Description

Indication & Scope

Oteseconazole Capsules (Ruibikang®) is a novel oral azole antifungal innovative drug for recurrent vulvovaginal candidiasis (RVVC), applied to inhibit fungal growth and reduce recurrent yeast infection episodes in non-reproductive-age females.

Mechanism
Oteseconazole is an azole metalloenzyme inhibitor that selectively targets fungal sterol 14α-demethylase (CYP51). It blocks ergosterol synthesis, disrupts fungal membrane integrity, and exerts sustained fungistatic and fungicidal effects, with far higher selectivity for fungal CYP51 than human CYP enzymes.
Drug class
Class 1 innovative chemical prescription antifungal, oral tetrazole azole preparation for recurrent vulvovaginal candidiasis.
Clinical use
Phase III multi-center clinical trials verified long-term sustained efficacy against recurrent VVC with low relapse rate; orally administered with food, the first domestic oral innovative drug specially approved for recurrent vulvovaginal candidiasis.

Specification

Generic Name	Oteseconazole Capsules
Brand Name	RuiBiKang®
Ingredient	Oteseconazole
Dosage Form	Hard Capsule
Package	0.15g*7 capsules/box
Conditions Treated	For the treatment of recurrent vulvovaginal candidiasis (RVVC, severe vulvovaginal candidiasis) in females without reproductive potential.
Taboos	Contraindicated for females of reproductive potential, pregnant women, lactating women; patients hypersensitive to oteseconazole, excipients or other azole antifungals.
Place of origin	Princeton,USA
Priscription Type	Prescription drug (Rx)
Storage Conditions	Store at 20–25℃, protected from light; transient storage between 15–30℃ is permitted
Manufacturer	eVENUS PHARMACEUTICAL LABORATORIES INC.
Registration Authority	National Medical Products Administration (NMPA)
Approval number	HJ20230084
Date of Revision	October 21, 2023
Shelf Life	24 months

How to use ?

Recommended Dose: Take with food, swallow whole capsules intact, do not chew or crush.Single-agent regimen: Day 1: 600mg (4×150mg) single dose; Day 2: 450mg (3×150mg) single dose; starting Day 14: 150mg once weekly for 11 consecutive weeks.
Time: Complete full 12-week course to prevent recurrence; discontinue if severe hypersensitivity occurs.
Interaction: It is a BCRP inhibitor; co-administration with rosuvastatin and other BCRP substrates requires dose adjustment and monitoring. Avoid concurrent use of other systemic azole antifungals.
Side effects: Common mild transient reactions: headache, nausea, diarrhea, rash. Rare adverse events: abnormal menstruation, bacterial vaginitis, elevated liver enzymes; severe anaphylaxis is extremely rare.

Important Notice

This product shall only be used for post-exposure rabies prophylaxis by professional medical staff. It must be applied combined with rabies vaccine and injected via wound infiltration plus intramuscular routes as specified. Do not administer intravenously or alter the dosage at will. Hypersensitivity monitoring is required throughout the whole injection process.

Packaging & Shipping

Packaging

Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.

Shipping Methods

Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.

Export Support