STARTING GILENYA®

Not an actual patient.

STEP 1: Pretests

You can expect your health care professional to request these tests:

Routine blood tests

including complete blood count and liver enzyme checks

Eye exams

to look for pre-existing conditions and help monitor potential changes

ECG

or electrocardiogram, which tests whether extra precautions should be taken in case of certain heart conditions

If your child is starting GILENYA, they'll also need to complete scheduled vaccines.

STEP 2: Your first day taking GILENYA

On your first day of taking GILENYA, a first-dose observation (FDO) will happen to help you start safely.

Here's what to expect:

An ECG will be done

You'll take GILENYA—
it's a pill that's swallowed with water

Pulse and blood pressure will be monitored each hour for 6 hours

After 6 hours, another ECG will be done

In some instances, like if you have certain heart problems or experience a serious side effect, your health care professional may decide further observation is needed. If so, you'll stay in a medical facility overnight and for at least 6 hours after your second dose.

Once you complete these steps and your health care professional clears you for continued treatment, you're all set! GILENYA becomes a part of your routine.

Still have questions?

If you have any questions about treatment for RMS, talk to your health care professional.

AN RMS TREATMENT WITH POWERFUL RESULTS*

Learn about KESIMPTA®, a once-monthly† B-cell treatment you can take from the comfort of your own home.

*In 2 studies vs AUBAGIO® (teriflunomide).

†After 3 weekly starter doses.

EXPLORE KESIMPTA

For adults only.

Kristin C. has taken KESIMPTA and has been compensated for her time.

For adults only.

Kristin C. has taken KESIMPTA and has been compensated for her time.

AN RMS TREATMENT WITH POWERFUL RESULTS*

Learn about KESIMPTA®, a once-monthly† B-cell treatment you can take from the comfort of your own home.

*In 2 studies vs AUBAGIO® (teriflunomide).

†After 3 weekly starter doses.


EXPLORE KESIMPTA

IMPORTANT SAFETY INFORMATION

Who should not take KESIMPTA?

Do NOT take KESIMPTA if you have active hepatitis B virus (HBV) infection.

What is the most important information I should know about KESIMPTA?

KESIMPTA can cause serious side effects such as:

  • Infections. Serious infections can happen during treatment with KESIMPTA. If you have an active infection, your healthcare provider (HCP) should delay your treatment with KESIMPTA until your infection is gone. KESIMPTA taken before or after other medicines that weaken the immune system may increase your risk of getting infections. Tell your HCP right away if you have any infections or get any symptoms including painful and frequent urination, nasal congestion, runny nose, sore throat, fever, chills, cough, or body aches.
  • HBV reactivation. If you have ever had HBV infection, it may become active again during or after treatment with KESIMPTA (reactivation). If this happens, it may cause serious liver problems including liver failure or death. Before starting KESIMPTA, your HCP will do a blood test to check for HBV. They will also continue to monitor you during and after treatment with KESIMPTA for HBV. Tell your HCP right away if you get worsening tiredness or yellowing of your skin or the white part of your eyes.
  • Progressive Multifocal Leukoencephalopathy (PML). PML may happen with KESIMPTA. PML is a rare, serious brain infection caused by a virus that may get worse over days or weeks. PML can result in death or severe disability. Tell your HCP right away if you have any new or worsening neurologic signs or symptoms. These may include weakness on one side of your body, loss of coordination in arms and legs, vision problems, changes in thinking and memory, which may lead to confusion and personality changes.
  • Weakened immune system. KESIMPTA taken before or after other medicines that weaken the immune system could increase your risk of getting infections.

Before you take KESIMPTA, tell your HCP about all your medical conditions, including if you:

  • Have or think you have an infection including HBV or PML.
  • Have ever taken, currently take, or plan to take medicines that affect your immune system. These medicines could increase your risk of getting an infection.
  • Have had a recent vaccination or are scheduled to receive any vaccinations.
    • You should receive any required 'live' or 'live-attenuated' vaccines at least 4 weeks before you start treatment with KESIMPTA. You should not receive 'live' or 'live-attenuated' vaccines while you are being treated with KESIMPTA and until your HCP tells you that your immune system is no longer weakened.
    • Whenever possible, you should receive any 'non-live' vaccines at least 2 weeks before you start treatment with KESIMPTA.
    • Talk to your HCP about vaccinations for your baby if you used KESIMPTA during your pregnancy.
  • Are pregnant, think that you might be pregnant, or plan to become pregnant. It is not known if KESIMPTA will harm your unborn baby. Females who can become pregnant should use birth control (contraception) during treatment with KESIMPTA and for 6 months after your last treatment. Talk with your HCP about what birth control method is right for you during this time.
  • Are breastfeeding or plan to breastfeed. It is not known if KESIMPTA passes into your breast milk. Talk to your HCP about the best way to feed your baby if you take KESIMPTA.

