Oteseconazole

What is Oteseconazole?

• Oteseconazole (Vivjoa) is an azole antifungal used to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential.

Oteseconazole v01

Oteseconazole

What are the uses of this medicine?

• Oteseconazole (Vivjoa) is a prescription medicine used to reduce the risk of vaginal yeast infections that keep coming back (recurrent vulvovaginal candidiasis, RVVC) in females with a history of RVVC.

Limitations of use:

• Vivjoa should only be taken by females who are not pregnant and who are not able to become pregnant.
• It is not known if Vivjoa is safe and effective in females who have not had their first menstrual period.

How does this medicine work?

• Oteseconazole is an antifungal drug.
• 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.

Oteseconazole has been shown to be active against most isolates of the following microorganisms associated with RVVC: • Candida albicans • Candida glabrata • Candida krusei • Candida parapsilosis • Candida tropicalis • Candida lusitaniae • Candida dubliniensis

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• Are able to become pregnant.
• Are pregnant or plan to become pregnant. Vivjoa may harm your unborn baby.
• Are breastfeeding or plan to breastfeed. It is not known if Vivjoa passes into your breastmilk.
• Are allergic to oteseconazole or any of the ingredients in Vivjoa.

What drug interactions can this medicine cause?

• Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• Especially tell your doctor if you take medicines called breast cancer resistance protein (BCRP) transporter substrates, including the cholesterol lowering medicine rosuvastatin.

Is this medicine FDA approved?

• It was approved for medical use in the United States in April 2022.

How should this medicine be used?

Recommended dosage: There are two recommended Vivjoa dosage regimens:

• 1.a VIVJOAonly regimen
• 2.Fluconazole/Vivjoa regimen

1.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)

2.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).

Administration:

• Take Vivjoa capsules by mouth with food.
• Swallow Vivjoa capsules whole. Do not chew, crush, dissolve, or open the capsules.

Take fluconazole and Vivjoa exactly as your doctor tells you to take it. Talk to your doctor if you have any questions.

• On Day 1, Day 4, and Day 7: Take 1 fluconazole tablet (150 mg) by mouth, then
• On Days 14 through 20: Take 1 Vivjoa capsule (150 mg) by mouth 1 time each day for 7 days, then
• On Day 28: Take 1 Vivjoa capsule (150 mg) by mouth 1 time each week (every 7 days) for 11 weeks.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 150 mg of oteseconazole.

This medicine is available in fallowing brand namesː

• Vivjoa

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache and nausea

What special precautions should I follow?

• Based on animal studies, Vivjoa may cause fetal harm. Advise patients that Vivjoa is contraindicated in females of reproductive potential, and in pregnant and lactating women because of potential risks to a fetus or breastfed infant.
• Advise patients to inform their health care provider if they are taking a BCRP substrate (e.g., rosuvastatin). Concomitant use with Vivjoa may increase the exposure of drugs that are BCRP substrates, which may increase the risk of adverse reactions associated with these drugs.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• 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.

Can this medicine be used in children?

• The safety and effectiveness of Vivjoa have not been established in pre-menarchal pediatric females.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: oteseconazole
• Inactive Ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose, magnesium stearate, silicified
• microcrystalline cellulose, and sodium lauryl sulfate.
• Capsule shell and print constituents: FD&C Blue #1, FD&C Red #3, gelatin, Opacode SW-9008/SW-9009 and titanium dioxide.
• Vivjoa does not contain gluten (wheat, barley, or rye).

Who manufactures and distributes this medicine?

Manufactured for and Distributed by:

• Mycovia Pharmaceuticals, Inc.
• Durham, NC.

What should I know about storage and disposal of this medication?

• Store Vivjoa at room temperature between 68◦F to 77◦F (20◦C to 25◦C).
• Protect from light when removed from the outer carton.

• Dailymed label info on Oteseconazole
• FDA Oteseconazole

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