Pronunciation:

fin-GOL-i-mod

Brand Names:

• Gilenya
• Tascenso ODT

Dosage Forms:

• Tablet, Disintegrating
• Capsule

Classifications:

Therapeutic—

Immune Modulator

Pharmacologic—

Sphingosine 1-Phosphate Receptor Modulator

Uses of This Medicine:

Fingolimod is used to treat the relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. This medicine will not cure MS, but it may slow some disabling effects and decrease the number of relapses of the disease.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of fingolimod in children younger than 10 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies on the relationship of age to the effects of fingolimod have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related kidney or liver problems, which may require caution in patients receiving fingolimod.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amiodarone
• Bepridil
• Bretylium
• Cisapride
• Disopyramide
• Dofetilide
• Dronedarone
• Ibutilide
• Levoketoconazole
• Levomethadyl
• Mesoridazine
• Pimozide
• Piperaquine
• Procainamide
• Quinidine
• Saquinavir
• Sotalol
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol
• Adagrasib
• Adenovirus Vaccine, Live
• Alfuzosin
• Alprenolol
• Amisulpride
• Amitriptyline
• Amoxapine
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arotinolol
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Atenolol
• Azithromycin
• Bacillus of Calmette and Guerin Vaccine, Live
• Bedaquiline
• Befunolol
• Betaxolol
• Bevantolol
• Bisoprolol
• Bopindolol
• Bucindolol
• Bupranolol
• Buprenorphine
• Buserelin
• Carteolol
• Carvedilol
• Celiprolol
• Ceritinib
• Chloroquine
• Chlorpromazine
• Cholera Vaccine, Live
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Dengue Tetravalent Vaccine, Live
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Digoxin
• Dilevalol
• Diltiazem
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Ebastine
• Ebola Zaire Vaccine, Live
• Efavirenz
• Encorafenib
• Entrectinib
• Eribulin
• Erythromycin
• Escitalopram
• Esmolol
• Famotidine
• Felbamate
• Fexinidazole
• Flecainide
• Fluconazole
• Fluoxetine
• Formoterol
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Iloperidone
• Imipramine
• Influenza Virus Vaccine, Live
• Inotuzumab Ozogamicin
• Itraconazole
• Ivabradine
• Ivosidenib
• Ketoconazole
• Labetalol
• Landiolol
• Lapatinib
• Lefamulin
• Lenvatinib
• Leuprolide
• Levobunolol
• Levofloxacin
• Lofexidine
• Lopinavir
• Lumefantrine
• Macimorelin
• Measles Virus Vaccine, Live
• Mefloquine
• Mepindolol
• Methadone
• Methotrimeprazine
• Metipranolol
• Metoprolol
• Metronidazole
• Mifepristone
• Mirtazapine
• Mizolastine
• Mobocertinib
• Moricizine
• Moxifloxacin
• Mumps Virus Vaccine, Live
• Nadolol
• Nafarelin
• Nebivolol
• Nelfinavir
• Nilotinib
• Nipradilol
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxprenolol
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Papaverine
• Paroxetine
• Pasireotide
• Pazopanib
• Penbutolol
• Pentamidine
• Perphenazine
• Phenobarbital
• Pimavanserin
• Pindolol
• Pipamperone
• Pitolisant
• Poliovirus Vaccine, Live
• Ponesimod
• Posaconazole
• Primidone
• Probucol
• Prochlorperazine
• Promethazine
• Propafenone
• Propranolol
• Protriptyline
• Quetiapine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Ribociclib
• Risperidone
• Ritonavir
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Smallpox Monkeypox Vaccine, Live Non-Replicating
• Smallpox Vaccine
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Talinolol
• Tamoxifen
• Telaprevir
• Telavancin
• Telithromycin
• Tertatolol
• Tetrabenazine
• Timolol
• Tolterodine
• Toremifene
• Trazodone
• Triclabendazole
• Trifluoperazine
• Trimipramine
• Triptorelin
• Typhoid Vaccine, Live
• Vandetanib
• Vardenafil
• Varicella Virus Vaccine, Live
• Vemurafenib
• Venlafaxine
• Verapamil
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Yellow Fever Vaccine
• Zoster Vaccine, Live
• Zotepine
• Zuclopenthixol

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Angina (chest pain poorly controlled within the past 6 months) or
• Arrhythmia (heart rhythm problem) or
• Heart attack (within the past 6 months) or
• Heart block without a pacemaker (abnormal heart rhythm) or
• Heart failure (poorly controlled within the past 6 months) or
• Heart rhythm problems (eg, Mobitz type II second-degree, third-degree heart block, sick sinus syndrome), without a pacemaker or
• QT prolongation (abnormal heart rhythm) or
• Sick sinus syndrome without a pacemaker (abnormal heart rhythm) or
• Stroke (within the past 6 months) or
• Transient ischemic attack (within the past 6 months)—Should not be used in patients with these conditions.

• Bradycardia (slow heartbeat) or
• Breathing problems or
• Hypertension (high blood pressure)—Use with caution. May make these conditions worse.

• Congenital long QT syndrome (abnormal heart rhythm) or
• Congestive heart failure or
• Diabetes or
• Heart attack, history of or
• Heart block (abnormal heart rhythm) or
• Heart rhythm problems (eg, arrhythmia, bradycardia), history of or
• Hypertension (high blood pressure), poorly controlled or
• Hypokalemia (low potassium in the blood) or
• Hypomagnesemia (low magnesium in the blood) or
• Sleep apnea, severe and not treated or
• Stroke, history of or
• Syncope (fainting), history of or
• Uveitis (swelling of the eye), history of—Use with caution. May cause side effects to become worse.

