If you have a certain type of multiple sclerosis (MS), your doctor might suggest Gilenya (fingolimod) as a treatment option for you.
Gilenya is a prescription medication that’s used to treat the following conditions in adults and some children:
- relapsing-remitting MS (RRMS)
- active secondary progressive MS (SPMS)
- clinically isolated syndrome (CIS), which may develop into MS
Gilenya belongs to a group of drugs called sphingosine 1-phosphate receptor modulators.
This article describes the dosages of Gilenya, as well as its strengths and how to take the drug. To learn more about Gilenya, see this in-depth article.
Note: This article covers Gilenya’s typical dosages, which are provided by the drug’s manufacturer. But when taking Gilenya, always take the dosage that your doctor prescribes.
In this section, you’ll find common dosage information for Gilenya. This includes dosing instructions and what your doctor will watch for when you first take the drug. Before you start Gilenya treatment, your doctor will go over a dosing schedule specific to your condition.
What is Gilenya’s form?
Gilenya comes as capsules that you take by mouth.
What strengths does Gilenya come in?
Gilenya comes in the following strengths:
- 0.25 milligrams (mg)
- 0.5 mg
What are the typical dosages of Gilenya?
Typically, your Gilenya dosage will depend on your age and weight. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.
The information below describes dosages that are commonly used or recommended. But be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.
Dosage for relapsing-remitting MS or active secondary progressive MS
For adults who weigh over 40 kilograms (kg),* the recommended dosage of Gilenya for RRMS or active SPMS is 0.5 mg once daily.
* A weight of 40 kg is equal to about 88 lbs. For the dosage for people who weigh less than this, see the chart in “What’s the dosage of Gilenya for children?” below.
Dosage for clinically isolated syndrome
For adults who weigh over 40 kg,* the recommended dosage of Gilenya for CIS is 0.5 mg once daily.
* A weight of 40 kg is equal to about 88 lbs. For the dosage for people who weigh less than this, see the chart in “What’s the dosage of Gilenya for children?” below.
What’s the dosage of Gilenya for children?
Gilenya is used to treat RRMS, active SPMS, and CIS in children ages 10 years and older. The dosage of Gilenya for children varies based on their weight:
| Weight | Gilenya dosage |
| 40 kg or less* | 0.25 mg once daily |
| more than 40 kg | 0.5 mg once daily |
* A weight of 40 kg is equal to about 88 lbs. Note that this dosage also applies to adults who weigh 40 kg or less.
What is first-dose observation, and why does Gilenya require it?
After you take your first dose of Gilenya, your doctor will monitor you closely, usually in a hospital or their office. This is called first-dose observation.
When you start taking Gilenya, it may temporarily lower your heart rate to unsafe levels. You’re more likely to experience this within 6 hours after taking the first dose of Gilenya. As a result, your doctor will check your heart rate and rhythm before and for at least 6 hours after your first dose.
In some situations, a healthcare professional may be able to monitor you at home.
Your doctor will need to repeat this monitoring if you miss a dose of Gilenya or stop taking it for more than 14 days. In addition, children will need monitoring after any dose increase.
The following section describes what happens during first-dose observation. For details about this part of Gilenya treatment, talk with your doctor.
Protocol for Gilenya first-dose observation
The protocol for first-dose observation typically follows these steps:
- Before you take your first dose of Gilenya, you’ll have an electrocardiogram (ECG).
- If there are no problems with your heart rate or rhythm, you’ll take your first dose of Gilenya.
- Your doctor will check your blood pressure and pulse every hour for 6 hours after your first dose.
- After 6 hours, you’ll have another ECG.
- Depending on the results of your ECG and blood pressure and pulse checks, your doctor will decide if it’s safe for you to continue taking Gilenya.
If your heart rate is too low or your heart rhythm isn’t regular after 6 hours, your doctor will continue to monitor you. You may need to stay in a hospital overnight or take medication to bring your heart rate back up.
If you’re monitored at home, you may need to go to an emergency room if your heart rate is too low after 10 hours.
Is Gilenya used long term?