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use KESIMPTA?

See the detailed Instructions for Use that comes with KESIMPTA for information about how to prepare and inject a dose of KESIMPTA and how to properly throw away (dispose of) used KESIMPTA Sensoready pens or prefilled syringes.

  • Use KESIMPTA exactly as your HCP tells you to use it.
  • Your HCP will show you how to prepare and inject KESIMPTA the right way before you use it for the first time.
  • Do not inject into areas where the skin is tender, bruised, red, scaly or hard. Avoid areas with moles, scars, or stretch marks.

KESIMPTA may cause serious side effects including:

  • Injection-related reactions. Injection-related reactions are a common side effect of KESIMPTA. Injecting KESIMPTA can cause injection-related reactions that can happen within 24 hours (1 day) following the first injections and with later injections. Talk with your HCP if you have any of these signs and symptoms:
    • at or near the injection site: redness of the skin, swelling, itching, and pain or
    • that may happen when certain substances are released in your body: fever, headache, pain in the muscles, chills, and tiredness.
  • Low immunoglobulins. KESIMPTA may cause a decrease in some types of antibodies. Your HCP will do blood tests to check your blood immunoglobulin levels.

The most common side effects of KESIMPTA include:

  • Upper respiratory tract infection, with symptoms such as sore throat and runny nose, and headache.
  • Headache.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

INDICATION

What is KESIMPTA (ofatumumab) injection?

KESIMPTA is a prescription medicine used to treat adults with relapsing forms of multiple sclerosis (MS) including clinically isolated syndrome (CIS), relapsing-remitting disease, and active secondary progressive disease.

It is not known if KESIMPTA is safe or effective in children.

Please see full Prescribing Information, including Medication Guide.

RMS=relapsing multiple sclerosis.

KESIMPTA and the KESIMPTA logo are registered trademarks of Novartis AG.

AUBAGIO is a registered trademark of Genzyme, a Sanofi company.

Important Safety Information

You should not take GILENYA if in the last 6 months you experienced heart attack, unstable angina, stroke or mini-stroke (transient ischemic attack or TIA), or certain types of heart failure. Do not take GILENYA if you have an irregular or abnormal heartbeat (arrhythmia), including a heart finding called prolonged QT as seen on an ECG, or if you take medicines that change your heart rhythm. Do not take GILENYA if you are allergic to fingolimod or any of the other ingredients.

Indication

GILENYA is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults and children 10 years of age and older.

Important Safety Information

You should not take GILENYA if in the last 6 months you experienced heart attack, unstable angina, stroke or mini-stroke (transient ischemic attack or TIA), or certain types of heart failure. Do not take GILENYA if you have an irregular or abnormal heartbeat (arrhythmia), including a heart finding called prolonged QT as seen on an ECG, or if you take medicines that change your heart rhythm. Do not take GILENYA if you are allergic to fingolimod or any of the other ingredients.

Indication

GILENYA is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults and children 10 years of age and older.

GILENYA may cause serious side effects such as:

  • Slow heart rate, especially after first dose. Adults and children will be monitored by a health care professional for at least 6 hours after the first dose or after a child takes the first dose of 0.5mg of GILENYA when switching from 0.25mg daily dose. Your pulse and blood pressure will be checked hourly. You'll get an ECG before and 6 hours after your first dose. If any heart problems arise or your heart rate is still low, you'll continue to be monitored. If you have any serious side effects, especially those that require treatment with other medicines, or if you have certain types of heart problems, or if you're taking medicines that can affect your heart, you'll be watched overnight. If you experience slow heart rate, it will usually return to normal within 1 month. Call your doctor, or seek immediate medical attention if you have any symptoms of slow heart rate, such as dizziness, tiredness, feeling like your heart is beating slowly or skipping beats, or chest pain. Symptoms can happen up to 24 hours after the first dose. Call your doctor if you miss 1 or more doses of GILENYA—you may need to repeat the 6-hour monitoring.

  • During pregnancy. Consult your doctor before getting pregnant. You should avoid becoming pregnant while taking GILENYA or in the 2 months after you stop taking it because of the risk of harm to the baby.

  • Increased risk of serious infections, some of which could be life threatening and cause death. You should not receive live vaccines during treatment with GILENYA and for 2 months after you stop taking GILENYA. Vaccines may not work as well when given during treatment with GILENYA. Because GILENYA has an increased risk of human papilloma virus (HPV), women should consult their doctor about a routine pap-smear. GILENYA lowers the number of white blood cells (lymphocytes) in your blood. This will usually go back to normal within 2 months of stopping GILENYA. Your doctor may do a blood test to check your white blood cells before you start GILENYA. Call your doctor right away if, while taking GILENYA or for 2 months after your last dose, you have fever, tiredness, body aches, chills, nausea, vomiting, or headache accompanied by fever, neck stiffness, sensitivity to light, nausea, and/or confusion. These may be symptoms of meningitis.

