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VIVJOA MECHANISM OF ACTION

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VIVJOA - A Mechanism of Action Designed for Recurrent Vulvovaginal Candidiasis (RVVC)

VIVJOA is the first FDA-approved medication to reduce the incidence of RVVC.1

VIVJOA is designed to inhibit fungal CYP51, which is required for fungal cell wall integrity. This selective interaction is also toxic to fungi, resulting in the inhibition of fungal growth.1,2

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Oteseconazole exhibits minimal interactions with human CYP51 and is the key drug metabolizing human CYPs. This, together with its high protein binding profile (over 99%), contributes to its long half-life of ~138 days.1,2

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Oteseconazole is >2000 times more selective than fluconazole for fungal CYP51 and has a lower affinity for human CYP enzymes than other azoles due to its unique tetrazole binding system.2

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INDICATION

VIVJOA® (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.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Females of Reproductive Potential: VIVJOA is contraindicated in females of reproductive potential. Females who are NOT of reproductive potential are defined as: persons who are biological females who are postmenopausal or have another reason for permanent infertility (e.g., tubal ligation, hysterectomy, salpingo-oophorectomy).

Pregnant and Lactating Women: VIVJOA is contraindicated in pregnant and lactating women.

Hypersensitivity: VIVJOA is contraindicated in patients with known hypersensitivity to oteseconazole.

WARNINGS AND PRECAUTIONS

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.

ADVERSE REACTIONS

The most frequently reported adverse reactions among VIVJOA-treated patients in clinical studies included headache (7.4%) and nausea (3.6%).

DRUG INTERACTIONS

Effect of VIVJOA on Other Drugs: Oteseconazole is a Breast Cancer Resistance Protein (BCRP) inhibitor. Concomitant use of VIVJOA with BCRP substrates (e.g., rosuvastatin) may increase the exposure of BCRP substrates (e.g., rosuvastatin), 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 drug and monitor for adverse reactions.

USE IN SPECIFIC POPULATIONS

Pregnancy: VIVJOA is contraindicated in females of reproductive potential and in pregnant women. Based on animal studies, VIVJOA 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.

Lactation: VIVJOA is contraindicated in lactating women and females of reproductive potential. There are no data on the presence of oteseconazole in human or animal milk or data on the effects of oteseconazole on milk production. There were no reported adverse effects in breastfed infants following maternal exposure to oteseconazole during lactation; however, given the limited duration of follow-up of the oteseconazole-exposed infants during the post-natal period, no conclusions can be drawn from these data.

Females of Reproductive Potential: VIVJOA is contraindicated in females of reproductive potential based on data from rat studies.

Pediatric Use: The safety and effectiveness of VIVJOA have not been established in pre-menarchal pediatric females.

Geriatric Use: Clinical studies of VIVJOA 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: No dosage adjustment of VIVJOA is recommended in patients with mild to moderate renal impairment. VIVJOA is not recommended for use in patients with severe renal impairment or end-stage renal disease, as clinical studies did not include sufficient numbers of these patients.

Hepatic Impairment: No dosage adjustment of VIVJOA is recommended in patients with mild hepatic impairment. VIVJOA is not recommended for use in patients with moderate or severe hepatic impairment, as there is insufficient information in these patients.

Please see full Prescribing Information and Patient Information.

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.

REFERENCES: 1. VIVJOA (oteseconazole). Prescribing Information. Mycovia Pharmaceuticals, Inc.; 4/2022 2. Warrilow AGS, Hull CM, Parker JE, et al. The clinical candidate VT-1161 is a highly potent inhibitor of Candida albicans CYP51 but fails to bind the human enzyme. Antimicrob Agents Chemother. 2014;58(12):7121-7127.
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INDICATION

VIVJOA® (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.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Females of Reproductive Potential: VIVJOA is contraindicated in females of reproductive potential. Females who are NOT of reproductive potential are defined as: persons who are biological females who are postmenopausal or have another reason for permanent infertility (e.g., tubal ligation, hysterectomy, salpingo-oophorectomy).

Pregnant and Lactating Women: VIVJOA is contraindicated in pregnant and lactating women.

Hypersensitivity: VIVJOA is contraindicated in patients with known hypersensitivity to oteseconazole.

WARNINGS AND PRECAUTIONS

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.

ADVERSE REACTIONS

The most frequently reported adverse reactions among VIVJOA-treated patients in clinical studies included headache (7.4%) and nausea (3.6%).

DRUG INTERACTIONS

Effect of VIVJOA on Other Drugs: Oteseconazole is a Breast Cancer Resistance Protein (BCRP) inhibitor. Concomitant use of VIVJOA with BCRP substrates (e.g., rosuvastatin) may increase the exposure of BCRP substrates (e.g., rosuvastatin), 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 drug and monitor for adverse reactions.

USE IN SPECIFIC POPULATIONS

Pregnancy: VIVJOA is contraindicated in females of reproductive potential and in pregnant women. Based on animal studies, VIVJOA 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.

Lactation: VIVJOA is contraindicated in lactating women and females of reproductive potential. There are no data on the presence of oteseconazole in human or animal milk or data on the effects of oteseconazole on milk production. There were no reported adverse effects in breastfed infants following maternal exposure to oteseconazole during lactation; however, given the limited duration of follow-up of the oteseconazole-exposed infants during the post-natal period, no conclusions can be drawn from these data.

Females of Reproductive Potential: VIVJOA is contraindicated in females of reproductive potential based on data from rat studies.

Pediatric Use: The safety and effectiveness of VIVJOA have not been established in pre-menarchal pediatric females.

Geriatric Use: Clinical studies of VIVJOA 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: No dosage adjustment of VIVJOA is recommended in patients with mild to moderate renal impairment. VIVJOA is not recommended for use in patients with severe renal impairment or end-stage renal disease, as clinical studies did not include sufficient numbers of these patients.

Hepatic Impairment: No dosage adjustment of VIVJOA is recommended in patients with mild hepatic impairment. VIVJOA is not recommended for use in patients with moderate or severe hepatic impairment, as there is insufficient information in these patients.

Please see full Prescribing Information and Patient Information.

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.