Oteseconazole is a novel azole-class antifungal agent that inhibits the fungal enzyme 14α-demethylase (CYP51). This enzyme is vital for synthesizing ergosterol, a key component of fungal cell membranes. Inhibition of CYP51 leads to toxic sterol accumulation, compromising fungal cell integrity. The tetrazole metal-binding feature in oteseconazole ensures greater selectivity for fungal enzymes over human CYP enzymes, minimizing human side effects.
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Vulcan is used to prevent recurring episodes of vulvovaginal candidiasis (RVVC) in women with a documented history of RVVC who are not of reproductive potential. If fungal culture tests are done before starting treatment, antifungal therapy may begin beforehand and should be adjusted based on the results.
Caution is advised when using Vulcan with BCRP (Breast Cancer Resistance Protein) substrates, as oteseconazole may increase their systemic exposure, raising the risk of adverse effects. Starting at the lowest effective dose of BCRP substrate drugs or reducing their dose is recommended, along with close monitoring.
1. Oteseconazole-Only Regimen:
Day 1: 600 mg (single dose)
Day 2: 450 mg (single dose)
From Day 14: 150 mg once weekly for 11 weeks (Week 2–12)
2. Fluconazole + Oteseconazole Regimen:
Day 1, 4, 7: Fluconazole 150 mg
Day 14–20: Oteseconazole 150 mg once daily
From Day 28: Oteseconazole 150 mg once weekly for 11 weeks (Week 4–14)
Swallow capsules whole with food. Do not crush, chew, or open the capsules.
Vulcan is strictly contraindicated in women who are pregnant, breastfeeding, or capable of becoming pregnant. Animal studies show a risk of fetal harm, and the drug has a long biological half-life, leading to an extended exposure period (~690 days). There is no data on its presence in human or animal breast milk or on its safety in breastfeeding infants.
Vulcan has shown teratogenic effects in animal studies, including severe ocular deformities (e.g., cataracts, retinal damage, lens degeneration). These were observed at exposures ~3.5x higher than typical human doses.
Patients must be informed about the potential fetal and neonatal risks and avoid use during pregnancy or breastfeeding.
Store at 20°C to 25°C. Keep away from light and out of the reach of children.
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