MY VIVJOA SUPPORT PROGRAM
MY VIVJOA SUPPORT PROGRAM
PRESCRIBING VIVJOA
HOW TO GET STARTED
Send your patient’s prescription to vitaCare℠ Prescription Services via one of the following methods:
E-PRESCRIBE TO
vitaCare℠ PRESCRIPTION SERVICES
(951 Yamato Road, Suite 160, Boca Raton, FL 33431)
NCPDP #5728045
What to expect
SUPPORT
- Text your patient when their prescription is received.
- Direct your patient to call vitaCare at 833-873-6300 to process their prescription, or vitaCare will call them to assist.
COVERAGE AND SAVINGS
- Verify patient insurance coverage and out-of-pocket cost – as little as $5 for 12-week course of therapy for eligible patients*
- Communicate with your office if Prior Authorization is required
- Keep patients informed of prescription status
CONVENIENCE
- Offer free home delivery or pick up at a local in-network pharmacy if available
My VIVJOA Savings Program
Based on insurance eligibility, patients will be connected to the appropriate program. Restrictions may apply.*
Download
Resource to reinforce the availability of the VIVJOA Savings Program for eligible patients.
A vitaCare customer care advocate will apply all applicable savings programs and provide out-of-pocket cost information to your patient.
My VIVJOA PRESCRIBING RESOURCES
The downloadable resources below summarize the steps of prescribing VIVJOA through vitaCare.
My VIVJOA Office Prescribing Instructions Powered by vitaCare℠
Resource to outline various options on how to get started wth prescribing VIVJOA through vitaCare.
vitaCare℠ Patient Resource
Resource for patients on what to expect after their VIVJOA prescription has been sent to vitaCare.
My VIVJOA SUPPORT RESOURCES
The downloadable resources below provide information after prescribing and obtaining access for VIVJOA.
Navigating Prior Authorizations
Resource with considerations and clinical requirements that may be requested by payers to obtain approval for VIVJOA.
Letter of Medical Necessity Example
Example provided to help to generate a customized Letter of Medical Necessity — used to support coverage for treatment and should contain all pertinent patient information.
Letter of Appeals Example
Example provided to help to generate a customized Letter of Appeals — used when there is a denial of coverage for treatment and additional information is needed to reconsider coverage.
Questions?
1-833-873-6300 or email vivjoasupport@vitacarerx.com
VIVJOA is the first FDA-approved medication to reduce the incidence of RVVC.1
INDICATION
VIVJOA® (oteseconazole) is indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Females of Reproductive Potential: VIVJOA is contraindicated in females of reproductive potential. Females who are NOT of reproductive potential are defined as: persons who are biological females who are postmenopausal or have another reason for permanent infertility (e.g., tubal ligation, hysterectomy, salpingo-oophorectomy).
Pregnant and Lactating Women: VIVJOA is contraindicated in pregnant and lactating women.
Hypersensitivity: VIVJOA is contraindicated in patients with known hypersensitivity to oteseconazole.
WARNINGS AND PRECAUTIONS
Embryo-Fetal Toxicity: Based on animal studies, VIVJOA may cause fetal harm. 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. Advise patients that VIVJOA is contraindicated in females of reproductive potential, and in pregnant and lactating women because of potential risks to a fetus or breastfed infant.
ADVERSE REACTIONS
The most frequently reported adverse reactions among VIVJOA-treated patients in clinical studies included headache (7.4%) and nausea (3.6%).
DRUG INTERACTIONS
Effect of VIVJOA on Other Drugs: Oteseconazole is a Breast Cancer Resistance Protein (BCRP) inhibitor. Concomitant use of VIVJOA with BCRP substrates (e.g., rosuvastatin) may increase the exposure of BCRP substrates (e.g., rosuvastatin), which may increase the risk of adverse reactions associated with these drugs. Use the lowest possible starting dose of the BCRP substrate or consider reducing the dose of the substrate drug and monitor for adverse reactions.
USE IN SPECIFIC POPULATIONS
Pregnancy: VIVJOA is contraindicated in females of reproductive potential and in pregnant women. Based on animal studies, VIVJOA may cause fetal harm when administered to pregnant women. In addition, 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.
Lactation: VIVJOA is contraindicated in lactating women and females of reproductive potential. There are no data on the presence of oteseconazole in human or animal milk or data on the effects of oteseconazole on milk production. 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.
Females of Reproductive Potential: VIVJOA is contraindicated in females of reproductive potential based on data from rat studies.
Pediatric Use: The safety and effectiveness of VIVJOA have not been established in pre-menarchal pediatric females.