• Infection, acute or chronic, active—Should be treated first before starting fingolimod.

• Kidney disease, severe or
• Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not suddenly stop taking it. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance for side effects.

Your doctor will give you the first dose of this medicine in a medical facility. You will be checked for unwanted effects for at least 6 hours after receiving the medicine to check for unwanted effects.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

If you are using the disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack until you are ready to take the tablet. Peel back the foil and take the tablet out. Do not push the tablet through the foil. Place the tablet on your tongue and allow it to melt. Take the tablet without liquid.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules, disintegrating tablets):
  • For multiple sclerosis:
    • Adults and children 10 years of age and older weighing more than 40 kilograms (kg)—0.5 milligrams (mg) once a day.
    • Children 10 years of age and older weighing 40 kg or less—0.25 mg orally once a day.
    • Children younger than 10 years of age—Use and dose must be determined by your doctor.

Missed dose—

Call your doctor or pharmacist for instructions.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood and urine tests and tests for heart function may be needed to check for unwanted effects.

Symptoms of your MS may return and become worse after stopping treatment with this medicine. Do not stop using this medicine without checking first with your doctor.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for 2 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause your or your child's heart rate to slow down, especially after taking the first dose. You or your child will be observed in a hospital or clinic for 6 hours for signs and symptoms of bradycardia (slow heartbeat). Symptoms may include chest pain or discomfort, lightheadedness, dizziness, or fainting, slow or irregular heartbeat, or unusual tiredness.

This medicine may increase your risk of developing infections, including a herpes infection or a serious brain infection called meningitis or progressive multifocal leukoencephalopathy. Avoid being near people who are sick or have infections while you are using this medicine. Wash your hands often. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.

Fingolimod may cause a rare condition called immune reconstitution inflammatory syndrome (IRIS). This may occur after a person stops receiving this medicine after developing PML during treatment. Tell your doctor right away if you have an inflammatory reaction to an infection that includes mild burning, stinging, or tingling of the skin, or a feeling of heat, redness, or swelling of the skin.

While you are being treated with fingolimod, and for 2 months after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Your child should also have a complete immunization record before starting treatment with this medicine. Fingolimod may lower your or your child's body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you or your child should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

This medicine may cause macular edema (swelling of the back of the eye), especially during the first 3 to 4 months of treatment. Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want an eye doctor (ophthalmologist) to check your eyes.

This medicine may cause a serious nervous system problem called posterior reversible encephalopathy syndrome (PRES). Check with your doctor right away if you or your child have a sudden and severe headache, confusion, vision changes, or seizures with this medicine.

Tell your doctor right away if you have a cough, trouble breathing, chest tightness, or any type of breathing problem with this medicine. These could be symptoms of a serious lung problem.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause a severe increase in disability, including worsening of MS symptoms (eg, blurred vision, difficulty controlling your bladder or bowels, trouble walking, swallowing, or speaking, numbness or tingling in your arms, legs, or face, muscle spasms) for at least 12 to 24 weeks after stopping the medicine. Talk to your doctor if you have concerns about this.

Your doctor will check your blood pressure on a regular basis while you are using this medicine. Tell your doctor right away if you have a severe headache, lightheadedness, or changes in your vision.

This medicine may increase your risk of having skin cancer (eg, basal cell carcinoma, melanoma) or lymphoma. Tell your doctor right away if you notice any skin nodules, patches, or open sores that do not quickly heal. Avoid exposure to sunlight. Wear sunscreen with a high sun protection factor. Do not use sunlamps or tanning beds.

This medicine may cause serious allergic reactions, including angioedema, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you or your child have a rash, hives or itching skin, or large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Blurred vision

chest tightness

chills

cough

cough-producing mucus

diarrhea

difficult or labored breathing

dizziness

fever

general feeling of discomfort or illness

headache

joint pain

loss of appetite

muscle aches and pains

nausea

nervousness

pounding in the ears

runny nose

seizures

shivering

slow or fast heartbeat

sore throat

sweating

trouble sleeping

unusual tiredness or weakness

vomiting

Less common

Black, tarry stools

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest pain or discomfort

headache, severe and throbbing

hoarseness

lightheadedness, dizziness, or fainting

lower back or side pain

painful or difficult urination

sores, ulcers, or white spots on the lips or in the mouth

swollen glands

unusual bleeding or bruising

Incidence not known

Agitation

back pain

bleeding gums

blood in the urine or stools

change in size, shape, or color of existing mole

confusion

difficulty in moving

difficulty in speaking

double vision

drowsiness

epileptic seizure that will not stop

hives, itching, skin rash

inability to move the arms, legs, or facial muscles

inability to speak

irritability

joint stiffness or swelling

loss of consciousness

mole that leaks fluid or bleeds

mood or mental changes

muscle pain, cramps, or stiffness

new mole

pinpoint red spots on the skin

redness of the skin

seeing, hearing, or feeling things that are not there

slow speech

stiff neck

swelling of the eyelids, face, lips, hands, or feet

trouble swallowing

weight loss

yellow skin and eyes

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Pain or tenderness around the eyes and cheekbones

stuffy nose

Less common

Decreased weight

depression

eye pain

hair loss or thinning of the hair

itching in the genitals or other skin areas

lack or loss of strength

scaling

stomach pain

skin rash, encrusted, scaly, and oozing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.