Otes (Oteseconazole) is an azole antifungal. It’s a USFDA-approved Tetrazole antifungal agent for fungal diseases, particularly recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential. It is 2000 times more selective than Fluconazole for fungal CYP51 and the unique tetrazole binding system of Otes (Oteseconazole) ensures greater affinity for the fungal enzymes. It is available in capsule formulation.
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.
Otes 150 Capsule: Each capsule contains Oteseconazole INN 150 mg.
Oteseconazole is indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential.
There are two recommended dosage regimens: A Oteseconazole-only regimen and a Fluconazole/ Oteseconazole regimen. Use one of these two dosage regimens. Administer Otes orally with food.
For the Oteseconazole-only Dosage Regimen:
On Day 1: Administer Otes 150 mg 4 capsules 600 mg (as a single dose), then
On Day 2: Administer Otes 150 mg 3 capsules 450 mg (as a single dose), then
Beginning on Day 14: Administer Otes 150 mg once a week (every 7 days) for 11 weeks (Weeks 2 through 12).
For the Fluconazole/ Oteseconazole Dosage Regimen:
On Day 1, Day 4, and Day 7: Administer fluconazole 150 mg orally, then
On Days 14 through 20: Administer Otes 150 mg once daily for 7 days, then
Beginning on Day 28: Administer Otes 150 mg once a week (every 7 days) for 11 weeks (Weeks 4 through 14)
• Females of Reproductive Potential
• Pregnant and Lactating women
• Hypersensitivity to Oteseconazole
Embryo-Fetal Toxicity: Based on animal studies, Oteseconazole may cause fetal harm. The drug exposure window of approximately 690 days (based on 5 times the half-life of Oteseconazole) precludes adequate mitigation of the embryo-fetal toxicity risks. Advise patients that Oteseconazole is contraindicated in females of reproductive potential, and in pregnant and lactating women because of potential risks to a fetus or breastfed infant.
The most frequently reported adverse reactions (incidence > 2%) were headache and nausea.
BCRP (Breast Cancer Resistance Protein) Substrates: Concomitant use of Oteseconazole with BCRP substrates may increase the exposure to drugs that are BCRP substrates, 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 drugs and monitor for adverse reactions.
Pregnancy: Oteseconazole is contraindicated in females of reproductive potential and pregnant women.
Lactation: Oteseconazole is contraindicated in lactating women.
Pediatrics: The safety and effectiveness of Oteseconazole have not been established in pre-menarchal pediatric females.
Geriatric Use: Clinical studies of Oteseconazole did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
Renal Impairment: Not recommended in severe renal impairment or ESRD (with or without dialysis).
Hepatic Impairment: Not recommended in moderate or severe hepatic impairment.
Otes 150 Capsule: Each box contains 6 capsules in alu-alu blister pack.
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