Fingolimod

Gilenya Tablets

Gilenya is a brand-name drug used to treat episodes of multiple sclerosis (MS). In such conditions or illnesses, the immune system attacks the central nervous system (CNS). If you have relapsing forms of MS, you have a time when these symptoms occur at a peak level, followed by mild or no symptoms. This illness can happen in adults and children of 10 or above. Besides, the medication can also be used to prevent clinically isolated syndrome. It can be an indication of multiple sclerosis. While adults and children can use the medication, ensure that you follow your doctor’s advice for the dosages, as it can vary from person to person.

Product Overview

Gilenya is an FDA-approved prescription medication primarily used for treating relapse forms of multiple sclerosis (MS). Its active ingredient, Fingolimod, works by reducing the frequency of MS relapses and slowing the progression of physical disability. Fingolimod acts as a sphingosine 1-phosphate receptor modulator, which helps retain certain white blood cells in the lymph nodes, refraining them from reaching the central nervous system (CNS) and causing inflammation and damage.

Gilenya is available in the form of oral capsules, with a standard strength of 0.5 mg. It is typically taken once daily with or without food. This medication is suitable for adults and children aged 10 years and above who have been diagnosed with relapsing forms of MS. The medication helps to control the immune system, reducing the autoimmune response that targets the protective cover of nerves.

Common side effects of Gilenya include headache, back pain, and diarrhea. Patients may also experience high liver enzymes, cough, and an increased risk of infections. Additionally, it is crucial to monitor heart rate when starting Gilenya due to the risk of a slow heart rate, especially after the first dose. Before starting this treatment, patients should discuss their medical history, especially if they have a history of heart disease, liver problems, or infections. If a dose is missed, take it as soon as remembered. In case of an overdose of Gilenya, seek immediate medical attention. You can store these capsules at room temperature, away from moisture and heat. Always follow your healthcare provider’s instructions for use and ensure regular check-ups to monitor your progress on this medication.

Uses of Gilenya

This medication is used for:

• Preventing the episodes of multiple sclerosis symptoms
• Reducing the risk of disability in adults and children with relapsing forms of MS
• Treating clinically isolated syndrome (CIS).

Gilenya Dosage

Strengths and Forms

Gilenya is available in capsule form that can be swallowed. It has the following strengths:

• 0.2 mg capsules, and 
• 0.50 mg capsules

Recommended Dosage for Different Patients

For Adults

• Patients who weigh more than 40 kg, the recommended daily dosage is 0.5 mg once a day, with or without food.
• Patients weighing 40 kg or less are advised to consult a medical professional for their daily dosage.

For Children

• Patients aged 10 years and above with a body weight that exceeds 40 kg are recommended to take 0.5 mg once daily.
• Patients aged 10 and above with a weight of 40 kg or less are advised to take 0.25 mg one time each day. 

[Note: Remember, these recommendations may vary from person to person. Discuss it with your doctor, and they’ll customize your dosage accordingly.]

How to Take Gilenya?

• First and foremost, read the medication guide thoroughly and follow the instructions that are mentioned in your prescription label.
• Take the capsule by mouth, with or without the food, as directed by your medical practitioner.
• Remove the capsule from the package with dry hands whenever you are ready to take your medicines. 
• Take them immediately after opening your medicine package.
• Swallow the capsule as a whole with a half glass of water unless instructed otherwise.
• Do not chew or crush it.
• If you are having difficulty swallowing your tablets, talk to your healthcare professional. They will suggest some methods or alternate options.
• Take the medicines at the same time to get the most benefit out of it.
• Do not stop taking your medication without asking it first from your doctor. 
• The dosage is based on your condition and body needs, so do not exceed or subceed the doses.

[Note: Your doctor will decide the right amount for you based on your condition, following guidelines and studies on the drug. They’ll adjust it as needed over time.]

How Does Gilenya Work?

Multiple sclerosis (MS) is said to affect an individual’s central nervous system. This condition occurs due to an overactive immune system that attacks the myelin sheath (a protective layer around nerve fibers) and disturbs the process through which the layer aids nerves in sending signals quickly and correctly to the body. The damaged myelin sheath causes inflammation and scarring on the nerves, known as lesions, thus preventing the nerves from sending signals appropriately throughout the body. All this results in common symptoms of MS, which may include difficulty in walking and balancing, pain, and muscle weakness.

When a patient takes a dose of Gilenya, the drug starts working by attaching itself to molecules called sphingosine 1-phosphate (S1P) receptors. Thus, the drug prevents some immune system cells, known as lymphocytes, from leaving the lymph nodes. This means that your immune system can not attack the myelin sheaths throughout the body. This process helps in reducing the severe symptoms of MS.

