; no human data available; risk of fetal harm, including teratogenicity based on animal data at 1.6x, 2.9x, 3.2x, and 8.5x MRHD
Pregnancy Registry
enroll patients in Nuzolvence Pregnancy Registry at 1-800-651-3861
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective contraception during tx and x3mo after D/C in male pts
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: for zoliflodacin: liver; CYP: 1A2, 2C8, 2C9, 2C19, 3A4/5 (primary) substrate
Excretion: for zoliflodacin: feces 79.6% (1.5% unchanged), urine 18.2% (2.5% unchanged); Half-life: 5.5-6.4h
Subclass: Spiropyrimidinetriones
Mechanism of Action
for zoliflodacin: inhibits DNA gyrase and topoisomerase IV, blocking DNA replication
Formulary .
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