Oteseconazole Image (pending)
KEY POINTS
- Oteseconazole (Vivjoa) is an Azole antifungal that works by inhibiting fungal sterol, a component of the fungal cell wall
- Oteseconazole was approved April 26th 2022 with the indication of reducing the incidence of recurrent Vulvovaginall candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential
- Oteseconazole has been found active versus the following yeasts: Candida albicans, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, Candida lusitaniae, and Candida dubliniensis
- There are two regimens available. One with fluconazole. One without fluconazole. See package insert for full information.
- Not recommended for use in severe renal impairment or ESRD (with or without dialysis)
- Not recommended for use in moderate or severe hepatic impairment
- Supplied as 150 mg oteseconazole capsules, stored at room temperature, protect from light
- Has a median terminal half-life of ~138 days
- Does not undergo significant metabolism
- Contraindications include: female of reproductive potential, pregnancy, breastfeeding, and hypersensitivity to oteseconazole
- Holds a warning for embryo-fetal toxicity
- The most common side effects were headache and nausea
- At 5x the maximum exposure of the recommended dose, does not prolong the QT interval to any clinically relevant extent
- Beware drug interactions with breast cancer resistance protein (BCRP) substrates
- The last 2 pages of the package insert have a patient counseling sheet that may be helpful
RESOURCES
- Vivjoa Package Insert
- Oteseconazole: an advance in treatment of recurrent vulvovaginal candidiasis | Future Microbiology 2021
- 107. A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Oteseconazole (VT-1161) Oral Capsules versus Fluconazole and Placebo in the Treatment of Acute Vulvovaginal Candidiasis Episodes in Subjects with Recurrent Vulvovaginal Candidiasis (ultraViolet) | OFID 2021
- 719. Susceptibility Testing of Oteseconazole (VT-1161) Against Clinical Isolates from Phase 3 Clinical Studies in Subjects with Recurrent Vulvovaginal Candidiasis | OFID 2021