Generic Name: fingolimod (Oral route)
Commonly used brand name(s)
In the U.S.
Available Dosage Forms:
Therapeutic Class: Immune Modulator
Uses For Gilenya
Fingolimod is used to treat the relapsing forms of multiple sclerosis (MS). This medicine will not cure MS, but it may slow some disabling effects and decrease the number of relapses of the disease.
This medicine is available only with your doctor's prescription.
Before Using Gilenya
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of fingolimod in the pediatric population. Safety and efficacy have not been established.
Although appropriate studies on the relationship of age to the effects of fingolimod have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution in patients receiving fingolimod.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Bacillus of Calmette and Guerin Vaccine, Live
- Influenza Virus Vaccine, Live
- Inotuzumab Ozogamicin
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Poliovirus Vaccine, Live
- Rotavirus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Vaccine
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
- Typhoid Vaccine
- Varicella Virus Vaccine
- Yellow Fever Vaccine
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Angina (poorly controlled within the past 6 months) or
- Heart attack (within the past 6 months) or
- Heart block without a pacemaker (abnormal heart rhythm) or
- Heart failure (poorly controlled within the past 6 months) or
- QT prolongation (abnormal heart rhythm) or
- Sick sinus syndrome without a pacemaker (abnormal heart rhythm) or
- Stroke (within the past 6 months) or
- Transient ischemic attack (within the past 6 months)—Should not be used in patients with these conditions.
- Bradycardia (slow heartbeat) or
- Breathing problems or
- Hypertension (high blood pressure)—Use with caution. May make these conditions worse.
- Congenital long QT syndrome (abnormal heart rhythm) or
- Congestive heart failure or
- Diabetes or
- Heart attack, history of or
- Heart block (abnormal heart rhythm) or
- Heart rhythm problems (eg, arrhythmia, bradycardia), history of or
- Hypertension (high blood pressure), poorly controlled or
- Hypokalemia (low potassium in the blood) or
- Hypomagnesemia (low magnesium in the blood) or
- Sleep apnea, severe and not treated or
- Stroke, history of or
- Syncope (fainting), history of or
- Uveitis (inflammation of the eye), history of—Use with caution. May make side effects become worse.
- Infection, acute or chronic, active—Should be treated first before starting fingolimod.
- Kidney disease, severe or
- Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use of Gilenya
Take this medicine exactly as directed by your doctor. Do not suddenly stop taking it, do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance for side effects.
Your first dose will be given in a hospital or clinic. You will be checked for side effects for at least 6 hours after the first dose.
This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Take this medicine with or without food.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (capsules):
- For multiple sclerosis:
- Adults—0.5 milligrams (mg) once per day.
- Children—Use and dose must be determined by your doctor.
- For multiple sclerosis:
Call your doctor or pharmacist for instructions.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using Gilenya
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests and tests for heart function may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. You should not become pregnant during treatment with this medicine and for 2 months after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.
This medicine may cause your heart rate to slow down, especially after taking the first dose. You will be observed in a hospital or clinic for 6 hours for signs and symptoms of bradycardia (slow heartbeat). Symptoms may include chest pain or discomfort, lightheadedness, dizziness, or fainting, shortness of breath, slow or irregular heartbeat, or unusual tiredness.
Fingolimod can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection (including a serious brain infection called progressive multifocal leukoencephalopathy), which could be life-threatening. If you can, avoid people with infections. Check with your doctor right away if you think you have an infection or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
While you are being treated with fingolimod, and for 2 months after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Fingolimod may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.
This medicine may cause macular edema (swelling of the back of the eye), especially during the first 3 to 4 months of treatment. Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want an eye doctor (ophthalmologist) to check your eyes.
This medicine may cause a rare condition called posterior reversible encephalopathy syndrome (PRES). Check with your doctor right away if you have a sudden and severe headache, confusion, vision changes, or seizures with this medicine.
Check with your doctor right away if you have shortness of breath, difficult or labored breathing, or tightness in the chest while taking this medicine.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may increase your risk of having skin cancer (eg, basal cell carcinoma, melanoma). Tell your doctor right away if you notice any skin nodules, patches, or open sores that do not quickly heal. Avoid exposure to sunlight. Wear sunscreen with a high sun protection factor. Do not use sunlamps or tanning beds.
This medicine may cause serious allergic reactions, including angioedema, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, hives or itching skin, or large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Gilenya Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:More common
- Blurred vision
- cough-producing mucus
- difficult or labored breathing
- general feeling of discomfort or illness
- joint pain
- loss of appetite
- muscle aches and pains
- pounding in the ears
- runny nose
- slow or fast heartbeat
- sore throat
- tightness in the chest
- trouble sleeping
- unusual tiredness or weakness
- Black, tarry stools
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain or discomfort
- headache, severe and throbbing
- lightheadedness, dizziness, or fainting
- lower back or side pain
- painful or difficult urination
- sores, ulcers, or white spots on the lips or in the mouth
- swollen glands
- unusual bleeding or bruising
- difficulty in speaking
- double vision
- inability to move the arms, legs, or facial muscles
- inability to speak
- slow speech
- weight loss
- yellow skin and eyes
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- Back pain
- pain or tenderness around the eyes and cheekbones
- stuffy nose
- Decreased weight
- eye pain
- hair loss or thinning of the hair
- itching in the genitals or other skin areas
- itching skin
- lack or loss of strength
- stomach pain
- skin rash, encrusted, scaly, and oozing
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
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