DESCRIPTION

Vivjoa (oteseconazole) is an azole antifungal medication used to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females who are not of reproductive potential. RVVC is a condition in which a woman has four or more episodes of vaginal yeast infections in a 12-month period.

USES

Vivjoa is used to help prevent RVVC in females who are not of reproductive potential. It is not used to treat active vaginal yeast infections.

HOW TO USE

Vivjoa is taken orally with food. There are two recommended dosage regimens:

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

DOSAGE

The recommended dosage of Vivjoa for females who are not of reproductive potential is 150 mg once a week for 12 weeks.

MECHANISM OF ACTION

Vivjoa is an azole antifungal medication that works by inhibiting the production of ergosterol, a compound that is essential for the integrity of fungal cell membranes. Without ergosterol, fungal cells cannot grow and reproduce.

STORAGE CONDITIONS

Vivjoa should be stored at room temperature (68°F to 77°F or 20°C to 25°C) and protected from moisture and light.

PRECAUTIONS

Vivjoa should be used with caution in women with liver disease or kidney disease. It should also be used with caution in women who are taking other medications that may interact with Vivjoa.

INTERACTIONS

Vivjoa can interact with a number of other medications, including:

• Midazolam
• Triazolam
• Alpha-hydroxyfentanyl
• Fentanyl
• Ergotamine
• Dihydroergotamine
• Simvastatin
• Lovastatin
• Atorvastatin
• Rosuvastatin
• Mefloquine
• Quinidine
• Cisapride
• Pimozide
• Sotalol
• Amiodarone
• Dofetilide

CONTRAINDICATIONS

Vivjoa is contraindicated in:

• Females of reproductive potential
• Pregnant women
• Lactating women
• Women with a hypersensitivity to oteseconazole

SIDE EFFECTS

The most common side effects of Vivjoa are headache, nausea, and diarrhea. Other possible side effects include:

• Abdominal pain
• Constipation
• Dyspepsia
• Flatulence
• Rash
• Pruritus
• Vaginal discharge
• Vaginal dryness
• Vaginal irritation
• Vaginal pain

OVERDOSE

There is no information available on overdose with Vivjoa. In the event of an overdose, contact your local poison control center immediately.

IMPORTANT SAFETY INFORMATION

Vivjoa may cause serious birth defects if taken during pregnancy. It is important to avoid pregnancy while taking Vivjoa. If you become pregnant while taking Vivjoa, stop taking the medication and contact your doctor immediately.

Vivjoa is not approved for use in females of reproductive potential. It is important to use a reliable form of contraception while taking Vivjoa.

Vivjoa can interact with a number of other medications. It is important to tell your doctor about all of the medications you are taking before you start taking Vivjoa.