Gilenya Side Effects

Common side effects of Gilenya may include:

• Diarrhea
• Nausea
• Headache
• Back pain
• Cough
• Upper respiratory infections
• Stomach pain
• Pain in arms and legs
• Flu

Serious side effects of Gilenya may include:

• Slow heart rate (Bradycardia). Its symptoms may include:
  • Fatigue
  • Dizziness
  • Low blood pressure
  • Heart palpitations
• Infections due to low levels of lymphocytes (a type of white blood cell). Some of the examples are:
  • Herpes 
  • Meningitis
  • Shingles (varicella zoster)
  • Pneumonia
• Progressive multifocal leukoencephalopathy (brain infection). 
• Macular edema (retina swelling). Its symptoms may include:
  • Trouble seeing details
  • Blurred vision
  • Difficulty in seeing colors
• Posterior reversible encephalopathy syndrome (brain disorder). Symptoms are:
  • Confusion
  • Blurred vision
  • Seizures
  • Vision loss
  • Extreme headache
  • Shortness of breath
• Liver issues. Its symptoms may include:
  • Nausea
  • Vomiting
  • Stomach pain
  • High levels of liver enzymes
  • Weakness
  • Not feeling hungry
  • Dark urine
  • Jaundice
• High blood pressure. Its symptoms are:
  • Dizziness
  • Headache
  • Difficulty in breathing
• Cancer
• Tumefactive MS
• Serious allergic reactions

[Note: Remember, this list may not cover all possible side effects. Always consult with your healthcare giver for medical advice about side effects.]

Gilenya Warnings

• Infections: Gilenya impairs your immune system and makes it weaker when performing any activity. As a result, your body gradually loses its ability to fight infections. Therefore, if you have any infections, your doctor will treat them first before starting your treatment with this medication.
• Diabetes: Patients suffering from such a condition are at high risk of developing eye problems like macular edema. To prevent such situations, your healthcare provider will closely monitor you during the treatment.
• Uveitis: If you have swelling in your eyes or uveitis, you may experience macular edema. There is no need to panic, as the professionals will monitor these issues during your treatment with Gilenya.
• Heart Problems: The medication can cause heart block or slow heart rate. So, if you have such a condition, tell your doctor, as Gilenya can exacerbate the issue. Patients may experience heart problems like strokes, irregular heart rhythms, heart attacks, unstable angina, etc. 
• Breathing Problems: This drug may likely reduce the amount of air that you need to breathe out from your lungs. So, if you have breathing problems like asthma, this reduction can make breathing difficult. Consult with a medical professional before taking this medicine.
• Tumefactive Multiple Sclerosis: This condition involves multiple masses in the brain, which can occur with Gilenya treatment. If you are having a relapse of MS symptoms while taking your medicines or after the treatment, talk to your healthcare practitioner. They may suggest imaging tests to examine any signs of tumefactive MS.
• Skin Cancer: The medication increases the risk of skin cancer in patients. If you have had skin cancer or have one, talk to your doctor before starting your treatment with Gilenya.  

Gilenya Precautions

• If you have allergies to Gilenya and any of its ingredients, tell your doctor immediately, as the product may contain some inactive components that can cause allergic reactions. To avoid such situations, your medical practitioner may suggest some alternate options.
• If you have gotten a vaccine or are planning to get one, inform your doctor beforehand, as this can cause certain problems. Your medical practitioner may suggest you to wait for some time before beginning your treatment with Gilenya.
• Patients with high blood pressure are advised to inform their doctors before taking this medicine as it can increase levels of blood pressure and make the situation worse. 
• It is important to inform your healthcare provider about your medical history. If you have any history of conditions like breathing problems, heart issues, infections, fainting, eye problems, and diabetes, make sure you are telling everything.
• The medication can increase the chances of infections in patients. Therefore, it is advised to stay away from people who have infections like chickenpox, COVID-19, flu or measles that may spread easily. 
• Avoid getting any vaccination for 2 months after your ending dose of Gilenya.
• If you are undergoing any surgery or medical procedure, tell your doctor/dentist about every product you are using, including prescription drugs, nonprescription drugs, and herbal products.
• Women are advised not to get pregnant or plan on having a baby during Gilenya treatment, as the drug can harm the unborn baby. It is important to check whether you are pregnant before starting this medication. Ask your doctor about reliable birth control pills when using this medication. 
• Breastfeeding is not recommended in lactating mothers as there is no specific study about this. However, it is believed that the drug can enter into the breast milk and harm the baby.

