fingolimod 0.25 mg capsule

Generic name:
Fingolimod - oral

Pronunciation
(fin-GOL-i-mod)

Brand name(s)
Gilenya

This medication is used to treat multiple sclerosis-MS. It is not a cure for MS but it is thought to help by preventing immune system cells (lymphocytes) from attacking the nerves in your brain and spinal cord. It helps decrease the number of episodes of worsening and may prevent or delay disability.

Read the Medication Guide provided by your pharmacist before you start taking fingolimod and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once a day. The dosage is based on your age and weight.

Do not stop taking this medication without consulting your doctor. Your condition may become worse when this drug is stopped. Tell your doctor right away if your MS symptoms are much worse after stopping fingolimod.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Tell your doctor if your condition gets worse.

Cough, headache, back pain, or diarrhea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Slow heartbeat may also occur, especially when you first start this medication. You will be monitored for at least 6 hours after the first dose to make sure your heartbeat does not go too slow. You may also need to be monitored if you restart this medication or after a dosage increase (in children). Ask your doctor for more details.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including:

• signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine)
• shortness of breath
• unusual tiredness

Fingolimod may increase the risk of skin cancer and lymphoma. Tell your doctor right away if you notice any new or changing skin growths/moles, or swollen lymph nodes.

This medication can weaken your immune system/increase the risk of infection while you are taking it and for 2 months after your last dose. You may be more likely to get a serious (possibly fatal) infection (such as bronchitis, pneumonia, herpes). Tell your doctor right away if you develop any signs of infection (such as cough/sore throat that doesn't go away, fever/chills, cold/flu symptoms, sores, or blisters). Do not start fingolimod if you already have an infection.

This medication may increase your risk of getting a rare but very serious (possibly fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Symptoms of PML can seem like a worsening MS attack. Get medical help right away if you have any of these side effects:

• clumsiness
• loss of coordination/balance
• weakness
• sudden change in your thinking (such as confusion, difficulty concentrating, memory loss)
• difficulty talking/walking
• seizure

Get medical help right away if you have any very serious side effects, including:

• very slow heartbeat
• fast/irregular heartbeat
• severe dizziness
• fainting
• chest pain
• eye pain/sensitivity to light
• vision changes (such as blurred vision, blind spot/shadows in the center of your vision, color changes)
• sudden/severe headache

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking fingolimod, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• heart problems (such as slow/irregular heartbeat, heart failure, previous heart attack, chest pain, QT prolongation in the EKG)
• family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death)
• low levels of magnesium/potassium in the blood
• stroke/mini-stroke
• high blood pressure
• breathing problems (such as asthma, bronchitis, emphysema, sleep apnea)
• current/recent/returning infection (including hepatitis and tuberculosis)
• diabetes
• fainting
• certain eye problems (macular edema, uveitis)
• liver disease

Fingolimod can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your doctor your vaccine history and ask if you need to get any vaccines before starting treatment with this medication. Tell your health care professional that you are using fingolimod before having any immunizations/vaccinations. Avoid getting a live vaccine for 2 months after the last dose of this medication. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

This medication may increase your risk of developing skin cancer. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Your doctor may direct you to avoid phototherapy while you use this product. Ask your doctor for details.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using fingolimod. Fingolimod may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication and for 2 months after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some of the products that may interact with this drug include:

• drugs that slow down your heartbeat (including digoxin, beta-blockers such as atenolol/metoprolol, calcium channel blockers such as diltiazem/verapamil)
• certain drugs for irregular heartbeat (including amiodarone, disopyramide, dofetilide, dronedarone, ibutilide, procainamide, quinidine, sotalol)
• other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab)

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count, blood pressure, pulse, EKG, MRI, eye/skin exams, liver/lung function, Pap smear) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

It is very important to follow your treatment regimen exactly. Ask your doctor ahead of time what you should do if you miss a dose of fingolimod. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.