Gilenya (Fingolimod)

Name of the generic: fingolimod (Oral route)
Drug class: Selective immunosuppressants

Brands that are commonly used name(s)

In the U.S.

Gilenya
Tascenso ODT

Available Dosage Forms:

Capsule

Therapeutic Class: Immune Modulator

Pharmacologic Class: Sphingosine 1-Phosphate Receptor Modulator

Uses for Gilenya

Gilenya is a treatment for the relapsing types of multiple sclerosis (MS), which include the clinically isolated syndrome, relapsing-remitting disease, and an active secondary progressive disorder. It is not a cure for MS however, it could reduce some of the symptoms that are disabling and lessen the risk of relapses.¶

Gilenyan is only available on prescription from your physician.

Before making use of Gilenya

When deciding whether to take a medication, the potential risks of using the medication must be considered against the benefits it will bring. It is a choice you and your physician will take. To determine the appropriate medicine to be considered, the following factors should be assessed:

Allergies

Discuss with your physician whether you’ve had an unusual reaction or reaction to this medication or any other medication. Be sure to inform your health doctor if you are suffering from other allergies, for example, to dyes, food preservatives, animal products, or other substances. For products that are not prescription-only, you must review the label or the ingredient list carefully.

Pediatric

The right studies haven’t been conducted on the relation of age and the effects of fingolimod on children under 10 years old. of age. The safety and efficacy of the drug have not been proven.

Geriatric

While appropriate studies regarding the impact of age on the effect of fingolimod haven’t been conducted in the population of geriatrics, no specific geriatric issues have been identified at this time. However, patients who are elderly have a higher likelihood to suffer from liver or kidney problems that are a result of age that may warrant cautiousness in those taking fingolimod.

Breastfeeding

There aren’t enough studies on women to determine the risks to babies when using this medication while breastfeeding. Be sure to weigh the potential benefits against the risk of using this medication during nursing.

Interactions with medications

Certain medicines shouldn’t be combined in any way In other instances, two medicines can be taken together, even though there is a chance of interaction. In these situations, the doctor may decide to adjust the dosage or take other precautions if required. If you are taking this medication, it is essential to let your doctor know whether you’re using any one of these medications that are listed below. These interactions have been determined based on their potential impact and may not be all-inclusive.

Utilizing this medicine in conjunction together with any of the following medications is not advised. Your doctor might choose not to treat you with this medicine or modify any other medication you are taking.

Amiodarone
Bepridil
Bretylium
Cisapride
Disopyramide
Dofetilide
Dronedarone
Ibutilide
Levomethadyl
Mesoridazine
Pimozide
Piperaquine
Procainamide
Quinidine
Saquinavir
Sotalol
Sparfloxacin
Terfenadine
Thioridazine
Ziprasidone

Utilizing this medicine in conjunction together with any of the following medications is typically not advised, however it may be necessary in certain situations. If two medicines are prescribed at the same time and your doctor recommends a change in the dosage or frequency you take one or both of the medications.

