Oteseconazole
Vulvovaginal Candidiasis
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Drug Status
Government Approvals
US(FDA)
WHO Essential Medicine
NO
Known Teratogen
No
Pharmaceutical Class
Azole Antifungal
Controlled Drug Substance
No
Oteseconazole
Summary
Oteseconazole is used to reduce the number of recurrent vaginal yeast infections in women who are not able to become pregnant. It is specifically indicated for females with a history of recurrent vulvovaginal candidiasis (RVVC).
Oteseconazole is an azole antifungal that works by inhibiting a key enzyme necessary for the biosynthesis of ergosterol, a key component of fungal cell membranes. This disruption slows fungal growth and helps fight the infection.
Oteseconazole is typically taken orally. The usual dosage is 4 capsules on day 1, 3 capsules on day 2, and then 1 capsule once a week starting on day 14 for 11 weeks. Alternatively, it can be taken as 1 capsule daily for 7 days followed by 1 capsule weekly starting on day 15 for 11 weeks.
The most frequently reported side effects of Oteseconazole are headache, occurring in about 7.4% of patients, and nausea, occurring in about 3.6% of patients.
Oteseconazole should not be used by females of reproductive potential, pregnant women, and lactating women due to potential risks to the fetus or breastfed infant. It is also contraindicated in patients with known hypersensitivity to Oteseconazole.
Indications and Purpose
How does Oteseconazole work?
Oteseconazole is an azole antifungal that works by inhibiting the fungal sterol, 14α demethylase (CYP51), an enzyme necessary for the biosynthesis of ergosterol, a key component of fungal cell membranes. This inhibition leads to the accumulation of toxic sterols, disrupting fungal cell membrane formation and integrity, thereby slowing fungal growth.
Is Oteseconazole effective?
Clinical trials have shown that Oteseconazole is effective in reducing the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential. The trials demonstrated a significant reduction in the number of culture-verified acute VVC episodes in patients treated with Oteseconazole compared to placebo.
What is Oteseconazole?
Oteseconazole is used to reduce the number of recurrent vaginal yeast infections in women who are not able to become pregnant. It belongs to a class of medications called azole antifungals and works by slowing the growth of fungi that cause infection. It is specifically indicated for females with a history of recurrent vulvovaginal candidiasis.
Directions for Use
For how long do I take Oteseconazole?
Oteseconazole is typically used for a duration of 11 weeks, following the initial loading doses on day 1 and day 2. This regimen is designed to reduce the incidence of recurrent vaginal yeast infections.
How do I take Oteseconazole?
Oteseconazole should be taken by mouth with food. The capsules must be swallowed whole and should not be chewed, crushed, dissolved, or opened. There are no specific food restrictions mentioned, so you can continue your normal diet unless advised otherwise by your doctor.
How should I store Oteseconazole?
Oteseconazole should be stored at room temperature between 68°F to 77°F (20°C to 25°C) and protected from light when removed from the outer carton. It should be kept in its original container, tightly closed, and out of reach of children to prevent accidental ingestion.
What is the usual dose of Oteseconazole?
For adults, Oteseconazole is typically taken as 4 capsules on day 1, 3 capsules on day 2, and then 1 capsule once a week starting on day 14 for 11 weeks. Alternatively, it can be taken as 1 capsule daily for 7 days, followed by 1 capsule weekly starting on day 15 for 11 weeks. There is no established dosage for children as the safety and effectiveness in pediatric patients have not been established.
Warnings and Precautions
Can I take Oteseconazole with other prescription drugs?
Oteseconazole is a BCRP inhibitor and may increase the exposure of BCRP substrates, such as rosuvastatin, potentially increasing the risk of adverse reactions. Patients should inform their healthcare provider of all medications they are taking to manage potential interactions effectively.
Can Oteseconazole be taken safely while breastfeeding?
Oteseconazole is contraindicated in lactating women due to potential harm to the breastfed infant. There is no data on the presence of oteseconazole in human or animal milk, but given the potential risks, breastfeeding women should avoid using this medication.
Can Oteseconazole be taken safely while pregnant?
Oteseconazole is contraindicated during pregnancy due to potential risks of fetal harm. Animal studies have shown that it may cause ocular abnormalities in offspring. There is limited human data, but the drug exposure window precludes adequate mitigation of embryo-fetal toxicity risks. Pregnant women should not use this medication.
Is Oteseconazole safe for the elderly?
There is no specific information provided about the use of Oteseconazole in the elderly. However, as with any medication, it is important for elderly patients to consult their doctor before starting treatment to ensure it is safe and appropriate for their health condition.
Who should avoid taking Oteseconazole?
Oteseconazole is contraindicated in females of reproductive potential, pregnant women, and lactating women due to potential risks to the fetus or breastfed infant. It should not be used by patients with known hypersensitivity to oteseconazole. Patients should inform their doctor of all medications they are taking to avoid potential drug interactions.
