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. Tell your doctor if you have slow heartbeats, chest pain, shortness of breath, or feel like your heart is skipping beats.

You may have increased sensitivity to light, blurred vision, eye pain, or have a blind spot or shadows in the center of your vision, unusual color to your vision, or other vision problems while you are taking fingolimod, which may occur 3 to 4 months after your first dose.

What is fingolimod?

Fingolimod is used in adults and children at least 10 years old to treat relapsing forms of multiple sclerosis (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease).

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);
• a serious heart condition such as "sick sinus syndrome" or "AV block" (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.

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 received a varicella vaccine (Varivax). You may need to receive the vaccine and then wait 1 month before taking fingolimod.

Make sure you are current on all vaccines before you start taking fingolimod.

Tell your doctor if you have recently received a vaccine, or if you are scheduled to receive a vaccine.

Tell your doctor if you have ever had:

• fever or an active or chronic infection;
• a weak immune system (caused by disease or by using certain medicine);
• a heart rhythm disorder;
• chest pain (angina) or other heart problems;
• a heart attack or stroke, including "mini-stroke";
• high blood pressure;
• fainting;
• diabetes;
• skin cancer;
• sleep apnea, or other breathing disorder;
• an eye condition called uveitis; or
• liver disease.

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. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may need medical tests before and while taking fingolimod including blood tests, tests to check your heart function, blood pressure, vision exams, liver function tests and skin exams.

Take fingolimod once per day with or without food.

Remove an orally disintegrating tablet from the blister pack with dry hands only when you are ready to take the medicine. Take this medicine immediately after opening the blister pack. Allow the orally disintegrating tablet to dissolve in your mouth without chewing.

If you stop taking this medicine, do not start it again without your doctor's advice.

Your condition may get worse if you stop taking fingolimod suddenly. Ask your doctor before stopping the medicine.

You may get infections more easily, even serious or fatal infections.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are taking fingolimod.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while taking fingolimod?

Avoid receiving a "live" vaccine while taking fingolimod, and for at least 2 months after your treatment ends. The vaccine may not work as well while you are taking fingolimod. Receiving a "live" vaccine while taking fingolimod may cause you to develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

What are the possible side effects of fingolimod?

Fingolimod can affect your immune system (even 2 months after you've taken this medicine). You may get infections more easily, even serious or fatal infections. Call your doctor if you have:

• signs of a new infection --fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

• new darkened area on your skin, a sore that does not heal, a mole that has changed in size or color, a bump that looks shiny, pearly, or pink;
• vision problems such as increased sensitivity to light, blurred vision, having a blind spot or shadows in the center of your vision, or unusual color to 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;
• new or worsening symptoms of multiple sclerosis at least 12 weeks after your last dose;
• sudden confusion, severe headache, weakness, vision loss, or seizure;
• increased blood pressure;
• a light-headed feeling, like you might pass out;
• heart problems --chest pain, slow or irregular heartbeats, and feeling dizzy or tired; or
• liver problems --nausea, loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, 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.

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?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Fingolimod can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Tell your doctor about all your current medicines. Many drugs can affect fingolimod, especially:

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

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 doctor or pharmacist can provide more information about fingolimod.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every 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 outside 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 should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid 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.

Copyright 1996-2023 Cerner Multum, Inc. Version: 8.02. Revision date: 6/22/2023.