Gilenya – Information, Uses, Side Effects and Dosage


Drug trade Name: Gilenya

Category: Immunomodulator for treating Multiple Sclerosis

Generic Name: fingolimod hydrochloride

Introduction and Quick Information:


Gilenya belongs to a group of drugs called as sphingosine 1-phosphate receptor modulators used for the treatment of multiple sclerosis.  Multiple sclerosis is a disease in which nerves do not work properly and people experience loss of muscle coordination, weakness, numbness and problems with speech, bladder control and vision. Gilenya acts by decreasing the action of immune cells that are responsible for nerve damage and further casuing health discomforts.

Is Gilenya Approved by U.S. FDA?

United States food and drug administration  approved Gilenya on September 21, 2010, for the treatment of multiple sclerosis. You may visit FDA’s official website for further  FDA approval status of Gilenya.

Usage and Benefits of Gilenya:

Gilenya is a prescription medication approved to treat multiple sclerosis.  Specifically, Gilenya is prescribed to prevent relapse and to rectify the physical inability caused by multiple sclerosis.

Multiple sclerosis is a medical condition where nerves do not work properly that further causes several health conditions such as loss of muscle coordination, numbness, problems in bladder control,  muscle stiffness (medically known as spasticity), dizziness, tingling, loss of balance, memory loss, depression, fatigue etc.

Multiple sclerosis has four basic patterns or types which are caused by different body condition. Gilenya is prescribed and approved to treat all four types of multiple sclerosis. However, it is still unknown how exactly Gilenya acts to treat symptoms of multiple sclerosis.  Gilenya is not approved to be used in children to treat symptoms of multiple sclerosis. This medicine cannot be prescribed for people younger than 18 years. This medicine may have some off-label uses which are not listed in this medication guide.

Gilenya Side Effects:

Gilenya side effects can be fatal or life-threatening. Seek a doctor’s attention if you experience any of these symptoms of an allergic reaction to Gilenya such as swelling on face, tongue, throat, difficulty in breathing, hives etc. Get immediate medical help if you notice any of these Gilenya side effects while taking this medicine such as

  • Upper Stomach Pain
  • Itchy Rash, or Other Signs of Skin Infection
  • Slow Heart Rate, Dizziness
  • Feeling Very Weak or Tired
  • Problems with Speech or Walking
  • Weakness or Sudden Numbness
  • Body Aches, Chills, Flu symptoms
  • Fever, Nausea and Vomiting
  • Blurred Vision, Eye Pain
  • Dark Urine, Clay-Colored Stools
  • Itching, Nausea
  • Oozing, Redness
  • Trouble Breathing
  • Wheezing, Chest Tightness
  • Severe Headache
  • Cough with Yellow or Green Mucus
  • Pounding heartbeats or Fluttering in your chest
  • Sores in your mouth and throat
  • Chest Pain, Swelling, Feeling of Warmth
  • Loss of Appetite, Vision Problems
  • Jaundice, Increased Sensitivity to Light
  • Having a Blind Spot or Shadows in the Center of your Vision
  • Back Pain
  • Sinus Pain
  • Tired Feeling
  • Headache
  • Cough, Diarrhea, Stuffy Nose

There could be more side effects not listed in the medication guide. Seek immediate medical attention if you notice or experience any of these side effects while taking Gilenya. You must ask your healthcare provider to explain you about the risks and complications related to Gilenya side effects.

General Recommended Dosage of Gilenya:

There is only one standard dose of Gilenya which can only be prescribed by your healthcare provider. The standard dose of Gilenya is 0.5 mg and is prescribed to take once every day in a month. Certain medical studies have shown that over 0.5 mg dose of this drug can increase the chance of side effects without being effective. There are some considerations that you should keep it in your mind while taking this medicine such as-

  • Gilenya comes in the form of capsule and is taken by mouth once in a day
  • Gilenya can be taken with or without food but you should tell your doctor if you have upset stomach
  • Your healthcare provider needs to monitor you when you will be taking the first dose of this medicine to check your heart rate not going too low.
  • Take this medicine as it was prescribed for you to treat multiple sclerosis.
  • Talk to your doctor if you have any doubt over Gilneya’s benefits and effectiveness.

Never break your dosing schedule as it may have some adverse reactions.

In Case I Miss The Dose?

Missed dose consequences are not known. Tell your doctor if you have missed a dose as you may need to reschedule you dosing. Remember, after missing doses never try to take an extra amount of medicine to make up for the missed one as this may lead to dire consequences.

In Case I Take Overdose?

An overdose of Gilenya can be harmful to you and may worsen your condition for which you are taking this medicine. Seek medical assistance immediately if you think you have taken an overdose of this medicine.

Drug Interactions of Gilenya:

There are some drugs or medications that can potentially interact with Gilenya. This is an essential topic to discuss with your doctor before you start taking this medicine.  Inform your doctor to explain your risks and complications associated with interaction of other drugs. Here are some medically known Gilenya interactions with other drugs such as:

  • a beta-blocker such as propranolol, carvedilol, metoprolol, labetalol, sotalol, atenolol, nadolol
  • a heart rhythm medication such as propafenone, disopyramide, procainamide, flecainide, mexiletine, quinidine
  • a calcium channel blocker such as verapamil, nifedipine, diltiazem, amlodipine,
  • ketoconazole
  • medications that weaken the immune system
  • other multiple sclerosis drugs

This is not a complete list of Gilenya drug interaction. You must inform your healthcare provider if you have been taking any of these medications as he may need to change medicine or adjust dosages. Tell your doctor if you are taking any vitamin and herbal supplement as well.

Life Style and Food Habit You Must Follow When on Gilenya:

You should not take this drug if you have an allergic reaction to fingolimod. Lifestyle and certain food habits do matter when you are taking Gilenya. There are some food and poor lifestyle habits that can increase health discomforts. Talk to your doctor if you have drug abuse/addiction or sedentary lifestyle as you may need to adopt a good and healthy lifestyle and food habit to speedy recovery while taking this medicine.  There are certain medical conditions that you should inform your doctor about, conditions like-

  • asthma or other breathing disorder
  • heart disease, high blood pressure
  • congestive heart failure
  • an active or chronic infection
  • a serious heart condition
  • kidney or liver disease
  • diabetes
  • a history of fainting
  • low blood pressure (hypotension)
  • history of an eye condition called uveitis

Some of these health conditions are considered as life-threatening hence you should not take any sorts of risk while taking Gilenya. You must tell your doctor if you have any of these health issues.

How Safe is Gilenya for Pregnant Women and Nursing Mothers?

It has been categorized as US FDA pregnancy category: C. This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. It has been listed in US FDA pregnancy category: C Fingolimod does not have any harmful reaction to pregnant women or nursing mothers. However, you should tell your doctor if you are expecting or planning to become pregnant while taking this medicine. If you want to take this medicine during pregnancy then you have to follow every instruction given by your doctor.

Complications and Conditions Possible Due to Prolonged Use of Gilenya:

Do not use this medicine longer than prescribed as it may have some adverse reactions to the body. Take Gilenya as long as it is prescribed for you to treat multiple sclerosis. Tell your doctor if Gilenya has stopped working or is not showing expected result as it should provide.

Availability of Gilenya:

Gilenya is available at every government and FDA approved drug stores but you cannot get this medicine without a doctor’s prescription. Apart from this, you can buy Gilenya from online drug stores. On World Wide Web, plenty of drug manufacturing companies are selling their product.