Gilenya (Fingolimod)

What is Gilenya?

Gilenya is a prescription medication used in the treatment of relapsing forms of multiple sclerosis (MS), a chronic autoimmune disease affecting the central nervous system. The active ingredient in Gilenya is fingolimod, which belongs to a class of medications known as sphingosine 1-phosphate receptor modulators.

How to use Gilenya?

Using Gilenya (fingolimod) effectively involves following the prescribed dosage and instructions provided by your healthcare provider.

Here's a step-by-step guide on how to use Gilenya:

• Consultation with Healthcare Provider: Before starting Gilenya, consult with your healthcare provider. They will evaluate your condition and determine if Gilenya is the right treatment option for you.
• Baseline Evaluation: Your healthcare provider may perform baseline tests, such as blood tests, to assess your overall health before starting Gilenya treatment.
• Starting Dosage: Your healthcare provider will prescribe the appropriate dosage of Gilenya for you based on your age, weight, medical history, and other factors. The typical starting dosage for adults and adolescents aged 10 years and older is 0.5 mg once daily.
• First Dose Observation: For the first dose of Gilenya, you will likely be observed by a healthcare professional for at least six hours after taking the medication. This observation period is to monitor for potential side effects, including changes in heart rate or other adverse reactions.
• Regular Dosage: After the initial observation period, you can continue taking Gilenya at home as prescribed by your healthcare provider. Take Gilenya exactly as directed, typically once daily, with or without food.

What is Gilenya used for?

Gilenya is used in the treatment of relapsing forms of multiple sclerosis (MS), a chronic autoimmune disease affecting the central nervous system.

Specifically, Gilenya is indicated for the following:

• Relapsing-Remitting Multiple Sclerosis (RRMS): Gilenya is approved for the treatment of relapsing-remitting MS (RRMS), the most common form of MS. RRMS is characterized by periods of symptom flare-ups (relapses) followed by periods of remission.
• Active Secondary Progressive MS (SPMS) with Relapses: Gilenya is also indicated for the treatment of active secondary progressive MS (SPMS) with relapses. SPMS involves a gradual worsening of symptoms and disability over time, with or without periods of relapse.

What are the Side Effects of Gilenya?

Gilenya (fingolimod) is generally well-tolerated, but like any medication, it may cause side effects in some individuals.

Common side effects of Gilenya include

• Headache
• Fatigue
• Dizziness
• Nausea
• Diarrhea
• Persistent Cough
• Elevated Liver Enzymes
• Infections
• Bradyarrhythmia and Bradycardia
• Macular Edema
• Breathing Problems

Safety/ Warnings:

Here are some important safety warnings:

• Cardiac Effects: Gilenya may cause slowing of the heart rate (bradycardia) or other heart rhythm abnormalities, particularly after the first dose. Some patients may experience a transient decrease in heart rate that may require monitoring. Healthcare providers typically conduct an electrocardiogram (ECG) before and during the initial dosing period to monitor for cardiac effects.
• Macular Edema: Gilenya may cause macular edema, a condition characterized by swelling of the macula, the central part of the retina in the eye. This can lead to vision problems, including blurriness or decreased vision. Healthcare providers may perform eye exams before starting Gilenya treatment and periodically thereafter to monitor for macular edema.
• Infections: Gilenya may increase the risk of infections, including respiratory infections, urinary tract infections, and herpes viral infections. Before starting Gilenya treatment, patients should be screened for infections, and treatment of pre-existing infections should be completed. Patients should be monitored for signs and symptoms of infection during treatment with Gilenya.
• Liver Function: Gilenya may cause elevations in liver enzyme levels, which can be detected through blood tests. Healthcare providers typically monitor liver function periodically during Gilenya treatment. Patients with pre-existing liver conditions may require closer monitoring.
• Breathing Problems: Gilenya may cause breathing problems, particularly in individuals with pre-existing respiratory conditions. Patients should be monitored for respiratory symptoms during treatment with Gilenya.
• Vaccinations: Live vaccines should be avoided during treatment with Gilenya due to the risk of infection. Patients should discuss vaccination plans with their healthcare provider before starting Gilenya treatment.
• Fetal Risk: Gilenya may cause harm to the fetus if used during pregnancy. Women of childbearing potential should use effective contraception during treatment with Gilenya and for at least two months after discontinuing treatment.
• Drug Interactions: Gilenya may interact with certain medications, including other immunosuppressive drugs, antihypertensive medications, and drugs that affect heart rate or rhythm. Patients should inform their healthcare provider about all medications they are taking before starting Gilenya treatment.
• Hepatic and Renal Impairment: Gilenya should be used with caution in patients with hepatic or renal impairment, as dosage adjustments may be necessary.

