FINGOLIMOD

(fin GOE li mod) Brand: Gilenya

What is the most significant information I must know about fingolimod?

• You must not use fingolimod if you are allergic to it, or if you have determined serious heart conditions, especially severe heart failure, "AV block," sick sinus syndrome (unless you have a pacemaker), if you take determined heart rhythm medicines, or if you have recently had a heart onslaught, stroke (including "mini-stroke"), chest pain (unstable angina), or another serious heart problem.

• Till you take fingolimod, speak your doctor if you have an infection, a very slow heart course, low blood pressure or a history of fainting, tall blood pressure, diabetes, liver or kidney malady, asthma or another breathing mess, congestive heart failure, heart rhythm mess, a serious heart condition, or if you have ever had an eye condition called uveitis.

• Also speak your doctor if you have never had chickenpox or if you have never received a varicella vaccine (Varivax).

• You will receive your first doze of fingolimod in a hospital setting where your heart rhythm can be monitored, in case the medicine causes serious side effects. Your blood pressure and heart course will be constantly monitored for at least 6 hours after your first doze of fingolimod.

• To be certain this medicine is not causing deleterious effects, your blood cells, blood pressure, liver function, and lung function will need to be tested often. You may also need to eye exams. Fingolimod can have long lasting effects on your body. Do not miss any follow up visits to your doctor for blood trials or eye exams.

• Speak your doctor if you use any heart or blood pressure medications. Do not receive a "live" vaccine while using fingolimod.

• Do not stop taking fingolimod without first talking to your doctor. Stopping suddenly may create your condition worse. If you stop taking fingolimod for 2 weeks or longer, do not start taking it again without asking your doctor. You will need to restart the medicine in a hospital setting under observation.

What is fingolimod?

• Fingolimod is an immunosuppressant. It works by keeping immune cells trapped in your lymph nodes so they cannot reach the central nervous system (brain and spinal cord).

• Fingolimod is used to treat relapsing multiple sclerosis (MS) in adults. This medicine will not cure MS, it will only decrease the frequency of relapse symptoms.

• Fingolimod may also be used for purposes not listed in this medicine guide.

What must I discuss with my healthcare provider till taking fingolimod?

• You must not use fingolimod if you are allergic to it, or if you have determined serious heart conditions, especially:

· severe heart failure (that required you to be in the hospital);

· "AV block" or sick sinus syndrome (unless you have a pacemaker);

· a last (within the past 6 months) heart onslaught, stroke, "mini-stroke" or TIA, chest pain (unstable angina), or another serious heart problem; or

· if you take any of these heart rhythm medications -- amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), flecainide (Tambocor), dronedarone (Multaq), ibutilide (Corvert), mexiletine (Mexitil), procainamide (Procan, Pronestyl), propafenone, (Rythmol), quinidine (Quin-G), or sotalol (Betapace).

• Till you take fingolimod, speak your doctor if you have never had chickenpox or if you have never received a varicella vaccine (Varivax). You may need to receive the vaccine and then wait 1 month till taking fingolimod.

• To create certain you can safely take fingolimod, speak your doctor if you have any of these another conditions:

· an active or chronic infection;

· a very slow heart course (fewer than 55 beats for minute);

· low blood pressure or a history of fainting;

· tall blood pressure, heart malady, congestive heart failure;

· a history of Long QT syndrome;

· diabetes;

· liver or kidney disease;

· asthma or another breathing mess; or

· history of an eye condition called uveitis.

• FDA pregnancy category C. It is not known whether fingolimod will harm an unborn child. Speak your doctor if you are pregnant or plan to become pregnant while using this medicine. Use effective birth control while you are using this medicine and for at least 2 months after your treatment ends.

• Fingolimod can pass into breast milk and may harm a nursing child. You must not breast-feed while you are using fingolimod.

• Do not give this medicine to anyone under 18 years old without medical advice.

How must I take fingolimod?

• Take exactly as predesigned by your doctor. Do not take in larger or less amounts or for longer than recommended. Follow the directions on your prescription label.

