Fingolimod (oral)

Fingolimod eases the symptoms of relapsing-remitting multiple sclerosis in adults.

Overview

Fingolimod is a multiple sclerosis relapse treatment. It slows down the progression of the disease, providing patients with a better quality of life.

Many people who have multiple sclerosis suffer from a subtype called relapsing-remitting multiple sclerosis(RRMS).

The Main Benefits of Fingolimod:

Gilenya does not offer a cure for multiple sclerosis. However, it prevents and slows down the body-damaging effects of the disorder over time. Some of the main benefits of this medicine are:

  • Delays Physical Disabilities
  • Reduces the Number of Relapses
  • Lower the Amount of Flare-Ups

This drug effectively cuts the number of relapses in half, according to medical studies.

Fingolimod is available by prescription only and is sold under the U.S. brand Gilenya.

What is Multiple Sclerosis?

Multiple sclerosis or MS is a type of autoimmune disorder that affects the central nervous system. The disease eats away at healthy tissues and nerve fibers, disrupting communication between the brain and the rest of the body. Though scientists are unsure of the root causes of MS, they do know that people who are susceptible to this condition due to genetics may develop new signs of MS based on environmental triggers.

The majority of people with MS receive a diagnosis between the ages of 20 and 50. In the United States alone, it is estimated that roughly 400,000 people suffer from multiple sclerosis.

What is Relapsing Multiple Sclerosis?

Multiple sclerosis most commonly progresses to relapsing MS. The primary symptoms of this new development include:

  • Localized Inflammatory Attacks
  • A Growing Amount of Neurological Issues

This period is often classified as relapses or exacerbations. Following an attack, the disease is defined as going into remission as the symptoms disappear and patient recover totally or partially.

Due to the sporadic nature of the disease, no two patients are alike when it comes to pinpointing symptoms.

However, the most common telltale signs of relapsing MS include:

  • Confusion
  • Feeling Depressed
  • Heat Sensitivities
  • Incontinence
  • Lethargy
  • Lightheadedness
  • Low Sex Drive
  • Muscle Stiffness
  • Numbness
  • Uneven Sense of Balance
  • Vision Changes

Relapses can last for one day or several months. To reduce incidences of relapses, doctors may prescribe Fingolimod, which is taken once per day by mouth.

In most cases, immunotherapy drugs such as Fingolimod are used in conjunction with physical therapy, exercise, and a controlled diet. It may also be prescribed in conjunction with other medicines.

Conditions Treated?

  • Relapsing Multiple Sclerosis, RRMS

Type Of Medicine?

  • Immunosuppressant, Immunomodulating Drug, Sphingosine 1-Phosphate Receptor Modulator

Side Effects

Gilenya may cause a number of side effects, including:

  • A Tingling Sensation
  • Appetite Loss
  • Blurriness
  • Changes in Stool Color
  • Chest Tightness
  • Coughing, Runny Nose, Sore Throat, and other Flu-Like Symptoms
  • Depression
  • Difficulty Urinating
  • Ear Pounding
  • Feeling Jittery or Nervous
  • Fevers or Chills
  • Hair Loss
  • Headaches
  • Insomnia
  • Lethargy
  • Mouth Ulcers
  • Pain in the Chest
  • Pain in the Eye
  • Pain in the Joints or Muscles
  • Pain in the Side of Back
  • Perspiration
  • Runny Stools
  • Skin Rashes
  • Skin that Bruises Easily
  • Swollen Glands
  • Syncope
  • Trouble Breathing
  • Weakness
  • Weight Changes
  • Yellow Eyes
  • Yellow Skin

If your symptoms persist or you think you are having a serious adverse reaction to the drug, call 911 right away.

Examples of When to Call a Doctor

The following set of symptoms are indicative that medical intervention is needed right away:

  • Slowed Heart Beat ' Accompanied by lethargy and a dizzy spell
  • Pain in the Chest ' With a drumming heartbeat
  • Speech or Mobility Loss 'With a headache and sudden weakness
  • Trouble Breathing'With hives, rashes, and an abnormal heartbeat
  • Cold or Flu-Like Symptoms' Such as spikes or dips in temperature, aching muscles, and coughing up mucus

Dosage

Gilenya is supplied as a white 0.5 mg pill.

Directions provided by your healthcare provider should be followed precisely. This is to reduce the chances of developing adverse side effects to the drug. Your doctor will tell you:

  • Never Stop the Medicine Abruptly
  • Do Not Take More Than Prescribed
  • Do Not Extend the Treatment Period

If you have any questions or concerns while using this medicine, do not hesitate to contact your pharmacist or medical provider.

What to Expect

The preliminary dose of Gilenya is provided in a medical setting. This extra precaution is taken to meter patient responses. Expect to complete an assessment lasting six or more hours. During this timeframe, your medical provider will evaluate if any side effects occur after the initial dose before proceeding with at-home prescriptions.

