For the combination regimen: Day 1, Day 4, Day 7: single dose of 150mg fluconazole Days 14 to 20: 150mg oteseconazole once daily for 1 week For information on new subscriptions, product The first two studies consisted of two phases. 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 [see WARNINGS AND PRECAUTIONS, Use In Specific Populations and CLINICAL PHARMACOLOGY]. Store at room temperature away from light and moisture. 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. Oteseconazole has been shown to be active against most isolates of the following microorganisms associated with RVVC [see INDICATIONS AND USAGE]: In an oral carcinogenicity study, Sprague Dawley rats were administered doses of 0.5, 1.5, or 5 mg/kg/day oteseconazole once daily for up to 90 weeks. The US Food and Drug Administration (FDA) has approved oteseconazole capsules (Vivjoa), an azole antifungal agent for the prevention of recurrent yeast infections in females who . Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of one drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. DURHAM, N.C., August 02, 2022--Mycovia Pharmaceuticals, Inc. ("Mycovia"), an emerging biopharmaceutical company dedicated to recognizing and empowering those living with unmet medical needs by developing novel therapies, has announced that it will present topline results from two studies evaluating VIVJOA (oteseconazole) capsules in patients with recurrent vulvovaginal candidiasis (RVVC) at . 0. Oteseconazole does not undergo significant metabolism. Store at room temperature away from moisture, heat, and light. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Sexually Transmitted Infections Treatment Guidelines, 2021. A very serious allergic reaction to this drug is rare. Many people using this medication do not have serious side effects. WebMD does not provide medical advice, diagnosis or treatment. To help you . A total of 191 patients (87%) in the VIVJOA group and 91 patients (83%) in the placebo group completed the trial. To help you remember, mark your calendar with reminders when to take your medication(s). Vivjoa (oteseconazole) only - dosing lasts a total of 12 weeks Day 1: Take 600 mg (4 capsules) by mouth once. 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. Following oral administration of radiolabeled oteseconazole, approximately 56% of the radiolabeled dose was recovered in feces primarily through biliary excretion and 26% was recovered in urine. Do not chew, crush, dissolve, or open the capsules. This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions. Starting on Day 14: Take 150 mg (1 capsule) by mouth once a week (every 7 days) for 11 weeks. ICH GCP. 5 in yeast and fungi, the formation of ergosterol plays an important role in the integrity, permeability and fluidity of cell membranes. Copyright 2022 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. It can be taken on its own, or in combination with fluconazole during the treatment period. It is distributed by as Vivjoa. Against certain Candida spp. 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. Evaluation of clinical signs and symptoms included erythema(redness), edema (swelling), excoriation (skin picking), itching, burning and irritation. Selected from data included with permission and copyrighted by First Databank, Inc. It will not prevent or treat colds, the flu, or infections caused by bacteria or viruses. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. Overall, similar percentages of serious adverse reactions and adverse reactions leading to drug discontinuation were reported across the VIVJOA and comparator patient dosing groups. If specimens for fungal culture are obtained prior to therapy, antifungal therapy may be instituted before the results of the cultures are known. Based on animal studies, VIVJOA may cause fetal harm when administered to pregnant women. VIVJOA (oteseconazole) capsules, the first FDA-approved product for Mycovia, are an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females . Oteseconazole may cause fetal harm. Vivjoa (oteseconazole) and fluconazole (Diflucan): - dosing lasts a total of 14 weeks Advise patients that oteseconazole is contraindicated in females of reproductive potential, and in pregnant and lactating women because of potential risks to a fetus or breastfed infant. The fluconazole/VIVJOA dosage regimen is in an 18-count (NDC 74695-945-18) blister package within a child resistant wallet. The Company plans to submit a New Drug Application in the first half of 2021. Trial 3 was a randomized, double-blind trial evaluating the efficacy and safety of VIVJOA versus fluconazole and placebo in adults and post-menarchal pediatric females with RVVC. VIVJOA was superior to fluconazole/placebo in the proportion of patients with 1 culture-verified recurring acute VVC episode during the maintenance phase (post randomization through Week 50) or failed clearing their infection during the induction phase and the proportion of patients with 1 culture-verified recurring acute VVC episode or took VVC medication known to treat VVC during the maintenance phase (post randomization through Week 50) or who failed clearing their infection during the induction phase. A Study of Oral Oteseconazole