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FDA Approves VIVJOA (Oteseconazole) to Reduce the Incidence of Recurrent Vulvovaginal Candidiasis

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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.

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