Gilenya (fingolimod) is a brand-name prescription medication. The Food and Drug Administration (FDA) has approved it to treat relapsing forms of multiple sclerosis in adults and children ages 10 years and older.
Gilenya contains the active ingredient fingolimod. Gilenya belongs to a drug class called disease-modifying therapies. It’s not currently available in a generic version in the United States.
Gilenya comes as a capsule that you swallow.
For information about the dosages of Gilenya, including its strengths and how to take the drug, keep reading. For a comprehensive look at Gilenya, see this article.
This article describes typical dosages for Gilenya provided by the drug’s manufacturer. When taking Gilenya, always follow the dosage prescribed by your doctor.
This section describes the typical dosages of Gilenya.
Gilenya comes as an oral capsule.
Gilenya comes in two strengths: 0.25 milligrams (mg) and 0.5 mg.
The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.
Dosage for multiple sclerosis
For details about what to expect with your first dose, including monitoring and protocol, see “Frequently asked questions” below.
In adults and children ages 10 years and older who weigh more than 40 kg* (about 88 lb), the recommended dose of Gilenya is 0.5 mg. Gilenya should be taken by mouth once per day with or without food.
* 1 kilogram (kg) is about 2.2 pounds (lb).
Gilenya is FDA-approved to treat children ages 10 years and older who have relapsing forms of multiple sclerosis.
The recommended dose of Gilenya for children who weigh 40 kg* (about 88 lb) or less is 0.25 mg by mouth once per day.
Children ages 10 years and older who weigh more than 40 kg (about 88 lb) will likely take 0.5 mg of Gilenya by mouth once per day.
Children can take Gilenya with or without food.
* 1 kg is about 2.2 pounds (lb).
Gilenya is meant to be 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.
The Gilenya dosage your doctor prescribes will depend on several factors. These include:
- the type and severity of the condition you’re using Gilenya to treat
- your weight
- your age
Other medical conditions you have can also affect your Gilenya dosage.
If you miss a dose of Gilenya, do not take the missed dose. Call your doctor right away to schedule an appointment. They may need to monitor you when you take the missed dose. Gilenya can cause serious heart problems, so it’s best to call your doctor if you miss a dose of Gilenya.
To help make sure you don’t miss a dose, 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.
This section answers frequently asked questions about Gilenya dosage.
What will I experience before and during my first dose of Gilenya?
Before you start taking Gilenya, your doctor will complete the Gilenya first dose protocol. For the first dose protocol, your doctor will closely monitor you after your first dose of Gilenya. This is to make sure you don’t have a reaction to the drug. Your doctor will do the following before you start Gilenya:
- perform a heart evaluation if you have certain conditions
- take a blood sample
- ask what other medications you take
- test you for antibodies to varicella zoster virus. If you don’t have antibodies, you will likely be vaccinated before starting Gilenya.
Starting treatment with Gilenya will likely decrease your heart rate. For this reason, your doctor will perform first-dose monitoring when you take your first dose of Gilenya.
Before taking your first dose of Gilenya and at the end of the observation period, you will have an electrocardiogram (EKG).
Your doctor will continue to monitor you for the first 6 hours after taking your dose of Gilenya. You may need to be monitored longer if your heart rate is not in the correct range or if you have certain conditions. Some people may need to be monitored overnight with their first dose of Gilenya.
Talk with your doctor about instances where you may need to be monitored longer than 6 hours.
Will my Gilenya dosage ever be greater than 0.5 mg daily?
It’s not likely. There has been no benefit shown for taking more than 0.5 mg of Gilenya per day. However, there have been reports of added side effects if you take more than 0.5 mg of Gilenya per day. Your doctor is not likely to recommend you take more than 0.5 mg of Gilenya per day.
Read the “Gilenya and overdose” section below for what to do if you take more Gilenya than your doctor prescribes.
Your Gilenya dosage and administration will depend on your weight and whether it’s your first dose.
As monitoring is required with your first dose of Gilenya, you will likely take the first dose in a healthcare setting. After your first dose, you can take Gilenya at home.
Gilenya comes as a capsule that you take by mouth once per day. It’s best to swallow the capsule whole.
If you have trouble swallowing capsules, see this article for tips on how to take this form of medication. You can also talk with your doctor or pharmacist.
Accessible drug labels and containers
If you’re having trouble reading your prescription label, talk with your doctor or pharmacist. Some pharmacies offer labels with large print, braille, or a code you scan with a smartphone to convert text to speech. If your local pharmacy doesn’t have these options, your doctor or pharmacist might be able to recommend a pharmacy that does.
If you’re having trouble opening medication bottles, ask your pharmacist about putting Gilenya in an easy-open container. They may also recommend tools that can make it easier to open bottles.
If you take more Gilenya than your doctor prescribes, you may develop serious side effects.
It’s important that you do not take more Gilenya than your doctor advises. If you take more Gilenya than advised, you will need to be observed overnight with continuous electrocardiogram (EKG) monitoring. Your doctor or healthcare professional will also monitor your blood pressure closely.
Symptoms of an overdose
Overdose symptoms of Gilenya can include:
- slow heart rate
- symptoms of heart block, including dizziness, fainting, tiredness, and shortness of breath
If you take more than the recommended amount of Gilenya
Call your doctor right away if you believe you’ve taken too much Gilenya. Another option is to call the American Association of Poison Control Centers at 800-222-1222 or use its online tool. If you have severe symptoms, immediately call 911 or your local emergency number, or go to the nearest emergency room.
The dosages in this article are typical dosages provided by the drug’s manufacturer. If your doctor recommends Gilenya for you, they will prescribe the dosage that’s right for you. Always follow the dosage that your doctor prescribes for you.
As with any drug, never change your dosage of Gilenya without your doctor’s recommendation. If you have questions about the dosage of Gilenya that’s right for you, talk with your doctor.
Besides learning about dosage, you may want other information about Gilenya. These additional articles might be helpful:
- More details. For details about other aspects of Gilenya, refer to this article.
- Drug comparison. See how Gilenya compares with Tecfidera.
- Information about multiple sclerosis (MS). For more information on MS, see our MS hub and this list of related articles, as well as this article about Gilenya for MS.
Disclaimer: Medical News Today 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.