oteseconazole (Rx)

Brand and Other Names:Vivjoa

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 150mg
  • NOTE: Fluconazole is not supplied in carton

Vulvovaginal Candidiasis

Indicated to reduce incidence of recurrent vulvovaginal candidiasis (RVVC) in females with history of RVVC who are NOT of reproductive potential

Oteseconazole-only regimen

  • Day 1: 600 mg PO x 1 dose, THEN
  • Day 2: 450 mg PO x 1 dose, THEN
  • Beginning on Day 14: 150 mg PO qWeek for 11 weeks (Weeks 2 through 12)

Fluconazole and oteseconazole regimen

  • Days 1, 4, and 7: Fluconazole 150 mg PO x 1 dose, THEN
  • Days 14 through 20: Oteseconazole 150 mg PO qDay x 7 Days, THEN
  • Beginning on Day 28: Oteseconazole 150 mg PO qWeek for 11 weeks (Weeks 4 through 14)

Dosage Modifications

Renal impairment

  • Mild or moderate (eGFR 30-89 mL/min): No dosage adjustment necessary
  • Severe and end-stage renal disease with or without dialysis (eGFR <29 mL/min) Not recommended

Hepatic impairment

  • Mild (Child-Pugh A): No dosage adjustment necessary
  • Moderate or severe (Child-Pugh B or C): Not recommended

Dosing Considerations

Contraindicated in females of reproductive potential and in pregnant and lactating females

Females who are NOT of reproductive potential are defined as: Persons who are biological females who are postmenopausal or have other reasons for permanent infertility (eg, tubal ligation, hysterectomy, salpingo-oophorectomy)

Usage

  • May institute antifungal therapy before results of fungal cultures are known
  • Once results are available, adjust antifungal therapy accordingly

Premenarchal females: Safety and effectiveness not established

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Interactions

Interaction Checker

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      Serious - Use Alternative

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            Contraindicated (0)

              Serious - Use Alternative (2)

              • pitavastatin

                oteseconazole will increase the level or effect of pitavastatin by Other (see comment). Avoid or Use Alternate Drug. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • rimegepant

                oteseconazole will increase the level or effect of rimegepant by Other (see comment). Avoid or Use Alternate Drug. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              Monitor Closely (37)

              • alpelisib

                oteseconazole will increase the level or effect of alpelisib by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • atorvastatin

                oteseconazole will increase the level or effect of atorvastatin by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • chlorothiazide

                oteseconazole will increase the level or effect of chlorothiazide by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • cimetidine

                oteseconazole will increase the level or effect of cimetidine by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • daunorubicin

                oteseconazole will increase the level or effect of daunorubicin by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • dipyridamole

                oteseconazole will increase the level or effect of dipyridamole by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • doxorubicin

                oteseconazole will increase the level or effect of doxorubicin by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • ethinylestradiol

                oteseconazole will increase the level or effect of ethinylestradiol by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • fluvastatin

                oteseconazole will increase the level or effect of fluvastatin by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • glyburide

                oteseconazole will increase the level or effect of glyburide by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • imatinib

                oteseconazole will increase the level or effect of imatinib by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • irinotecan

                oteseconazole will increase the level or effect of irinotecan by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • lapatinib

                oteseconazole will increase the level or effect of lapatinib by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • ledipasvir/sofosbuvir

                oteseconazole will increase the level or effect of ledipasvir/sofosbuvir by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • leflunomide

                oteseconazole will increase the level or effect of leflunomide by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • lenvatinib

                oteseconazole will increase the level or effect of lenvatinib by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • methotrexate

                oteseconazole will increase the level or effect of methotrexate by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • mitoxantrone

                oteseconazole will increase the level or effect of mitoxantrone by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • nitrofurantoin

                oteseconazole will increase the level or effect of nitrofurantoin by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • osimertinib

                oteseconazole will increase the level or effect of osimertinib by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • ozanimod

                oteseconazole will increase the level or effect of ozanimod by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • pantoprazole

                oteseconazole will increase the level or effect of pantoprazole by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • pazopanib

                oteseconazole will increase the level or effect of pazopanib by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • riociguat

                oteseconazole will increase the level or effect of riociguat by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • selexipag

                oteseconazole will increase the level or effect of selexipag by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • selumetinib

                oteseconazole will increase the level or effect of selumetinib by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • sofosbuvir

                oteseconazole will increase the level or effect of sofosbuvir by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • sulfasalazine

                oteseconazole will increase the level or effect of sulfasalazine by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • talazoparib

                oteseconazole will increase the level or effect of talazoparib by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • tenofovir AF

                oteseconazole will increase the level or effect of tenofovir AF by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • tenofovir DF

                oteseconazole will increase the level or effect of tenofovir DF by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • topotecan

                oteseconazole will increase the level or effect of topotecan by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • ubrogepant

                oteseconazole will increase the level or effect of ubrogepant by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • velpatasvir

                oteseconazole will increase the level or effect of velpatasvir by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • vemurafenib

                oteseconazole will increase the level or effect of vemurafenib by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              • voclosporin

                voclosporin, oteseconazole. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Coadministration with drugs associated with nephrotoxicity may increase the risk for acute and/or chronic nephrotoxicity.