Average Doses

The normal dose of Gilenya includes:

  • Children: Varies Based on the Doctor's Discretion
  • Adults: 0.5 mg | 1X Daily

Patients who stop taking this medicine for more than 2 weeks require first-dose monitoring once more, should be medicine be re-prescribed.

Best Practices for Use

Gilenya can be taken with or without meals. No significant differences have been shown when the medicine is taken with and without foods.

Missed Doses

If you forget to take your medicine, consult your healthcare provider or pharmacist right away. Personalized instructions will be provided for the best course of action in these events.

Overdoses

If you take more than the prescribed amount of Fingolimod, call 911 right away or head to your local emergency department. There is an increased risk of developing a declining heart rate or Bradycardia if you take more than the recommended dose prescribed. As a result, it is important to seek medical help in the event of an overdose.

Interactions

Several drug interactions have been discovered by medical researchers studying Fingolimod. These include:

Drug Interactions

Healthcare researchers advise against prescribing Gilenya with the below drugs ' unless it is completely necessary. In these cases, modified doses for one or both drugs may be required:

  • Landiolol
  • Imipramine
  • Granisetron
  • Carteolol
  • Amiodarone
  • Prochlorperazine
  • Ziprasidone
  • Paliperidone
  • Norfloxacin
  • Amitriptyline
  • Zuclopenthixol
  • Posaconazole
  • Deslorelin
  • Gonadorelin
  • Erythromycin
  • Aripiprazole
  • Efavirenz
  • Sevoflurane
  • Ivabradine
  • Hydroxyzine
  • Delamanid
  • Sulpiride
  • Buserelin
  • Celiprolol
  • Donepezil
  • Triptorelin
  • Pimozide
  • Chloroquine
  • Bopindolol
  • Bupranolol
  • Ibutilide
  • Esmolol
  • Tacrolimus
  • Dabrafenib
  • Diltiazem
  • Nelfinavir
  • Pentamidine
  • Arotinolol
  • Befunolol
  • Mepindolol
  • Bisoprolol
  • Cisapride
  • Leuprolide
  • Nafarelin
  • Goserelin
  • Ciprofloxacin
  • Verapamil
  • Amifampridine
  • Astemizole
  • Quinidine
  • Methadone
  • Vinflunine
  • Nipradilol
  • Telavancin
  • Digoxin
  • Mesoridazine
  • Panobinostat
  • Sparfloxacin
  • Trifluoperazine
  • Metoprolol
  • Piperaquine
  • Dasatinib
  • Betaxolol
  • Gemifloxacin
  • Solifenacin
  • Dronedarone
  • Sodium Phosphate, Monobasic
  • Acebutolol
  • Nebivolol
  • Levomethadyl
  • Citalopram
  • Toremifene
  • Alprenolol
  • Nadolol
  • Metronidazole
  • Atenolol
  • Trimipramine
  • Thioridazine
  • Bevantolol
  • Ofloxacin
  • Sorafenib
  • Pasireotide
  • Ranolazine
  • Vandetanib
  • Telithromycin
  • Histrelin
  • Quinine
  • Dolasetron
  • Metipranolol
  • Timolol
  • Lapatinib
  • Haloperidol
  • Pimavanserin
  • Quetiapine
  • Sotalol
  • Bretylium
  • Oxprenolol
  • Azithromycin
  • Lumefantrine
  • Alfuzosin
  • Droperidol
  • Trazodone
  • Saquinavir
  • Promethazine
  • Clomipramine
  • Halofantrine
  • Dilevalol
  • Dofetilide
  • Lopinavir
  • Perflutren Lipid Microsphere
  • Amisulpride
  • Levobunolol
  • Voriconazole
  • Apomorphine
  • Hydroxychloroquine
  • Ketoconazole
  • Clarithromycin
  • Propafenone
  • Desipramine
  • Procainamide
  • Penbutolol
  • Terfenadine
  • Vardenafil
  • Disopyramide
  • Escitalopram
  • Sunitinib
  • Bucindolol
  • Amoxapine
  • Pazopanib
  • Propranolol
  • Moxifloxacin
  • Protriptyline
  • Nilotinib
  • Tertatolol
  • Pitolisant
  • Anagrelide
  • Arsenic Trioxide
  • Octreotide
  • Clozapine
  • Probucol
  • Mefloquine
  • Vemurafenib
  • Fluconazole
  • Levofloxacin
  • Labetalol
  • Ondansetron
  • Iloperidone
  • Pindolol
  • Talinolol
  • Degarelix
  • Crizotinib
  • Domperidone
  • Fluoxetine
  • Carvedilol
  • Sodium Phosphate
  • Asenapine
  • Salmeterol
  • Flecainide
  • Nortriptyline
  • Sodium Phosphate, Dibasic
  • Chlorpromazine
  • Bepridil