Geriatric Use: Clinical studies of VIVJOA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
Renal Impairment: No dosage adjustment of VIVJOA is recommended in patients with mild to moderate renal impairment. VIVJOA is not recommended for use in patients with severe renal impairment or end-stage renal disease, as clinical studies did not include sufficient numbers of these patients.
Hepatic Impairment: No dosage adjustment of VIVJOA is recommended in patients with mild hepatic impairment. VIVJOA is not recommended for use in patients with moderate or severe hepatic impairment, as there is insufficient information in these patients.
Please see full Prescribing Information and Patient Information.
To report SUSPECTED ADVERSE REACTIONS, contact Mycovia Pharmaceuticals, Inc. at 1-855-299-0637 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
*With the VIVJOA® (oteseconazole) Savings Card, eligible commercially-insured patients may pay as little as $5, up to the maximum benefit. Patients with prescription coverage through any type of federal or state government-funded program (eg, Medicare, Medicaid, TRICARE, Veterans Administration [VA]) are not eligible. Offer is valid for one use every calendar year. A valid Prescriber ID# is required on the prescription. By participating in this program, the patient and pharmacy acknowledge that, at the time of usage, the patient meets the eligibility criteria and complies with the following terms and conditions.
Terms and Conditions: This offer is valid in the United States and is subject to change at any time. Offer not valid for prescriptions reimbursed under a Medicare drug benefit plan, Medicaid, TRICARE, Veterans Administration [VA], or other federal or state government-funded program. The patient must use the Program for a valid prescription of VIVJOA at a participating pharmacy, and the patient and participating pharmacy are each obligated to inform the insurance plan of any benefit received under the Savings Program and may not participate if the Savings Program conflicts with the plan’s policy. It is illegal to (or offer to) sell, purchase, or trade this offer. This offer is not transferable, is limited to one offer per person per calendar year, and cannot be combined with any other offer. Mycovia Pharmaceuticals, Inc., reserves the right to rescind, revoke, or amend this offer without notice at any time. Void where prohibited by law.
INDICATION
VIVJOA® (oteseconazole) is indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Females of Reproductive Potential: VIVJOA is contraindicated in females of reproductive potential. Females who are NOT of reproductive potential are defined as: persons who are biological females who are postmenopausal or have another reason for permanent infertility (e.g., tubal ligation, hysterectomy, salpingo-oophorectomy).
Pregnant and Lactating Women: VIVJOA is contraindicated in pregnant and lactating women.
Hypersensitivity: VIVJOA is contraindicated in patients with known hypersensitivity to oteseconazole.
WARNINGS AND PRECAUTIONS
Embryo-Fetal Toxicity: Based on animal studies, VIVJOA may cause fetal harm. 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. Advise patients that VIVJOA is contraindicated in females of reproductive potential, and in pregnant and lactating women because of potential risks to a fetus or breastfed infant.
ADVERSE REACTIONS
The most frequently reported adverse reactions among VIVJOA-treated patients in clinical studies included headache (7.4%) and nausea (3.6%).
DRUG INTERACTIONS
Effect of VIVJOA on Other Drugs: Oteseconazole is a Breast Cancer Resistance Protein (BCRP) inhibitor. Concomitant use of VIVJOA with BCRP substrates (e.g., rosuvastatin) may increase the exposure of BCRP substrates (e.g., rosuvastatin), which may increase the risk of adverse reactions associated with these drugs. Use the lowest possible starting dose of the BCRP substrate or consider reducing the dose of the substrate drug and monitor for adverse reactions.
USE IN SPECIFIC POPULATIONS
Pregnancy: VIVJOA is contraindicated in females of reproductive potential and in pregnant women. Based on animal studies, VIVJOA may cause fetal harm when administered to pregnant women. In addition, 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.
Lactation: VIVJOA is contraindicated in lactating women and females of reproductive potential. There are no data on the presence of oteseconazole in human or animal milk or data on the effects of oteseconazole on milk production. 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.
Females of Reproductive Potential: VIVJOA is contraindicated in females of reproductive potential based on data from rat studies.
Pediatric Use: The safety and effectiveness of VIVJOA have not been established in pre-menarchal pediatric females.
Geriatric Use: Clinical studies of VIVJOA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
Renal Impairment: No dosage adjustment of VIVJOA is recommended in patients with mild to moderate renal impairment. VIVJOA is not recommended for use in patients with severe renal impairment or end-stage renal disease, as clinical studies did not include sufficient numbers of these patients.
Hepatic Impairment: No dosage adjustment of VIVJOA is recommended in patients with mild hepatic impairment. VIVJOA is not recommended for use in patients with moderate or severe hepatic impairment, as there is insufficient information in these patients.
Please see full Prescribing Information and Patient Information.
To report SUSPECTED ADVERSE REACTIONS, contact Mycovia Pharmaceuticals, Inc. at 1-855-299-0637 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.