Generic Name: Fingolimod (fin GOL i mod)
Brand Name: Gilenya
Uses of Gilenya:
- It is used to lower the number of setbacks with MS (multiple sclerosis).
What do I need to tell my doctor BEFORE I take Gilenya?
- If you have an allergy to fingolimod or any other part of Gilenya (fingolimod).
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you have had any of these health problems in the last 6 months: Chest pain (angina), heart attack, heart failure, mini-stroke or TIA, or stroke.
- If you have any of these health problems: Certain types of abnormal heartbeats (heart block, sick sinus syndrome) without a working pacemaker.
- If you have a long QT on ECG.
- If you are taking any drugs used for a heartbeat that is not normal.
- If you are breast-feeding or plan to breast-feed.
This is not a list of all drugs or health problems that interact with this medicine.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Gilenya with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take Gilenya?
- Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
- Avoid driving and doing other tasks or actions that call for you to be alert until you see how Gilenya affects you.
- Check blood pressure and heart rate as the doctor has told you. Talk with the doctor.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- Have an eye exam as you have been told by your doctor.
- Slow heartbeat and a heartbeat that does not feel normal may happen when first starting this medicine. Most of the time, this happens within 6 hours of your first dose. Sometimes, this can happen up to 24 hours after your first dose. Call your doctor right away if you have dizziness, slow heartbeat or a heartbeat that does not feel normal, or tiredness.
- You will need an ECG before starting Gilenya and during treatment. Talk with your doctor.
- This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
- You may have more chance of getting an infection while you take Gilenya and for 2 months after you stop it. Wash hands often. Stay away from people with infections, colds, or flu.
- Very bad and sometimes deadly infections have happened in patients who take this medicine. If you have any infection, are taking antibiotics now or in the recent past, or have had many infections, talk with your doctor.
- If you have not had chickenpox or a chickenpox vaccine, talk with your doctor.
- Talk with your doctor before getting any vaccines while you take Gilenya and for 2 months after you stop it. Use with this medicine may either raise the chance of an infection or make the vaccine not work as well.
- This medicine may raise the chance of getting cancer like lymphoma or skin cancer. Talk with the doctor.
- This medicine may cause harm to the unborn baby if you take it while you are pregnant.
- Use birth control that you can trust during care and for 2 months after care ends.
- If you get pregnant while taking Gilenya or within 2 months after your last dose, call your doctor right away.
How is this medicine (Gilenya) best taken?
Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- The first dose is given in a doctor's office. You will be watched for at least 6 hours after the first dose.
- Take with or without food.
- To gain the most benefit, do not miss doses.
- Keep taking Gilenya (fingolimod) as you have been told by your doctor or other health care provider, even if you feel well.
- Do not stop taking this medicine without calling the doctor who ordered it for you.
What do I do if I miss a dose?
- Call your doctor to find out what to do.
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
- Signs of meningitis like headache with fever, stiff neck, upset stomach, confusion, or if lights bother your eyes.
- Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- Chest pain or pressure or passing out.
- Shortness of breath.
- Trouble breathing that is new or worse.
- Change in eyesight, eye pain, or very bad eye irritation.
- A burning, numbness, or tingling feeling that is not normal.
- Change in color or size of a mole.
- A skin lump or growth.
- Skin wound that will not heal.
- A big weight loss.
- Night sweats.
- Swollen gland.
- A very bad and sometimes deadly brain problem called posterior reversible encephalopathy syndrome (PRES) has happened with Gilenya. Call your doctor right away if you have signs like feeling confused, lowered alertness, change in eyesight, loss of eyesight, seizures, or very bad headache.
- A very bad brain problem called progressive multifocal leukoencephalopathy (PML) has happened with this medicine. It may cause disability or can be deadly. Tell your doctor right away if you have signs like confusion, memory problems, low mood (depression), change in the way you act, change in strength on 1 side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight.
What are some other side effects of Gilenya?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Flu-like signs.
- Loose stools (diarrhea).
- Back pain.
- Pain in arms or legs.
- Belly pain.
- Sinus pain.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How do I store and/or throw out Gilenya?
- Store in the original container at room temperature.
- Store in a dry place. Do not store in a bathroom.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
Consumer Information Use and Disclaimer
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else's drugs.
- Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
- Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
- This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Gilenya is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
This information should not be used to decide whether or not to take Gilenya or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Gilenya. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
Review Date: November 1, 2017
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- Drug class: selective immunosuppressants