Vivjoa

Drug overview for VIVJOA (oteseconazole):

Generic name: oteseconazole (oh-TES-e-KON-a-zole)
Drug class: Antifungals-Systemic
Therapeutic class: Anti-Infective Agents

Oteseconazole, a selective inhibitor of fungal lanosterol demethylase, is an azole antifungal agent.

No enhanced Uses information available for this drug.

DRUG IMAGES

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The following indications for VIVJOA (oteseconazole) have been approved by the FDA:

Indications:
Recurrent Vulvovaginal Candidiasis

Professional Synonyms:
Recurrent Vulvovaginal Candidosis
Recurrent Vulvovaginal Moniliasis
Relapsing Vaginal Yeast Infection

Dosing information for VIVJOA
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
VIVJOA 150 MG CAPSULE	Maintenance	Adults take 1 capsule (150 mg) by oral route every 7 days with food for 11 weeks

The following drug interaction information is available for VIVJOA (oteseconazole):

Contraindicated
Severe
Moderate

There are 0 contraindications.

There are 5 severe interactions. These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.

Drug Interaction	Drug Names
Pazopanib/Selected Inhibitors of P-gp or BCRP SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Inhibitors of P-glycoprotein (P-gp) or BCRP may increase the absorption of pazopanib.(1) CLINICAL EFFECTS: The concurrent administration of pazopanib with an inhibitor of P-glycoprotein or BCRP may result in elevated levels of pazopanib and signs of toxicity.(1) PREDISPOSING FACTORS: The risk of QT prolongation or torsade de pointes may be increased in patients with cardiovascular disease (e.g. heart failure, myocardial infarction, history of torsade de pointes, congenital long QT syndrome), hypokalemia, hypomagnesemia, hypocalcemia, bradycardia, female gender, or advanced age.(2) Concurrent use of more than one drug known to cause QT prolongation or higher systemic concentrations of either QT prolonging drug are additional risk factors for torsade de pointes. Factors which may increase systemic drug concentrations include rapid infusion of an intravenous dose or impaired metabolism or elimination of the drug (e.g. coadministration with an agent which inhibits its metabolism or elimination, and/or renal/hepatic dysfunction).(2) PATIENT MANAGEMENT: The US manufacturer of pazopanib states concurrent use of P-gp inhibitors or BCRP inhibitors should be avoided.(1) Monitor patients for increased side effects from pazopanib. If concurrent therapy is warranted, consider obtaining serum calcium, magnesium, and potassium levels and monitoring ECG at baseline and at regular intervals. Correct any electrolyte abnormalities. Instruct patients to report any irregular heartbeat, dizziness, or fainting. DISCUSSION: Pazopanib is a substrate of P-gp and BCRP. Inhibitors of these transporters are expected to increase pazopanib levels.(1) BCRP inhibitors linked to this monograph include: asciminib, belumosudil, clopidogrel, cyclosporine, curcumin, darolutamide, eltrombopag, enasidenib, febuxostat, fostemsavir, grazoprevir, lazertinib, leflunomide, leniolisib, momelotinib, oteseconazole, pantoprazole, pirtobrutinib, regorafenib, resmetirom, ritonavir, rolapitant, roxadustat, tafamidis, teriflunomide, tolvaptan, turmeric, and vadadustat.(1,3-5) P-glycoprotein inhibitors linked to this monograph include: asunaprevir, belumosudil, capmatinib, carvedilol, cyclosporine, danicopan, daridorexant, diltiazem, flibanserin, fostamatinib, ginseng, glecaprevir/pibrentasvir, isavuconazonium, ivacaftor, ledipasvir, neratinib, sofosbuvir/velpatasvir/voxilaprevir, tepotinib, tezacaftor, ticagrelor, valbenazine, verapamil, vimseltinib, and voclosporin.(3,4)	PAZOPANIB HCL, VOTRIENT
Cladribine/Selected Inhibitors of BCRP SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Inhibitors of BCRP may increase the absorption of cladribine.(1-2) CLINICAL EFFECTS: The concurrent administration of cladribine with an inhibitor of BCRP may result in elevated levels of cladribine and signs of toxicity.(1-2) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of cladribine states concurrent use of BCRP inhibitors should be avoided during the 4- to 5-day cladribine treatment.(1-2) Selection of an alternative concurrent medication with no or minimal transporter inhibiting proprieties should be considered. If this is not possible, dose reduction to the minimum mandatory dose of the BCRP inhibitor, separation in timing of administration, and careful patient monitoring is recommended.(1-2) Monitor for signs of hematologic toxicity. Lymphocyte counts should be monitored. DISCUSSION: Cladribine is a substrate of BCRP. Inhibitors of this transporter are expected to increase cladribine levels.(1-2) BCRP inhibitors linked to this monograph include: capmatinib, clopidogrel, curcumin, danicopan, darolutamide, dasabuvir, eltrombopag, enasidenib, febuxostat, fostamatinib, fostemsavir, glecaprevir/pibrentasvir, grazoprevir, lazertinib, oteseconazole, pacritinib, pantoprazole, paritaprevir, regorafenib, resmetirom, ritonavir, rolapitant, roxadustat, selpercatinib, sofosbuvir/velpatasvir/voxilaprevir, tafamidis, ticagrelor, tolvaptan, turmeric, and vadadustat.(1-4)	CLADRIBINE, MAVENCLAD
