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This document outlines essential safety and warning information for the use of Fingolimod (Gilenya). It is crucial to go through these details carefully and discuss any concerns with your healthcare provider.

• Slow Heart Rate: Fingolimod may cause a significant decrease in heart rate, especially within the first 24 hours of starting the medication. Inform your healthcare provider if you have any heart-related issues or are on medications affecting heart rate. You will need heart monitoring for at least 6 hours after the first dose. Seek medical help if you experience symptoms such as fatigue, confusion, or chest pain. Risks include heart problems, concurrent medications affecting heart rate, and restarting the medication after a break.

• Infections: Fingolimod can impair your immune system, increasing the chance of serious infections. Ensure all vaccinations are current before starting treatment. If you develop symptoms like fever or difficulty breathing, contact your provider as you may need to stop the medication temporarily. Those at higher risk include individuals over 65, those with chronic infections, or on immunosuppressants.

• Progressive Multifocal Leukoencephalopathy (PML): This rare but serious brain infection linked to a weakened immune system requires immediate medical attention if symptoms such as weakness, vision changes, or personality shifts occur. Risks include prolonged use of Fingolimod and concurrent use of immunosuppressants.

• Eye Disorders: The medication can lead to macular edema, especially in individuals with diabetes or a history of eye inflammation. Regular eye exams are recommended, and any changes in vision should be reported promptly.

• Liver Damage: Although uncommon, serious liver issues can occur early in treatment. Regular blood tests will be conducted to monitor liver function. Symptoms such as jaundice or dark urine require immediate medical attention.

• Respiratory Issues: Breathing problems may arise, particularly in those with pre-existing lung conditions. Always carry a rescue inhaler if prescribed and inform your provider of any breathing difficulties.

• Pregnancy Risks: Fingolimod may harm an unborn baby. Women of childbearing age should use effective contraception during treatment and for two months after the last dose. Notify your provider if pregnancy occurs.

• Cancer Risk: There is a potential, albeit low, risk of developing certain cancers. Regular check-ups and lab tests are advised. Report symptoms like swollen lymph nodes or unusual skin changes to your healthcare provider.

• Brain Conditions: Though rare, some individuals might experience a condition called posterior reversible encephalopathy syndrome (PRES). Symptoms such as sudden headaches or seizures require urgent medical consultation.

Contraindications:

• Recent heart attack, stroke, or heart failure within the past six months.
• Existing heart rhythm issues, including AV block or sick sinus syndrome.
• Current use of specific heart rhythm medications.

This information is vital for ensuring safe use of Fingolimod. Always consult your healthcare provider for personalized advice and before making any changes to your treatment plan.

Common side effects:

• Headache
• Diarrhea
• Cough
• Back pain
• Nausea
• Stomach pain
• High liver enzymes
• Sinus inflammation
• Flu-like symptoms

Less common but important to monitor:

• High blood pressure
• Blurry vision
• Hair loss

Serious side effects:

• Slow heart rate
• Serious infections (bronchitis or pneumonia)
• Signs of liver disease
• Progressive multifocal leukoencephalopathy (PML)
• Skin cancer
• Lymphoma
• Allergic reaction

Interactions with high risk of serious adverse effects and should be avoided:

• natalizumab
• rituximab

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• Digoxin
• Atenolol
• metoprolol
• diltiazem
• Verapamil
• Amiodarone
• disopyramide
• Dofetilide
• dronedarone
• ibutilide
• procainamide
• quinidine
• Sotalol