Top Drug Classes to Avoid

Since Gilenya is proven to slow down the heart rate in certain patients, this medicine should not be prescribed concomitantly with other medicines that do the same. This increases the risk of Bradycardia ' or a slow heart rate. A few examples of these negative interactions include:

  • Beta Blockers
  • Calcium Channel Blockers

Immunizations

Patients taking Gilenya should avoid the following vaccines, as contraindications have been found:

  • Live Adenovirus Immunization Type 4
  • Live Adenovirus Immunization Type 7
  • Live Bacillus of Calmette and Guerin Immunization
  • Live Influenza Virus Immunization
  • Live Measles Virus Immunization
  • Live Mumps Virus Immunization
  • Live Poliovirus Immunization
  • Live Rotavirus Immunization
  • Live Rubella Virus Immunization
  • Smallpox Immunization
  • Typhoid Immunization
  • Varicella Virus Immunization
  • Yellow Fever Immunization

Underlying Disorders

The presence of pre-existing conditions could affect the use of Gilenya. For example, extra precautions should be taken for patients with an existing case of:

  • A History of Fainting Syncope
  • Diabetes
  • Eye Inflammations
  • Heart Health Issues (Heart Block, Heart Attacks, Heart Failure, Abnormal Heart Rhythm, Or Bradycardia)
  • High Blood Pressure
  • Low Magnesium Hypomagnesemia
  • Low Potassium Hypokalemia
  • Recent Transient ischemic attack
  • Respiratory Issue
  • Severe Kidney Disease
  • Severe Liver Disease
  • Severe Sleep Apnea
  • Stroke
  • Uncontrolled Angina

Doctors generally inquire into patients' full medical history. Your healthcare provider will also ask you to make a full list of all current medications being used, including over the counter medicines, such as herbal supplements or vitamins, for example.

Warnings

Patients are advised to read the instruction leaflet that comes with each prescription. When taking Gilenya, your doctor may inform you to:

Keep All Returning Doctor's Appointments

This includes to your primary care physician as well as specialists referred to you. During follow-up visits, doctors assess if the medicine is working and if any adverse side effects develop. The main medical tests completed are heart assessments and blood tests, which check for low potassium or magnesium, for example.

Risk of Bradycardia 'A Slow Heartbeat

One of the risks associated with taking Gilenya is developing a slow heartbeat. Patients sometimes experience a slow heart rate, particularly after the preliminary dosage. As a result, patients are usually monitored in a controlled setting 'in a hospital or clinic 'for roughly 6 hours after the first dose is administered.

Some of the tests to expect during the first-dose monitoring include:

1. An EEG
2. Hourly Vital Checks

Some of the main warning signs of Bradycardia include:

  • Pain in the Chest
  • Feeling Lightheaded, Faint, or Dizzy
  • Experiencing Shortness of Breath
  • Extreme Drowsiness or Lethargy

In the event of Bradycardia, medical workers on duty will take the appropriate measures to stabilize the heartbeat.

Risk of Infections

Gilenya could provisionally reduce the white blood cell count 'offering leeway for new infections to multiply. A brain infection could possibly develop, and it's known as progressive multifocal leukoencephalopathy.

To reduce this risk, doctors advise Gilenya users to stay away from others who are sick. If you suspect a new infection, consult your healthcare provider immediately. Some of the main warning signs of an infection are:

  • Coughing
  • Fluctuations in Bodily Temperatures 'Fevers, Chills
  • Pain in the Back and Muscles
  • Strain While Urinating

Because Fingolimod lowers the body's immunity responses, it's critical to stay away from others who are recently vaccinated.

Patients, too, should not get immunized unless a doctor has approved this course of action. Taking or going within close proximity to individuals who have recently received a live Immunization ' and while taking Gilenya ' increases the risk of getting the disease. Rather than prevent the disease, you may open the chances of acquiring the following infections, for example:

  • Mumps
  • Measles
  • Influenza
  • Poliovirus
  • Rotavirus
  • Rubella

Patients should also note that Gilenya remains in the bloodstream for up to 8 weeks after the last dose. If you stop taking this medicine under a doctor's order, the same precautions must be exercised as above.

Risk of Macular Edema

Macular edema may develop in patients taking Gilenya, particularly within the first 12-16 weeks of using the drug. To mitigate the risks associated with macular edema, referrals are generally provided to an ophthalmologist.