Drug Interactions:

Here are some common drug interactions associated with Gilenya:

• Vaccines: Live vaccines should be avoided during treatment with Gilenya due to the risk of infection. Patients should discuss vaccination plans with their healthcare provider before starting Gilenya treatment.
• Immunosuppressants: Concurrent use of Gilenya with other immunosuppressive drugs, such as corticosteroids or disease-modifying therapies for MS, may increase the risk of immunosuppression and infections.
• Antihypertensive Medications: Gilenya may cause bradycardia (slow heart rate) or other cardiac effects. Concurrent use of Gilenya with antihypertensive medications, particularly beta-blockers or calcium channel blockers, may potentiate these effects and lead to further slowing of the heart rate. Healthcare providers may monitor heart rate and blood pressure more closely when Gilenya is used with antihypertensive medications.
• Drugs Affecting Heart Rate or Rhythm: Gilenya may affect heart rate and rhythm. Concurrent use of Gilenya with other drugs that affect heart rate or rhythm, such as antiarrhythmic medications or medications that prolong the QT interval, may increase the risk of cardiac effects. Healthcare providers should exercise caution when combining Gilenya with these medications.
• Antidepressants: Some antidepressant medications, particularly tricyclic antidepressants, may prolong the QT interval and increase the risk of cardiac arrhythmias. Concurrent use of Gilenya with these medications may potentiate the cardiac effects of both drugs.
• Antifungal Agents: Certain antifungal medications, such as ketoconazole and itraconazole, may inhibit the metabolism of Gilenya and increase its blood levels. Healthcare providers may monitor for potential signs of Gilenya toxicity when used concomitantly with these antifungal agents.
• Antibiotics: Some antibiotics, such as clarithromycin and erythromycin, may inhibit the metabolism of Gilenya and increase its blood levels.Healthcare providers may monitor for potential signs of Gilenya toxicity when used concomitantly with these antibiotics.
• HIV Medications: Certain medications used to treat HIV, such as ritonavir and atazanavir, may inhibit the metabolism of Gilenya and increase its blood levels. Healthcare providers may monitor for potential signs of Gilenya toxicity when used concomitantly with these HIV medications.

Different Dosages:

Gilenya (fingolimod) is typically available in a single strength: 0.5 milligrams (mg) in capsule form.

Storage:

Here are some guidelines for storing Gilenya:

• Room Temperature: Store Gilenya capsules at room temperature, ideally between 68°F to 77°F (20°C to 25°C). Avoid exposing Gilenya to extreme temperatures, such as heat or cold, as this may affect its stability and potency.
• Protect from Light: Keep Gilenya capsules in their original packaging or container to protect them from light. Exposure to light can degrade the medication over time.
• Moisture Control: Store Gilenya capsules in a dry place away from moisture. Moisture can cause the capsules to degrade and lose their effectiveness.
• Keep Out of Reach of Children: Store Gilenya capsules in a secure location out of reach of children and pets to prevent accidental ingestion.
• Avoid Bathroom Storage: Avoid storing Gilenya capsules in the bathroom or other areas with high humidity, as humidity can degrade the medication. Instead, choose a cool, dry place for storage.

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FAQs:

Why Gilenya Medication is Prescribed?

Gilenya (fingolimod) is prescribed for the treatment of relapsing forms of multiple sclerosis (MS), a chronic autoimmune disease affecting the central nervous system.

How Should Gilenya be Used?

Blood test before starting the treatment. Your healthcare provider will prescribe the appropriate dosage of Gilenya for you based on your age, weight, medical history, and other factors. The standard starting dosage for Gilenya is 0.5 milligrams (mg) orally once daily. For the first dose of Gilenya, you will likely be observed by a healthcare professional for at least six hours after taking the medication.

What Should I Do if I Forget a Dose of Gilenya?

If you realize that you missed a dose of Gilenya and it is within 24 hours of the missed dose time, take the missed dose as soon as you remember. f it is more than 24 hours since the missed dose time, skip the missed dose and take your next dose at the regular time. Do not take a double dose to make up for the missed dose.

How long does it take for Gilenya to work?

In general, Gilenya may start to show its effects within the first few months of treatment. However, the full therapeutic benefits of Gilenya may take several months to become apparent. Some individuals may experience a reduction in relapses and disease activity relatively quickly after starting Gilenya, while others may require more time to achieve optimal control of their MS symptoms.

When should I stop Gilenya?

If Gilenya is not effectively controlling your multiple sclerosis (MS) symptoms or preventing relapses, your healthcare provider may consider alternative treatment options. If you experience severe or intolerable side effects from Gilenya that cannot be managed or resolved, your healthcare provider may consider discontinuing the medication. If you are planning to become pregnant, Gilenya should be stopped before conception due to potential risks to the fetus.

References:

• https://www.webmd.com/drugs/2/drug-154676/gilenya-oral/details
• https://www.drugs.com/gilenya.html