GILENYA

Gilenya is a brand name for the generic medication Fingolimod. It is a registered trademark of Novartis, AG. This drug got FDA approval in 2010 for the treatment of patients with relapsing kinds of multiple sclerosis. It is the first oral capsule for RMS (Relapsing Multiple Sclerosis) known to benefit more than 310,000 patients across the globe in more than a decade of its existence in the pharmacy market. It can help reduce the frequency of experiencing exacerbations and delay physical disability caused by Relapsing Multiple Sclerosis but cannot cure the condition.

Each 0.5mg Gilenya capsule contains Fingolimod hydrochloride as its active ingredient and the following inactive ingredients: gelatin, titanium dioxide, magnesium stearate, mannitol, and yellow iron oxide. Whereas, each 0.25mg Gilenya capsule contains Fingolimod as its active ingredient and the following inactive ingredients: gelatin, titanium dioxide, hydroxypropylbetadex, magnesium stearate, yellow iron oxide, hydroxypropyl cellulose, and mannitol. Fingolimod hydrochloride is a white powder chemically designated as 2-amino-2-[2-(4-octylphenyl) ethyl] propan-1,3-diol hydrochloride.

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Gilenya belongs to the pharmacological class: Sphingosine 1-Phosphate Receptor Modulators, Selective Immunosuppressants.

Sphingosine 1-Phosphate Receptor Modulators are a type of selective immunosuppressants. They are the immunomodulators that help subdue the functioning of the immune system by its selective action. They work to prevent or delay the severe disability associated with relapsing forms of multiple sclerosis.

Gilenya capsules come in two strengths:

• 0.25 mg hard gelatin capsules having an ivory opaque body with a black radial band and a cap with radial black imprint “FTY 0.25mg”
• 0.5 mg hard gelatin capsules having a white opaque body with two yellow radial bands and a bright yellow cap with radial black imprint “FTY 0.5mg”.

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Gilenya users are people aged 10 years older and experiencing the following forms of relapsing multiple sclerosis:

• Relapsing-Remitting Multiple Sclerosis (RRMS): A most common course of MS wherein exacerbations (relapses) are followed by partial/complete recovery (remissions).
• Active Secondary Progressive Multiple Sclerosis: It is a stage of MS that often is seen after RRMS for many people. With his type of MS, there are new or constant neurological symptoms- physical disability steadily gets worse.
• Clinically isolated syndrome: It is another course of MS, a first episode of neurological symptoms, as seen in MS.

• The recommended dosage for adults diagnosed with multiple sclerosis is 0.5mg orally once a day with or without food.
• The recommended dosage for children aged 10 years above but weighing 40kg or less is 0.25mg orally once a day. If weighing more than 40kg, the suggested dosage is 0.5mg orally once a day.

Gilenya capsules are designed for oral administration, which means they are taken by mouth. These capsules contain the active ingredient fingolimod, which belongs to a class of drugs known as sphingosine 1-phosphate receptor modulators.

The common side effects are:

• Headache
• Stuffy nose
• Diarrhea
• Backache
• Sinus-related pain
• Extreme tiredness
• Influenza
• Cough
• Elevated levels of liver transaminase.

Some of the serious side effects are:

• Hives/ Urticaria
• Breathing difficulties, shortness of breath.
• Non-healing sores- cold sores, mouth/throat sores, or genital/anal sores.
• Slow or irregular heartbeats.
• Shiny skin nodules.
• Swollen throat, lips, tongue, or face.
• Speech problems
• Problems with muscle movement.
• Dizziness
• Fever and Chills.
• Nausea and Vomiting.
• Body aches
• Stiff neck
• Eye pain
• Headache
• Seizure
• Upper stomach ache.
• Loss of appetite.
• Dark urine

Some drugs known to interact with Gilenya include:

• Systemic ketoconazole
• Live attenuated vaccines.
• Digoxin
• Beta-blockers
• Erythromycin
• Haloperidol
• Calcium-channel blockers
• Citalopram
• Immuno-suppressive medications.
• Cancer medications
• Haloperidol
• Chlorpromazine
• Medications for hypertension or heart problems.
• Methadone.

The intake of Gilenya capsules is not safe in the following cases:

• Medical history of past 6 months showing confirmed diagnosis of transient ischemic attack (TIA), unstable angina, myocardial infarction, decompensated heart failure requiring hospitalization or Class III/IV heart failure, and stroke.
• Previous medical record of having serious heart conditions like sick sinus syndrome or Mobitz Type II second-degree or third-degree AV block. Its exception is having a functioning pacemaker.
• Electrocardiograph reports showing baseline QTc interval greater than or equal to 500 msec (a long QT syndrome).
• Cardiac arrhythmias which require treatment with Class Ia or Class III antiarrhythmic drugs.
• Medical conditions like weak immune system, active/chronic infections like Hepatitis B, hypertension, diabetes, skin cancer, sleep apnea, liver disease, and uveitis.
• Children aged below 10 years.
• Known hypersensitivity to fingolimod or any of the ingredients of Gilenya.
• Pregnancy.

Before starting to take Gilenya capsules, keep in mind and follow these precautions:

• Avoid sunlight exposure or the use of tanning beds. Before going outdoors in the daytime, apply sunscreen and wear sun-protective clothing.
• Do not take the live-attenuated vaccine for both during and after 2 months of taking the last dose of Gilenya.
• Tell your doctor if you are pregnant or planning for it, breastfeeding, have any allergies, take other drugs/supplements, or have any medical condition.

• Store Gilenya capsules at controlled room temperature, preferably at 20-25℃, away from heat and moisture.
• The capsules may get spoiled or their efficacy may become low below 15℃ and above 30℃.
• Keep it away from moisture, pets, and children.

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