Selected BCRP Substrates/Oteseconazole SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Oteseconazole is an inhibitor of the BCRP transporter, which may result in increased absorption of BCRP substrates.(1) CLINICAL EFFECTS: Administration of oteseconazole with BCRP substrates may result in elevated levels of and toxicity of the BCRP substrates.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of oteseconazole states that the lowest possible starting dose of the BCRP substrate should be used and to consider reducing the dose of the substrate drug according to the product labeling and monitor for adverse reactions.(1) DISCUSSION: Oteseconazole increased the area-under-curve (AUC) and maximum concentration (Cmax) of rosuvastatin, a BCRP substrate, by 118% and 114%, respectively.(1) BCRP substrates linked to this monograph include: ciprofloxacin, diclofenac, glyburide, imatinib, irinotecan, lapatinib, methotrexate, mitoxantrone, rosuvastatin, and sulfasalazine.(1-2)	ARTHROTEC 50, ARTHROTEC 75, AZULFIDINE, CIPRO, CIPROFLOXACIN, CIPROFLOXACIN HCL, CRESTOR, DICLOFENAC, DICLOFENAC POTASSIUM, DICLOFENAC SODIUM, DICLOFENAC SODIUM ER, DICLOFENAC SODIUM MICRONIZED, DICLOFENAC SODIUM-MISOPROSTOL, EZALLOR SPRINKLE, GLEEVEC, GLYBURIDE, GLYBURIDE MICRONIZED, GLYBURIDE-METFORMIN HCL, IMATINIB MESYLATE, IMKELDI, INFLAMMACIN, INFLATHERM(DICLOFENAC-MENTHOL), JYLAMVO, LAPATINIB, LOFENA, METHOTREXATE, ROSUVASTATIN CALCIUM, ROSUVASTATIN-EZETIMIBE, ROSZET, SULFASALAZINE, SULFASALAZINE DR, TREXALL, TYKERB, XATMEP, ZIPSOR, ZORVOLEX
Atorvastatin/Selected BCRP Inhibitors SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: BCRP inhibitors may result in increased absorption of atorvastatin.(1) CLINICAL EFFECTS: Administration of atorvastatin with BCRP inhibitors may result in elevated levels of atorvastatin, which could result in rhabdomyolysis.(1) PREDISPOSING FACTORS: The risk for myopathy or rhabdomyolysis may be greater in patients 65 years and older, inadequately treated hypothyroidism, renal impairment, carnitine deficiency, malignant hyperthermia, or in patients with a history of myopathy or rhabdomyolysis. Patients with a SLCO1B1 polymorphism that leads to decreased function of the hepatic uptake transporter OATP1B1 may have increased statin concentrations and be predisposed to myopathy or rhabdomyolysis. PATIENT MANAGEMENT: Atorvastatin is a substrate of the efflux transporter BCRP.(1) The US manufacturers of darolutamide and leniolisib recommend avoiding concurrent use with BCRP substrates such as atorvastatin.(2,3) If concurrent therapy is deemed medically necessary, monitor patients for signs and symptoms of myopathy/rhabdomyolysis, including muscle pain/tenderness/weakness, fever, unusual tiredness, changes in the amount of urine, and/or discolored urine.(2) DISCUSSION: Concurrent administration of darolutamide with rosuvastatin increased the mean area-under-the-curve (AUC) and maximum concentration (Cmax) of rosuvastatin approximately 5-fold.(2) The study authors found that darolutamide has no effect on total or renal clearance of rosuvastatin and thus no likely effect on OATP or OAT3, which suggests the increase in rosuvastatin plasma concentrations is due to BCRP inhibition.(4) Concurrent administration of leniolisib with rosuvastatin increased the systemic exposure of rosuvastatin by 2-fold.(3) BCRP inhibitors linked to this monograph include: capmatinib, danicopan, darolutamide, febuxostat, fostamatinib, leflunomide, leniolisib, momelotinib, oteseconazole, pirtobrutinib, regorafenib, selpercatinib, sofosbuvir/velpatasvir/voxilaprevir, teriflunomide, ticagrelor, vadadustat, and velpatasvir.(5,6)	AMLODIPINE-ATORVASTATIN, ATORVALIQ, ATORVASTATIN CALCIUM, CADUET, LIPITOR
Topotecan/BCRP Inhibitors SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Inhibitors of the BCRP transporter may increase the intestinal absorption and hepatic uptake of topotecan.(1) CLINICAL EFFECTS: The concurrent administration of topotecan with an inhibitor of BCRP may result in elevated levels of topotecan and signs of toxicity. These signs may include but are not limited to anemia, diarrhea, and thrombocytopenia.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of topotecan states that the use of topotecan and BCRP inhibitors should be avoided. If concurrent use is warranted, carefully monitor patients for adverse effects.(1) DISCUSSION: In clinical studies, the combined use of elacridar (100 mg to 1000 mg), a BCRP and P-gp inhibitor, increased the area-under-curve (AUC) of topotecan approximately 2.5-fold.(1) BCRP inhibitors linked to this monograph include: capmatinib, clopidogrel, curcumin, danicopan, dasabuvir, elbasvir, enasidenib, febuxostat, fostamatinib, fostemsavir, glecaprevir, grazoprevir, lazertinib, oteseconazole, pacritinib, pantoprazole, paritaprevir, pibrentasvir, pirtobrutinib, regorafenib, resmetirom, ritonavir, roxadustat, tafamidis, ticagrelor, tolvaptan, turmeric, vadadustat, velpatasvir, and voxilaprevir.(2,3)	HYCAMTIN, TOPOTECAN HCL