Yes, Gilenya is typically used as a long-term treatment. If you and your doctor determine that Gilenya is safe and effective for you, you’ll likely take it long term.
If you miss a dose of Gilenya, let your doctor know right away. You may need to have an ECG to check your heart rate and rhythm before taking your next dose. And when you take the dose, your doctor may monitor you the same way they did after your first dose of the drug. For details, see “What is first-dose observation, and why does Gilenya require it?” above.
If you need help remembering to take your dose of Gilenya on time, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.
The dosage of Gilenya you’re prescribed may depend on several factors. These include:
- your age
- your weight
You’ll take Gilenya capsules once daily with or without food.
You’ll likely take your first dose at a hospital or your doctor’s office. This is because Gilenya may temporarily lower your heart rate to unsafe levels after your first dose. (For details, see “What is first-dose observation, and why does Gilenya require it?” above.) This side effect can also occur after missing a dose, so it’s important that you take Gilenya each day.
If you have trouble swallowing capsules, see this article for tips on how to take this form of medication.
For information on Gilenya expiration, storage, and disposal, see this article.
Do not take more Gilenya than your doctor prescribes. Taking more than this can lead to serious side effects. Call your doctor right away or go to your nearest emergency room if you think you’ve taken too much Gilenya.
Symptoms of overdose
Taking too much Gilenya may cause your heart rate to slow down too much.
If your heart is beating too slowly, you may have symptoms such as:
- chest pain
- confusion
- dizziness
- fainting
- feeling like your heart is skipping beats
- shortness of breath
- tiredness
What to do in case you take too much Gilenya
Call your doctor right away or go to your nearest emergency room if you think you’ve taken too much Gilenya. You can also call 800-222-1222 to reach the American Association of Poison Control Centers or use its online resource. But if you have severe symptoms, call 911 (or your local emergency number) immediately or go to the nearest emergency room.
Gilenya does not cause withdrawal symptoms or dependence. But if you stop taking this medication, your MS symptoms may worsen.
If you and your doctor decide that you need to stop taking Gilenya, they’ll monitor your MS symptoms. You may need to start taking medication again to manage any symptoms you develop.
The sections above describe the typical dosages provided by the drug manufacturer. If your doctor recommends Gilenya for you, they’ll prescribe the dosage that’s right for you.
Remember, you should not change your dosage of Gilenya without your doctor’s recommendation. Only take Gilenya exactly as prescribed. Talk with your doctor if you have questions or concerns about your current dosage.
Here are some examples of questions you may want to ask your doctor:
- Will I need to stay in the hospital overnight after taking my first dose of Gilenya?
- Do I need to take Gilenya at the same time each day?
- Will my teen’s dosage need to change if they lose weight?
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Q:
Will my Gilenya dosage need to change if I have liver problems?
AnonymousA:
It’s possible for Gilenya to cause liver injury. It may also worsen it in people who already have liver problems before starting treatment. Liver injury wasn’t found in studies, but it was reported after the drug became available to the public. Liver injury was seen as early as 10 days after the first dose of Gilenya. It has also been reported with long-term Gilenya treatment.
Within 6 months of starting Gilenya treatment, your doctor will check your liver enzymes and total bilirubin levels. They’ll continue to do this regularly throughout treatment and for up to 2 months after you stop taking Gilenya.
If you have severe liver problems, let your doctor know. In this case, the level of Gilenya in your body may double, which may increase your risk of side effects. Your doctor may need to monitor you more closely.
If you have any signs of liver damage, such as loss of appetite, dark urine, or jaundice (yellowing of the whites of your eyes or skin), let your doctor know right away. They’ll test your liver function.
Depending on the results, your doctor will have you hold off taking Gilenya until they know whether the drug caused injury to your liver. If Gilenya was the cause of your symptoms or the changes in your liver function test results, your doctor will have you stop Gilenya treatment permanently.
Melissa Badowski, PharmD, MPH, FCCPAnswers represent the opinions of our medical experts. All content is strictly informational and should not be considered medical advice.Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
