Why is this medication prescribed?

Gilenya (fingolimod) is prescribed primarily for the treatment of relapsing forms of multiple sclerosis (MS). It is used to reduce the frequency of relapses and delay the progression of disability associated with MS. MS is an autoimmune disease where the body’s immune system attacks the protective myelin sheath surrounding nerve fibers in the brain and spinal cord, leading to communication problems between the brain and the rest of the body.

Gilenya works by modulating the immune system. It reduces the activity of certain immune cells, specifically lymphocytes, which are involved in the autoimmune response that leads to damage of the myelin sheath in MS. By reducing the activity of these immune cells, Gilenya helps to decrease inflammation and prevent further damage to the nervous system, thereby slowing the progression of MS and reducing the frequency of MS relapses.

How should this medicine be used?

Here’s how Gilenya should be used:

• Initial Dose Monitoring: The first dose of Gilenya requires careful monitoring because it can cause a decrease in heart rate. Patients typically undergo an electrocardiogram (ECG) before taking the first dose to ensure their heart is healthy enough for treatment. Following the first dose, patients are observed for at least six hours in a medical setting to monitor for any potential side effects, particularly related to heart rate and rhythm.
• Maintenance Dose: After the initial dose monitoring, patients typically take Gilenya once daily by mouth, as prescribed by their healthcare provider. The usual maintenance dose is 0.5 mg daily.
• Regular Monitoring: Patients should be regularly monitored by their healthcare provider while taking Gilenya to evaluate its effectiveness and to watch for any potential side effects. This may include periodic blood tests and other assessments.
• Adherence to Treatment: It’s essential for patients to take Gilenya exactly as prescribed by their doctor. Skipping doses or taking more than the prescribed amount can affect the medication’s effectiveness and increase the risk of adverse effects.
• Potential Side Effects: Patients should be aware of potential side effects associated with Gilenya, including but not limited to headaches, liver enzyme elevation, respiratory issues, and infections. It’s essential to promptly report any concerning symptoms to a healthcare provider.
• Pregnancy and Contraception: Gilenya can harm an unborn baby, so it’s crucial for women of childbearing age to use effective contraception while taking Gilenya and for two months after stopping treatment. Additionally, women should not breastfeed while taking Gilenya.
• Other Medications: Patients should inform their healthcare provider about all medications, supplements, and herbal remedies they are taking before starting Gilenya, as it may interact with certain drugs.

It’s important for patients to follow their healthcare provider’s instructions carefully and to communicate any questions or concerns they may have about their treatment with Gilenya.

Other uses for this medicine

Gilenya (fingolimod) is primarily used for the treatment of relapsing forms of multiple sclerosis (MS). However, it’s essential to note that Gilenya should only be used for its approved indications and under the supervision of a healthcare professional. Using Gilenya for other purposes not approved by the FDA or other regulatory agencies is not recommended and can be potentially harmful.

What special precautions should I follow?

Regarding special precautions for Gilenya, here are some important considerations:

• Cardiac Monitoring: Before starting Gilenya treatment, patients need to undergo cardiac evaluation, including an electrocardiogram (ECG), due to the risk of bradycardia (slow heart rate) and atrioventricular conduction block associated with the first dose. Patients may also need monitoring for at least six hours after the first dose to observe for any cardiac issues.
• Infections: Gilenya can increase the risk of infections, including serious infections such as progressive multifocal leukoencephalopathy (PML), a rare but severe brain infection. Patients should be monitored for signs and symptoms of infections, and healthcare providers may consider testing for certain infections before starting treatment.
• Vaccinations: Live vaccines should generally be avoided during treatment with Gilenya due to the risk of infection. Patients should discuss vaccination schedules with their healthcare provider, as some vaccines may need to be administered before starting Gilenya.
• Liver Function: Gilenya may cause liver enzyme elevation, so liver function tests should be monitored periodically during treatment.
• Respiratory Effects: Patients with a history of respiratory conditions, such as chronic obstructive pulmonary disease (COPD) or asthma, should be monitored for respiratory symptoms during treatment with Gilenya.
• Macular Edema: Gilenya has been associated with the development of macular edema (swelling in the central part of the retina), which can lead to vision changes. Patients should undergo an eye examination before starting treatment and periodically thereafter.
• Fetal Risk: Gilenya can harm an unborn baby, so women of childbearing potential should use effective contraception during treatment and for two months after stopping Gilenya.
• Other Medications: Patients should inform their healthcare provider about all medications, including over-the-counter drugs, supplements, and herbal remedies they are taking, as Gilenya may interact with certain medications.