  • Progressive multifocal leukoencephalopathy (PML). PML is a rare brain infection that usually leads 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 doctor right away if you have any new or worsening symptoms of PML that have lasted several days, including changes in your thinking or memory, changes in your vision, decreased strength, problems with balance, weakness on 1 side of your body, loss of coordination in your arms and legs, confusion, or changes in your personality.

  • Macular edema, a vision problem that can cause some of the same vision symptoms as an MS attack (optic neuritis), or no symptoms. If it happens, macular edema usually starts in the first 3 to 4 months after starting GILENYA. Your doctor should test your vision before you start GILENYA, 3 to 4 months after you start GILENYA, and any time you notice vision changes. Vision problems may continue after macular edema has gone away. Your risk of macular edema is higher if you have diabetes or have had an inflammation of your eye (uveitis). Call your doctor right away if you have blurriness, shadows, or a blind spot in the center of your vision; sensitivity to light; or unusually colored vision.

  • Swelling and narrowing of the blood vessels in your brain. A condition called PRES (posterior reversible encephalopathy syndrome) has happened rarely in adults taking GILENYA. Symptoms of PRES usually get better when you stop taking GILENYA. However, if left untreated, it may lead to a stroke. Call your doctor right away if you experience any symptoms, such as sudden severe headache, sudden confusion, seizures, or sudden loss of vision.

  • Liver damage. Your doctor should do blood tests to check your liver before you start GILENYA and periodically during treatment. Call your doctor right away if you have nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine, or if your skin or the whites of your eyes turn yellow.

  • Breathing problems. Some patients have shortness of breath. Call your doctor right away if you have trouble breathing.

  • Severe worsening of MS after stopping GILENYA. Many people who have worsening of MS symptoms after stopping GILENYA do not return to the level of function that they had before or during treatment with GILENYA. This can also occur in women stopping due to pregnancy or planning a pregnancy. This worsening happens most often within 12 weeks after stopping GILENYA, but can happen later. Do not stop taking GILENYA without talking with your doctor. Tell your doctor if you have worsening symptoms of MS after stopping GILENYA.

  • Increases in blood pressure (BP). BP should be monitored during treatment.

  • Cancers including basal, squamous, and Merkel cell carcinomas and melanoma. Tell your doctor if you have any changes in the appearance of your skin, including changes in a mole, new darkened area in your skin, a sore that does not heal, or growths on your skin such as a bump that may be shiny, pearly white, skin colored, or pink. While taking GILENYA, limit the amount of time you spend in sunlight and ultraviolet (UV) light as well as use sunscreen with a high sun protection factor and wear protective clothing. Lymphoma has also occurred in patients receiving GILENYA.

GILENYA may harm your unborn baby. Talk to your doctor if you are pregnant or planning to become pregnant. Women should stop taking GILENYA 2 months before trying to become pregnant. Women who can become pregnant should use effective birth control while on GILENYA, and for at least 2 months after stopping. If you become pregnant while taking GILENYA, or within 2 months after stopping, tell your doctor right away. It is not known if GILENYA passes into breast milk. Talk to your doctor about the best way to feed your baby if you take GILENYA. A pregnancy registry is available for women who become pregnant during GILENYA treatment. For more information, contact the GILENYA Pregnancy Registry by calling Quintiles at 1-877-598-7237, by e-mailing gpr@quintiles.com, or by going to www.gilenyapregnancyregistry.com.

Tell your doctor about all your medical conditions, including if you had or now have an irregular or abnormal heartbeat; stroke or mini-stroke; heart problems; a history of repeated fainting; a fever or infection, or if you are unable to fight infections due to a disease or are taking medicines that lower your immune system, including corticosteroids, or have taken them in the past; eye problems; diabetes; breathing or liver problems; or uncontrolled high blood pressure. Also tell your doctor if you have had chicken pox or have received the chicken pox vaccine. Your doctor may test for the chicken pox virus, and you may need to get the full course of the chicken pox vaccine and wait 1 month before starting GILENYA. Children 10 years and older should complete their vaccination schedule before starting GILENYA.

If you take too much GILENYA, call your doctor or go to the nearest hospital emergency room right away.

Tell your doctor about all the medicines you take or have recently taken, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects with GILENYA were headache, abnormal liver tests, diarrhea, cough, flu, sinusitis, back pain, abdominal pain, and pain in arms or legs.

In the pediatric study:

  • The safety in children 10 years and older receiving GILENYA was similar to that seen in adults.

  • The rate of seizures was higher in GILENYA-treated patients compared to that of a leading injectable.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.1-800-FDA-1088.

Indication

GILENYA is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults and children 10 years of age and older.

Please see full Prescribing Information, including Medication Guide.