Gilenya

What is Gilenya?

Gilenya, or fingolimod, belongs to the class of drugs called sphingosine-l-phosphate receptor moderators. Fingolimod reduces the activity of immune cells, which may cause nerve damage. Gilenya helps to slow down the progression of disability and prevent episodes of symptoms in adults and children with multiple sclerosis. Gilenya does not cure MS. It will only reduce the frequency of relapses.

Warnings

Do not take Gilenya if you are taking certain heart-rhythm medicines or have had a serious condition within the last 6 months. Fingolimod may slow down your heart rate as soon as you begin taking it. Your first dose will be administered in an environment where your heart rate can be monitored. If you experience chest pain, shortness of breath, slow heartbeats, or feel as if your heart is skipping a beat, tell your doctor. You could get more infections, including serious or deadly infections. Contact your doctor immediately if you experience flu symptoms, night sweats, or neck stiffness. You may be at risk for infection up to 2 months after stopping this medication. While taking Gilenya, you may experience increased sensitivity to the light, blurred or clouded vision, eye pain, or a blind spot in the middle of your vision. You may also notice an unusual color or tint to your vision.

Similar/related drugs

Aubagio, Copaxone, Tecfidera, Avonex, Tysabri, and Rebif

Before you take this drug

Gilenya should not be used if:

• Severe heart failure (requiring hospitalization);
• A serious heart condition, such as "sick-sinus syndrome" or an "AV block" (unless you already have a pacemaker);
• Long QT syndrome;
• Recent (within 6 months) heart attacks, strokes, "mini-strokes" or tias, chest pain (unstable angina), and other serious heart problems

Gilenya can have unwanted or harmful effects on some heart rhythm medications. If you are also taking amiodarone or disopyramide as well as dronedarone, ibutilide, mexiletine, procainamide, propafenone, quinidine, and sotalol, your doctor may need to change your treatment plan. Tell your doctor before taking Gilenya if you've never had chickenpox or if you've received the varicella vaccine (varivax). It may be necessary to wait a month after receiving the varicella vaccine before you can take this medication. Gilenya should only be taken if you have received all your vaccines. Tell your doctor whether you've recently received a vaccination or are scheduled to get one.

Tell your doctor about any of the following to ensure that Gilenya will be safe for you:

• Infection, active or chronic virus.
• Substance abuse or certain medicines can weaken an individual's immunity and compromise it, leaving the immune system compromised and susceptible to illness and infection.
• A heart rhythm disorder.
• Chest pain (angina) or other heart conditions
• A heart attack or stroke (including "mini-strokes");
• High blood pressure
• Fainting;
• Diabetes;
• Skin cancer
• Sleep apnea or other breathing disorders;
• Uveitis is a condition of the eye.
• Liver disease

Fingolimod can harm an unborn child. Gilenya should not be taken if you're pregnant. Inform your doctor immediately if you fall pregnant. You may find your name on a registry for pregnant women to track the effects of the drug on the child. Ask your doctor if you can breastfeed safely while taking this medication.

How to take Gilenya?

Gilenya should be taken exactly as prescribed by your physician. Read and follow all instructions provided on your prescription label. Sometimes your doctor will change the dose. Gilenya may slow down your heart rate as soon as you begin taking it. Your first dose will be administered in a medical environment. You will receive your first Gilenya dose in a medical setting. Before and during taking this medication, you may need to undergo medical tests, including blood tests, tests for your blood pressure and heart function, eye exams, liver tests, and skin tests. Gilenya can be taken with or without food. Only when you're ready to take your medicine should you remove the tablet from the blister with dry hands. Do not wait to take this medication after you have opened the blister pack.Allow the tablet to dissolve without chewing. Do not take this medication again without consulting with your healthcare provider first. You may worsen your condition if you suddenly stop taking Gilenya. Before stopping Gilenya, consult your doctor. You could get serious infections or even fatal ones. Store the container in its original container away from moisture, heat, and humidity. This medication could affect the results of certain medical tests. Inform any doctor that you see about your medication.