If you think you have macular edema or swelling in the back of the eye, consult your healthcare provider immediately. Some of the main warning signs of this condition include:

  • Blurriness
  • Challenges Ready
  • Fluctuations in Vision

Risk of Posterior Reversible Encephalopathy Syndrome (PRES)

Posterior Reversible Encephalopathy Syndrome is a rare condition that could develop with Gilenya use. Its main symptoms include:

  • A Sudden Headache
  • Changes in Vision
  • Difficulty Concentrating
  • Convulsions

Risk of Serious Liver Disease

Moreover, Gilenya may cause a serious liver condition to develop. Tell your doctor immediately if you have:

  • Upper Stomach Pain or Discomfort
  • Changes in Stool or Urine Color
  • Appetite Loss
  • Nausea
  • Fatigue
  • Eyes or Skin That Looks Yellow

Risk of Hypersensitivities

Gilenya may also cause serious allergic reactions, including anaphylaxis. Watch out for the telltale signs of allergies, including:

  • Hives
  • Itchiness
  • Rashes
  • Swelling
  • Chest Tightness
  • Difficulty Breathing

In this event, contact 911 immediately.

Risk of Basal Cell Carcinoma

Basal Cell Carcinoma is a form of skin cancer that could develop while using Gilenya. This condition is marked by the following symptoms:

  • Slow Healing
  • Nodules on the Skin
  • New Patches on the Skin

Note:

If new skin lesions develop, set up an appointment with your medical provider right away.

Familial and Personal Medical History

Not all patients tolerate this medicine. To decrease the risk of adverse reactions, you should tell your doctor if you have or a family member has a history of:

  • AV Block
  • Bradycardia
  • Cardiac Arrest
  • Cerebrovascular Disease
  • Congestive Heart Failure
  • Fainting
  • Heart Block
  • Ischemic Heart Disease
  • Myocardial Infarction
  • Sleep Apnea
  • Uncontrolled Hypertension

Patients who are at an increased risk of the side effects of Gilenya are usually monitored overnight during the first round of treatment.

Use in Pregnancy

Gilenya is not recommended for expecting mothers as this medicine could cause serious injury to an unborn baby. As an extra precaution, female users are advised to start birth control to prevent pregnancy.

If you stop using this medicine and attempt to get pregnant, allow at least 8 weeks after discontinuation before trying. Continue using birth control medicines within this timeframe until your doctor provides the go-ahead to stop use.

In the event you do get pregnant while using Gilenya, tell your medical specialist immediately.

Use in Minors

Gilenya is not recommended for patients under the age of 18 years old.

Recap of Top Warnings

To summarize the risks, Gilenya may cause:

  • Allergic Reactions
  • Bradyarrhythmia
  • Fetal Risk
  • Heart Blocks
  • High Blood Pressure
  • Infections
  • Liver Injury
  • Low Immunity
  • Posterior Reversible Encephalopathy Syndrome
  • Progressive multifocal leukoencephalopathy
  • Respiratory Failure
  • Skin Cancer

Storage

Gilenya can be safely kept at a room temperature of 15°C to 30°C (59°F to 86°F).

Keep away from:

  • Direct Sunlight
  • Moisture
  • Heat
  • Weather Extremes

Additionally, place this medicine out of the reach of children. In the event of an accidental dosage, call 911. Another great resource for overdose is the American Association of Poison Control Centers, available around the clock at 1 800) 222-1222.

Summary

Gilenya is suggested for relapsing MS in adults. This prescription-only medicine is not considered a cure. However, it postpones the disabling effects of multiple sclerosis and lowers the number of flare-ups experienced by patients. In fact, medical researchers report that MS patients who take this medicine for at least two years typically experienced a significantly reduced number of relapses. Gilenya potentially cuts these flare-ups in half.

Multiple sclerosis is a disabling disease where the nerve fibers are attacked by cells known as lymphocytes.

When taking the first dose of Gilenya, it is expected that the heart rate will slow down. To mitigate the risk of Bradycardia, as this condition is otherwise known, doctors prescribe the first dose in a controlled hospital setting. Patients are observed for approximately 6 hours to ensure the heart rate is normal before sending patients home. Patients who temporarily discontinue the treatment will need to be monitored again if treatment is reinitiated.

Patients are also highly susceptible to contracting new infections because this medicine lowers the white blood cell count. As such, patients are usually told to stay away from Immunizations or anyone who is sick.

Other risk factors when taking this medicine include progressive multifocal leukoencephalopathy, macular edema, and skin cancer. It is therefore vital that patients keep all appointments with their respective healthcare provider. Precautions are also provided in the insert label, which tells you when it's time to call a doctor.

Additionally, Gilenya may cause fetal harm, and is therefore not recommended for pregnant or nursing mothers. A contraception should be in effect when using this medicine to stop pregnancy.

Gilenya ultimately offers promising results for patients with MS. It postpones the accrual of physical disabilities and helps patients enjoy a better quality of life.