              • voxilaprevir

                oteseconazole will increase the level or effect of voxilaprevir by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.

              Minor (0)

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                Adverse Effects

                1-10%

                Headache (eg, headache, migraine, sinus headache) (7.4%)

                Nausea (3.6%)

                Dyspepsia (<2%)

                Hot flush (<2%)

                Dysuria (<2%)

                Menorrhagia (eg, genital hemorrhage, menorrhagia, menometrorrhagia, uterine hemorrhage, vaginal hemorrhage) (<2%)

                Metrorrhagia (<2%)

                Vulvovaginal irritation (eg, vulvovaginal burning sensation, vulvovaginal discomfort, vulvovaginal pain) (<2%)

                Elevated serum creatine phosphokinase ≥10x ULN (1.9%)

                <1%

                Allergic dermatitis (<0.2%)

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                Warnings

                Contraindications

                Females of reproductive potential

                Pregnant and lactating females

                Hypersensitivity to oteseconazole

                Cautions

                Based on animal studies, fetal harm may occur (see Pregnancy & Lactation)

                Drug interaction overview

                • Inhibitor of breast cancer resistance protein (BCRP)
                • BCRP substrates
                  • Use lowest possible starting dose of BCRP substrate, or consider reducing BCRP substrate dose; monitor adverse reactions
                  • Oteseconazole may increase effects and toxicities of BCRP substrates
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                Pregnancy & Lactation

                Pregnancy

                Contraindicated in females of reproductive potential and in pregnant females

                Drug exposure window is ~690 days (based on 5x the half-life of oteseconazole) to prevent any risks of embryofetal toxicities

                Animal data

                • Ocular abnormalities (eg, cataracts, opacities, exophthalmos/buphthalmos, optic nerve/retinal atrophy, lens degeneration, hemorrhage) observed in rat offspring from Gestation Day 6 through Lactation Day 20 at doses 3.5x the recommended human dose
                • Data are insufficient to exclude any potential risk of cataracts or other eye abnormalities in human infants

                Lactation

                Contraindicated in lactating females

                There are no data on presence of oteseconazole in human or animal milk or its effects on milk production

                There were no reported adverse effects in breastfed infants following maternal exposure to oteseconazole during lactation

                Owing to limited duration of follow-up of oteseconazole-exposed infants during postnatal period, no conclusions can be drawn from data

                Pregnancy Categories

                A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                NA: Information not available.

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                Pharmacology

                Mechanism of Action

                Azole metalloenzyme inhibitor targets fungal sterol 14-alpha demethylase (CYP51) Inhibition of CYP51 results in accumulation of 14-methylated sterols, which may be toxic to fungi

                Active against most isolates of following microorganisms associated with RVVC:

                • Candida albicans
                • Candida glabrata
                • Candida krusei
                • Candida parapsilosis
                • Candida tropicalis
                • Candida lusitaniae
                • Candida dubliniensis
                • Note: Clinical significance unknown

                Absorption

                Peak plasma concentration: 2.8 mcg/mL

                Minimum plasma concentration: 2.5 mcg/mL

                Peak plasma time: 5-10 hr

                AUC: 64.2 mcg·hr/mL

                Effect of food

                • High-fat, high-calorie meal (800-100 calories; 50% fat): Increased peak plasma concentration by 45% and AUC by 35%
                • Low-fat, low-calorie meal: No significant difference

                Distribution

                Vd: 423 L

                Protein bound: 99.5-99.7%

                Metabolism

                No significant metabolism

                Elimination

                Half-life: 138 days

                Excretion: 56% (feces vial biliary excretion); 26% (urine)

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                Administration

                Oral Administration

                Administer with food

                Swallow capsule whole; do NOT chew, crush, dissolve, or open

                Storage

                Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)

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                Patient Handout

                A Patient Handout is not currently available for this monograph.
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                Formulary

                FormularyPatient Discounts

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                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
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                QL Quantity Limits
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.