Vivjoa

Vivjoa (oteseconazole) capsules are a prescription medication used to treat the symptoms of vulvovaginal candidiasis in women who are not of reproductive potential.

Vivjoa belongs to a class of drugs called Antifungals, Systemic. 

Vivjoa may be used alone or with other medications.

It is not known if Vivjoa is safe and effective in children prior to starting their menstrual period (menarche). 

Vivjoa is contraindicated in:

• Females of reproductive potential
• Pregnant and lactating women
• Patients with known hypersensitivity to oteseconazole

Vivjoa may cause serious side effects including:

• hives, 
• difficulty breathing, 
• swelling of your face, lips, tongue, or throat, 
• increased blood creatine phosphokinase, 
• indigestion,  
• hot flashes, 
• burning or discomfort with urination, 
• heavy menstrual bleeding lasting more than 7 days, and 
• vulvovaginal irritation (burning, discomfort or pain)

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Vivjoa include:

• headache, and 
• nausea 

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Vivjoa. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

There are two recommended Vivjoa dosage regimens: a Vivjoa-only regimen and a Fluconazole/Vivjoa regimen. Use one of the following two dosage regimens:

• Vivjoa-only dosage regimen [see Vivjoa-only Dosage Regimen below]
• Fluconazole/Vivjoa dosage regimen [see Fluconazole/Vivjoa Dosage Regimen below]

Administer Vivjoa orally with food. Swallow the capsules whole. Do not chew, crush, dissolve, or open the capsules.

Vivjoa-only Dosage Regimen

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).

Fluconazole/Vivjoa Dosage Regimen

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).

Effect of Vivjoa on Other Drugs

BCRP (Breast Cancer Resistance Protein) Transporter Substrates

• 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 the lowest possible starting dose of the BCRP substrate or consider reducing the dose of the substrate drug and monitor for adverse reactions.

• Vivjoa is contraindicated in females of reproductive potential and in pregnant women. Based on animal studies, Vivjoa may cause fetal harm when administered to pregnant women.
• Vivjoa is contraindicated in lactating women and females of reproductive potential. There are no data on the presence of oteseconazole in human or animal milk or data on the effects of oteseconazole on milk production.
• There were no reported adverse effects in breastfed infants following maternal exposure to oteseconazole during lactation; however, given the limited duration of follow-up of the oteseconazole-exposed infants during the post-natal period, no conclusions can be drawn from these data