There are 1 moderate interactions. The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.

Drug Interaction	Drug Names
Ubrogepant/P-gp or BCRP Inhibitors SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Inhibitors of P-glycoprotein (P-gp) or BCRP may increase the absorption of ubrogepant.(1) CLINICAL EFFECTS: The concurrent administration of ubrogepant with an inhibitor of P-glycoprotein or BCRP may result in elevated levels of ubrogepant.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer recommends a dosage adjustment of ubrogepant when coadministered with P-gp or BCRP inhibitors. The dose of ubrogepant should not exceed 50 mg for initial dose. If a second dose of ubrogepant is needed, the dose should not exceed 50 mg.(1) The manufacturer of vimseltinib states concurrent use with P-gp substrates should be avoided. If concurrent use cannot be avoided, take vimseltinib at least 4 hours prior to ubrogepant.(3) DISCUSSION: Ubrogepant is a substrate of P-gp and BCRP transporters. Use of P-gp or BCRP inhibitors may increase the exposure of ubrogepant. Clinical drug interaction studies with inhibitors of these transporters were not conducted. The US manufacturer of ubrogepant recommends dose adjustment if ubrogepant is coadministered with P-gp or BCRP inhibitors.(1) BCRP inhibitors linked to this monograph include: belumosudil, clopidogrel, curcumin, eltrombopag, febuxostat, fostemsavir, leniolisib, momelotinib, oteseconazole, pantoprazole, regorafenib, resmetirom, ritonavir, rolapitant, roxadustat, tafamidis, oral tedizolid, turmeric, and vadadustat.(2-5) P-glycoprotein inhibitors linked to this monograph include: asunaprevir, belumosudil, carvedilol, danicopan, daridorexant, neratinib, osimertinib, propafenone, quinidine, sofosbuvir/velpatasvir/voxilaprevir, tepotinib, tezacaftor, valbenazine, vimseltinib, and voclosporin.(2-5)	UBRELVY