Acebutolol
Adenovirus Vaccine Type 4, Live
Adenovirus Vaccine Type 7, Live
Alfuzosin
Alprenolol
Amisulpride
Amitriptyline
Amoxapine
Anagrelide
Apomorphine
Aripiprazole
Aripiprazole Lauroxil
Arotinolol
Arsenic Trioxide
Asenapine
Astemizole
Atazanavir
Atenolol
Azithromycin
Bacillus of Calmette and Guerin Vaccine, Live
Bedaquiline
Befunolol
Betaxolol
Bevantolol
Bisoprolol
Bopindolol
Bucindolol
Bupranolol
Buprenorphine
Buserelin
Carteolol
Carvedilol
Celiprolol
Ceritinib
Chloroquine
Chlorpromazine
Ciprofloxacin
Citalopram
Clarithromycin
Clofazimine
Clomipramine
Clozapine
Crizotinib
Cyclobenzaprine
Dabrafenib
Dasatinib
Degarelix
Delamanid
Dengue Tetravalent Vaccine, Live
Desipramine
Deslorelin
Deutetrabenazine
Digoxin
Dilevalol
Diltiazem
Dolasetron
Domperidone
Donepezil
Doxepin
Droperidol
Ebastine
Efavirenz
Encorafenib
Entrectinib
Eribulin
Erythromycin
Escitalopram
Esmolol
Famotidine
Felbamate
Fexinidazole
Flecainide
Fluconazole
Fluoxetine
Formoterol
Foscarnet
Fosphenytoin
Fostemsavir
Galantamine
Gatifloxacin
Gemifloxacin
Glasdegib
Gonadorelin
Goserelin
Granisetron
Halofantrine
Haloperidol
Histrelin
Hydroquinidine
Hydroxychloroquine
Hydroxyzine
Iloperidone
Imipramine
Influenza Virus Vaccine, Live
Inotuzumab Ozogamicin
Itraconazole
Ivabradine
Ivosidenib
Ketoconazole
Labetalol
Landiolol
Lapatinib
Lefamulin
Lenvatinib
Levobunolol
Levofloxacin
Lofexidine
Lopinavir
Lumefantrine
Macimorelin
Measles Virus Vaccine, Live
Mefloquine
Mepindolol
Methadone
Methotrimeprazine
Metipranolol
Metoprolol
Metronidazole
Mifepristone
Mirtazapine
Mizolastine
Mobocertinib
Moricizine
Moxifloxacin
Mumps Virus Vaccine, Live
Nadolol
Nafarelin
Nebivolol
Nelfinavir
Nilotinib
Nipradilol
Norfloxacin
Nortriptyline
Octreotide
Ofloxacin
Olanzapine
Ondansetron
Osilodrostat
Osimertinib
Oxaliplatin
Oxprenolol
Ozanimod
Paliperidone
Panobinostat
Papaverine
Paroxetine
Pasireotide
Pazopanib
Penbutolol
Pentamidine
Perphenazine
Pimavanserin
Pindolol
Pipamperone
Pitolisant
Poliovirus Vaccine, Live
Ponesimod
Posaconazole
Probucol
Prochlorperazine
Promethazine
Propafenone
Propranolol
Protriptyline
Quetiapine
Quinine
Ranolazine
Ribociclib
Risperidone
Ritonavir
Rotavirus Vaccine, Live
Rubella Virus Vaccine, Live
Selpercatinib
Sertindole
Sertraline
Sevoflurane
Siponimod
Smallpox Vaccine
Sodium Phosphate
Sodium Phosphate, Dibasic
Sodium Phosphate, Monobasic
Solifenacin
Sorafenib
Sulpiride
Sultopride
Sunitinib
Tacrolimus
Talinolol
Tamoxifen
Telaprevir
Telavancin
Telithromycin
Tertatolol
Tetrabenazine
Timolol
Tofacitinib
Tolterodine
Toremifene
Trazodone
Triclabendazole
Trifluoperazine
Trimipramine
Triptorelin
Typhoid Vaccine, Live
Vandetanib
Vardenafil
Varicella Virus Vaccine, Live
Vemurafenib
Venlafaxine
Verapamil
Vilanterol
Vinflunine
Voclosporin
Voriconazole
Vorinostat
Yellow Fever Vaccine
Zoster Vaccine, Live
Zotepine
Zuclopenthixol

Interactions with alcohol/food/tobacco/alcohol

Certain medications shouldn’t be used during or in conjunction with having food items or eating particular kinds of food as interactions could happen. The use of tobacco or alcohol along with certain medications may create interactions. Talk to your doctor about the interaction of your medication when you are taking it with alcohol, food, or tobacco.

Other medical conditions

The presence of medical conditions could affect the usage of this medicine. Be sure to inform your physician if you suffer from any other medical conditions particularly:

Angina (chest pain not properly controlled over the last six months)
Arrhythmia (heart rhythm problem)
Heart attack (within the last six months)
Heart block with no pacemaker (abnormal heart rhythm)
Heart failure (poorly controlled in the last six months)
The QT may be prolonged (abnormal heart rate)
Sinusitis that is not accompanied by any pacemaker (abnormal heart rhythm)
Stroke (within the last six months)
Ischemic attack that is transient (within the last six months)–Should not be prescribed to patients suffering from these conditions.

Bradycardia (slow heartbeat)
Trouble breathing
Hypertension (high blood pressure)–Use with care. This can cause the conditions to worsen.

