Gilenya contains the active ingredient fingolimod hydrochloride, a sphingosine 1-phosphate receptor modulator. It is available in the form of 0.5 mg hard gelatin capsules for oral use. Key inactive ingredients include maltodextrin, sodium stearyl fumarate, and talc, with additional components in the capsule shell and ink such as gelatin and iron oxides.

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While this medication may be prescribed for children as young as 10 years, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss any doses. Talk to your care team about what to do if you miss a dose.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from moisture. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Change in vision
• Dizziness, loss of balance or coordination, confusion or trouble speaking
• Increase in blood pressure
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Shortness of breath
• Slow heartbeat—dizziness, feeling faint or lightheaded, confusion, trouble breathing, unusual weakness or fatigue
• Sudden and severe headache, confusion, change in vision, seizures, which may be signs of posterior reversible encephalopathy syndrome (PRES)

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Back pain
• Diarrhea
• Headache
• Pain in the hands or feet
• Sinus pain or pressure around the face or forehead
• Stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Diabetes
• Heart disease
• High blood pressure
• History of eye inflammation
• Irregular heartbeat or rhythm
• History of stroke
• Immune system problems
• Infection, especially a viral infection, such as chickenpox, cold sores, herpes
• Liver disease
• Lung or breathing disease, such as asthma
• Skin cancer
• Recent or upcoming vaccine
• An unusual or allergic reaction to fingolimod, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

What may interact with this medication?

Do not take this medication with any of the following:

• Certain medications for irregular heartbeat, such as amiodarone, bretylium, disopyramide, dofetilide, dronedarone, ibutilide, procainamide, quinidine, or sotalol
• Cisapride
• Dextromethorphan; quinidine
• Ketoconazole
• Levoketoconazole
• Live virus vaccines
• Thioridazine

This medication may also interact with the following:

• Beta blockers, such as metoprolol or propranolol
• Citalopram
• Digoxin
• Diltiazem
• Haloperidol
• Medications that lower your chance of fighting infection
• Mitoxantrone
• Natalizumab
• Other medications that may cause heart rhythm changes
• Verapamil

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. You may get blood work done while you are taking this medication.

Your vision may be tested before and during use of this medication. Tell your care team right away if you have any change in your eyesight.

You will be observed by your care team for at least 6 hours after your first dose, if the dose is increased, or if you restart treatment after stopping.

Talk with your care team if you have not had chickenpox or the vaccine for chickenpox.

This medication may increase your risk of melanoma or skin cancer. Check your skin for changes to moles or for new growths while taking this medication. Call your care team if you notice any of these skin changes. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects. Effective contraception is recommended during and for 2 months after stopping treatment.

If you stop taking this medication, your MS symptoms may get worse. You may have more weakness, trouble using your arms or legs, or changes in balance. Talk to your care team right away if your symptoms get worse.