Otegal 150mg Capsule

Otegal is indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential. If specimens for fungal culture are obtained prior to therapy, antifungal therapy may be instituted before the results of the cultures are known. However, once these results become available, antifungal therapy should be adjusted accordingly.

Pharmacology

Oteseconazole is an antifungal drug. Oteseconazole exposure-response relationships and the time course of pharmacodynamic response are unknown. 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.

Dosage & Administration

There are two recommended Oteseconazole dosage regimens:

For the Oteseconazole-only dosage regimen:

• On Day 1: Administer Oteseconazole 600 mg (as a single dose), then
• On Day 2: Administer Oteseconazole 450 mg (as a single dose), then
• Beginning on Day 14: Administer Oteseconazole 150 mg once a week (every 7 days) for 11 weeks (Weeks 2 through 12).

• On Day 1, Day 4, and Day 7: Administer fluconazole 150 mg orally, then
• On Days 14 through 20: Administer Oteseconazole 150 mg once daily for 7 days, then
• Beginning on Day 28: Administer Oteseconazole 150 mg once a week (every 7 days) for 11 weeks (Weeks 4 through 14).

Interaction

BCRP (Breast Cancer Resistance Protein) Substrates: Concomitant use of Otegal with BCRP substrates may increase the exposure of 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.

Contraindications

Oteseconazole is contraindicated in:

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

Side Effects

The most frequently reported adverse reactions (incidence >2%) were headache and nausea.

Pregnancy & Lactation

Oteseconazole is contraindicated in females of reproductive potential and in pregnant women. Based on animal studies, Oteseconazole may cause fetal harm when administered to pregnant women. In addition, 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.

Therapeutic Class

Other Antifungal preparationsStorage ConditionsStore at 20°C to 25°C. Protect from light when removed from the outer carton. Keep the medicine out of the reach of children.