Gilenya is a prescription medication that is used to treat relapsing multiple sclerosis (MS). Gilenya contains the immunosuppressant fingolimod and works to treat MS by keeping the immune cells trapped so they are unable to reach the brain or spinal cord. This medication does not cure MS but can help to decrease the frequency of symptoms.

Make sure to always read the patient information and instructions before using this medication. Always follow your doctor’s directions.

• The first dose of Gilenya is typically taken in a hospital setting so that you can be monitored for at least six hours.
• This medication can be taken with or without food.
• Speak to your doctor before stopping this medication, as MS may return and symptoms may worsen.
• If you stop taking Gilenya, speak to your doctor before starting again.

Tell your doctor and pharmacist:

• About your drug and other allergies.
• If you take any other prescription or over-the-counter medications.
• Your medical history particularly of heart conditions, heart failure, AV block, sick sinus syndrome, heart attack, stroke, angina, skin cancer, liver disease, “mini-stroke”, high blood pressure, low blood pressure, diabetes, fainting, uveitis, asthma, sleep apnea, other breathing disorders or an active or chronic infection.
• If you are breast-feeding.

You should also know:

• This medication can harm an unborn baby. Use birth control while taking Gilenya and for at least two months after finishing your treatment.
• Gilenya can increase the risk of skin cancer. Wear protective clothing and use sunscreen while outdoors. Avoid tanning beds.
• This medication may cause some vaccines to be less effective. Avoid ‘live’ vaccines while taking this medication and for at least two months after ending treatment. Speak to your doctor for more information.

Common side effects of Gilenya include but are not limited to:

• Headaches.
• Abnormal liver function tests.
• Flu symptoms including cough or stuffy nose.
• Stomach pain or diarrhea.
• Pain in your arms, legs, or back.

Get medical help if you have any of the following side effects of fingolimod:

• New or worsening breathing problems.
• Sores on or in your mouth, throat, anus or genitals, cold sores, or sores that do not heal.
• Shiny skin nodules.
• Unusual moles that change size or color.
• Eye pain.
• Vision problems including blurred vision or blind spots or shadows in your vision. This may occur 3-4 months after taking this medication.
• Signs of a heart problem including chest pain, dizziness, tiredness, or irregular heartbeats.
• Signs of a liver problem including dark urine, jaundice, tiredness, upper stomach pain, nausea, or loss of appetite.
• Signs of a brain blood vessel problem including changes to mental status, sudden vision loss, seizures, confusion, or headaches.
• Infection symptoms including fever, nausea, vomiting, body aches, chills, neck stiffness, tiredness, or increased sensitivity to light.
• Signs of a brain infection including speech problems, thinking problems, vision problems, or troubles with muscle movements. These symptoms may start gradually and worsen.
• Symptoms of an allergic reaction such as difficulty breathing, hives, or swelling in your face, lips, or throat.

What should I do if I miss a dose of Gilenya?

Speak to your doctor immediately. You may need to take your next dose under medical observation.

What is the strength of Gilenya?

Gilenya is available in a strength of 0.5mg.