Gilenya (Fingolimod Hydrochloride)
Complete patient guide for uses, dosage, side effects, and safety information
Prescription RequiredQuick Facts
What Is Gilenya Used For?
Gilenya is a medication that helps manage multiple sclerosis by changing how your immune system works to protect your nervous system.
Primary Uses
Gilenya is used to treat relapsing forms of multiple sclerosis (MS) in adults, children and adolescents who are 10 years of age and above. It helps slow the progression of physical disability and decreases the number of flare-ups (relapses) in patients with relapsing MS.
How It Works
Gilenya works by altering how your body’s immune system functions. It helps fight against attacks on myelin (the protective cover around nerves) by stopping inflammatory cells from reaching the brain. This reduces nerve damage caused by MS. The medication may also have a direct beneficial effect on certain brain cells involved in repairing or slowing down MS damage.
Good to know: This medicine is designed to help reduce both the frequency of MS relapses and slow down physical disability progression.
How to Take Gilenya
Gilenya should be taken consistently at the same time each day for best results. Your first dose requires special monitoring at your doctor’s office.
Dosage Instructions
Adults: Take one 0.5 mg capsule once daily. Children and adolescents (10 years and above): Dose depends on body weight – those weighing 40 kg or less take one 0.25 mg capsule daily, while those over 40 kg take one 0.5 mg capsule daily. Swallow the capsule whole with water. Can be taken with or without food. Take at the same time each day.
What If You Miss a Dose?
If it’s almost time for your next dose, skip the missed dose and take your next dose at the regular time. Never take a double dose to make up for a missed one. Your doctor may need to monitor you when you take your next dose, especially if you’ve missed doses during early treatment.
Important: Your first dose requires 6 hours of heart monitoring at your doctor’s office due to potential effects on heart rate.
Available Tablet Strengths
Side Effects
Like all medications, this medicine can cause side effects. Most are mild and temporary, but some require medical attention.
Common Side Effects
These side effects occur relatively frequently and usually don’t require emergency care:
- Flu symptoms
- Headache
- Diarrhea
Seek immediate medical attention if you experience:
- Coughing with phlegm
- Chest pain
- Shingles/herpes zoster
- Slow or irregular heartbeat
- Blurred vision
- Skin nodules
- Signs of infection (fever, flu-like symptoms)
- Vision changes (blurry center vision, blind spots, color/detail problems)
- Skin changes (unusual moles, patches, sores that don’t heal)
- Signs of liver problems (nausea, vomiting, abdominal pain, yellowing of skin/eyes)
- Symptoms of brain disorders (weakness, visual changes, new unusual symptoms)
Important Warnings
Gilenya has several important warnings you should know about before starting treatment, especially regarding heart conditions and infections.
Who Should Not Take Gilenya
Do not take Gilenya if you are allergic to fingolimod or any ingredients, have had a heart attack, unstable angina, stroke or certain heart failure in the last 6 months, have certain irregular heartbeats, or are taking medicines for irregular heartbeat like quinidine, disopyramide, amiodarone or sotalol.
Medical Conditions to Discuss
Tell your doctor if you have heart problems, stroke history, irregular heartbeat, severe heart disease, uncontrolled high blood pressure, severe breathing difficulties during sleep, slow heart rate, liver problems, lowered immune response, current infections, or if you need vaccinations. Children must complete their vaccination schedule before starting treatment.
Pregnancy and Breastfeeding
Avoid becoming pregnant while taking Gilenya or for 2 months after stopping, as it may harm your unborn baby. A pregnancy test is recommended before starting treatment. If you become pregnant while taking Gilenya, tell your doctor immediately. Do not breastfeed while taking this medicine as it can pass into breast milk.
Elderly Patients: Experience with Gilenya in people over 65 years old is limited.
Drug Interactions
Several medications can interact with Gilenya and affect how it works or increase side effects. Always tell your doctor about all medicines you’re taking.
Vaccine Warning: Do not receive live attenuated vaccines during treatment and for up to 2 months after stopping Gilenya.
- Medicines for irregular heartbeat (quinidine, procainamide, amiodarone, sotalol)
- Heart rate slowing medicines (atenolol, verapamil, diltiazem, ivabradine, digoxin)
- Medicines causing abnormal heart rhythm (citalopram, chlorpromazine, haloperidol, methadone, erythromycin)
- Immune system suppressing medicines (beta-interferon, glatiramer acetate, natalizumab, mitozantrone, dimethyl fumarate, teriflunomide, alemtuzumab, corticosteroids)
- Live attenuated vaccines
Alcohol & Driving
Be cautious with activities requiring alertness until you know how Gilenya affects you, and discuss alcohol use with your doctor.
Alcohol
Tell your doctor if you drink alcohol. The interaction between Gilenya and alcohol should be discussed with your healthcare provider.
Driving and Operating Machinery
Be careful before driving or using machines until you know how Gilenya affects you. The medication may cause dizziness in some people. Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely.
Storage
Store Gilenya in a cool, dry place away from moisture, heat, and sunlight. Keep 0.5 mg capsules below 30°C and 0.25 mg capsules below 25°C. Store in the original container and keep away from children. Do not store in bathrooms, near sinks, in cars, or on window sills.
Overdose Information
If you think you’ve taken too much Gilenya, seek immediate medical attention. Call the Poisons Information Centre (13 11 26), contact your doctor, or go to the nearest hospital emergency department, even if you feel fine. Overdose symptoms may include swelling in hands or feet, tingling or numbness, muscle pain, and fever. Your doctor may need to monitor your heart rate and blood pressure.
Frequently Asked Questions
Gilenya works by reducing the number of MS relapses and slowing disability progression over time. Your doctor will monitor your progress to ensure the medicine is working effectively.
Yes, Gilenya can be taken with or without food. It doesn’t matter whether you take it before or after eating.
Do not stop taking Gilenya unless your doctor tells you to. Your MS symptoms may return or become worse if you stop treatment. Gilenya stays in your body for up to 2 months after stopping, and side effects may still occur during this time.
You should tell your doctor if you drink alcohol. The interaction between Gilenya and alcohol should be discussed with your healthcare provider.
Gilenya may temporarily affect your heart rate when you take the first dose, so you’ll need to stay at the doctor’s office for 6 hours for heart rate and blood pressure monitoring, plus ECG tests.
You should not receive live attenuated vaccines during treatment and for up to 2 months after stopping Gilenya. Other vaccines may not work as well. Always consult your doctor before getting any vaccination.
Tell your doctor immediately if you think you have an infection, fever, or feel like you have the flu. You may get infections more easily while taking Gilenya, and any existing infection may get worse.
Important Disclaimer
This information is intended for general educational purposes only and should not be considered medical advice. Always consult your healthcare provider or pharmacist before starting, stopping, or changing any medication.
If you think you may have a medical emergency, call your doctor or emergency services immediately.