Vivjoa

About Oteseconazole (Vivjoa)

• Vivjoa received Food and Drug Administration (FDA) approval on April 28, 2022, which belongs to the class of drugs known as antifungal.
• Oteseconazole, a new orally bioavailable and selective inhibitor of the fungal cytochrome P450 enzyme 51 (CYP51), demonstrates favorable effectiveness in treating recurrent vulvovaginal candidiasis (RVVC) in patients. 
• Oteseconazole is sold under the brand name Vivjoa. 
• Vivjoa is an azole antifungal prescribed to lower the occurrence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT capable of reproduction.
• Oteseconazole targets fungal cytochrome P450 enzyme 51 (CYP51), crucial for maintaining cell membrane integrity. By inhibiting CYP51, oteseconazole prevents ergosterol synthesis, a key membrane component, leading to increased membrane permeability and fungal cell death. 
• This selective action makes oteseconazole highly effective against Candida species, especially in treating recurrent vulvovaginal candidiasis (RVVC). 
• Additionally, oteseconazole capsule demonstrates superior activity against certain fungi like Candida glabrata compared to common antifungals.
• Recurrent vulvovaginal candidiasis (RVVC) presents as a persistent and challenging vaginal infection, attributed to Candida species. This condition, affecting women across various age groups, ethnicities, and social backgrounds, is characterized by its chronic nature.

Strength: 

Vivjoa capsule is available as 150 mg. Fluconazole is not supplied in carton. 

Recommended Dosage:

Follow one of the recommended Vivjoa dosage regimens: either the Vivjoa-only regimen or the Fluconazole/Vivjoa regimen. Administer Vivjoa orally with food.

Vivjoa-only Dosage Regimen:

• – Day 1: Vivjoa 600 mg (single dose)
• – Day 2: Vivjoa 450 mg (single dose)
• – Starting on Day 14: Vivjoa 150 mg once a week for 11 weeks (Weeks 2 through 12).

Fluconazole/Vivjoa Dosage Regimen:

• Prescribe fluconazole in addition to:
• – Day 1, Day 4, and Day 7: Administer fluconazole 150 mg orally
• – Days 14 through 20: Administer Vivjoa 150 mg once daily for 7 days
• – Beginning on Day 28: Administer Vivjoa 150 mg once a week for 11 weeks (Weeks 4 through 14).

Important:

Before starting Vivjoa capsule, it is essential to discuss your medical history and current medications with your healthcare provider. This includes providing details about smoking and alcohol consumption. Offering a comprehensive list of medications is crucial for a safe introduction of new drugs, enabling healthcare providers to make informed decisions tailored to individual patient needs.

Warnings & Precautions

• It is imperative to avoid taking Vivjoa capsule if you fall under specific categories, including females of reproductive potential, pregnant and lactating women, and individuals with hypersensitivity to oteseconazole. 
• Before using Vivjoa, inform your doctor about your medical conditions, particularly if you have kidney or liver problems. Provide a comprehensive list of all medications, including prescription and over-the-counter drugs, vitamins, and herbal supplements.
• Specifically, let your doctor know if you are taking medications classified as breast cancer resistance protein (BCRP) transporter substrates, such as the cholesterol-lowering drug rosuvastatin. If unsure, consult your doctor or pharmacist for a list of these medicines. 
• Combining Vivjoa (a BCRP inhibitor) with BCRP transporter substrates may heighten the risk of side effects associated with these medications.
• It is essential to carefully consider these factors and consult with your healthcare provider to ensure the appropriate and safe use of the medication based on your health circumstances.

Common Vivjoa Side Effects:

• Headache
• Nausea
• Stomach upset
• Hot flush
• Painful urination
• Vaginal bleeding
• Vaginal irritation
• Burning while urinating
• Difficult or painful urination 

Use in Specific Population

• The use of Vivjoa is not recommended in individuals with severe renal impairment or end-stage renal disease (ESRD), whether or not they are undergoing dialysis.
• Additionally, Vivjoa is not recommended in cases of moderate or severe hepatic impairment, and it is contraindicated in females of reproductive potential, pregnant women, and breastfeeding women. 
• The contraindication for females of reproductive potential is based on findings from animal studies. Furthermore, the safety and effectiveness of Vivjoa have not been established in pre-menarchal pediatric females. 
• Clinical studies of Vivjoa did not include a sufficient number of patients aged 65 and older to determine whether they respond differently from younger adult patients. 
• It is crucial for individuals with these specific health conditions to consult with their healthcare providers for personalized guidance on medication use.

Storage and Handling

• Store Vivjoa in a controlled environment with temperatures ranging from 68°F to 77°F (20°C to 25°C). 
• Brief excursions between 59°F and 86°F (15°C to 30°C) are acceptable but should be minimized. 
• Ensure proper storage to maintain the efficacy of the medication. 
• Protect the medicine from direct light exposure, and avoid freezing it. 
• Keep Vivjoa out of reach of pets and children, emphasizing the importance of secure and responsible storage practices.