Gilenya
(Fingolimod)

What Gilenya is and what it is used for

What Gilenya is The active substance of Gilenya is fingolimod. What Gilenya is used for Gilenya is used in adults to treat relapsing-remitting multiple sclerosis (MS), more specifically in: Patients who have failed to respond despite treatment with an MS treatment. or Patients who have rapidly evolving severe MS. Gilenya does not cure MS, but it helps to reduce the number of relapses and to slow down the progression of physical disabilities due to MS.

How to take Gilenya

What is multiple sclerosis MS is a long-term condition that affects the central nervous system (CNS), comprised of the brain and spinal cord. In MS inflammation destroys the protective sheath (called myelin) around the nerves in the CNS and stops the nerves from working properly. This is called demyelination. Relapsing-remitting MS is characterised by repeated attacks (relapses) of nervous system symptoms that reflect inflammation within the CNS. Symptoms vary from patient to patient but typically involve walking difficulties, numbness, vision problems or disturbed balance. Symptoms of a relapse may disappear completely when the relapse is over, but some problems may remain. How Gilenya works Gilenya helps to protect against attacks on the CNS by the immune system by reducing the ability of some white blood cells (lymphocytes) to move freely within the body and by stopping them from reaching the brain and spinal cord. This limits nerve damage caused by MS. Gilenya also reduces some of the immune reactions of your body.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some side effects could be or could become serious

Common (may affect up to 1 in 10 people):
•Coughing with phlegm, chest discomfort, fever (signs of lung disorders)
•Herpes virus infection (shingles or herpes zoster) with symptoms such as blisters, burning, itching or pain of the skin, typically on the upper body or the face. Other symptoms may be fever and weakness in the early stages of infection, followed by numbness, itching or red patches with severe pain
•Slow heartbeat (bradycardia), irregular heart rhythm
•A type of skin cancer called basal cell carcinoma (BCC) which often appears as a pearly nodule, although it can also take other forms.

Uncommon (may affect up to 1 in 100 people):
•Pneumonia with symptoms such as fever, cough, difficulty breathing
•Macular oedema (swelling in the central vision area of the retina at the back of the eye) with symptoms such as shadows or blind spot in the centre of the vision, blurred vision, problems seeing colours or details
•Reduction in blood platelets which increases risk of bleeding or bruising
•Malignant melanoma (a type of skin cancer which usually develops from an unusual mole). Possible signs of melanoma include moles which may change size, shape, elevation or colour over time, or new moles. The moles may itch, bleed or ulcerate.

Rare (may affect up to 1 in 1,000 people):
•A condition called posterior reversible encephalopathy syndrome (PRES). Symptoms may include sudden onset of severe headache, confusion, seizures and/or vision disturbances.
•Lymphoma (a type of cancer that affects the lymph system).
•Squamous cell carcinoma: a type of skin cancer which may present as a firm red nodule, a sore with crust, or a new sore on an existing scar.

Very rare (may affect up to 1 in 10,000 people):
•Electrocardiogram anomaly (T-wave inversion).
•Tumour related to infection with human herpes virus 8 (Kaposi’s sarcoma).

Not known (frequency cannot be estimated from the available data):
•Allergic reactions, including symptoms of rash or itchy hives, swelling of lips, tongue or face, which are more likely to occur on the day you start Gilenya treatment.
•Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). The symptoms of PML may be similar to an MS relapse. Symptoms might also arise that you might not become aware of by yourself, such as changes in mood or behaviour, memory lapses, speech and communication difficulties, which your doctor may need to investigate further to rule out PML. Therefore, if you believe your MS is getting worse or if you or those close to you notice any new or unusual symptoms, it is very important that you speak to your doctor as soon as possible.
•Cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as headache accompanied by stiff neck, sensitivity to light, nausea, and/or confusion. 8
•Merkel cell carcinoma (a type of skin cancer). Possible signs of Merkel cell carcinoma include flesh-coloured or bluish-red, painless nodule, often on the face, head or neck. Merkel cell carcinoma can also present as a firm painless nodule or mass. Long-term exposure to the sun and a weak immune system can affect the risk of developing Merkel cell carcinoma. If you experience any of these, tell your doctor straight away.

Other side effects

Very common (may affect more than 1 in 10 people):
•Infection from flu virus with symptoms such as tiredness, chills, sore throat, aching in the joints or muscles, fever
•Feeling of pressure or pain in the cheeks and forehead (sinusitis)
•Headache
•Diarrhoea
•Back pain
•Blood testing showing higher levels of liver enzymes
•Cough

Common (may affect up to 1 in 10 people):
•Ringworm, a fungal infection of the skin (tinea versicolor)
•Dizziness
•Severe headache often accompanied by nausea, vomiting and sensitivity to light (migraine)
•Low level of white blood cells (lymphocytes, leucocytes)
•Weakness
•Itchy, red, burning rash (eczema)
•Itching
•Blood fat (triglycerides) level increased
•Hair loss
•Breathlessness
•Depression
•Blurred vision (see also the section on macular oedema under “Some side effects could be or could become serious”)
•Hypertension (Gilenya may cause a mild increase in blood pressure)

Uncommon (may affect up to 1 in 100 people):
•Low level of certain white blood cells (neutrophils)
•Depressed mood
•Nausea

Rare (may affect up to 1 in 1,000 people):
•Blood vessel disorders
•Nervous system disorders
•Cancer of the lymphatic system (lymphoma)

Not known (frequency cannot be estimated from the available data):
•Peripheral swelling If any of these affects you severely, tell your doctor

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. 9 Ireland: HPRA Pharmacovigilance Earlsfort Terrace IRL
•Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: [email protected] Malta: ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal United Kingdom: Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

How to Store Gilenya

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister foil after “EXP”. The expiry date refers to the last day of that month. Do not store above 25ºC. Store in the original package in order to protect from moisture. Do not use any pack that is damaged or shows signs of tampering. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.