Gilenya

The usual adult dose is 0.5 mg once a day, taken by mouth with half a glass of water. Gilenya (Fingolimod) can be taken with or without food.

Children (over 10 years old) who weigh 40 kg and less should take 0.25 mg once daily. Children who weigh more than 40 kg should take 0.5 mg once daily.

Gilenya (Fingolimod) will stay in your body for up to 2 months after you stop taking it. Your white blood cell count (lymphocyte count) may also remain low during this time and you may still experience side effects.

You will take the first dose of Gilenya (Fingolimod) in your doctor’s office or clinic and will need to stay at the office for at least 6 hours after the first dose. You may also need to stay if your dose is increased from 0.25 to 0.5 mg daily. This will allow the doctor to monitor for side effects such as slowed heartbeat and treat any problems before they become an emergency.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that Gilenya (Fingolimod) be taken exactly as prescribed by your doctor. If you miss a dose, take the next dose as planned. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

If you have been taking Gilenya (Fingolimod) for less than 2 weeks and you forget to take a dose for one day or more, or if you stop taking Gilenya (Fingolimod) for more than 7 days after 3 or 4 weeks of treatment, contact your doctor as soon as possible. Your doctor may choose to monitor you for heart and blood pressure effects before you restart the medication.

If Gilenya (Fingolimod) is stopped for more than 2 weeks, contact your doctor. It will be necessary to be monitored for heart and blood pressure effects again when you restart the medication.

Store Gilenya (Fingolimod) at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g., down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may decrease your heart rate; it may cause headaches; it may cause diarrhea; it may cause dizziness - use caution when getting up from a lying or sitting position and use caution if driving; it may increase your blood pressure; it may cause blurred vision. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

0.25 mg
Each capsule with an ivory opaque body and cap, with black radial imprint "FTY 0.25 mg" on the cap and a black radial band on the capsule body, contains 0.25 mg of Gilenya (Fingolimod). Nonmedicinal ingredients: mannitol, hydroxypropylcellulose, hydroxypropylbetadex, magnesium stearate; capsule shell: gelatin, titanium dioxide, iron oxide yellow.

0.5 mg
Each capsule with a white opaque body and bright yellow opaque cap, with "FTY 0.5 mg" imprinted in black ink, and two bands imprinted on the body with yellow ink, contains 0.5 mg of Gilenya (Fingolimod). Nonmedicinal ingredients: gelatin, magnesium stearate, mannitol, titanium dioxide, and yellow iron oxide.

Do not take Gilenya (Fingolimod) if you:

• are allergic to Gilenya (Fingolimod) or any ingredients of the medication
• have a severe active infection or an active chronic infection such as hepatitis or Tuberculosis
• have a weakened immune system due to disease (e.g., immunodeficiency syndrome) or use medicines or treatments that suppress the immune system (e.g., to treat cancer or bone marrow transplantation)
• have an active cancer (except for a type of Skin Cancer called basal cell carcinoma)
• have severe liver disease
• have had a Heart Attack, unstable Angina, a Transient Ischemic Attack (mini-stroke), or heart failure in the past 6 months
• have a severe irregular heartbeat and are taking certain medications to treat it
• have heart block or sick-sinus syndrome and do not have a pacemaker
• have a prolonged QT interval
• are or may become pregnant and are not using effective birth control

There may be an interaction between Gilenya (Fingolimod) and any of the following:

