VIVJOA is the first FDA-approved medication to reduce the incidence of RVVC.1
DOSING
VIVJOA® is available as an 18-count blister pack with clear dosing instructions
VIVJOA®
150 mg capsules
Size 2 capsule
- VIVJOA capsules are supplied as lavender capsules imprinted with OTE 150 in black ink in an 18-count blister package within a child resistant wallet1
- There is one blister pack per wallet and one wallet per outer carton1
DOSING INSTRUCTIONS
Administer VIVJOA 600 mg (as a single dose), then
Administer VIVJOA 450 mg (as a single dose), then
Administer VIVJOA 150 mg once a week (every 7 days) for 11 weeks (Weeks 2 through 12)
VIVJOA DOSAGE REGIMEN
Dosing instructions found on the blister pack.
Dosing guide also provided in the Patient Prescribing Information brochure as follows:
How to prescribe VIVJOA
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.
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.