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Vivjoa Generic Name & Formulations
Legal Class
Rx
General Description
Oteseconazole 150mg; hard gel caps.
Pharmacological Class
Azole antifungal.
How Supplied
Caps—18
Manufacturer
Generic Availability
NO
Mechanism of Action
Oteseconazole is an azole metalloenzyme inhibitor targeting the fungal sterol, 14α demethylase (CYP51), an enzyme that catalyzes an early step in the biosynthetic pathway of ergosterol, a sterol required for fungal cell membrane formation and integrity. Inhibition of CYP51 results in the accumulation of 14-methylated sterols, some of which are toxic to fungi. Through the inclusion of a tetrazole metal-binding group, oteseconazole has a lower affinity for human CYP enzymes.
Vivjoa Indications
Indications
To reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential.
Vivjoa Dosage and Administration
Adult
Swallow whole. Take with food. Vivjoa-only regimen: give 600mg (as a single dose) on Day 1; then 450mg (as a single dose) on Day 2; and then 150mg once weekly (every 7 days) starting on Day 14 for 11 weeks (Weeks 2 through 12). Fluconazole/Vivjoa regimen (prescribe fluconazole separately): give oral fluconazole 150mg once on Days 1, 4, and 7; then Vivjoa 150mg once daily for 7 days on Days 14 through 20; and then Vivjoa 150mg once weekly starting on Day 28 for 11 weeks (Weeks 4 through 14).
Children
Pre-menarchal: not established.
Vivjoa Contraindications
Contraindications
Females of reproductive potential. Pregnant and lactating women.
Vivjoa Boxed Warnings
Not Applicable
Vivjoa Warnings/Precautions
Warnings/Precautions
Embryo-fetal toxicity. End-stage renal disease (eGFR <15mL/min). Severe hepatic impairment (Child-Pugh Class C): not studied.
Vivjoa Pharmacokinetics
Absorption
Time to peak plasma concentration: ~5 to 10 hours.
Distribution
Central volume of distribution: ~423 L. Plasma protein bound: 99.5–99.7%.
Elimination
Fecal (56%), renal (26%). Half-life (median): ~138 days.
Vivjoa Interactions
Interactions
May potentiate BCRP substrates (eg, rosuvastatin); use lowest possible starting dose or consider reducing dose of substrate; monitor for adverse reactions.
Vivjoa Adverse Reactions
Adverse Reactions
Headache, nausea.
Vivjoa Clinical Trials
See Literature
Vivjoa Note
Not Applicable
Vivjoa Patient Counseling
See Literature
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