for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection) A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oteseconazole (VT-1161) Oral Capsules in the Treatment of Subjects With Recurrent Vulvovaginal Candidiasis A total of 580 patients were treated with VIVJOA in three clinical trials (Trial 1, Trial 2, and Trial 3) [see Clinical Studies]. If your doctor has prescribed this medication to be taken alone, it is usually taken for 2 days in a row. Advise patients that oteseconazole is contraindicated in lactating women because it may cause harm to the breastfed infant. The FDA has approved the first drug to reduce recurrent vulvovaginal candidiasis (RVVC) in women. You have reached your article limit for the month. Clinical studies of oteseconazole did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. Advise the patient to read the FDA-approved patient labeling (Patient Information). Efficacy was assessed by the proportion of patients with 1 culture verified acute VVC episode during the maintenance phase (post-randomization through Week 50) or who failed clearing their infection during the induction phase. This survey is being conducted by the WebMD marketing sciences department. The structural formula is. Fluconazole is not supplied in the carton. The trial consisted of two phases: induction and maintenance. We are proud to announce the US availability of VIVJOA (oteseconazole) capsules in a network of partner pharmacies. This medication belongs to a class of drugs known as azole antifungals. Oteseconazole can be prescribed to reduce the incidence of RVVC in women with a history of RVVC who are not of reproductive potential.1. Abortions occurred in rabbits in the presence of maternal toxicity (reduced bodyweight gain with reduced food consumption) but there were no malformations at 15 mg/kg/day following administration of oteseconazole during organogenesis in pregnant rabbits about 6 times the maximum human exposure for RVVC based on AUC comparisons. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. The mean age of patients was 35 years (range 16-78) with 80% of patients aged 18-44 years and 19% of patients aged 45 years and older. Common side effects of oteseconazole may include: This is not a complete list of side effects and others may occur. VIVJOA (oteseconazole capsules) contains oteseconazole which is an oral azole antifungal agent. There were no effects on pregnancy or parturition in these pre and postnatal studies at any dose. durham, n.c., july 18, 2022 -- ( business wire )-- mycovia pharmaceuticals, inc. ("mycovia"), an emerging biopharmaceutical company dedicated to recognizing and empowering those living with unmet. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. (NEJM Evidence, 2022) report on two phase 3, randomized placebo-controlled clinical trials of oteseconazole oral capsules in the treatment of RVVC through 48 weeks; METHODS: Two global, phase 3, multicenter, randomized, double-blind, placebo-controlled trials In the third study, the induction phase consisted of oteseconazole 600 mg on day 1 and 450 mg on day 2, or three sequential doses of fluconazole 150 mg on days 1, 4, and 7. Vulvovaginal candidiasis: A review of the evidence for the 2021 Centers for Disease Control and Prevention of Sexually Transmitted Infections Treatment Guidelines. In the ITT population (n = 219), outcomes (percent with verified acute VVC through week 50 or unresolved VVC during the induction phase) were 10.3% for oteseconazole vs. 42.9% for fluconazole/placebo. 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 dose based on AUC comparisons. A total of 112 patients (76%) in the VIVJOA group and 55 patients (76%) in the fluconazole/placebo group completed the trial. Inhibition of CYP51 results in the accumulation of 14-methylated sterols, some of which are toxic to fungi. Written by Cerner Multum. Protect from light when removed from the outer carton. Version: 1.01. fluconazole, nystatin topical, clotrimazole topical, Diflucan, itraconazole, miconazole topical. Oteseconazole is 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. You should not use oteseconazole if you are allergic to it, or if you: May harm an unborn baby. Advise patients to inform their health care provider if they are taking a BCRP substrate (e.g., rosuvastatin). Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye). (oteseconazole capsules), 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. trials, alternative billing arrangements or group and site discounts please call [2] [3] It was developed by Mycovia Pharmaceuticals. Oteseconazole is contraindicated in females of reproductive potential and in pregnant women. You should not become pregnant while using oteseconazole. Neurodegeneration Biomarkers in Patients with Subjective Cognitive Complaints. We hope you found our articles There are no data on the presence of oteseconazole in human or animal milk or data on the effects of oteseconazole on milk production. It includes over 1,000 articles published annually, Although females of reproductive potential were included in the clinical safety data, VIVJOA is contraindicated in females of reproductive potential due to the risk of embryo-fetal toxicity [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and Use In Specific