MAYZENT FAQs

ALONGSIDE MS IS HERE TO HELP YOUR PATIENTS GET STARTED ON MAYZENT®

Alongside MS Alongside MS

Alongside MS is designed to provide support by delivering what patients need, including financial support, help getting started, and more.

Call 1-877-MAYZENT (1-877-629-9368) for assistance or questions about how to enroll. Support is available 24 hours a day, 7 days a week.

Call 1-877-MAYZENT (1-877-629-9368) for assistance or questions about how to enroll. Support is available 24 hours a day, 7 days a week.

Your Support Team

Alongside MS
Coordinator

Alongside MS
Coordinator

A dedicated, one-on-one coordinator works remotely with each patient to help them get started and to provide ongoing support for up to 2 years.*

Case Manager

Case Manager

Works remotely with HCP offices and patients to coordinate follow-up and manage patient benefits by offering support with reimbursement, prior authorization, and appeals related to coverage, assessments, and initiation.

Field
Reimbursement
Manager (FRM)

Field Reimbursement Manager (FRM)

Provides in-office education on the Alongside MS program and support with patient status updates, access, and reimbursement.

ACCESS &
FINANCIAL SUPPORT

  • Identify financial assistance options for your patients

  • Bridge Program for eligible patients

  • $0 co-pay for eligible patients


ASSESSMENT
SUPPORT

  • Assistance with coordinating assessments

  • Support for assessment-related costs, if eligible

  • Access to ECG equipment to conduct an FDO, if necessary§


DELIVERY &
INITIATION

  • Help coordinating with specialty pharmacy

  • Free Starter Kit

  • Assistance with refill reminders

$0 Copay for Your Patients $0 Copay for Your Patients

$0 CO-PAY FOR ELIGIBLE PATIENTS

ECG=electrocardiogram; FDO=first-dose observation; MS=multiple sclerosis.

*Information provided by Alongside MS is for educational purposes only and is not intended to replace discussions with a health care provider. All medical decisions regarding patient care must be made with their health care provider.

See Start Form for eligibility and additional details.

Limitations apply. Up to a $18,000 annual limit. Offer not valid under Medicare, Medicaid, or any other federal or state program. Novartis reserves the right to rescind, revoke, or amend this Program without notice. See complete Terms & Conditions for details at www.mayzent.com.

§The ECG equipment and over-read services provided in connection with the MAYZENT ECG Access Program may be used solely for MAYZENT patients undergoing a cardiac evaluation and/or first-dose observation (FDO). Limitations apply. See Health Care Provider Certification, which will be provided by CardioNet. Program is subject to termination or modification at any time. CardioNet does not make any treatment recommendations with respect to MAYZENT. The decision to start therapy with MAYZENT and the determination as to whether a patient is appropriate for discharge following the FDO should be made by the physician who is conducting the FDO in accordance with his or her clinical judgment.

For all patients prescribed a 2-mg maintenance dose of MAYZENT, a 5-day starter pack and 1 month of maintenance supply are available at no cost when starting or restarting therapy. To avoid an unintended lapse in therapy, patients insured through federal or state health care programs will receive this free medication after confirmation of insurance coverage for MAYZENT. Patients prescribed a 1-mg maintenance dose with either commercial insurance or without any insurance are eligible for their first month's supply when starting or restarting MAYZENT at no cost. Patients will self-titrate to their 1-mg maintenance dose using their first month's supply. Patients prescribed a 1-mg maintenance dose and whose prescriptions are paid for in whole or in part by a federal or state health care program are not eligible for this offer. No purchase required. Free medication will be dispensed by the MAYZENT Program Pharmacy, Homescripts, to the patient or to the health care provider overseeing the first dose observation, as directed. This offer is not health insurance and may not be submitted for insurance reimbursement. Limitations may apply. Novartis reserves the right to rescind, revoke, or amend the Program and discontinue support at any time without notice.

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Indication and Important Safety Information

INDICATION

MAYZENT® (siponimod) is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

IMPORTANT SAFETY INFORMATION

Contraindications

  • Patients with a CYP2C9*3/*3 genotype

  • In the last 6 months, experienced myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization, or Class III/IV heart failure

  • Presence of Mobitz type II second-degree, third-degree atrioventricular block, or sick sinus syndrome, unless patient has a functioning pacemaker

INDICATION

MAYZENT® (siponimod) is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Infections: MAYZENT may increase risk of infections with some that are serious in nature. Life-threatening and rare fatal infections have occurred.

Before starting MAYZENT, review a recent complete blood count (CBC) (ie, within 6 months or after discontinuation of prior therapy). Delay initiation of treatment in patients with severe active infections until resolved. Employ effective treatments and monitor patients with symptoms of infection while on therapy. Consider discontinuing treatment if patient develops a serious infection.

