FDA Approves VIVJOA (Oteseconazole) to Reduce the Incidence of Recurrent Vulvovaginal Candidiasis (RVVC) in Females with a History of RVVC who are Not of Reproductive Potential

On April 26, 2022, the U.S. Food and Drug Administration (FDA) approved VIVJOA (oteseconazole) to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential.

There are two recommended VIVJOA dosage regimens: a VIVJOA-only regimen and a fluconazole/VIVJOA regimen. VIVJOA should be administered orally with food. Swallow the capsules whole. Do not chew, crush, dissolve, or open the capsules.

  • For the VIVJOA-only Dosage Regimen:
    • On Day 1: Administer VIVJOA 600 mg (as a single dose), then
    • On Day 2: Administer VIVJOA 450 mg (as a single dose), then
    • Beginning on Day 14: Administer VIVJOA 150 mg once a week (every 7 days) for 11 weeks (Weeks 2 through 12).
  • For the Fluconazole/VIVJOA Dosage Regimen, prescribe fluconazole and:
    • On Day 1, Day 4, and Day 7: Administer fluconazole 150 mg orally, then
    • On Days 14 through 20: Administer VIVJOA 150 mg once daily for 7 days, then
    • Beginning on Day 28: Administer VIVJOA 150 mg once a week (every 7 days) for 11 weeks (Weeks 4 through 14).

Additional information regarding dosage and administration as well as warnings and precautions about embryo-fetal toxicity can be found in the full prescribing information linked below.


Mechanism of Action (MOA), and Pharmacokinetics (PK)

MOA: Oteseconazole is an azole antifungal drug.

General PK: The AUC of oteseconazole increased approximately dose proportionally while the Cmax increased less than dose proportionally over a dose range of 20 mg (0.13 times the lowest recommended dose) to 320 mg (0.53 times the highest recommended dose). The PK parameters of oteseconazole associated with the administration of the recommended dosing regimen of VIVJOA are presented in Table 1.

Table 1: PK Parameters of Oteseconazole

PK Parametera

Mean (± SD)

Cmax (µg/mL)

2.8 (1.25)

AUC24h (h·µg/mL)

64.2 (29.4)

Cmin (µg/mL)

2.5 (1.19)

a Following repeat dose administration of oteseconazole at the approved recommended dosage for RVVC at the end of treatment.


Absorption: The time to peak plasma concentrations of oteseconazole was approximately 5 to 10 hours.

Effect of Food: Administration of oteseconazole with a high-fat, high-calorie meal (800-1000 Calories; 50% fat) increased Cmax and AUC0-72h by 45% and 36%, but no significant differences were observed with a low-fat, low-calorie meal.

Distribution: The central volume of distribution of oteseconazole is approximately 423 L. Oteseconazole is 99.5-99.7% bound to plasma proteins. Animal studies indicated that oteseconazole exposures in vaginal tissue are comparable to plasma exposures.

Elimination: The median terminal half-life of oteseconazole is approximately 138 days.

Metabolism: Oteseconazole does not undergo significant metabolism.

Excretion: Following oral administration of radiolabeled oteseconazole, approximately 56% of the radiolabeled dose was recovered in feces primarily through biliary excretion and 26% was recovered in urine.


Drug Interactions

BCRP (Breast Cancer Resistance Protein) Transporter Substrates: Use the lowest possible starting dose of the BCRP substrate or consider reducing the dose of the substrate drug and monitor for adverse reactions. Oteseconazole is a BCRP inhibitor. Concomitant use of VIVJOA with BCRP substrates (e.g., rosuvastatin) may increase the exposure of BCRP substrates (e.g., rosuvastatin), which may increase the risk of adverse reactions associated with these drugs.


Use in Specific Populations

There were no clinically significant differences in the PK of oteseconazole based on sex, race/ethnicity or mild to moderate renal impairment.

Oteseconazole is not recommended in severe renal impairment or ESRD (with or without dialysis) (eGFR ≤ 29 mL/min) and in moderate or severe hepatic impairment (Child-Pugh B-C).


Efficacy and Safety

Efficacy of VIVJOA was evaluated in two randomized, multicenter, multinational, double-blind, placebo-controlled trials and one randomized, multicenter, double-blind trial that enrolled patients with RVVC [defined as ≥ 3 episodes of vulvovaginal candidiasis (VVC) in a 12-month period]. Efficacy was assessed by the proportion of patients with ≥ 1 culture-verified acute VVC episode (positive fungal culture for Candida species associated with a clinical signs and symptoms score of ≥ 3) during the maintenance phase (all trials) or who failed clearing their infection during the induction phase (non-placebo-controlled trial only). Additional information regarding efficacy trials can be found in the full prescribing information linked below.

The most frequently reported adverse reactions (incidence > 2%) were headache and nausea.

Full prescribing information is available at https://go.usa.gov/xuUsy.

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This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.