Drug Interaction

Drug Names

Ubrogepant/P-gp or BCRP Inhibitors

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Inhibitors of P-glycoprotein (P-gp) or BCRP may increase the absorption of ubrogepant.(1)

CLINICAL EFFECTS: The concurrent administration of ubrogepant with an inhibitor of P-glycoprotein or BCRP may result in elevated levels of ubrogepant.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer recommends a dosage adjustment of ubrogepant when coadministered with P-gp or BCRP inhibitors. The dose of ubrogepant should not exceed 50 mg for initial dose. If a second dose of ubrogepant is needed, the dose should not exceed 50 mg.(1)

The manufacturer of vimseltinib states concurrent use with P-gp substrates should be avoided. If concurrent use cannot be avoided, take vimseltinib at least 4 hours prior to ubrogepant.(3)

DISCUSSION: Ubrogepant is a substrate of P-gp and BCRP transporters. Use of P-gp or BCRP inhibitors may increase the exposure of ubrogepant. Clinical drug interaction studies with inhibitors of these transporters were not conducted.

The US manufacturer of ubrogepant recommends dose adjustment if ubrogepant is coadministered with P-gp or BCRP inhibitors.(1) BCRP inhibitors linked to this monograph include: belumosudil, clopidogrel, curcumin, eltrombopag, febuxostat, fostemsavir, leniolisib, momelotinib, oteseconazole, pantoprazole, regorafenib, resmetirom, ritonavir, rolapitant, roxadustat, tafamidis, oral tedizolid, turmeric, and vadadustat.(2-5) P-glycoprotein inhibitors linked to this monograph include: asunaprevir, belumosudil, carvedilol, danicopan, daridorexant, neratinib, osimertinib, propafenone, quinidine, sofosbuvir/velpatasvir/voxilaprevir, tepotinib, tezacaftor, valbenazine, vimseltinib, and voclosporin.(2-5)

UBRELVY

Contraindication List
Lactation
Pregnancy

More Frequent	Less Frequent
Headache disorder Nausea	Vaginal irritation

Rare/Very Rare
Abnormal vaginal bleeding Allergic dermatitis Drug-induced hot flash Dyspepsia Dysuria Increased creatine kinase level Menorrhagia Vaginal burning

The following precautions are available for VIVJOA (oteseconazole):

Pediatric
Pregnant
Lactation
Geriatric

Safety and effectiveness of oteseconazole in premenarchal pediatric female patients have not been established.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Oteseconazole is contraindicated in females of reproductive potential and in pregnant women (see Warnings and Precautions). There are limited human data in pregnant women who were exposed to oteseconazole during clinical trials; these data are insufficient to exclude a potential risk of cataracts or other eye abnormalities in human infants.

Oteseconazole is contraindicated in lactating women. There are no data on the presence of oteseconazole in human or animal milk or the effects on milk production. There were no reported adverse effects in breast-fed 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.

Ocular abnormalities were observed in a pre- and postnatal study in the offspring of rats administered oteseconazole from Gestation Day 6 through Lactation Day 20 at doses approximately 3.5 times the recommended human dosage based on AUC comparisons. The relationship between the observed animal findings and breast-fed infants is unknown.

Clinical studies with oteseconazole did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently than younger subjects.

Recurrent vulvovaginal candidiasis
B37.3	Candidiasis of vulva and vagina
B37.31	Acute candidiasis of vulva and vagina
B37.32	Chronic candidiasis of vulva and vagina