Vivjoa®Oteseconazole Capsules

1. Indications and Usage
Recurrent Vulvovaginal Candidiasis (RVVC): Treatment of recurrent vulvovaginal candidiasis in females who have passed menopause.
Limitation of Use: Safety and efficacy have not been established in females of reproductive potential.
2. Dosage and Administration
Administration: Oral administration with food. Capsules must be swallowed whole (do not chew, crush, dissolve, or open) .
Dosing Regimens:
Vivjoa Only Regimen:
Day 1: 600 mg single dose.
Day 2: 450 mg single dose.
From Day 14 onwards: 150 mg once weekly for 11 weeks (Weeks 2-12) .
Fluconazole/Vivjoa Regimen:
Days 1, 4, and 7: Fluconazole 150 mg orally.
Days 14-20: Vivjoa 150 mg once daily for 7 days.
From Day 28 onwards: Vivjoa 150 mg once weekly for 11 weeks (Weeks 4-14) .
3. Mechanism of Action
Oteseconazole is a triazole antifungal agent.
It inhibits the fungal enzyme lanosterol 14α-demethylase (CYP51), which converts lanosterol to ergosterol.
This inhibition leads to the depletion of ergosterol and the accumulation of 14α-methylsterols in the fungal cell membrane, resulting in increased membrane permeability and fungal cell death. It has a narrower spectrum of activity (targeting Candida spp.) compared to other azoles, sparing gut flora .
4. Safety and Warnings
Contraindications: Pregnancy; Hypersensitivity to oteseconazole or any excipients .
Reproductive Toxicity: May cause fetal harm. It is contraindicated in pregnant women.
CYP2C Substrate: Oteseconazole is a substrate of CYP2C8 and CYP2C9. Caution is advised when co-administered with inhibitors or inducers of these enzymes .
Hepatic Impairment: Safety and efficacy have not been established in patients with severe hepatic impairment (Child-Pugh Class C) .
5. Adverse Reactions
The most common adverse reactions (incidence ≥2% and more common than placebo) include:
Nausea
Diarrhea
Vomiting
Headache
Fatigue
6. Drug Interactions
CYP2C8/2C9 Inhibitors: Co-administration with strong inhibitors (e.g., gemfibrozil, fluconazole) may increase oteseconazole exposure.
CYP3A4 Substrates: Oteseconazole has low potential to inhibit CYP3A4, but monitoring is advised for sensitive substrates.
P-gp Inhibitors: May increase oteseconazole plasma concentration .
7. Pharmaceutical Information
Chemical Name: (Z)-2-(2,4-difluorophenyl)-3-(5-(4-(trifluoromethyl)phenoxy)pentyl)-1H-1,2,4-triazol-1-yl)pyrrolidin-2-one [Standard Oteseconazole structure].
Molecular Formula: C22H21F6N3O2 .
Molecular Weight: 469.4 .
Storage: Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) .