Fingolimod, Oral

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KEY POINTS

• This medicine is taken by mouth to reduce the frequency of relapses caused by multiple sclerosis. Take it exactly as directed.
• You may get infections more easily when you are taking this medicine.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: 1-phosphate receptor modulator

Generic and brand names: fingolimod, oral; Gilenya

What is this medicine used for?

This medicine is taken by mouth to reduce the frequency of flare-ups (relapses) caused by multiple sclerosis (MS).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A history of fainting
• A heart attack, unstable angina, or stroke
• Diabetes
• Eye problems, especially an inflammation of the eye called uveitis
• Heart problems, an irregular heartbeat, or a slow heartbeat
• High blood pressure
• Liver problems
• Long QT syndrome (problems with electrical activity in the heart muscle)
• Lung or breathing problems such as asthma, COPD, or sleep apnea
• Low levels of potassium or magnesium in your blood

Tell your healthcare provider if you have a cough, fever, or infection, or if you have received any vaccines with a month of starting this medicine. Also, tell your doctor if you have had chicken pox or have received the vaccine for chicken pox. Your healthcare provider may do a blood test for chicken pox virus.

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. You should use effective birth control while taking this medicine and for at least 2 months after you stop treatment. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

You will be given your first dose in your provider’s office or in a clinic where you can be observed for 6 hours.

Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Do not stop taking it without your healthcare provider’s approval. If you do not take this medicine for at least 2 weeks, do not start taking it again unless you talk with your healthcare provider. You will need to be watched again for 6 hours after you take it again.

Also, if you do not take this medicine for more than 1 day within the first 2 weeks of treatment, or for more than 7 days during week 3 and 4 of treatment, do not start taking it again unless you talk with your healthcare provider. You will need to be watched for 6 hours after you take it again.

Check with your healthcare provider before using this medicine in children under age 18.

You may take this medicine with or without food.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. If you do not take this medicine for more than 1 day within the first 2 weeks of treatment, do not start taking it again unless you talk with your healthcare provider. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: slow or irregular heartbeat, chest pain.

What should I watch out for?

This medicine increases the risk of progressive multifocal leukoencephalopathy (PML), a brain infection that can lead to death or severe disability. Tell your healthcare provider right away if you have:

• Changes in mood or behavior
• Confusion, thinking problems, loss of memory
• Changes in vision, speech, or walking
• Decreased strength or weakness on one side of the body

This medicine may slow down your heart rate, especially after you take the first dose. You will be monitored closely for at least 6 hours after your first dose. You may feel dizzy or tired, or be aware of a slow or irregular heartbeat. Talk with your healthcare provider about this.

This medicine may lower the number of white blood cells in your body. As a result, you may get infections more easily when you are taking this medicine. This will usually return to normal about 2 months after you stop taking this medicine. Stay away from people with colds, flu, or other infections. Also, do not have any vaccines without getting your healthcare provider's approval first. You should not get certain vaccines for 1 month before and for at least 2 months after you stop taking this medicine. If you take certain vaccines, you may get the infection the vaccine should have prevented.

This medicine may cause a buildup of fluid in the eye called macular edema. You may need an eye exam before you start taking this medicine, then 3 to 4 months later, or any time you notice vision changes while taking this medicine. Contact your provider right away if you notice changes in your vision, such as sensitivity to light, unusual color tint in your vision, blurriness, or any trouble seeing.

Your healthcare provider will want to check you regularly while you are receiving this medicine. You may need blood tests before, during, and after you stop taking this medicine to see how this medicine affects you. Keep all appointments.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat), sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Yellowing of your skin or eyes, dark urine; unexplained nausea, vomiting, or stomach pain; bloody or cloudy urine, trouble urinating, seizures, trouble breathing, unusual tiredness or weakness, sore throat, unexplained fever, chills, or cough, loss of appetite, vision problems or changes, breathing problems, severe dizziness or fainting, chest pain, irregular or slow heartbeat.

Other: Headache, back pain, diarrhea, hair loss.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alfuzosin (Uroxatral)
• Antiarrhythmic medicines (to treat irregular heartbeat) such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), procainamide, and quinidine
• Antibiotics such as azithromycin (Zithromax, Zmax), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), levofloxacin (Levaquin), metronidazole, moxifloxacin (Avelox), pentamidine (NebuPent, Pentam), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, citalopram (Celexa), desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac), imipramine (Tofranil), and nortriptyline (Pamelor)
• Antifungal medicines such as fluconazole (Diflucan), ketoconazole (Nizoral), and voriconazole (Vfend)
• Antipsychotic medicines such as asenapine (Saphris), chlorpromazine, haloperidol (Haldol), iloperidone (Fanapt), paliperidone (Invega), pimozide (Orap), quetiapine (Seroquel), thioridazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, and phenytoin (Dilantin, Phenytek)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), pindolol, and sotalol (Betapace, Sorine)
• Calcium channel blockers such as diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), and verapamil (Calan, Covera, Verelan)
• Cancer medicines such as arsenic trioxide (Trisenox), cisplatin, doxorubicin (Doxil), hydroxyurea (Droxia, Hydrea), toremifene (Fareston), vandetanib (Caprelsa), vemurafenib (Zelboraf), vinblastine, and vincristine (Marqibo)
• Corticosteroids such as betamethasone (Celestone), cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Dextromethorphan/quinidine (Nuedexta)
• Digoxin (Lanoxin)
• Diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), torsemide (Demadex), and triamterene (Dyrenium)
• Doxepin (Silenor)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), mycophenolate (CellCept, Myfortic), and tacrolimus (Astagraf, Prograf, Protopic)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• Methadone (Dolophine, Methadose)
• Mifepristone (Korlym, Mifeprex)
• Mitoxantrone (Novantrone)
• Natalizumab (Tysabri)
• Nausea medicines such as dolasetron (Anzemet) and ondansetron (Zofran)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Vaccines

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine in the original container at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.