Name of the generic: fingolimod (Oral route)
Drug class: Selective immunosuppressants
Brands that are commonly used name(s)
In the U.S.
- Tascenso ODT
Available Dosage Forms:
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:
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.
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.
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.
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.
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.
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Bacillus of Calmette and Guerin Vaccine, Live
- Dengue Tetravalent 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, Live
- Varicella Virus Vaccine, Live
- Yellow Fever Vaccine
- Zoster Vaccine, Live
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
- 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.
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.
- For MS:
Consult your physician or pharmacist to get instructions.
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:
- Vision blurred
- Mucus that causes cough
- breath is difficult or labored.
- general sensation of the feeling of
- joint pain
- Appetit loss
- Muscle aches and pains
- A pounding sound in the ears
- nasal runny nose
- the chills of a chilly night.
- Heartbeats that are slow or fast
- sore throat
- Tightness in the chest
- Trouble sleep
- unusual weakness or fatigue
- 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.
- 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.
- Back in pain
- changes in the size, shape, or color of a mole
- difficult to move
- problems with speaking
- double vision
- an epileptic seizure, which will not end
- Itching, hives itching, rash
- inability to move legs, arms, or facial muscles
- inability to speak
- 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:
- Tenderness or pain around the cheekbones and eyes.
- stuffy nose
- Weight loss
- Eye discomfort
- hair loss or loss of hair
- itching on the genitals or other areas of the skin
- weakness or lack of strength or
- stomach pain
- skin rash encrusted red, and bubbling
Other side effects that aren’t mentioned could also be present in certain patients. If you observe any other side effects, you should consult with your doctor.
Consult your physician for advice from a medical professional regarding adverse effects. You can report any symptoms to the FDA at 1-800-FDA-1088.
Always consult your physician to make sure the information presented on this site is appropriate to your specific situation.