Populations]. Oteseconazole is a white to off-white crystalline powder and is practically insoluble in water within a pH range of 1 to 9 but is soluble in a variety of organic solvents. Ocular abnormalities including cataracts, opacities, exophthalmos/buphthalmos, optic nerve/retinal atrophy, lens degeneration, and hemorrhage were observed in the offspring of rats administered oteseconazole from Gestation Day 6 through Lactation Day 20 at 7.5 mg/kg day (about 3.5 times the recommended human dose based on AUC comparisons). The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. Fluconazole is not supplied in the carton. IMPORTANT SAFETY INFORMATION Contraindications VIVJOA is contraindicated in females of reproductive potential. Each oteseconazole capsule for oral use contains 150 mg of oteseconazole and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose, magnesium stearate, silicified microcrystalline cellulose, and sodium lauryl sulfate. In Trial 2, a total of 425 patients were enrolled into the induction phase with 330 patients entering the maintenance phase with 220 subjects randomized to VIVJOA and 110 patients randomized to placebo. 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. drugs a-z list
Learn more about our commercialization efforts here: https://bit.ly/3B28T5g Oteseconazole is used to reduce the risk of vaginal yeast infections that keep coming back (recurrent vulvovaginal candidiasis-RVVC). Recurrent Yeast Infection of Vagina and Surrounding Area. Based on animal studies, oteseconazole may cause fetal harm when administered to pregnant women. Concomitant use with substrates of BCRP may increase the systemic exposure, possibly leading to higher risk of adverse reactions (e.g., rosuvastatin). Your doctor may occasionally change your dose. Visit the FDA MedWatch website or call 1-800-FDA-1088. Does Oteseconazole 150 Mg Capsule interact with other drugs you are taking? Revised: Apr 2022. By continuing to use our site, you consent to the use of cookies outlined in our Privacy Policy. Abortions occurred in rabbits in the presence of maternal toxicity (reduced bodyweight gain with reduced food consumption) but there were no malformations at 15 mg/kg/day following administration of oteseconazole during organogenesis in pregnant rabbits about 6 times the maximum human exposure for RVVC based on AUC comparisons. Oteseconazole Oteseconazole, sold under the brand name Vivjoa, is a medication used for the treatment of vaginal yeast infections. Vivjoa may be used alone or with other medications. A total of 182 patients (84%) in the VIVJOA group and 91 patients (83%) in the placebo group completed the trial. The most frequently reported adverse reactions (incidence > 2%) were headache and nausea. Available for Android and iOS devices. Patients returned 14 days after the first dose and moved to the maintenance phase if the acute VVC episode was resolved. The relationship between the observed animal findings and breastfed infants is unknown. Printed black "OTE 150" on the capsule and contain 150 mg oteseconazole. There is insufficient information to determine the safety of oteseconazole in patients with moderate or severe hepatic impairment (Child-Pugh B-C). We comply with the HONcode standard for trustworthy health information. Learn more about our Shared by Rose Corbet The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. There will be one blister pack per wallet and one wallet per outer carton. Vivjoa may be used alone or with other medications. Oteseconazole - a novel, oral, selective fungal cytochrome P450 enzyme 51 inhibitor, designed to avoid off-target toxicities. 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. Table 1: Pharmacokinetic (PK) Parameters of Oteseconazole. Oteseconazole shouldn't be taken if you can get pregnant. Oteseconazole may be used as monotherapy or in combination with fluconazole, another systemic antifungal medication. Brand name: Vivjoa This document does not contain all possible drug interactions. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. It is available as 150 mg capsules. 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 [see WARNINGS AND PRECAUTIONS]. What conditions does Oteseconazole 150 Mg Capsule treat? There will be one blister pack per wallet and one wallet per outer carton. In Trial 1, a total of 483 patients were enrolled in the induction phase with 326 patients entering the maintenance phase with 217 patients randomized to VIVJOA and 109 patients randomized to placebo. Swallow the capsules whole. Other drugs may affect oteseconazole, including prescription and over-the-counter medicines, vitamins, and herbal products. Copyright 1996-2022 Cerner Multum, Inc. The safety and effectiveness of oteseconazole have not been established in pre-menarchal pediatric females. Oteseconazole (VIVJOA) is an orally administered azole antifungal agent developed by Mycovia Pharmaceuticals for the treatment of fungal infections. Generic name: oteseconazole [oh-TES-e-KON-a-zole] Call your doctor for medical advice about side effects. Evaluation of clinical signs and symptoms included erythema (redness), edema (swelling), excoriation (skin picking), itching, burning and irritation. 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