Fingolimod

Before taking fingolimod,

• tell your doctor and pharmacist if you are allergic to fingolimod. If you have had a serious allergic reaction to fingolimod or any of the ingredients in fingolimod capsules (rash, hives, swelling of the face, eyes, mouth, throat, tongue, lips, hands, feet, ankles, or lower legs), your doctor will probably tell not to fingolimod. Also, tell your doctor if you are allergic to any other medications. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor if you are taking medications for irregular heartbeat such as amiodarone (Cordarone, Nexterone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), procainamide, quinidine (in Nuedexta), and sotalol (Betapace, Sorine, Sotylize). Your doctor will probably tell you not to take fingolimod if you are taking one or more of these medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take during your treatment with fingolimod and for 2 months after your treatment. Be sure to mention any of the following: beta-blockers such as atenolol (Tenormin, in Tenoretic), carteolol, labetalol (Trandate), metoprolol (Lopressor, Toprol-XL, in Dutoprol, in Lopressor HCT), nadolol (Corgard, in Corzide), propranolol (Hemangeol, Inderal LA, Innopran XL), and timolol; calcium channel blockers such as diltiazem (Cardizem, Cartia, Tiazac, others) and verapamil (Calan, Covera, Verelan, in Tarka); chlorpromazine; citalopram (Celexa); oral corticosteroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos); digoxin (Lanoxin); erythromycin (E.E.S., Ery-Tab, PCE, others); haloperidol; ketoconazole (Extina, Nizoral, Xolegel); medications to control the immune system; medications for cancer, heart problems, or high blood pressure; and methadone (Dolophine, Methadose). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with fingolimod, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• tell your doctor if you have or have had any of these conditions in the last six months: fainting, heart attack, angina (chest pain), stroke or mini-stroke, or heart failure. Also tell your doctor if you have long QT syndrome (condition that increases the risk of developing an irregular heartbeat that may cause fainting or sudden death) or irregular heart rhythm. Your doctor may tell you not to take fingolimod.
• tell your doctor if you have ever fainted, if you currently have a fever or other signs of infection, if you have an infection that comes and goes or that does not go away, and if you have or have ever had diabetes; sleep apnea (condition in which you briefly stop breathing many times during the night) or other breathing problems; high blood pressure; uveitis (inflammation of the eye) or other eye problems; a slow heartbeat; low levels of potassium or magnesium in your blood; or liver, or kidney disease.
• tell your doctor if you have never had chicken pox and have not received the chicken pox vaccine. Your doctor may order a blood test to see if you have been exposed to chicken pox. You may need to receive the chicken pox vaccine and then wait one month before beginning your treatment with fingolimod.
• tell your doctor if you are pregnant or plan to become pregnant, or are breast-feeding. You should use birth control to prevent pregnancy during your treatment and for 2 months after your treatment. If you become pregnant while taking fingolimod or within 2 months after you stop taking fingolimod, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking fingolimod.
• do not have any vaccinations during your treatment with fingolimod or for 2 months after your treatment without talking to your doctor.

Fingolimod may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• weakness
• back pain
• pain in the hands or feet
• diarrhea
• migraine

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• slow or pounding heartbeat
• chest pain
• rash
• hives
• itching
• swelling of the face, eyes, mouth, throat, tongue, lips, hands, feet, ankles, or lower legs
• difficulty breathing or swallowing
• excessive tiredness
• dizziness
• fainting
• sore throat, body aches, fever, chills, cough, and other signs of infection and for 2 months after your treatment
• headache
• neck stiffness
• confusion
• seizure
• blurriness, shadows, or a blind spot in the center of your vision
• sensitivity to light
• unusual color to your vision
• changes in vision
• skin sores or lesions
• sores that do not heal
• weakness on one side of the body or clumsiness of the arms or legs
• changes in your thinking, memory, or orientation that can cause confusion or personality changes
• shortness of breath
• nausea
• vomiting
• loss of appetite
• stomach pain
• yellowing of the skin or eyes
• dark urine

Fingolimod may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• chest tightness or discomfort

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests and eye exams and will monitor your blood pressure before and during your treatment to be sure that it is safe for you to begin taking or continue to take fingolimod.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking fingolimod.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

GENERIC AVAILABLE: No

Capsules: 0.5 mg.