Cases of fatal cryptococcal meningitis (CM) were reported in patients treated with another sphingosine 1-phosphate (S1P) receptor modulator. Rare cases of CM have occurred with MAYZENT. If CM is suspected, MAYZENT should be suspended until cryptococcal infection has been excluded. If CM is diagnosed, appropriate treatment should be initiated.

No cases of progressive multifocal leukoencephalopathy (PML) were reported in MAYZENT clinical trials; however, they have been observed in patients treated with another sphingosine 1-phosphate (S1P) receptor modulator and other multiple sclerosis (MS) therapies. If PML is suspected, MAYZENT should be discontinued.

Cases of herpes viral infection, including one case of reactivation of varicella zoster virus leading to varicella zoster meningitis, have been reported. Patients without a confirmed history of varicella zoster virus (VZV) or without vaccination should be tested for antibodies before starting MAYZENT. If VZV antibodies are not present or detected, then VZV immunization is recommended and MAYZENT should be initiated 4 weeks after vaccination.

Use of live vaccines should be avoided while taking MAYZENT and for 4 weeks after stopping treatment.

Caution should be used when combining treatment (ie, anti-neoplastic, immune-modulating, or immunosuppressive therapies) due to additive immune system effects.

Macular Edema: In most cases, macular edema occurred within 4 months of therapy. Patients with history of uveitis or diabetes are at an increased risk. Before starting treatment, an ophthalmic evaluation of the fundus, including the macula, is recommended and at any time if there is a change in vision. The use of MAYZENT in patients with macular edema has not been evaluated; the potential risks and benefits to the individual patient should be considered.

Bradyarrhythmia and Atrioventricular Conduction Delays: Prior to initiation of MAYZENT, an ECG should be obtained to determine if preexisting cardiac conduction abnormalities are present. In all patients, a dose titration is recommended for initiation of MAYZENT treatment to help reduce cardiac effects.

MAYZENT was not studied in patients who had:

Reinitiation of treatment (initial dose titration, monitoring effects on heart rate and AV conduction [ie, ECG]) should apply if ≥4 consecutive daily doses are missed.

Respiratory Effects: MAYZENT may cause a decline in pulmonary function. Spirometric evaluation of respiratory function should be performed during therapy if clinically warranted.

Liver Injury: Elevation of transaminases may occur in patients taking MAYZENT. Before starting treatment, obtain liver transaminase and bilirubin levels. Closely monitor patients with severe hepatic impairment. Patients who develop symptoms suggestive of hepatic dysfunction should have liver enzymes checked, and MAYZENT should be discontinued if significant liver injury is confirmed.

Increased Blood Pressure: Increase in systolic and diastolic pressure was observed about 1 month after initiation of treatment and persisted with continued treatment. During therapy, blood pressure should be monitored and managed appropriately.

Fetal Risk: Based on animal studies, MAYZENT may cause fetal harm. Women of childbearing potential should use effective contraception to avoid pregnancy during and for 10 days after stopping MAYZENT therapy.

Posterior Reversible Encephalopathy Syndrome (PRES): Rare cases of PRES have been reported in patients receiving a sphingosine 1-phosphate (S1P) receptor modulator. Such events have not been reported for patients treated with MAYZENT in clinical trials. If patients develop any unexpected neurological or psychiatric symptoms, a prompt evaluation should be considered. If PRES is suspected, MAYZENT should be discontinued.

Unintended Additive Immunosuppressive Effects From Prior Treatment or After Stopping MAYZENT: When switching from drugs with prolonged immune effects, the half-life and mode of action of these drugs must be considered to avoid unintended additive immunosuppressive effects.

Initiating treatment with MAYZENT after treatment with alemtuzumab is not recommended.

After stopping MAYZENT therapy, siponimod remains in the blood for up to 10 days. Starting other therapies during this interval will result in concomitant exposure to siponimod.

Lymphocyte counts returned to the normal range in 90% of patients within 10 days of stopping therapy. However, residual pharmacodynamic effects, such as lowering effects on peripheral lymphocyte count, may persist for up to 3-4 weeks after the last dose. Use of immunosuppressants within this period may lead to an additive effect on the immune system, and therefore, caution should be applied 3-4 weeks after the last dose of MAYZENT.

Severe Increase in Disability After Stopping MAYZENT: Severe exacerbation of disease, including disease rebound, has been rarely reported after discontinuation of an S1P receptor modulator. The possibility of severe exacerbation of disease should be considered after stopping MAYZENT treatment, thus patients should be monitored upon discontinuation.

Most Common Adverse Reactions: Most common adverse reactions (>10%) are headache, hypertension, and transaminase increases.

Please click here for full Prescribing Information, including Medication Guide.