Fingolimod

Pediatric Medication

Brand Names: US

Gilenya

Brand Names: Canada

Gilenya

What is this drug used for?

  • It is used to treat MS (multiple sclerosis).

What do I need to tell the doctor BEFORE my child takes this drug?

  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child has ever had any of these health problems: Certain types of abnormal heartbeats (heart block, sick sinus syndrome, long QT on ECG), chest pain (angina), heart attack, heart failure, mini-stroke or TIA, or stroke.
  • If your child has had the varicella vaccine in the past month.
  • If your child is taking any drugs used for a heartbeat that is not normal.
This is not a list of all drugs or health problems that interact with this drug.
Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.

What are some things I need to know or do while my child takes this drug?

  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
  • Have your child’s blood pressure and heart rate checked often. Talk with your child’s doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Have your child get an eye exam as you have been told by the doctor.
  • Slow heartbeat and an abnormal heartbeat may happen when first starting this drug. Most of the time, this happens within 6 hours of the first dose. Sometimes, this can happen up to 24 hours after the first dose. Call your child’s doctor right away if your child has dizziness, slow heartbeat, a heartbeat that does not feel normal, or tiredness.
  • Your child will need an ECG before starting this drug and during treatment. Talk with the doctor.
  • This drug may affect certain lab tests. Tell all of your child’s health care providers and lab workers that your child takes this drug.
  • Your child may have more chance of getting an infection while taking this drug and for 2 months after stopping it. Have your child wash hands often. Have your child stay away from people with infections, colds, or flu.
  • Very bad and sometimes deadly infections have happened in patients who take this drug. If your child has any infection, is taking antibiotics now or in the recent past, or has had many infections, talk with the doctor.
  • Make sure your child is up to date with all vaccines before treatment with this drug.
  • If your child has not had chickenpox or a chickenpox vaccine, talk with your child’s doctor.
  • Talk with your child’s doctor before your child gets any vaccines while taking this drug and for 2 months after your child stops taking it. Vaccine use with this drug may either raise the chance of an infection or make the vaccine not work as well.
  • The chance of skin cancer may be raised. Have your child avoid lots of sun, sunlamps, and tanning beds. Use sunscreen and dress your child in clothing and eyewear that protects your child from the sun.
  • Have your child’s skin checked. Tell your child’s doctor if your child has any skin changes like a new wart, skin sore or reddish bump that bleeds or does not heal, or a change in the color or size of a mole.
  • A very bad and sometimes deadly brain problem called posterior reversible encephalopathy syndrome (PRES) has happened with this drug. Talk with the doctor.

If your child is or may be sexually active:

  • Have your child use birth control to prevent pregnancy while taking this drug and for 2 months after stopping this drug.

If your child is pregnant:

  • This drug may cause harm to the unborn baby if your child takes it during pregnancy.
  • If your child gets pregnant while taking this drug or within 2 months after her last dose, call the doctor right away.

If your child is breast-feeding a baby:

  • Tell the doctor if your child is breast-feeding a baby. You will need to talk about any risks to the baby.

What are some side effects that I need to call my child’s 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 child’s doctor or get medical help right away if your child has 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, swallowing, 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.
  • Signs of high or low blood pressure like very bad headache or dizziness, passing out, change in eyesight.
  • Chest pain or pressure.
  • Shortness of breath.
  • Trouble breathing that is new or worse.
  • Change in eyesight, eye pain, or very bad eye irritation.
  • Loss of eyesight.
  • Feeling confused.
  • Feeling less alert.
  • Seizures.
  • Very bad headache.
  • A very bad brain problem called progressive multifocal leukoencephalopathy (PML) may happen with this drug. It may cause disability or death. Tell the doctor right away if your child has signs like confusion, memory problems, low mood (depression), change in the way your child acts, 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 this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Headache.
  • Flu-like signs.
  • Loose stools (diarrhea).
  • Back pain.
  • Pain in arms or legs.
  • Stomach pain.
  • Sinus pain.
These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
You may report side effects to your national health agency.

How is this drug best given?

Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • The first dose is given in a doctor’s office or hospital. This will also be done if the dose is raised, or if your child is starting this drug again after stopping it for some time. Your child will be watched for at least 6 hours after the first dose of this drug. Some people may need to be watched overnight. Before starting this drug, tell your child’s doctor about all of your child’s other drugs and health problems.
  • Give this drug with or without food.
  • To gain the most benefit, do not miss giving your child doses.
  • Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
  • Do not stop giving this drug without calling the doctor who ordered it for your child.

What do I do if my child misses a dose?

  • Call your child’s doctor to find out what to do.

How do I store and/or throw out this drug?

  • 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.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

General drug facts

  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, 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.

Consumer Information Use and Disclaimer

This information should not be used to decide whether or not to take this medicine 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 this medicine. 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.

Last Reviewed Date

2018-05-22

Copyright

© 2018 Wolters Kluwer Clinical Drug Information, Inc. and its affiliates and/or licensors. All rights reserved.

Last Updated