Details on dosage

Adult dose for multiple sclerosis:
Orally, 0.5 mg once daily
Comments:
This drug can be taken either with or without food.
See Dosage Adjustments to learn about pre-dose monitoring and testing recommendations.
Use: Relapsing Multiple Sclerosis (MS)
The usual pediatric dose for multiple sclerosis is:
Weight 40 kg or less and 10 years old:
Take 0.25 mg once daily.
Weighing more than 40kg and 10 years old:
Orally, 0.5 mg once daily
Comments:
This drug can be taken either with or without food.
See Dosage Adjustments to learn about pre-dose monitoring and testing recommendations.
Use: Relapsing MS in patients aged 10 and older

What happens if I miss the dose?

For instructions, call your doctor. You may have to take the next dose at a medical facility if you missed one or more doses.

What happens if I overdose?

Call 1-800-222-1222 for poison help or seek immediate medical attention.

What should be avoided?

Fingolimod increases your skin cancer risk. Avoid tanning or sunlight. When you're outdoors, wear protective clothing and use sunblock (SPF 30 or higher). Avoid receiving "live" vaccinations while you are taking Gilenya and for at least two months after the treatment has ended. You may find that the vaccine does not work as effectively while taking Gilenya. You may develop a serious illness if you receive a "live vaccine" while on Gilenya. Live vaccines are measles (MMR), rubella, rotavirus (chickenpox), typhoid (yellow fever), varicella (chickenpox), zoster( shingles), rotavirus (typhoid), yellow fever (yellow fever), varicella, and zoster.

Side effects of Gilenya

If you experience any of the following symptoms of an allergic reaction: difficulty breathing, hives, swelling in your lips, face, throat, or tongue, seek emergency medical attention. Fingolimod can cause a brain infection that may lead to death or disability. If you experience issues in terms of speech, thinking, vision or muscle movements it is essential that they inform their doctor immediately.These symptoms may get worse very quickly.

Even two months after taking this medication, Fingolimod may affect your immune system. You could get more infections, including serious or deadly ones. You should call your doctor if:

• signs that a new infection is present: fever, sweats at night, swollen lymph nodes, cold sores (cough, wheezing), diarrhea, and weight gain.
• problems with balance, eye movements, or speech, or even a prickly sensation;
• Impotence, menstrual changes, swelling of the neck or throat (enlarged thyroid)

Call your doctor immediately if you:

• A new darkened spot on your skin a sore or mole that is not healing; one that has changed color or size; or a bump with a shiny or pearly appearance
• Vision problems, such as blurred vision, a blind spot in the middle of your vision, or a strange color (which may happen 3 to 4 months after starting Gilenya),
• New or worsening breathing problems
• Cold sores or sores around the genital area, mouth, throat, and genital region;
• At least 12 weeks after your last dose, you should notice any new or worsening symptoms.
• Startled by sudden confusion, severe headache, weakness, vision loss or seizure; seizures occur quickly.
• Increased blood pressure. A feeling of lightheadedness that makes one think they might faint.
• Heart issues: chest pains, irregular or slow heartbeats, and feelings of dizziness or fatigue;
• Liver disease: nausea; loss of appetite (upper right); fatigue; itching; dark urine and clay-colored stool; jaundice.

Common Gilenya Side Effects

• Back pain, headache
• Stomach pain, diarrhea;
• You may experience pain in the arms or legs.
• Flu symptoms include a stuffy nose and a cough.
• Abnormal liver function tests

There may be other side effects. For medical advice on side effects, call your doctor. The FDA can be contacted at 1-800-FDA-1088 to report side effects.

Interaction with other drug

ITaken simultaneously, certain medications may affect each other negatively and lead to side effects or decreased effectiveness of treatment. Fingolimod may cause serious heart problems. You may have a higher risk if you are also taking certain other medications for HIV, cancer, malaria, or HIV, as well as medicines to treat infections, high blood pressure, depression, and mental illnesses. Gilenya has a long-lasting effect on your body and your immune system. Tell any doctor you see for 2 months that you took Gilenya.

Inform your doctor of all the medications you are taking. Especially:

• Drugs that suppress the immune system, such as steroids, cancer medicines, and drugs to prevent transplant rejection,
• Ketoconazole;
• Heart medications are available in many different forms.

This list isn't complete, and other drugs can interact with fingolimod. These include prescription and over-the-counter medicines, vitamins, and herbal products; this list does not encompass every possible drug interaction.