Congenital long QT syndrome (abnormal heart rhythm) or
Congestive heart failure or
Diabetes or
Heart attack
Heart block
Heart rhythm issues (eg arrhythmias or bradycardia)
Hypertension (high blood pressure)
Hypokalemia (low potassium levels in the blood)
Hypomagnesemia (low magnesium levels in the blood)
Sleep apnea is a serious condition that should be untreated
Stroke
Syncope (fainting)
Uveitis (swelling of the eye)

Infections, chronic or acute

Kidney disease,
Liver disease, severe – Use with cautiousness. The effect may be heightened due to the slower elimination of the medication in the human body.

Proper use of Gilenya

This section provides information about the correct use of various products that contain Fingolimod. It is not particular to Gilenya. Be sure to read it with care.

This medicine should be taken exactly as prescribed by your physician. Do not abruptly discontinue taking it. Don’t use more and don’t take it for longer periods of time and do not use it for a longer duration than the time your doctor has prescribed. This could increase the likelihood of having adverse effects.

The doctor will prescribe you the first dose of the medicine at a medical facility. You will be screened for any unwanted side effects for a minimum of 6 hours after you have received the medicine to ensure that there are no adverse side effects.

The medicine must be accompanied by a Medication Guide. Take the time to read and follow the directions attentively. Consult your physician if you have any concerns.

You can take this medicine either with or without food.

Dosing

The dosage of this medicine is different for different people. Follow the doctor’s instructions or the instructions in the prescription. The information below is only the doses that are typical of this medication. If you have a dose that is different you should not alter it until your doctor advises you to change it.

The quantity of medicine you are taking is determined by how strong the drug is. In addition, the number of doses that you are taking each day, the amount of time between doses, and the duration of time that you are taking the medication will depend on the medical condition for which you’re taking the medication.

For oral dosage form (capsules):
- For MS:
  - Adults and children of 10 years of age or older who weigh more than 40 kg (kg)–0.5 milligrams (mg) every day.
  - Children aged 10 or older who weigh 40 kg or less–0.25 mg taken orally every day.
  - Children who are younger than 10 years old–Use and dosage must be determined by your doctor.

Missed dose

Consult your physician or pharmacist to get instructions.

Storage

Place the medication in a sealed bottle at room temperatures, and away from moisture, heat, and bright light. Avoid getting frozen.

Keep your items out of children’s reach.

Avoid keeping outdated medicines or medications that are no longer needed.

Consult your physician to tell you how to dispose of any medication that you do not take.

Use caution when using Gilenya.

It is vital that your physician check your child’s or your own progress during regular visits to ensure that the medication is functioning correctly. Urine and blood tests as well as tests for heart function could be necessary to look for unintended negative effects.

If you take this medicine when you are pregnant may cause harm to your baby. Make sure you use a safe method for birth control in order to prevent you from becoming pregnant. It is not recommended to get pregnant during treatment with this medication and for a period of 2 months after your last dose. If you suspect that you may have been pregnant during treatment with the medicine, consult your doctor immediately.

Gilenya could cause your or your child’s heart rate to decrease, particularly following the first dose. Your child or you will be observed in a medical facility or in a clinic for up to 6 hours for any signs or signs that indicate bradycardia (slow heartbeat). It can be accompanied by chest discomfort or pain or dizziness, lightheadedness or fainting, slow or irregular heartbeats, as well as unusual fatigue.

Gilenya 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. Other infections that have been reported include pneumonia, bronchitis, varicella zoster or herpes simplex. This threat could last for two months or more following the time you stop taking fingolimod. If you can, stay clear of people who are suffering from infections. Talk to your doctor promptly if you or your child has an infection, or if you are suffering from a chill or fever cough, hoarseness or hoarseness in the lower back, side or backache, or troublesome or painful urinary tract.

When you are treated with fingolimod and for a period of 2 months following the end of treatment, do not have any immunizations (vaccines) without your doctor’s permission. Your child must also be able to provide a complete list of immunizations prior to starting treatment with this medication.

Gilenya can lower your child’s immune system and thus the vaccine might not perform as well, or you may contract the disease that the vaccine is designed to stop. Furthermore, the child or you must not be in contact with other people in your home who have received live virus vaccinations since there is a possibility they will transmit the virus to you. Live vaccines are measles, mumps, and flu (nasal influenza vaccine) and the poliovirus (oral form) Rotavirus, measles, and rubella. Avoid getting close to them, and avoid being in the same room as them for long. If you have any questions regarding this, speak to your doctor.

