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Oteseconazole: Drug information

Oteseconazole: Drug information
(For additional information see "Oteseconazole: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Vivjoa
Pharmacologic Category
  • Antifungal Agent, Azole Derivative;
  • Antifungal Agent, Oral
Dosing: Adult
Candidiasis, vulvovaginal, recurrent

Candidiasis, vulvovaginal, recurrent:

Oteseconazole monotherapy: Oral:

Day 1: 600 mg as a single dose.

Day 2: 450 mg as a single dose.

Starting on day 14: 150 mg once weekly for 11 weeks.

Combination therapy with fluconazole regimen: Oral:

Days 1 to 7: Fluconazole 150 mg as a single dose on days 1, 4, and 7.

Days 14 to 20: Oteseconazole 150 mg once daily.

Starting on day 28: Oteseconazole 150 mg once weekly for 11 weeks.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

eGFR 30 to 89 mL/minute: No dosage adjustment necessary.

eGFR 15 to <30 mL/minute: Use is not recommended (has not been studied).

eGFR <15 mL/minute: Use is not recommended (has not been studied).

Hemodialysis: Use is not recommended (has not been studied).

Dosing: Hepatic Impairment: Adult

Mild impairment (Child-Pugh class A): No dosage adjustment necessary.

Moderate to severe impairment (Child-Pugh class B or C): Use in not recommended (has not been studied).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adolescents and adults.

1% to 10%:

Endocrine & metabolic: Hot flash (<2%)

Gastrointestinal: Dyspepsia (<2%), nausea (4%)

Genitourinary: Dysuria (<2%), heavy menstrual bleeding (including uterine hemorrhage and vaginal hemorrhage: <2%), vulvovaginal irritation (including vulvovaginal burning and vaginal pain [vulvovaginal]): <2%)

Nervous system: Headache (including migraine and sinus headache: 7%)

Neuromuscular & skeletal: Increased creatine phosphokinase in blood specimen (<2%)

Frequency not defined:

Dermatologic: Allergic dermatitis

Contraindications

Hypersensitivity to oteseconazole or any component of the formulation; patients of reproductive potential; pregnant and breastfeeding patients.

Warnings/Precautions

Disease-related concerns:

• Hepatic impairment: Not recommended in patients with moderate or severe (Child-Pugh class B or C) impairment.

• Renal impairment: Not recommended in patients with eGFR 15 to 29 mL/minute or end-stage renal disease.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule Therapy Pack, Oral:

Vivjoa: 150 mg (18 ea) [contains fd&c blue #1 (brilliant blue)]

Generic Equivalent Available: US

No

Pricing: US

Capsule Therapy Pack (Vivjoa Oral)

150 mg (per each): $194.69

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Oral: Administer with food. Swallow whole; do not chew, crush, dissolve, or open capsules.

Use: Labeled Indications

Vulvovaginal candidiasis, recurrent: To reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential, alone or in combination with fluconazole.

Metabolism/Transport Effects

Inhibits BCRP/ABCG2

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Alpelisib: BCRP/ABCG2 Inhibitors may increase the serum concentration of Alpelisib. Management: Avoid coadministration of BCRP/ABCG2 inhibitors and alpelisib due to the potential for increased alpelisib concentrations and toxicities. If coadministration cannot be avoided, closely monitor for increased alpelisib adverse reactions. Risk D: Consider therapy modification

BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors): Oteseconazole may increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Berotralstat: BCRP/ABCG2 Inhibitors may increase the serum concentration of Berotralstat. Management: Decrease the berotralstat dose to 110 mg daily when combined with BCRP inhibitors. Risk D: Consider therapy modification

Cladribine: BCRP/ABCG2 Inhibitors may increase the serum concentration of Cladribine. Management: Avoid concomitant use of BCRP inhibitors during the 4 to 5 day oral cladribine treatment cycles whenever possible. If combined, consider dose reduction of the BCRP inhibitor and separation in the timing of administration. Risk D: Consider therapy modification

Dichlorphenamide: Antifungal Agents (Azole Derivatives, Systemic) may enhance the hypokalemic effect of Dichlorphenamide. Risk C: Monitor therapy

Mizolastine: Antifungal Agents (Azole Derivatives, Systemic) may increase the serum concentration of Mizolastine. Risk X: Avoid combination

PAZOPanib: BCRP/ABCG2 Inhibitors may increase the serum concentration of PAZOPanib. Risk X: Avoid combination

Rosuvastatin: BCRP/ABCG2 Inhibitors may increase the serum concentration of Rosuvastatin. Risk C: Monitor therapy

Talazoparib: BCRP/ABCG2 Inhibitors may increase the serum concentration of Talazoparib. Risk C: Monitor therapy

Topotecan: BCRP/ABCG2 Inhibitors may increase the serum concentration of Topotecan. Risk X: Avoid combination

Ubrogepant: BCRP/ABCG2 Inhibitors may increase the serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 50 mg and second dose (at least 2 hours later if needed) of 50 mg when used with a BCRP inhibitor. Risk D: Consider therapy modification

Food Interactions

Administration with a high-fat, high-calorie meal increased Cmax and AUC0-72h by 45% and 36%, respectively. No significant differences were observed with a low-fat, low-calorie meal. Management: Administer with food.

Reproductive Considerations

Use is contraindicated in patients who could become pregnant.

Patients who are postmenopausal or have permanent infertility (eg, due to tubal ligation, hysterectomy, salpingo-oophorectomy) are considered to be not of reproductive potential.

Pregnancy Considerations

Ocular abnormalities were observed following administration of oral oteseconazole to rats during day 6 of gestation through day 20 of lactation at doses ~3.5 times the recommended human dose (based on AUC). Based on the data from animal reproduction studies, in utero exposure to oteseconazole may cause fetal harm. The long half-life of oteseconazole should also be considered. Use is contraindicated in pregnant patients.

Breastfeeding Considerations

It is not known if oteseconazole is present in breast milk.

If present in breast milk, the long half-life of oteseconazole should also be considered. Due to the potential for serious adverse reactions in the breastfed infant, use is contraindicated in breastfeeding patients.

Mechanism of Action

Oteseconazole is an azole metalloenzyme inhibitor of the fungal sterol, 14 alpha demethylase (CYP51), which results in accumulation of membrane disrupting 14-methylated sterols.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Cmax and AUC increased by 45% and 36%, respectively, with a high-fat, high-calorie meal (800 to 1,000 calories; 50% fat); no significant differences were observed with a low-fat, low-calorie meal.

Distribution: Vd: 423 L.

Protein binding: 99.5% to 99.7%.

Metabolism: Does not undergo significant metabolism.

Half-life elimination: ~138 days.

Time to peak: ~5 to 10 hours.

Excretion: Feces 56%; Urine 26%.

  1. Vivjoa (oteseconazole) [prescribing information]. Durham, NC: Mycovia Pharmaceuticals Inc; April 2022.
Topic 138579 Version 26.0

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