Indication

ZELTASIA is indicated for the treatment of adults with relapsing forms of multiple sclerosis (MS).

For adults with relapsing multiple sclerosis (MS) For US Audiences Only
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Support Program

Support Program is designed for one purpose: to make sure you and your loved ones have the support and answers you need when it comes to ZELTASIA and living with multiple sclerosis (MS).

How can we help?

A dedicated MS Nurse Navigator

This point of contact will be assigned to you and help by:

  • Scheduling key appointments when you get started with ZELTASIA
  • Making sure you take advantage of all the support that’s available
  • Getting to know your specific needs and answering questions about ZELTASIA for you and your loved ones

Help navigating insurance benefits

Your MS Nurse Navigator will work with a reimbursement specialist and your insurance carrier(s) to:

  • Determine your coverage for ZELTASIA
  • Explain your pharmacy benefits
  • Help you understand any out-of-pocket costs
  • Enroll you in the $0 co-pay offer* to determine if you’re eligible to pay as little as $0 a month for ZELTASIA

Assistance with financial support

If you’re on Medicare/Medicaid, we can help by identifying co-pay assistance foundations that may be able to assist with treatment costs and/or getting access to ZELTASIA.

Reimbursement for some medical costs*

There may be costs associated with some of the medical appointments and routine tests required before starting ZELTASIA. For eligible patients, these costs may be reimbursed.

Learn about costs
& reimbursement

The $0 co-pay offer*

For eligible patients, the cost for ZELTASIA may be as little as $0 every month.

Sign up now

Help getting ZELTASIA while you wait for insurance approvals

If you have private or commercial insurance and are experiencing delays or issues with coverage, the ZELTASIA Bridge Program may be able to provide a free 30-day supply of ZELTASIA to hold you over until these issues are resolved (for up to 24 months).†

The latest information sent directly to you

Through mail, e-mail, and text you can choose to receive:

  • Information about taking ZELTASIA
  • Tips for staying on treatment
  • Invitations to connect with others at live and online events
  • Ways to live a healthy lifestyle that can have an impact
  • Stories and videos from people living with MS

Sign up for the Support Program

Whether you’re already taking ZELTASIA or just want to stay up to date, become part of the program today.

Sign up

Other areas to explore:

  • Resources for
    care partners

    If you’re a friend or loved one of someone with MS, you may be surprised by the resources,
    tools, and support that are available to you.

    See what’s available

  • How MS organizations can help

    There are many MS organizations that offer helpful information, support, and ways to connect
    with others.

    Find out what they can do

*Depending on insurance coverage and where the full cost is not covered by patient’s insurance, eligible patients may receive a prescription benefit offer for out-of-pocket drug costs and pay as little as $0 per prescription, as well as a medical assessment benefit offer for out-of-pocket costs for the initial blood tests, ECG screening, and first dose observation. Maximum savings limit applies; patient out-of-pocket expenses may vary. This program is not health insurance. Offer not valid for patients enrolled in Medicare, Medicaid, or other federal or state health care programs. Please click here for Program Terms, Conditions, and Eligibility Criteria.

†To receive a free Bridge Supply of ZELTASIA, you must have an on-label diagnosis and be denied or experiencing a delay in obtaining coverage under your private or commercial insurance for ZELTASIA. Federal, state, or similar insurance plans are not eligible for Bridge. Once ZELTASIA is approved by your commercial insurance plan, you will no longer be eligible for the Bridge Program. The Bridge Program is available where not otherwise prohibited by state or local law.

Do not start ZELTASIA if you:

  • Have had a heart attack, chest pain (also known as unstable angina), stroke or mini-stroke (also known as transient ischemic attack or TIA) or certain types of heart failure in the last 6 months
  • Have a history or presence of certain types of irregular or abnormal heartbeat (also known as arrhythmia) that is not corrected by a pacemaker
  • Have severe breathing problems during your sleep (also known as sleep apnea)
  • Are allergic to litifimod or any of the ingredients in ZELTASIA

ZELTASIA may cause serious side effects, including:

  • Slow heart rate (also known as bradycardia) when you start taking ZELTASIA. ZELTASIA can cause your heart rate to temporarily slow down, especially after you take your initial dose. Slow heart rate may occur if you restart ZELTASIA after missing more than 14 consecutive days of treatment. Prior to restarting ZELTASIA, please consult with your physician as you will need a new 7-day starter pack to minimize the risk of heart rate reductions.
    Call your healthcare provider if you experience the following symptoms of slow heart rate such as:
    • Dizziness
    • Shortness of breath
    • Lightheadedness
    • Confusion
    • Feeling like your heart is beating slowly or skipping beats
    • Chest pain
  • Infections. ZELTASIA can increase the risk of infections. You should not receive live vaccines during treatment with ZELTASIA and for 3 months after you stop taking ZELTASIA. Vaccines may not work as well when given during treatment with ZELTASIA. ZELTASIA lowers the number of lymphocytes (a type of white blood cell) and this may lower the ability of your immune system to fight infections. This will usually go back to normal within 3 months of stopping treatment. Your health care provider should review a recent blood test of your white blood cells before you start taking ZELTASIA.
    Call your health care provider right away if you have any of these symptoms of an infection during treatment with ZELTASIA and for 3 months after your last dose of ZELTASIA:
    • Fever
    • Cough
    • Feeling very tired
    • Urinary discomfort
    • Flu-like symptoms
    • Rash
  • Progressive multifocal leukoencephalopathy (PML). Although no cases have been seen in patients in clinical trials with ZELTASIA, PML may occur. PML is a rare brain infection that may lead to death or severe disability. If PML happens, it usually happens in people with weakened immune systems but has happened in people who do not have weakened immune systems. Call your healthcare provider right away if you experience any new or worsening symptoms of PML such as:
    • Weakness on one side of the body
    • Changes in vision
    • Changes in thinking or memory
    • Confusion
    • Personality changes
  • A problem with your vision called macular edema. Macular edema can cause some of the same vision symptoms as a multiple sclerosis (MS) attack (also known as “optic neuritis”). Tell your healthcare provider any time you notice vision changes during treatment with ZELTASIA. Your risk of macular edema is higher if you have diabetes or have had an inflammation of your eye called uveitis. Call your healthcare provider right away if you have any of the following:
    • Blurriness or shadows in the center of your vision
    • A blind spot in the center of your vision
    • Sensitivity to light
    • Unusually colored vision

Before taking ZELTASIA, tell your healthcare provider about all of your medical conditions, including if you:

  • Have liver problems
  • Have a slow heart rate
  • Have a fever or infection
  • Are unable to fight infections due to a disease, or you take or have taken medicines that lower your immune system
  • Have received a vaccine in the past 30 days or are scheduled to receive a vaccine. ZELTASIA may cause vaccines to be less effective
  • Have macular edema or have risk factors for macular edema such as uveitis which is a type of (an inflammation of the eye) or diabetes
  • Are pregnant or plan to become pregnant.
    • If you are a female who can become pregnant, you should use effective birth control during your treatment with ZELTASIA and for at least 3 months after you stop taking ZELTASIA
  • Are breastfeeding or plan to breastfeed.
    • It is not known if ZELTASIA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take ZELTASIA, are breastfeeding, or plan to breastfeed

Tell your healthcare provider about all the medicines you take or have recently taken, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take or have taken medicines that affect your immune system, including corticosteroids, or other treatments for multiple sclerosis. Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist when you get a new medicine.

ZELTASIA cause possible side effects, including:

  • Swelling and narrowing of the blood vessels in your brain. A condition called PRES (Posterior Reversible Encephalopathy Syndrome) has happened rarely in adults taking ZELTASIA. It is not known if ZELTASIA caused this. ZELTASIA should be stopped if this condition occurs. PRES will usually get better. However, if left untreated, it may lead to a stroke. Call your healthcare provider right away if you have any of the following symptoms:
    • Sudden severe headache
    • Sudden confusion
    • Sudden loss of vision or other changes in your vision
  • Increased blood pressure. Your healthcare provider should check your blood pressure during treatment with ZELTASIA
  • Fetal risk. It is not known if ZELTASIA can cause abnormalities of the fetus. You should use effective birth control during your treatment with ZELTASIA and for at least 3 months after you stop taking ZELTASIA. Call your healthcare provider if you think you may be pregnant [See “What should I tell my healthcare provider before taking ZELTASIA?”]
  • Allergic reactions. Call your healthcare provider if you have symptoms of an allergic reaction, including a rash, itchy hives, or swelling of the lips, tongue or face

The most common side effects of ZELTASIA can include:

  • Colds and sore throat
  • Abnormal liver tests
  • Urinary tract infections
  • High blood pressure (hypertension)
  • Upper respiratory tract infections

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of ZELTASIA. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information, including Patient Information (Medication Guide)