Can Gilenya cause high blood pressure?

• In clinical studies, Gilenya (fingolimod) caused both high blood pressure (hypertension) and increases in blood pressure that were sustained with continued treatment.
• Tell your doctor before you start treatment if you have high blood pressure now or a history of high blood pressure from the past.
• Your doctor should monitor your blood pressure while you are taking Gilenya.

Hypertension (high blood pressure) was reported as a serious side effect in multiple sclerosis (MS) studies. High blood pressure occurred in 8% of people taking Gilenya 0.5 mg and in 4% of people on a placebo (a placebo is an inactive treatment, used for comparison).

Increases in blood pressure that persisted were first seen 1 month after starting with Gilenya 0.5 mg. Compared to placebo, people who took Gilenya had an average increase of:

• 3 mmHg in the systolic pressure (the top number of your blood pressure measurement)
• 2 mmHg in diastolic pressure (the bottom number of your blood pressure measurement)

Your blood pressure should be monitored while you are taking Gilenya. Ask your doctor what your goal blood pressure should be. A blood pressure below 120/80 is generally recommended. Call your doctor if your blood pressure is elevated.

Can Gilenya cause a slow heart rate?

Yes, Gilenya may cause a slow heart rate when you or your child first start treatment. A slow heart rate can occur after the first dose. A slow heart rate is also called bradycardia or bradyarrhythmia.

Symptoms of a slow heart rate can include:

• dizziness
• tiredness
• feeling like your heart is beating slowly or skipping beats
• chest pain

Tell your doctor about all of your medical conditions before you start taking Gilenya. Tell them if you have now or have had:

• high blood pressure
• an irregular or abnormal heartbeat (arrhythmia)
• a history of stroke or mini-stroke
• heart problems, including heart attack or angina
• a history of repeated fainting (syncope)

Also, tell your healthcare provider about all of the medicines you take, including prescription, over-the-counter (OTC), vitamins, herbals, or other dietary supplements.

Why do I need first-dose observation with Gilenya?

Because of the risk of a slow heart rate, you will have first-dose observation monitoring done by a healthcare professional during your first dose and for at least 6 hours afterwards. You will have a test called an electrocardiogram (ECG) before you take your first dose of Gilenya. An ECG checks the electrical activity of your heart.

Your pulse and blood pressure should be checked every hour after you take your first dose of Gilenya. At the end of the 6 hours, you will have another ECG. If your heart rate is still too slow or the ECG shows problems, your doctor will continue to observe you.

Related: What is an ECG?

Children should also be observed by a healthcare professional for at least 6 hours after taking their first dose of 0.5 mg of Gilenya (when switching from the lower 0.25 mg dose), and pulse and blood pressure should be checked every hour.

You may need to stay in a medical facility overnight to be observed and for at least 6 hours after your second dose. Ask your doctor for further information about your first-dose observation period.

If you have any of the symptoms of slow heart rate (dizziness, tiredness, feeling like your heart is beating slowly or skipping beats, chest pain), they will usually happen during the first 6 hours after your first dose. However, symptoms can happen up to 24 hours after your first dose. Call your doctor right away if you have any of these symptoms.

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Where is first-dose observation for Gilenya done?

Your first-dose observation can be done at the doctor’s office, at another medical facility, or in your own home. Talk to your doctor about which place may be best for you. You can still read, watch TV, or work while this time passes.

If you have the first-dose observation done at home, a medical team will come to your house. First-dose observations are also needed if you stop treatment for longer than 14 days, have a dose increase, or if you stop treatment within the first month of treatment. Call your doctor right away if you miss a dose of Gilenya.

Who should not take Gilenya?

You should not take Gilenya if you:

• have had a heart attack, unstable angina (chest pain while resting), stroke or mini-stroke (also called a transient ischemic attack or TIA) or certain types of heart failure in the last 6 months.
• have certain types of irregular or abnormal heartbeat (arrhythmia), including a prolonged QT
• have a heart block or sick sinus syndrome (unless you have a pacemaker)
• take medicines that affect your heart rhythm
• are allergic to the active ingredient fingolimod or any of the other ingredients in Gilenya. Symptoms of an allergic reaction may include a rash, itching, hives, or swelling of the lips, mouth, tongue or face.

You should avoid becoming pregnant while taking Gilenya or in the two months after you stop taking it because of the risk of harm to the baby.

You should read the Medication Guide that comes with each Gilenya prescription and refill because the guide is updated as new information becomes available.

This is not all the information you need to know about Gilenya (fingolimod) for safe and effective use and does not take the place of your doctor’s directions. Review the full Gilenya information and discuss this information and any questions you have with your doctor or other health care provider.