• Till you start taking fingolimod, your blood will need to be tested. Your heart function will also need to be checked using an electrocardiograph or ECG (sometimes called an EKG). This car measures electrical activity of the heart.

• You may take fingolimod with or without food.

• Fingolimod can magnify you risk of infection for up to 2 months after you stop taking the medication. Call your doctor if you develop any signs of a new infection.

• Do not stop taking this medicine without first talking to your doctor. Stopping suddenly may create your condition worse.

• If you stop taking fingolimod for 2 weeks or longer, do not start taking it again without asking your doctor. You will need to restart the medicine in a hospital setting under observation.

• Store in original package at room temperature away from moisture and heat.

What happens if I miss a dose?

• Take the missed doze as soon as you remember. Skip the missed doze if it is nearly time for your following scheduled doze. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.

• Overdose symptoms may include chest tightness.

What must I avoid while taking fingolimod?

• Do not receive a "live" vaccine while using fingolimod. The vaccine may not work as well during this time, and may not fully protect you from malady. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

What are the possible side effects of fingolimod?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your person, lips, tongue, or throat.

• Call your doctor at once if you have a serious side effect such as:

· slow heart course, dizziness, feeling very weak or tired;

· chest pain, pounding heartbeats or fluttering in your chest;

· sudden numbness or weakness, severe headache, problems with speech or walking;

· wheezing, chest tightness, trouble breathing, cough with yellow or green mucus;

· fever, chills, body aches, flu symptoms, nausea and vomiting, sores in your mouth and throat;

· swelling, warmth, redness, oozing, itchy rash, or another signs of skin infection;

· nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

· vision problems, blurred vision, eye pain, heighten sensitivity to easy, or having a blind spot or shadows in the center of your vision (vision problems may occur 3 to 4 months after you start taking fingolimod).

• Smaller serious side effects may include:

· headache, weary feeling;

· back pain;

· diarrhea; or

· stuffy nose, sinus pain, or cough.

• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect fingolimod?

• Speak your doctor if you use any heart or blood pressure medications, such as:

· a beta blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or

· a calcium channel blocker such as amlodipine (Norvasc, Caduet, Exforge, Lotrel, Tekamlo, Tribenzor, Twynsta), diltiazem (Cartia, Cardizem), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others.

• Speak your doctor about all another medicines you use, especially:

· ketoconazole (Nizoral);

· arsenic trioxide (Trisenox);

· tacrolimus (Prograf);

· vandetanib (Caprelsa);

· an antibiotic such as azithromycin (Zithromax, Zmax, Z-Pack), clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), levofloxacin (Levaquin), moxifloxacin (Avelox), or pentamidine (NebuPent, Pentam);

· an antidepressant such as amitriptylline (Elavil, Vanatrip, Limbitrol), citalopram (Celexa), clomipramine (Anafranil), or desipramine (Norpramin);

· anti-malaria medications such as chloroquine (Aralen), halofantrine (Halfan), or mefloquine (Lariam);

· heart rhythm medication such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), dronedarone (Multaq), flecainide (Tambocor), ibutilide (Corvert), procainamide (Procan, Pronestyl), propafenone (Rythmol), quinidine (Quin-G), or sotalol (Betapace);

· medication to prevent or treat nausea and vomiting such as dolasetron (Anzemet), droperidol (Inapsine), or ondansetron (Zofran);

· medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), clozapine (FazaClo, Clozaril), haloperidol (Haldol), mesoridazine (Serentil), pimozide (Orap), thioridazine (Mellaril), or ziprasidone (Geodon);

· migraine headache medication such as sumatriptan (Imitrex, Treximet) or zolmitriptan (Zomig);

· narcotic medicine such as methadone (Methadose, Diskets, Dolophine); or

· drugs that weaken the immune system, such as cancer medication, steroids, medicines to prevent rejection of a transplanted organ, and another drugs to treat MS.

• This list is not complete and another drugs may interact with fingolimod. Speak your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal commodity. Do not start a new medicine without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about fingolimod.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses external of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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