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Why is this medication prescribed?
With relapsing-remitting forms of multiple sclerosis (MS; a disease in which the nerves do not function properly, people may experience weakness, numbness, loss of muscle coordination, problems with vision, speech, and bladder control), fingolimod is used to prevent episodes of symptoms and slow the worsening of disability in adults and children 10 years of age and older. Sphingosine l-phosphate receptor modulators, which include fingolimod, are a group of drugs. It functions by reducing the activity of immune cells that could harm nerves.
How should this medicine be used?
Fingolimod is available as a pill to swallow. Typically, it is taken once day, with or without food. Fingolimod should be taken every day at about the same time. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Follow the fingolimod directions exactly. Never take it in larger or less amounts or more frequently than directed by your doctor.
Both adults and children who use fingolimod may experience slowed heartbeats, especially in the first six hours after taking the medication for the first time and when the dosage is increased in children after the initial dose. Both before and six hours after your first dose, you will have an electrocardiogram (ECG), a test that captures the electrical activity of the heart. Your first dose of fingolimod will be administered in a medical setting, such as a doctor’s office. After taking the medication, you must remain at the clinic for at least 6 hours so that you can be observed. If you have certain medical issues or use certain medications that increase the likelihood that your heartbeat will slow, or if your heartbeat slows more than you anticipated or continues to slow beyond the first 6 hours, you might need to stay at the medical institution for longer than 6 hours or overnight. If your heartbeat slows down too much after you take the first dose, you might also need to stay at a hospital for at least 6 hours after taking the second dose. Tell your doctor right away if you suffer any of the following during your treatment, especially in the first 24 hours following the administration of your first dose: lightheadedness, fatigue, chest pain, or a slow or irregular heartbeat.
Although it won’t treat multiple sclerosis, fingolimod may help control the disease. Never stop taking fingolimod without first consulting your doctor. Talk to your doctor before starting fingolimod again if you stop taking it for 1 day or more during the first 2 weeks of therapy, for 1 week or more between the third and fourth weeks of treatment, or for 2 weeks or more after the first month of treatment. The medicine must be restarted in your doctor’s office since you can experience slowed heartbeat when you start taking fingolimod again.
Whenever you refill your prescription for fingolimod, your doctor or pharmacist will give you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website.
Other uses for this medicine
Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.
What special precautions should I follow?
Before taking fingolimod,
- If you have fingolimod allergies, let your doctor and pharmacist know right away. Your doctor would likely advise against taking fingolimod if you have experienced a severe allergic response to it or any of the ingredients in fingolimod capsules (rash, hives, swelling of the face, eyes, mouth, neck, tongue, lips, hands, feet, ankles, or lower legs). Additionally, let your doctor know if you have any drug allergies or if any of the components in fingolimod capsules cause you any discomfort. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
- If you use any of the following drugs for irregular heartbeat: amiodarone (Nexterone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), ibutilide (Corvert), procainamide, quinidine (in Nuedexta), and sotalol (Betapace, Sorine, Sotylize), let your doctor know. If you are on any of these drugs, your doctor probably won’t let you take fingolimod.
- Inform your physician and pharmacist of all prescription and non-prescription drugs, vitamins, dietary supplements, and herbal products you are currently taking or intend to start taking while receiving treatment with fingolimod. Any of the following should be mentioned: Metoprolol (Lopressor, Toprol-XL, in Dutoprol, in Lopressor HCT), atenolol (Tenormin, in Tenoretic), carteol, labetalol (Trandate), and others are beta-blockers, timolol, propranolol (Inderal LA, Innopran XL), nadolol (Corgard, in Corzide), nebivolol (Bystolic, in Byvalson), and timolol; diltiazem (Cardizem, Cartia, Tiazac, others); Chlorpromazine, digoxin (Lanoxin), citalopram (Celexa), erythromycin (E.E.S., Ery-Tab, PCE, and other brands), haloperidol (Haldol); ketoconazole, heart-related drugs, methadone (Dolophine, Methadose), and verapamil (Calan, Verelan, in Tarka) are other examples. Also let your doctor know if you are currently taking any of the following medications or have ever taken them: corticosteroids as prednisone, dexamethasone, and methylprednisolone; treatments for cancer, as well as immunosuppressive drugs including teriflunomide (Aubagio), mitoxantrone, and natalizumab (Tysabri). Your doctor might need to adjust your medication doses or keep a close eye out for any negative side effects. Tell your doctor about all of the medications you are taking, including any that do not appear on this list, since many other drugs may also interact with fingolimod.
- If you have or have had a heart attack, angina (chest discomfort), stroke, mini-stroke, or heart failure within the last six months, let your doctor know. Additionally, let your doctor know if you have long QT syndrome, a condition that raises the possibility of experiencing an irregular heartbeat that could result in fainting or sudden death. Your physician might advise against taking fingolimod.
