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.
You should not use fingolimod if you are allergic to it, or if you have certain 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);
- 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 very slow heart rate;
- high or low blood pressure;
- heart problems, a heart attack, a stroke, or chest pain;
- fainting spells;
- liver or kidney 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.
Fingolimod may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using fingolimod, and for at least 2 months after your last dose. Tell your doctor if you become pregnant during this time.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of fingolimod on the baby.
You should not breast-feed while using fingolimod.
Fingolimod can slow your heart rate when you start taking it. You will receive your first dose in a medical setting. Your blood pressure and heart rate will be constantly monitored for at least 6 hours after your first dose of 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.
If you stop taking fingolimod, do not start taking it again without asking your doctor. You will need to be under medical observation when you restart this medication.
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.
If you stop taking fingolimod, watch for signs of worsening MS for at least 12 weeks after your last dose. Call your doctor right away if any new or worsening symptoms appear.
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.
Store fingolimod in the original package at room temperature away from moisture and heat.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Fingolimod may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.
Also call your doctor at once if you have:
- chest pain, slow or irregular heartbeats, dizziness, tiredness;
- shiny nodules on your skin, sores that do not heal, unusual moles that change in color or size;
- fever, chills, body aches, tiredness, nausea and vomiting, neck stiffness, increased sensitivity to light;
- sores in your mouth and throat, cold sores, sores on your genital or anal area;
- vision problems, blurred vision, eye pain, 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);
- headache, confusion, change in mental status, vision loss, seizure (convulsions);
- shortness of breath; or
- liver problems–nausea, upper stomach pain, tiredness, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes).
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.