Gilenya Contraindications

Gilenya is not recommended for patients who have:

• Experienced problems like unstable angina, myocardial infarction, stroke, TIA, and heart failure that require hospitalizations in the last 6 months. 
• Medical history of sick sinus syndrome or currently have one.
• A baseline QTc interval greater than or equal to 500 msec.
• Hypersensitivity to Fingolimod or any of the Gilenya ingredients.

Gilenya Missed Dose

Patients are usually advised not to miss a dose of Gilenya, but if someone has mistakenly missed or skipped a dose, they should take their next dose as soon as possible. After taking the skipped dose, patients should visit their doctor’s clinic for an observation. The doctor may examine the patient’s heart after taking a dose. However, it is recommended not to take double doses. If the patient has any queries or concerns, they can consult with their healthcare provider.

[Note: If you have missed a dose of your medication and are unsure about when to take the next one, immediately consult your doctor or pharmacist.]

Gilenya Overdose

Gilenya can cause bradycardia and AV conduction blocks. The heart rate reduction in such conditions starts within one hour of taking the first dose and peaks within six hours. Therefore, when a person overdosed Gilenya, doctors obverve patients overnight with continuous ECG monitoring and measurements of blood pressure. In the end, patients are advised to get medical assistance immediately, in case they have exceeded the maximum doses of Gilenya.

[Note: If you consumed more than the recommended dose, get medical help right away or call the Poison Help line at 1-800-222-1222.]

Gilenya Storage

• Store your capsules at a temperature of 20 ºC to 25ºC. 
• Medication can also be kept at 15ºC-30ºC for a brief period of time.
• Ensure that the capsules are kept away from moisture.
• Avoid contact with children and pets.
• Do not use the capsules when not in use.
• Do not flush them down the toilet.
• Discard the product once it has reached its expiration date.
• Avoid keeping the capsules in damp areas like the bathroom or near the sink. 
• Read the product’s label for detailed storage instructions.

[Note: Discuss with your healthcare professional about the proper disposal of any unused medicine and any questions you may have regarding its storage.]

Gilenya Interactions

• Quinidine
• Disopyramide
• Amiodarone
• Sotalol
• Atenolol
• Verapamil
• Ivabradine
• Ketoconazole
• Erythromycin
• Amitriptyline
• Lexapro
• Tizanidine
• Tramadol
• Trazodone

[Note: This isn’t a complete list, and there could be other drugs that interact with Gilenya. Make sure to tell your doctor about any prescription, over-the-counter medicines, and herbal products you’re taking.]

Gilenya Alternatives

• Alemtuzumab (Lemtrada)
• Azathioprine (Azasan, Imuran)
• Cladribine (Mavenclad)
• Dimethyl fumarate (Tecfidera)
• Glatiramer (Copaxone, Glatopa)
• Interferon beta-1a (Avonex, Rebif)
• Mitoxantrone
• Natalizumab (Tysabri)
• Ocrelizumab (Ocrevus)
• Teriflunomide (Aubagio)

[Note: Your doctor will choose what’s best for you. Don’t use any of these alternative medications without consulting your healthcare provider. Taking them by yourself may cause serious side effects.] 

Frequently Asked Questions

Can I lose or gain weight while taking Gilenya?

Patients might experience fluctuations in their weight while taking this medication. While weight gain or loss are not common side effects of Gilenya, the medicine can react differently in each person. Some patients may notice weight loss as a sign of liver damage as it makes you feel less hungry, thus resulting in weight loss. To know more about its side effects, talk to a medical professional. 

Can I stop taking Gilenya suddenly?

No, do not discontinue the use of your medication in the middle of the treatment, as this action can result in withdrawal symptoms like trouble with walking, balancing, vision, bowel control, and bladder. Therefore, patients are advised to follow their doctor’s instructions and complete the course of their treatment. If you want to discontinue the treatment, talk to your medical practitioner first and then take any action.

Can sun exposure during Gilenya treatment cause skin cancer?

Gilenya can cause skin cancer in rare cases, but you can spend time in the sun during your treatment. It is important to note that you are limiting your time with sun exposure. To avoid any complications in the near future, you can take protective measures like using sunscreen with high SPF and wearing clothes that cover your skin.

Can Gilenya be used in pediatric patients with multiple sclerosis?

Yes, Gilenya is approved for use in pediatric patients aged 10 years and above with relapsing forms of multiple sclerosis. The dosage and administration are carefully adjusted for younger patients to ensure safety and efficacy.

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