- If you currently have a fever or other signs of infection, if you have ever had diabetes, if you have ever fainted, had a heart attack, stroke, or small stroke, or if you have an infection that comes and goes or does not go away, please let your doctor know; high blood pressure, uveitis (eye inflammation), or other eye disorders; sleep apnea (disease in which you repeatedly temporarily cease breathing during the night); sluggish heartbeat, low blood potassium or magnesium levels, skin cancer, heart problems, or liver illness. Additionally, let your doctor know if you recently received a vaccination.
- If you are breastfeeding a child or intend to become pregnant, let your doctor know. Use birth control to avoid getting pregnant while receiving treatment and for two months after your last dosage. Call your doctor if you become pregnant while taking fingolimod or within two months after your last dose.
- avoid getting any shots without consulting your doctor while receiving fingolimod medication or for two months following the last dosage. Before starting therapy with fingolimod, discuss your child’s potential vaccine requirements with their physician.
- If you have never had chicken pox and have not received the chicken pox vaccine, let your doctor know. To determine whether you have been exposed to the chicken pox, your doctor might request a blood test. You might have to get the chicken pox vaccine and then hold off for a month before starting fingolimod therapy.
- Plan to use protective clothing, sunglasses, and sunscreen as well as to avoid unnecessary or prolonged exposure to sunlight and UV rays (such as tanning booths). Fingolimod may raise your risk of developing skin cancer by making your skin more vulnerable to the harmful effects of sunlight.
What special dietary instructions should I follow?
Keep eating normally unless your doctor instructs you otherwise.
What should I do if I forget a dose?
If you miss a dosage, take it as soon as you recall. However, if it is almost time for the subsequent dose, skip the missed dose and contact your physician instead. As you restart your medication, you might need to be watched. To make up for a missing dose, do not take a second one.
What side effects can this medication cause?
Side effects from fingolimod are possible. If any of these symptoms are severe or do not go away, let your doctor know right once:
- Back ache
- Hurting hands or feet
- Abdomen ache
- Migraine or a headache
- Hair fall
Some adverse effects can be very harmful. Call your doctor right away if any of these symptoms occur to you:
- Sluggish heartbeat
- Difficulty eating or breathing; rash, hives, itching; swelling of the face, eye, mouth, throat, tongue, or lips; or
- During treatment and for two months after your treatment if you experience a sore throat, body aches, fever, chills, cough, and other symptoms of infection
- Headache, stiff neck, fever, light sensitivity, motion sickness, or confusion both during and two months after therapy
- Sensitivity to touch, rash, itching, or unpleasant, burning, numb, or tingling sensation on the skin that lasts for two months following therapy
- Sudden severe headache, disorientation, vision changes, or seizures
- Haziness, darkness, or a blind spot in the middle of your field of vision; Light sensitivity, strange colors that cause headaches, or other visual issues
- Alterations to an existing mole; a new skin-darkened spot; not-healing wounds; any changes to your skin, such as growths like a lump that may be shiny, pearly white, flesh-colored, or pink
- Changes in your thinking, memory, or balance; a weakness on one side of your body or clumsiness in your arms or legs that gets worse with time; disorientation, personality changes, or weakness
- New or worsening breathlessness
- Gastrointestinal discomfort, vomiting, appetite loss, yellowing of the skin or eyes, or black urine
Fingolimod may make it more likely for people to develop skin cancer and lymphoma, a type of cancer that starts in the immune system cells. The dangers of using this drug should be discussed with your doctor.
Within three to six months of stopping fingolimod, MS symptoms may suddenly worsen and episodes of them may increase. If your MS symptoms get worse after discontinuing fingolimod, let your doctor know.
Other negative effects of fingolimod are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.
You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online at http://www.fda.gov/Safety/MedWatch or by phone at 1-800-332-1088 if you have a serious side event.
What should I know about storage and disposal of this medication?
Keep this medication tightly closed in the original container and out of the reach of children. Keep it at room temperature and out of the bathroom and other places with excessive heat and moisture.
As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning.http://www.upandaway.org
Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilizing a medicine take-back program is the best way to get rid of your medication. To find out about take-back programs in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back program, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.
In case of emergency/overdose
Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.
Overdose signs could include the following:
- Sluggish or erratic heartbeat
What other information should I know?
Maintain all scheduled times with your physician and the lab. To ensure that taking fingolimod is safe for you to start or continue, your doctor will prescribe specific lab tests, as well as skin and eye exams and blood pressure monitoring before and during your therapy.
Inform the lab staff and your doctor that you are taking fingolimod prior to any laboratory test.
No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.
You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.