Fingolimod should be stored at room temperature, 15 C - 30 C (59 F - 86 F).

Fingolimod is part of the drug class:

• Selective immunosuppressants

You should not use fingolimod if you have certain serious heart conditions, especially severe heart failure, "AV block," sick sinus syndrome (unless you have a pacemaker), if you take certain heart rhythm medicines, or if you have recently had a heart attack, stroke, chest pain, or other serious heart problem.

Fingolimod may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have any change in your mental state, decreased vision, weakness on one side of your body, or problems with speech or walking.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Before 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).

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

You may take fingolimod with or without food.

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

To be sure this medication is not causing harmful 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 tests or eye exams.

You should not stop using fingolimod suddenly. Stopping suddenly may make 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 medication in a hospital setting under observation.

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

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include chest tightness.

Administer with or without food.

Applies to fingolimod: oral capsule

General

The most common adverse events were headache, influenza, diarrhea, back pain, liver transaminase elevations, and cough.[Ref]

Cardiovascular

Common (1% to 10%): Hypertension, first degree AV block, bradycardia
Uncommon (0.1% to 1%): Symptomatic bradycardia, second degree AV block
Rare (0.01% to 0.1%): Peripheral arterial occlusive disease
Very rare (less than 0.01%): Hemophagocytic syndrome
Frequency not reported: Heart rate decrease, Mobitz type I (Wenckebach) block, Mobitz type II block
Postmarketing reports: Third degree AV block, AV block with junctional escape, transient asystole, peripheral arterial occlusive disease[Ref]

Hepatic

In the majority of cases, elevations in liver enzymes occurred within 6 to 9 months and returned to normal within approximately 2 months following discontinuation of fingolimod.[Ref]

Very common (10% or more): ALT/AST increased (14%)
Common (1% to 10%): Elevation in liver transaminases, GGT increased, hepatic enzyme increased, liver function test abnormal[Ref]

Immunologic

Infections occurred at a rate similar to placebo.[Ref]

Very common (10% or more): Influenza viral infection (13%), sinusitis (10.9%), infections
Common (1% to 10%): Herpes viral infection, bronchitis, gastroenteritis, tinea infection
Uncommon (0.1% to 1%): Pneumonia
Frequency not reported: Fatal herpetic infection, fatal varicella zoster virus infection[Ref]

Nervous system

Symptoms of posterior reversible encephalopathy syndrome included sudden onset of severe headache, altered mental status, visual disturbances, and seizure.[Ref]

Very common (10% or more): Headache (25%)
Common (1% to 10%): Dizziness, paresthesia, migraine
Rare (less than 0.1%): Posterior reversible encephalopathy syndrome, ischemic and hemorrhagic stroke
Frequency not reported: Neurological atypical disorders
Postmarketing reports: Syncope[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (12%)[Ref]

Hematologic

Common (1% to 10%): Lymphopenia, leukopenia
Uncommon (0.1% to 1%): Neutrophil count decreased[Ref]

Ocular

Macular edema occurred at a dramatically higher rate in patients with a history of uveitis.[Ref]

Common (1% to 10%): Vision blurred, eye pain
Uncommon (0.1% to 1%): Macular edema[Ref]

Respiratory

Very common (10% or more): Cough (10%)
Common (1% to 10%): Dyspnea, reduction in diffusion lung capacity, reduction in FEV1[Ref]

Musculoskeletal

Very common (10% or more): Back pain (12%)[Ref]

Dermatologic

Common (1% to 10%): Alopecia, eczema, pruritus[Ref]

Metabolic

Common (1% to 10%): Weight decreased, blood triglycerides increased[Ref]

Other

Common (1% to 10%): Asthenia
Postmarketing reports: Unexplained death[Ref]

Psychiatric

Common (1% to 10%): Depression
Uncommon (0.1% to 1%): Depressed mood[Ref]

Oncologic

Frequency not reported: Lymphoma[Ref]

Hypersensitivity

Postmarketing reports: Rash, urticaria, angioedema

Some side effects of fingolimod may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Mild to moderate hepatic impairment: No adjustment recommended.
Severe hepatic impairment: Closely monitor patients.