• Alfuzosin
• anticancer medications (e.g., azacitidine, Busulfan, Capecitabine, Cladribine, Cytarabine, Doxorubicin, Etoposide, Ifosfamide, Vincristine)
• antipsychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• Baricitinib
• BCG
• beta-adrenergic blockers (e.g., Atenolol, Propranolol, Sotalol)
• Carbamazepine
• Ceritinib
• chloroquine
• Clonidine
• corticosteroids (e.g., Dexamethasone, Hydrocortisone, Prednisone)
• Cyclosporine
• Denosumab
• Digoxin
• Diltiazem
• Domperidone
• Donepezil
• Dronedarone
• echinacea
• formoterol
• Galantamine
• Guanfacine
• Ivabradine
• Lacosamide
• Lanreotide
• Leflunomide
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• medications for irregular heartbeat such as Amiodarone, Disopyramide, procainamide, quinidine, or sotalol
• medications that suppress or modulate the immune system, including medications used to treat MS (e.g., beta-interferon, Glatiramer acetate, Natalizumab, Mitoxantrone)
• Methadone
• Midodrine
• mycophenolate
• Octreotide
• Pasireotide
• Pimecrolimus
• Primaquine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• Rivastigmine
• Roflumilast
• Romidepsin
• salmeterol
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• Tacrolimus
• Tizanidine
• Tofacitinib
• tyrosine kinase inhibitors (e.g., Bosutinib, Dasatinib, Nilotinib, Sunitinib, tofacitinib)
• vaccines
• Verapamil

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Gilenya (Fingolimod). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking.

Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Gilenya (Fingolimod).

HEALTH CANADA ADVISORY

January 18, 2021

Health Canada has issued new information concerning the use of Gilenya (Fingolimod). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Previous advisories on Gilenya (Fingolimod) were issued on December 19, 2019.

Blood pressure: Gilenya (Fingolimod) may also increase blood pressure and is not recommended for people who have uncontrolled high blood pressure. If you have high blood pressure, discuss with your doctor how Gilenya (Fingolimod) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Gilenya (Fingolimod), and whether any special monitoring is needed.

Breathing disorders: Gilenya (Fingolimod) may affect lung function for people with respiratory problems such as Pulmonary Fibrosis, Asthma, and COPD (Chronic Obstructive Pulmonary Disease). If you have respiratory problems, discuss with your doctor how Gilenya (Fingolimod) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Gilenya (Fingolimod), and whether any special monitoring is needed.

Contact your doctor if you experience any new or worsening shortness of breath.

If you have Sleep Apnea (periods during sleep when you stop breathing), talk to your doctor before starting Gilenya (Fingolimod). Very low heart rate may cause episodes of sleep apnea to become worse.

Cancer: Gilenya (Fingolimod) reduces the number of cells that fight infection in the body (white blood cells). This may increase your risk of developing infections and certain types of skin cancer and lymphoma (cancer of the lymph nodes).

While you are taking Gilenya (Fingolimod), it is important to limit your exposure to the sun and use appropriate sun protection such as sunscreen and protective clothing. Your doctor will monitor you for skin cancer while you are taking Gilenya (Fingolimod). Talk to your doctor if you have any concerns.

Cholesterol: Treatment with Gilenya (Fingolimod) may result in increased levels of total cholesterol, LDL cholesterol and triglycerides. If you have or are at increased risk of having High Cholesterol, discuss with your doctor how Gilenya (Fingolimod) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Gilenya (Fingolimod), and whether any special monitoring is needed.

Depression: People with MS often experience depression more often than the general public. Gilenya (Fingolimod) may contribute to the symptoms of depression. If you have depression or a history of depression, discuss with your doctor how Gilenya (Fingolimod) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Gilenya (Fingolimod), and whether any special monitoring is needed.

If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking Gilenya (Fingolimod) contact your doctor as soon as possible.

Eye problems: People who have Diabetes or a history of inflammation of the middle of the eye are at an increased risk of developing swelling in the macula of the eye. It is recommended that you have an eye examination after taking Gilenya (Fingolimod) for 3 or 4 months to check for changes in your eyes that have not caused symptoms. Report any changes in vision to your doctor as soon as possible.

Heart problems: Gilenya (Fingolimod) causes a decrease in heart rate a few hours after taking the first dose. Your doctor will want to check your heart before you start Gilenya (Fingolimod). You will also need to be observed in a doctor's office or clinic for 6 hours after your first dose. This allows the doctor to monitor your heart rate and treat any problems before they become an emergency. It may be necessary to be monitored for a longer period of time if you develop very low heart rate or an arrhythmia. People with certain heart conditions such as heart Arrhythmias, angina, Congestive Heart Failure or a history of heart attack, should not take Gilenya (Fingolimod). Gilenya (Fingolimod) may also cause mild increases in blood pressure.