It’s important for patients to discuss any questions or concerns about Gilenya with their healthcare provider before starting treatment. They should also report any unusual symptoms or side effects experienced during treatment promptly.

What special dietary instructions should I follow?

Regarding special dietary instructions for Gilenya, there are no specific dietary restrictions associated with this medication. However, maintaining a healthy and balanced diet can contribute to overall well-being, which may complement your treatment for MS.

What should I do if I forget a dose?

If you forget a dose of Gilenya, take it as soon as you remember on the same day. If you forget until the next day, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you have questions about missed doses or need guidance, consult your healthcare provider or pharmacist.

What side effects can this medication cause?

Gilenya (fingolimod) can cause various side effects, ranging from mild to severe. Common side effects experienced by individuals taking Gilenya include:

• Headache
• Fatigue
• Diarrhea
• Cough
• Back pain
• Influenza (flu)-like symptoms
• Sinusitis (sinus infection)
• Increased liver enzyme levels
• Bronchitis
• Urinary tract infection
• Abdominal pain
• Pain in the arms or legs
• Dizziness
• Nasopharyngitis (common cold)

Less common but potentially serious side effects of Gilenya include:

• Bradycardia (slow heart rate)
• Macular edema (swelling in the central part of the retina)
• Increased risk of infections, including serious infections such as progressive multifocal leukoencephalopathy (PML), which is a rare but severe brain infection
• Respiratory effects, particularly in patients with pre-existing respiratory conditions such as chronic obstructive pulmonary disease (COPD) or asthma
• Liver problems, including liver enzyme elevation
• Increased blood pressure
• Skin reactions such as rash or dermatitis
• Lymphopenia (low white blood cell count), which can increase the risk of infections
• Elevated levels of blood triglycerides
• Fetal risk if taken during pregnancy, including potential birth defects

It’s essential for individuals taking Gilenya to be aware of these potential side effects and to report any unusual symptoms or adverse reactions to their healthcare provider promptly. Additionally, regular monitoring by a healthcare professional can help detect and manage any side effects that may arise during treatment with Gilenya.

What should I know about storage and disposal of this medication?

Storage and Disposal:

• Storage: Store Gilenya capsules at room temperature between 68°F to 77°F (20°C to 25°C). Keep the medication in its original container and protect it from light and moisture. Do not store Gilenya in the bathroom. Keep it out of reach of children and pets.
• Disposal: Dispose of unused or expired Gilenya capsules properly according to local regulations. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Consult your healthcare provider or pharmacist for guidance on the proper disposal of Gilenya.

In case of emergency/overdose

In case of an overdose of Gilenya, seek emergency medical attention or contact a poison control center immediately. Overdose symptoms may include dizziness, drowsiness, blurred vision, nausea, vomiting, diarrhea, and difficulty breathing. Be prepared to provide information about the amount of Gilenya taken and any other relevant details.

What other information should I know?

• Inform all healthcare providers involved in your care that you are taking Gilenya, including dentists and pharmacists.
• Attend all scheduled appointments for monitoring while taking Gilenya, including cardiac evaluations and blood tests.
• Avoid live vaccines while taking Gilenya, as it may increase the risk of infection.
• If you experience any new or worsening symptoms or side effects while taking Gilenya, notify your healthcare provider promptly.
• Keep a list of all medications you are taking, including prescription and over-the-counter drugs, supplements, and herbal products, and share it with your healthcare provider.
• Follow your healthcare provider’s instructions carefully regarding dosing, monitoring, and any precautions or special instructions specific to your individual situation.

By following these guidelines, you can ensure the safe storage, disposal, and use of Gilenya while minimizing the risk of complications or adverse effects. Always consult your healthcare provider or pharmacist if you have any questions or concerns about Gilenya or its use.