VIVJOA (oteseconazole)

The AUC of oteseconazole increased approximately dose proportionally while the C max increased less than dose proportionally over a dose range of 20 mg (0.13 times the lowest recommended dose) to 320 mg (0.53 times the highest recommended dose). The pharmacokinetic parameters of oteseconazole associated with the administration of the recommended dosing regimen of VIVJOA are presented in Table 1.

Table 1Pharmacokinetic (PK) Parameters of Oteseconazole PK Parameter Following repeat dose administ...

Overview of the Clinical Studies A total of 656 adults and post-menarchal pediatric females with RVVC (defined as ≥3 episodes of vulvovaginal candidiasis (VVC) in a 12-month period) were randomized in two multicenter, multinational, double-blind, placebo-controlled trials:

Trial 1(NCT#03562156) and

Trial 2(NCT#03561701). A total of 219 adults and post-menarchal pediatric females with RVVC were randomized in a multicenter, double-blind trial [

Trial 3(NCT#03840616)]. Although females of reproductive potential were included in the clinical efficacy data, VIVJOA is contraindicated in females of...

The most frequently reported adverse reactions (incidence > 2%) were headache and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mycovia Pharmaceuticals, Inc. at 1-855-299-0637 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of one drug cannot be directly compared to rates in the clinical trials of another drug and may not ...

VIVJOA is contraindicated in: Females of reproductive potential [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3) ] Pregnant and lactating women [see Warnings and Precautions (5.1) , and Use in Specific Populations (8.1 , 8.2) ] Patients with known hypersensitivity to oteseconazole. Females of Reproductive Potential ( 4 ), ( 5.1 ), ( 8.3 ) Pregnant and Lactating women ( 4 )...

Embryo-Fetal Toxicity : Based on animal studies, VIVJOA 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 VIVJOA is contraindicated in females of reproductive potential, and in pregnant and lactating women because of potential risks to a fetus or breastfed infant. ( 5.1 , 8.1 , 8.2 , 8.3 ) 5.1 Embryo-Fetal Toxicity VIVJOA is contraindicat...

7 DRUG INTERACTIONS BCRP (Breast Cancer Resistance Protein) Substrates: Concomitant use of VIVJOA 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 react...