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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PROVEN EFFECTIVE
in clinical studies

The ZELTASIA clinical studies included more people than any other study that compared one MS medication to another.* In these studies, ZELTASIA was proven to reduce relapses and lesions more effectively than
a leading injectable medicine, (Avonex).†

The progression of physical disability was measured, too.

*1,769 people total, 880 took ZELTASIA and 889 took a leading injectable.
†Avonex (interferon beta-1a).

Fewer relapses in both studies

  • ONE-YEAR STUDY

    48% FEWER RELAPSES WITH ZELTASIA

    VS

    VS A LEADING INJECTABLE MEDICINE

    People taking ZELTASIA had an ARR of 0.181 vs 0.350 with a leading injectable.

    Annualized Relapse Rate (ARR) is the average number of relapses a group of patients has in one year. A total of 895 people were in this study (ZELTASIA 447, a leading injectable 448).

  • TWO-YEAR STUDY

    38% FEWER RELAPSES WITH ZELTASIA

    VS

    A LEADING INJECTABLE MEDICINE

    People taking ZELTASIA had an ARR of 0.172 vs 0.276 with a leading injectable.

    Annualized Relapse Rate (ARR) is the average number of relapses a group of patients has in one year. A total of 874 people were in this study (ZELTASIA 433, a leading injectable 441).

More people were relapse free†

  • ONE-YEAR STUDY

    78% OF PEOPLE WERE RELAPSE FREE WITH ZELTASIA

    VS

    66% OF PEOPLE WHO TOOK A LEADING INJECTABLE MEDICINE

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

  • TWO-YEAR STUDY

    76% OF PEOPLE WERE RELAPSE FREE WITH ZELTASIA

    VS

    64% OF PEOPLE WHO TOOK A LEADING INJECTABLE MEDICINE

    A total of 874 people were in this study (ZELTASIA 433, a leading injectable 441).

†A relapse was defined as new or worsening symptoms directly associated with MS that lasted more than twenty-four hours (after having a mostly stable neurological state for at least thirty days).

Disability progression
was also measured

9 out of 10 people who took ZELTASIA experienced NO PROGRESSION OF PHYSICAL DISABILTY

Physical disability progression was measured in both studies every three months in people who took ZELTASIA and those who took a leading injectable medicine. There was no statistically significant difference between the two (7.6% with ZELTASIA vs 7.8% with a leading injectable).

Fewer lesions in both studies

  • ONE-YEAR STUDY

    48% FEWER NEW OR ENLARGING LESIONS (T2) with ZELTASIA VS A LEADING INJECTABLE MEDICINE

    People taking ZELTASIA had an average of 1.465 lesions vs 2.836 with a leading injectable.

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

  • TWO-YEAR STUDY

    42% FEWER NEW OR ENLARGING LESIONS (T2) with ZELTASIA VS A LEADING INJECTABLE MEDICINE

    People taking ZELTASIA had an average of 1.835 lesions vs 3.183 with a leading injectable.

    A total of 874 people were in this study (ZELTASIA 433, a leading injectable 441).

T2 (lesions) refers to a type of magnetic resonance imaging (MRI) scan (a T2-weighted image) that can be used to identify the total number of lesions a person has.

Additional results from the studies

Although the clinical studies of ZELTASIA focused mainly on how
well it reduced relapses and lesions, other measurements were taken to provide even more information for people with MS.

See additional study results

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)