fingolimod 0.25 mg capsule

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Medication name

Generic name:
Fingolimod - oral

Pronunciation
(fin-GOL-i-mod)

Brand name(s)
Gilenya

Uses

This medication is used to treat a certain type of multiple sclerosis (relapsing 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.

How to use

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.

Before starting fingolimod, your doctor will do medical/laboratory tests (such as complete blood count, blood pressure, EKG, pulse, eye exam) to monitor for side effects. Take this medication by mouth with or without food as directed by your doctor, usually once a day. You will be monitored for at least 6 hours after the first dose to make sure your heartbeat does not go too slow. A very slow heartbeat increases the risk for a serious heart rhythm problem (QT prolongation in the EKG). Tell your doctor if you have low levels of magnesium/potassium in the blood, personal or family history of QT prolongation in the EKG, family history of sudden cardiac death, or heart failure. Also tell your doctor if you are taking other drugs that can slow down your heartbeat or affect heart rhythm (such as causing QT prolongation in the EKG). See also Drug Interactions section.

A small number of people using this drug have had MS symptoms become much worse - or become permanently disabled - after stopping fingolimod. Therefore, do not stop using fingolimod without talking to your doctor first. If your doctor temporarily stops your fingolimod, you may need to be heartbeat-monitored again for at least 6 hours after you restart this medication. Children who have their dosage increased may also need to be monitored again for 6 hours. Ask your doctor for details.

The dosage is based on your age and weight. Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and the risk of serious side effects may be increased.

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 does not improve or if it worsens.

Side effects

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

Remember that your doctor has prescribed this medication because he or she 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.

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 an infection such as persistent cough/sore throat, difficulty breathing, fever/chills, cold/flu symptoms, sores, or blisters. Do not start fingolimod if you already have an infection.

Fingolimod may increase the risk of a rare (possibly fatal) brain infection (progressive multifocal leukoencephalopathy-PML). This may sometimes occur even after treatment has stopped. Symptoms of PML can seem like a worsening MS attack. Tell your doctor right away if you have any new or worsening symptoms that have lasted for several days, such as clumsiness or problems with strength, balance, speech, eyesight, or thinking.

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

  • shortness of breath
  • chest pain
  • severe dizziness/fainting
  • slow/irregular/pounding/fast heartbeat
  • unusual tiredness/weakness
  • eye pain/sensitivity to light
  • vision changes (such as blurred vision, blind spot/shadows in the center of your vision, color changes)
  • mental changes (such as sudden confusion)
  • seizure
  • sudden/severe headache

This medication may rarely cause serious liver problems. Tell your doctor right away if you experience:

  • nausea/vomiting that doesn't stop
  • loss of appetite
  • stomach/abdominal pain
  • yellowing eyes/skin
  • dark urine

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.

Precautions

See also How to Use section.

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:

  • 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)
  • heart problems (such as slow/irregular heartbeat, heart failure, previous heart attack, chest pain, QT prolongation in the EKG)
  • high blood pressure
  • liver disease
  • stroke or "mini-stroke"/transient ischemic attack (TIA)

Have all necessary immunizations done before starting this medication. Do not have immunizations/vaccinations while you are taking fingolimod and for 2 months after your last dose without the consent of your doctor. Also, avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose and people who have infections that may spread to others (such as chickenpox, flu). Wash your hands well to prevent the spread of infections.

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 taking fingolimod. Fingolimod may harm an unborn baby. Ask about reliable forms of birth control while taking this medication and for 2 months after stopping treatment. 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. Therefore, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Drug interactions

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:

  • ketoconazole
  • 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)
Overdose

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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count, blood pressure, pulse, EKG, MRI, eye exams, liver function tests, lung/breathing tests, exams to check for skin cancer) may 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.

Missed dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

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.

Important note

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.

Information last revised August 2019.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.