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The following information outlines important safety warnings and precautions associated with the use of Fingolimod (Gilenya). Please read carefully and consult your healthcare provider if you have any concerns or questions.

• Heart Rate Concerns: Fingolimod can cause a significant drop in heart rate within the first 24 hours of starting the medication. It is crucial to inform your healthcare provider if you have any heart conditions or are taking other medications that affect heart rate. Your heart will be monitored for at least 6 hours after the initial dose. Seek immediate medical attention if you experience symptoms like fatigue, weakness, confusion, dizziness, difficulty breathing, or chest pain.

• Increased Infection Risk: This medication may weaken your immune system, increasing the risk of serious infections. Ensure all vaccinations are current before starting Fingolimod. If an infection develops during treatment, your healthcare provider may instruct you to stop taking the medication. Notify your provider if you experience symptoms like fever, respiratory issues, diarrhea, or chills.

• Progressive Multifocal Leukoencephalopathy (PML): Fingolimod may increase the risk of PML, a severe brain infection caused by the John Cunningham virus (JCV), especially in individuals with weakened immune systems. Seek immediate medical help if you notice weakness on one side, clumsiness, or changes in personality, vision, or memory.

• Eye Health: There is an increased risk of macular edema, an eye condition, with Fingolimod. Regular eye examinations are necessary before and during treatment. Report any changes in vision to your healthcare provider.

• Liver Health: Although rare, Fingolimod may cause serious liver issues. Blood tests will be conducted before and during treatment to monitor liver function. If you notice symptoms such as abdominal swelling, jaundice, dark urine, or pale stools, seek medical attention immediately.

• Respiratory Issues: Fingolimod can result in breathing difficulties, potentially appearing within a month of starting treatment. Individuals with a history of lung problems should keep a rescue inhaler accessible and report any breathing issues to their healthcare provider.

• Pregnancy: Fingolimod may harm unborn babies based on animal studies. Women of childbearing age should use effective contraception during treatment and for two months after the final dose. Notify your provider immediately if you become pregnant.

• Cancer Risk: There is a potential, albeit rare, increased risk of certain cancers, including blood and skin cancer. Regular examinations and lab tests are recommended to monitor this risk. Report symptoms like swollen lymph nodes, persistent fatigue, weight loss, appetite loss, nosebleeds, or skin changes to your provider.

• Brain Health: Rare cases of posterior reversible encephalopathy syndrome (PRES) have been reported. Contact your healthcare provider promptly if you experience sudden headaches, seizures, unconsciousness, or visual disturbances.

Contraindications: Fingolimod should not be used if you have had a recent heart attack, chest pain, stroke, or heart failure within the last six months, or if you have certain heart rate or rhythm disorders, including AV block or sick sinus syndrome. Additionally, avoid using this medication if you are taking specific heart rhythm drugs. Always consult your healthcare provider if you have any of these conditions before starting Fingolimod.

When taking this medication, you may experience common side effects such as headache, cough, back pain, diarrhea, nausea, stomach pain, or sinus inflammation. These effects are generally mild and often manageable, but if they persist or worsen, it is advisable to consult your healthcare provider. Some individuals may also notice high liver enzymes, influenza-like symptoms, or pain in the arms or legs.

This medication can also cause other side effects, including trouble breathing, high blood pressure, bronchitis, slow heartbeat, hair loss, blurry vision, and scaly skin. If you encounter any of these, particularly if they are severe, reach out to your healthcare provider for guidance.

Serious side effects are rare but require immediate medical attention. These include a dangerously slow heart rate, which may manifest as tiredness, weakness, confusion, fainting, or chest pain. Swelling in the brain can cause severe headache, sudden confusion, vision changes, or seizures. A serious brain infection may lead to weakness, clumsiness, personality changes, or light sensitivity. Other serious infections might present as fever, difficulty breathing, diarrhea, or chills. Additionally, serious liver problems could result in symptoms such as persistent nausea, vomiting, stomach pain, yellowing skin or eyes, or clay-colored stool.

It is crucial to be aware of the potential risk of skin cancer and lymphoma associated with this medication. Monitor for any new or changing skin growths or swollen lymph nodes. This medication can weaken your immune system, increasing your risk of infections like bronchitis, pneumonia, or herpes, and even a rare brain infection, progressive multifocal leukoencephalopathy (PML). Remain vigilant for symptoms such as persistent cough, fever, or sores.

While a severe allergic reaction is uncommon, seek urgent medical help if you notice symptoms like a rash, swelling, severe dizziness, or trouble breathing. Always report any unexpected effects to your healthcare provider.

Fingolimod (Gilenya) can interact with a variety of medications, potentially leading to adverse effects. It's important to inform your healthcare provider about all medications and supplements you're taking, including prescriptions, over-the-counter drugs, and vitamins.

Interactions to be aware of include medications that may slow your heart rate such as digoxin, beta-blockers like atenolol or metoprolol, and calcium channel blockers like diltiazem and verapamil. Additionally, drugs used to manage irregular heartbeats, such as amiodarone, disopyramide, dofetilide, dronedarone, ibutilide, procainamide, quinidine, and sotalol, may also interact with Fingolimod.

Other potential interactions include medications that can weaken your immune system or increase infection risk, such as natalizumab and rituximab. Your doctor may need to adjust your treatment plan if these drugs are involved to ensure your safety and the effectiveness of your treatment.