The medicine can create macular edema (swelling of the side part of the eye), especially in the initial 3-4 months following treatment. Talk to your doctor immediately if you notice you experience blurred vision or difficulty reading or other changes in your vision happen in the course or following treatment. Your doctor might recommend the services of an eye physician (ophthalmologist) to examine your eyes.

This medication could cause a rare condition known as posterior reversible encephalopathy syndrome (PRES). Talk to your doctor immediately when the child or you suffers from an abrupt and severe headache or vision problems, confusion, or seizures while taking this medication.

Consult your physician right now If either you or your kid has difficulty breathing or tightness of the chest when taking this medicine.

Consult your physician right immediately If either you or your children is suffering from discomfort or tenderness in the upper abdomen, faint stool, dark urine, vomiting, nausea, fatigue, or unusual weakness or eyes that are yellow or skin. These are signs of a more serious liver condition.

Gilenya could result in a significant rise in disability, which could include an increase in MS symptoms (eg blurred vision, trouble managing your bowels or bladder and difficulty walking, swallowing or speaking or speaking, tingling or numbness in your legs, arms, or face, as well as muscles spasms) for a minimum of 12 to 24 months after taking off the medication. Speak to your doctor should you have any concerns regarding this.

Gilenya may increase your chance of getting skin cancer (eg basal cell carcinoma or melanoma) and lymphoma. Inform your doctor immediately whenever you notice patches or skin nodules or sores open that don’t rapidly heal. Avoid exposure to the sun. Wear sunscreen that has effective UV protection. Don’t use the sunlamps, tanning beds or.

Gilenya may trigger severe allergic reactions, such as angioedema that could be life-threatening and requires urgent medical treatment. Contact your doctor immediately when either you or your children have symptoms of hives, a rash or itching skin, an enlarged, hive-like swelling that is visible on the eyelids, face or lips, tongue hand, legs, throat, and feet, or the genitals.

Do not take any other medications in the absence of discussing with your physician. This includes prescription and other non-prescription (over-the-counter OTC) medicine, herbal and vitamin supplements.

Gilenya side effects

In addition to its beneficial effects, medicines can result in unwanted side negative effects. Although not all negative side effects are likely to occur, if they occur, they might require medical attention.

Talk to your doctor immediately If any of these adverse effects happen:

More popular

Vision blurred
chills
cough
Mucus that causes cough
diarrhea
breath is difficult or labored.
dizziness
febrile
general sensation of the feeling of
headache
joint pain
Appetit loss
Muscle aches and pains
nausea
Nervousness
A pounding sound in the ears
nasal runny nose
seizures
the chills of a chilly night.
Heartbeats that are slow or fast
sore throat
sweating
Tightness in the chest
Trouble sleep
unusual weakness or fatigue
vomiting

Less popular

Stools made of black, tarry
burning and itching sensation of numbness, pain, “pins and needles” or tingling sensations
chest discomfort or pain
The headache is severe and the throbbing can be unbearable.
hoarseness
dizziness, lightheadedness, or fainting
Side or lower back discomfort
uncomfortable or painful urination
ulcers, sores, and white marks on your lips, or within the mouth
swollen glands
unusual bleeding or bleeding that isn’t normal

The exact cause is not known.

Agitation
Back in pain
changes in the size, shape, or color of a mole
confusion
difficult to move
problems with speaking
double vision
Drool
an epileptic seizure, which will not end
Itching, hives itching, rash
inability to move legs, arms, or facial muscles
inability to speak
irritability
joint stiffness, swelling, or swelling
loss of consciousness
a mole that leaks fluid, or bleeding
mood, mental or emotional changes
muscles, cramps, or stiffness
New mole
The skin is red
being able to hear, see or sense things that aren’t present
Slow speech
stiff neck
eyes the lips, face, feet, or hands
difficulty swallowing
weight loss
Yellow skin and eyes

There are some side effects that can occur but they usually do not require medical treatment. These symptoms may disappear when the body adapts to the medication. Additionally, your doctor could be able to inform you how to prevent or minimize the effects of these adverse effects. Talk to your doctor in the event that any of these adverse effects persist or are troubling or if there are any concerns about these: