Oteseconazole is a systemic antifungal medication used to treat recurrent vulvovaginal candidiasis in women without reproductive potential. The most frequently reported adverse reactions were headache (7.4%), nausea (3.6%), and increase in blood creatine phosphokinase (1.9% for 10 times upper limit of normal).1, Oteseconazole targets the fungal sterol, 14alpha demethylase (CYP51), disrupting fungal cell membrane formation and integrity.1 The efficacy of oteseconazole was evaluated in two randomized, placebo-controlled trials and one vs. fluconazole in subjects with RVVC ( 3 episodes of vulvovaginal candidiasis in a 12-month period).1. VIVJOA is indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential [see WARNINGS AND PRECAUTIONS, Use In Specific Populations, and Clinical Studies]. Animal studies indicated that oteseconazole exposures in vaginal tissue are comparable to plasma exposures. Licensee Jiangsu Hengrui Medicine is developing otesaconazole, as an oral capsule formulation, for treating fungal conditions, including RVVC, onychomycosis and invasive fungal infections, in Greater China and planned for a phase 3 trial in April 2021 for treating VVC. They are available in an 18-count (NDC 74695-823-18) blister package within a child resistant wallet. None of the remaining planners or authors for this educational activity have relevant financial relationships to disclose with ineligible companies whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients. The clinical relevance of these findings after very high doses (5 to 7 times the MRHD) for the lifetime of the rat remains unclear. One patient in the VIVJOA group did not receive drug therefore 146 patients received VIVJOA. Tell your doctor if you are pregnant, think you might be pregnant, or plan to get pregnant. Does Amantadine Treatment Reduce Levodopa-Induced Dyskinesias? If either of these effects lasts or gets worse, tell your doctor or pharmacist promptly. The most frequently reported adverse reactions (incidence > 2%) were headache and nausea. Concomitant use with oteseconazole may increase the exposure of drugs that are BCRP substrates, which may increase the risk of adverse reactions associated with these drugs. What Are the Best PsA Treatments for You? Proportion of Patients with 1 Culture-verified Acute VVC Episode through Week 50 or Unresolved VVC Episode During the Induction Phase, Proportion of Patients with 1 Culture-verified Acute VVC Episode or took VVC medication through Week 50 or Unresolved VVC Episode During the Induction Phase, Abbreviations: ITT=Intent-to-Treat (Population); VVC=vulvovaginal candidiasis. Nyirjesy P, Brookhart C, Lazenby G, et al. Oteseconazole - a novel, oral, selective fungal cytochrome P450 enzyme 51 inhibitor, designed to avoid off-target toxicities. AHFS Drug Information. In an induction phase, patients in the oteseconazole group received 600 mg of oteseconazole (four 150-mg capsules) on day 1; 450 mg of oteseconazole (three 150-mg capsules) on day 2; and a single placebo capsule on days 4 and 7. There is one blister pack of VIVJOA (oteseconazole capsules) per wallet and one wallet per outer carton. It inhibits cytochrome P450 (CYP) 51, thereby affecting the formation and integrity of the fungal cell membrane, but has a low affinity for human CYP enzymes due to its tetrazole metal-binding group. During the induction phase, patients received 1050 mg of VIVJOA over two days (600 mg [4x150mg] on Day 1 and 450 mg [3x150mg] on Day 2) or three sequential doses of 150 mg of fluconazole (every 72 hours) on Days, 1, 4 and 7. VIVJOA (oteseconazole capsules) contains oteseconazole which is an oral azole antifungal agent. Oteseconazole shouldn't be taken if you can get pregnant. The mean age of patients was 34 years old (range 18-73 years old) with 85% of patients aged 18-44 years and 15% of patients aged 45 years and older. Printed black "OTE 150" on the capsule and contain 150 mg oteseconazole. A phase 3 randomized, double-blind, controlled trial has shown that oteseconazole (Mycovia Pharmaceuticals), an oral antifungal agent, is safe and effective in treating acute and recurrent yeast. Route(s) of administration : Oral use. The relationship between the observed animal findings and breastfed infants is unknown. Based on animal studies, oteseconazole may cause fetal harm when administered to pregnant women. Take this medication regularly to get the most benefit from it. CAS number: 1340593-59-0. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. They are available in an 18-count ( NDC 74695-823-18) blister package within a child resistant wallet. 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action - Oteseconazole is an antifungal drug - [see - Microbiology (12.4)] . Keep all medications away from children and pets. durham, n.c., august 25, 2022 -- ( business wire )-- mycovia pharmaceuticals, inc. ("mycovia"), an emerging biopharmaceutical company, today announced the publication of its phase 3 ultraviolet. The relevant financial relationshipslisted have been mitigated. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. Protect from light when removed from the outer carton. AHFSfirstRelease. Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease. If specimens for fungal culture are obtained prior to therapy, antifungal therapy may be instituted before the results of the cultures are known. Call your doctor for medical advice about side effects. VIVJOA (oteseconazole capsules) contains oteseconazole which is an oral azole antifungal agent. POTENTIAL ADVANTAGES The long median elimination half-life of 138 days results in a long drug exposure window of 690 days (i.e., five half-lives). Table 3: Trial 3 Efficacy Endpoints ITT population. The most common side effects of Vivjoainclude: Tell the doctor if you have any side effect that bothers you or that does not go away. Other drugs may affect oteseconazole, including prescription and over-the-counter medicines, vitamins, and herbal products. Incidences of hemorrhage were increased in the adrenals, brain, coagulating gland, ears, epididymides, head, heart, lung, nose, pancreas, pharynx, prostate, seminal vesicles, spinal cord, testes, thymus, and bladder of male Crl:CD(SD) rats (after 77 weeks of dosing at about 5 times the MRHD based on AUC comparisons). Starting on day 28, take oteseconazole once a week (every 7 days) for 11 weeks. Fluconazole is not supplied in the carton. Read the Patient Information Leaflet if available from your pharmacist before you start taking oteseconazole and each time you get a refill. Based on animal studies, VIVJOA may cause fetal harm when administered to a pregnant woman or potential harm to the breastfed infant. 4 CONTRAINDICATIONS VIVJOA is contraindicated in: Females of reproductive potential [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3)] Reference ID: 4974238 Each oteseconazole capsule, for oral use, contains 150 mg oteseconazole and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose, magnesium stearate, silicified microcrystalline cellulose, and sodium lauryl sulfate. There are limited human data in pregnant women who were exposed to oteseconazole during the clinical trials; these data are insufficient to exclude a potential risk of cataracts or other eye abnormalities in human infants. The clinical trials population was 75% (435/580) White, 17% (96/580) Black or African American, 6% (36/580) Asian, and 2% (13/580) Other women. Oteseconazole exposure-response relationships and the time course of pharmacodynamic response are unknown. Revised: Apr 2022. Study Design. Therefore, VIVJOA is not recommended for use in patients with moderate or severe hepatic impairment [see CLINICAL PHARMACOLOGY]. Increased incidences of abnormal sperm were observed at 3 mg/kg/day and sperm counts were reduced at 10 mg/kg/day. It is not known if Vivjoa is safe and effective in children prior to menarche. Starting on day 28, take oteseconazole once a week (every 7 days) for 11 weeks. Generic name: oteseconazole [oh-TES-e-KON-a-zole] The observed ocular abnormalities included cataracts, opacities, exophthalmos/buphthalmos, optic nerve/retinal atrophy, lens degeneration and hemorrhage. Interested in Group Sales? Recurrent vulvovaginal candidiasis (RVVC), also known as recurrent yeast infections, is defined as at least 3 episodes of acute VVC in the past 12 months. There was no embryofetal toxicity or malformations at 40 mg/kg/day following administration of oteseconazole during organogenesis in pregnant rats at doses about 10 times the maximum human exposure for RVVC based on AUC comparisons. It is distributed by as Vivjoa. Patients returned 14 days after the first dose of fluconazole and if the acute VVC episode was resolved (vulvovaginal signs and symptoms score < 3) they were randomized (2:1) to receive either 150 mg of VIVJOA or placebo for 7 days followed by 11 weekly doses in the maintenance phase. The elevations were transient. It can be taken on its own, or in combination with fluconazole during the treatment period. If your doctor has prescribed this medication to be taken alone, it is usually taken for 2 days in a row. Eligible participants presenting with an active vulvovaginal candidiasis infection entered an induction phase in which they were randomly assigned 2:1 to receive 600 mg oral oteseconazole on day 1 and 450 mg on day 2, with matching placebo capsules, or to 3 sequential 150-mg oral doses (once every 72 hours) of fluconazole, with matching placebo . Learn more about our commercialization efforts here: https://bit.ly/3B28T5g Use the lowest possible starting dose of the BCRP substrate or consider reducing the dose of the substrate drug and monitor for adverse reactions [see CLINICAL PHARMACOLOGY]. Oteseconazole (VIVJOA) is an orally administered azole antifungal agent developed by Mycovia Pharmaceuticals for the treatment of fungal infections. Dr. Elliott is Assistant Clinical Professor of Medicine, University of California, San Francisco.Dr. Tell your doctor about all other medicines you use. The following selected adverse reactions occurred in <2% of patients receiving VIVJOA in Trial 1, Trial 2 and Trial 3: Serum creatine phosphokinase (CPK) (an indirect marker of muscle injury/necrosis) elevations greater than or equal to 10 times the upper limit of normal were observed in 11 (1.9%) patients treated with VIVJOA versus 2 (0.7%) patients in the comparator groups during the VIVJOA clinical trials. If you notice other effects not listed above, contact your doctor or pharmacist. VIVJOA is contraindicated in lactating women and females of reproductive potential. The AUC of oteseconazole increased approximately dose proportionally while the Cmax increased less than dose proportionally over a dose range of 20 mg (0.13 times the lowest recommended dose) to 320 mg (0.53 times the highest recommended dose). Concomitant use with VIVJOA may increase the exposure of drugs that are BCRP substrates, which may increase the risk of adverse reactions associated with these drugs [see DRUG INTERACTIONS]. What conditions does Oteseconazole 150 Mg Capsule treat? VIVJOA (oteseconazole) capsules are an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential. If specimens for fungal culture are obtained prior to therapy, antifungal therapy may be instituted before the results of the cultures are known.
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