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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ADDITIONAL
study measurements

While the focus of the ZELTASIA clinical studies was to measure how well it treats relapses and lesions, additional measurements were taken. Here are other ways ZELTASIA compared to a leading injectable medicine (Avonex): *

*Avonex (interferon beta-1a).

Measuring brain volume loss

What is brain volume loss? Everyone loses brain volume as they age, but with MS it can happen more quickly.

In clinical studies, the effect of ZELTASIA on the volume of the whole brain was studied as a secondary endpoint (an additional measurement to support or provide further information).

Decrease in brain volume

Measured as a percentage change in the average volume over one year

  • ONE-YEAR STUDY

    • ZELTASIA
    • LEADING INJECTABLE MEDICINE

    A total of 895 people were in this study (ZELTASIA 447, a leading injectable 448).

  • TWO-YEAR STUDY

    ZELTASIA -0.71% LEADING INJECTABLE MEDICINE -0.94%
    • ZELTASIA
    • LEADING INJECTABLE MEDICINE

    A total of 874 people were in this study (ZELTASIA 443, a leading injectable 441).

Based on the way the studies were designed, the difference between people who took ZELTASIA and those who took a leading injectable medicine was not considered statistically significant.

Grey matter loss
was also measured

The brain is made up of white matter and grey matter. With MS, the volume of both types of brain matter decreases more quickly.

Like brain volume loss, grey matter volume loss was evaluated in both clinical studies as an exploratory endpoint (another measurement looked at in the study to provide more information). It was used to see what effect, if any, ZELTASIA had on grey matter volume.

Decrease in grey matter

Measured as a percentage change in the average volume over one year

  • ONE-YEAR STUDY

    • Surface grey matter loss
      • ZELTASIA
      • LEADING INJECTABLE MEDICINE
    • Deep grey matter loss
      • ZELTASIA
      • LEADING INJECTABLE MEDICINE

    A total of 895 people were in this study (ZELTASIA 447, a leading injectable 448).

  • TWO-YEAR STUDY

    • Surface grey matter loss
      • ZELTASIA
      • LEADING INJECTABLE MEDICINE
    • Deep grey matter loss
      • ZELTASIA
      • LEADING INJECTABLE MEDICINE

    A total of 874 people were in this study (ZELTASIA 443, a leading injectable 441).

Based on the way the studies were designed, the difference between people who took ZELTASIA and those who took a leading injectable medicine was not considered statistically significant.

Measuring cognitive
processing speed

To put it simply, cognition refers to thinking—and how the brain processes information. So, cognitive processing speed measures how quickly the brain is able to receive information, process it correctly, and react to it.

After the clinical studies were complete, cognitive processing speeds were evaluated as part of a secondary endpoint (an additional measurement to support or provide further information).†

The differences in processing
speeds between people who took ZELTASIA and those who took a leading injectable medicine, were not statistically significant. That means it wasn’t proven whether these results were due to treatment or if they happened by chance. So, no definitive conclusions should be drawn from them.

Changes in cognitive
processing speed‡

For people taking ZELTASIA vs those taking a leading injectable medicine

IN A ONE-YEAR STUDY:

  • People who improved
    (by > 4 points)
    8% difference ZELTASIA 36% Leading injectable 28%
    • ZELTASIA
    • LEADING INJECTABLE MEDICINE
  • People who remained stable
    (change < 4 points)
    2% difference ZELTASIA 42% Leading injectable 44%
    • ZELTASIA
    • LEADING INJECTABLE MEDICINE
  • People who worsened
    (by > 4 points)
    6% difference ZELTASIA 22% Leading injectable 28%
    • ZELTASIA
    • LEADING INJECTABLE MEDICINE

†Changes in cognitive processing speed were measured over the course of one year using the Symbol Digit Modalities Test (SDMT). This test evaluates a person's ability to review, assess, and process information, and then perform a task based on that assessment. The SDMT was part of a broader test called the Multiple Sclerosis Functional Composite, which also measures arm/hand function (9-Hole Peg Test) and the ability to walk (Timed 25-Foot Walk).

‡To be considered a meaningful change, a SDMT score must change by 4 points or more.

Other areas to explore:

  • Learn about
    ZELTASIA safety

    The safety of ZELTASIA was evaluated in two separate clinical studies. Learn about the side effects that were reported.

    Side effects

  • Support Program

    Our support program is with you every step of the way with a dedicated MS Nurse Navigator, financial and insurance assistance, and more.

    How we can help

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)