If you have a heart problem, discuss with your doctor how Gilenya (Fingolimod) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Gilenya (Fingolimod), and whether any special monitoring is needed.

Heart rhythm: Gilenya (Fingolimod) can cause changes to the normal rhythm of the heart, including an irregular heartbeat called QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death. If you are at risk for heart rhythm problems (e.g., people with heart failure, angina, low potassium or magnesium levels), discuss with your doctor how Gilenya (Fingolimod) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Gilenya (Fingolimod), and whether any special monitoring is needed.

Infections: Gilenya (Fingolimod) works by decreasing the number of white blood cells in the blood stream. White blood cells are responsible for fighting infection in the body. As a result, people taking Gilenya (Fingolimod) may have an increased risk of infections. If you notice signs of an infection, such as fever, redness, or swelling, contact your doctor as soon as possible.

Kidney function: Kidney Disease or reduced kidney function may cause Gilenya (Fingolimod) to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how Gilenya (Fingolimod) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Gilenya (Fingolimod), and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause Gilenya (Fingolimod) to build up in the body, causing side effects. Gilenya (Fingolimod) may also reduce liver function and can cause liver failure. If you have liver problems, discuss with your doctor how Gilenya (Fingolimod) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Gilenya (Fingolimod), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Gilenya (Fingolimod).

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Progressive multifocal leukoencephalopathy (PML): There have been reports of PML after using Gilenya (Fingolimod). PML is a rare viral infection that causes nerve damage in the brain. If you experience memory loss, vision changes, trouble thinking, personality changes or difficulty walking, contact your doctor immediately.

Posterior Reversible Encephalopathy Syndrome (PRES): This is a rare disease of the brain that may occur when using Gilenya (Fingolimod). If you have had a previous episode of PRES, this may not be an appropriate medication for you. Make sure your doctor knows you have experienced this before. If you experience signs and symptoms of PRES, such as headache, nausea, vomiting, seizures, change in awareness or consciousness, or vision changes, contact your doctor immediately.

Seizures: If you have a history of seizures, discuss with your doctor how Gilenya (Fingolimod) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Gilenya (Fingolimod), and whether any special monitoring is needed. Gilenya (Fingolimod) may increase the frequency of seizures.

Vaccines: If you have not had Chickenpox or been vaccinated against chickenpox, talk to your doctor about receiving the chickenpox (Varicella zoster) vaccine at least 1 month before starting Gilenya (Fingolimod) treatment. During and for up to 2 months after stopping treatment with Gilenya (Fingolimod), some vaccines containing live viruses may result in the infection that the vaccination should prevent, while other vaccines may not work well enough to protect you. Talk to your doctor about which vaccinations you need before starting treatment, and which vaccines to avoid during treatment.

Pregnancy: Gilenya (Fingolimod) may cause harm to an unborn fetus and should not be used during pregnancy. If you become pregnant while taking Gilenya (Fingolimod), contact your doctor immediately. If you are taking Gilenya (Fingolimod) and could become pregnant, you should use an effective method of birth control (e.g., birth control pill, condoms) during treatment, and for 2 months after stopping treatment with Gilenya (Fingolimod).

Breast-feeding: Gilenya (Fingolimod) passes into breast milk. If you are a breast-feeding mother and are taking Gilenya (Fingolimod), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Gilenya (Fingolimod) have not been established for children under the age of 10 years. Children should complete routine immunizations prior to starting treatment with Gilenya (Fingolimod).

Seniors: Seniors may be more at risk of side effects from Gilenya (Fingolimod).

This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. It must be used regularly and continuously to maintain its beneficial effects. Be sure to keep an adequate supply on hand. This medication may be taken with or without food.