fingolimod

What is the most important information I should know about fingolimod?

Fingolimod can slow your heart rate when you start taking it. You will receive your first dose in a setting where your heart rhythm can be monitored. If you miss 1 or more doses, you may also need to restart fingolimod under medical observation.

What is fingolimod?

Fingolimod is used to treat relapsing multiple sclerosis (MS) in adults and children who are at least 10 years old. This medication will not cure MS, it will only decrease the frequency of relapse symptoms.

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

What should I discuss with my healthcare provider before taking fingolimod?

• severe heart failure (that required you to be in the hospital);
• "AV block" or sick sinus syndrome (unless you have a pacemaker);
• long QT syndrome; or
• recent (within the past 6 months) heart attack, stroke, "mini-stroke" or TIA, chest pain (unstable angina), or other serious heart problem.

Your doctor will check your heart function before you start taking fingolimod.

Some heart rhythm medications can cause unwanted or dangerous effects when used with fingolimod. Your doctor may change your treatment plan if you also use: amiodarone, disopyramide, dofetilide, flecainide, dronedarone, ibutilide, mexiletine, procainamide, propafenone, quinidine, or sotalol.

Before you take fingolimod, tell 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 before taking fingolimod.

Tell your doctor if you have ever had:

• an active or chronic infection;
• a heart rhythm disorder;
• chest pain (angina) or other heart problems;
• a heart attack or stroke, including "mini-stroke";
• high or low blood pressure;
• fainting spells;
• diabetes;
• skin cancer;
• liver disease;
• an eye condition called uveitis; or
• asthma, sleep apnea, or other breathing disorder.

Using fingolimod may increase your risk of developing skin cancer (melanoma). Ask your doctor about skin symptoms to watch for.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of fingolimod on the baby.

How should I take fingolimod?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take fingolimod with or without food.

Always ask your doctor before you stop taking fingolimod for any reason. When you stop taking fingolimod, your MS symptoms may return. In rare cases, some people who stopped taking fingolimod had MS symptoms that were worse than before or during treatment with this medicine.

Fingolimod affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis. Your risk of infection could last up to 2 months after you stop taking this medicine.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while taking fingolimod?

Do not receive a "live" vaccine while using fingolimod, and for 2 months after your last dose. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), or zoster (shingles).

What are the possible side effects of fingolimod?

• shiny nodules on your skin, sores that do not heal, unusual moles that change in color or size;
• blurred vision, eye pain, or a blind spot or shadows in the center of your vision (may occur 3 to 4 months after you start taking fingolimod);
• new or worsened breathing problems;
• sores in your mouth and throat, cold sores, sores on your genital or anal area;
• blood vessel problems in the brain --headache, confusion, change in mental status, sudden vision loss, seizure (convulsions);
• heart problems --chest pain, slow or irregular heartbeats, and feeling dizzy or tired;
• liver problems --nausea, upper stomach pain, tiredness, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes); or
• signs of infection --fever, chills, body aches, tiredness, nausea and vomiting, neck stiffness, increased sensitivity to light.

Common side effects may include:

• headache, back pain;
• stomach pain, diarrhea;
• pain in your arms or legs;
• cough, stuffy nose, flu symptoms; or
• abnormal liver function tests.

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

What other drugs will affect fingolimod?

Tell your doctor about all your other medicines, especially:

• drugs that weaken the immune system such as cancer medicine, steroids, and medicines to prevent organ transplant rejection.

This list is not complete and many other drugs may affect fingolimod. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about fingolimod.