Gilenya

The active ingredient in Gilenya is fingolimod, which is a disease-modifying therapy for relapsing-remitting MS. It is specifically known as a sphingosine 1-phosphate receptor modulator. The actual mechanism of action for MS is uncertain. However, it is suspected that Gilenya stops white blood cells from leaving your lymph nodes where they're made. This helps minimize the damage they cause to your nerves and eases MS symptoms.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Gilenya. However, the following is a synopsis of the general guidelines for the use of Gilenya:

• When you first start taking Gilenya, your heart rate may decrease. You'll get your first dose at the hospital or a doctor’s office. Your blood pressure and heart rate will be regularly checked for at least 6 hours following your first Gilenya dose.
• You may require medical testing prior to and while taking this medication, such as blood tests, heart function tests, blood pressure checks, vision exams, liver function tests, and skin exams.
• Take Gilenya once a day, with or without food.

Some mild and common side effects of Gilenya seen in clinical trials as compared to placebo include:

• Headaches.
• High liver enzymes.
• Nausea and vomiting.
• Stomach pain.
• Sinus inflammation.
• High blood pressure (hypertension).
• Hair loss.
• Blurred vision.
• Back pain.

Some individuals may experience serious side effects while using Gilenya. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Fatigue, weakness, confusion, feeling dizzy, shortness of breath, and chest discomfort are all symptoms of a dangerously low heart rate.
• Serious brain infection symptoms include weakness on one side of the body, clumsiness, disorientation, changes in personality, changes in vision, headache, stiff neck, light sensitivity, fever, and seizures.
• Longer treatment durations of Gilenya (more than 18 months) increase the risk of developing progressive multifocal leukoencephalopathy (PML), a rare brain infection, or posterior reversible encephalopathy syndrome (PRES).
• Other dangerous, serious infections include fever, breathing problems, diarrhea, weakness, cough, stomach discomfort, weight loss, sweating, and chills.
• Increased risk of certain skin cancers, such as basal cell carcinoma and melanoma.
• Serious liver problems include nausea, vomiting, stomach discomfort, swelling of the stomach, yellowing of the skin or whites of the eyes, clay-colored faeces, and disorientation.
• Severe, life-threatening allergic reaction to the medication.
• Worsening vision due to macular edema.

These are not all of the possible side effects of Gilenya. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Gilenya, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Severe heart failure.
• Chickenpox or herpes.
• A severe heart condition, such as "sick sinus syndrome" or "AV block" (unless you have a pacemaker).
• Long QT syndrome.
• A heart attack, stroke, "mini-stroke" or TIA, chest pain (unstable angina), or other major heart problems have occurred within the last six months.
• Fever, active or persistent infection.
• A weakened immune system (due to sickness or the use of certain medications).
• A heart rhythm abnormality or slow heart rate (bradycardia).
• Chest pain (angina) or other cardiovascular issues.
• A heart attack or stroke, even a "mini-stroke.
• High blood pressure.
• Diabetes.
• Skin cancer. Avoid the sun and tanning beds. When you are outside, use protective gear and sunscreen with an SPF of 30 or higher.
• Sleep apnea or another respiratory disorder.
• Uveitis is an eye ailment.
• Liver disease.
• Recent live vaccines.

• Within the recent six months, you had a heart attack, chest pain, a stroke, or heart failure.
• Certain heart rate or rhythm issues (e.g., AV block, sick sinus syndrome).
• Taking certain heart rhythm drugs.

Within 4 to 6 hours of the first Gilenya dose, blood lymphocyte counts had dropped to 60% of their baseline. Gilenya takes around two weeks to achieve its peak effect, which is a lymphocyte count of 30% of baseline, or around 500 cells/mcL.

When Gilenya is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Amiodarone.
• Disopyramide.
• Dofetilide.
• Flecainide.
• Dronedarone.
• Ibutilide.
• Mexiletine.

-Pocainamide.

• Propafenone.
• Quinidine.
• Sotalol.
• Natalizumab.

Adults and children aged 10 and above weighing more than 88 pounds: The normal dose is 0.5 mg taken orally once daily.

Children 10 years and older weighing 88 pounds or less: The normal dose is 0.25 mg orally once daily.

Store at room temperature and keep out of reach of children.

Novartis Inc. is the company that manufactures Gilenya.

There are several lower-cost generic versions available of Gilenya.

Do not stop taking Gilenya without first consulting your doctor. If you decide to discontinue taking Gilenya, you should keep an eye out for any worsening symptoms and notify your doctor right away. This may include: New or exacerbated weakness.

Fingolimod may harm an unborn child. Avoid using it if you are pregnant. Use effective birth control while using Gilenya and for at least two months following the final dose. Inform your doctor immediately if you become pregnant.

If you are pregnant, you are encouraged to enroll in the pregnancy registry to monitor the effects of fingolimod on you and your baby.

It is not known if this medication is found in breast milk. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.