Gilenya: Dosage, Uses, Side effects and Interactions

Overview

What is Gilenya?

Gilenya is the trade name for the immunomodulatory drug doctors prescribe for relapsing multiple sclerosis and clinically isolated syndrome in children over ten years and adults. Gilenya contains fingolimod as the active component. Fingolimod pertains to the drug class known as disease-modifying therapies ²Overview| Researched based study from Sciencedirect.com

Immunomodulatory drugs are medications that regulate the body’s immune system.

Multiple sclerosis is a persistent illness that impacts the spinal cord and brain. In this condition, the body’s immune cells erroneously attack the protective membrane (myelin sheath) that encloses the nerve fibers, thereby interrupting messages between the brain and other body parts. The protective membrane is vital in carrying messages from the brain to diverse body parts.

Facts of Gilenya

• Gilenya is accessible only in its trade name. It is not available in its generic form.
• In 2010, the Food and drug administration United States (FDA) approved Gilenya for treating relapsing multiple sclerosis in adults ¹Overview| Researched based study from Sciencedirect.com

Mode of action of Gilenya

• Gilenya reduces the number of immune cells viz; WBC (white blood cells) in the body and thus slows the body’s immune response.
• In multiple sclerosis, the overactive immune cells destroy the healthy body cells, including the myelin sheath of nerve fibers.
• The active component of Gilenya binds to sphingosine 1-phosphate receptors present in the immune cells of lymph nodes (small glands present in the body that help combat disease), thereby preventing lymphocytes (a kind of white blood cells) release and incorrect attack of the myelin sheath. It thus helps manage the symptoms of multiple sclerosis ³Dosage| Researched based study from Sciencedirect.com

Dosage

Dosage of Gilenya

• The dose of Gilenya will depend on the patient’s illness severity, age, and body mass.
• The commonly recommended dose of Gilenya is one tablet daily. However, always follow the exact quantity as the doctor advises.
• After the patient takes the Gilenya for the first dose, the doctor will observe the patient in a clinic or hospital for 6 to 8 hours to confirm changes in the patient’s heart rate so that doctors can immediately manage any abnormal changes.

Here are some of the standard doses that doctors recommend for multiple sclerosis

Adults of weight 40 kg (kilograms)

• Dose- 0.5 mg (milligram) per day

Children dose

Age over ten years (weight more than 40 kg)

• Dose-0.5 mg per day

Age over ten years (weight less than 40 kg)

• Dose- 0.25 mg per day ⁴Dosage| Researched based study from Sciencedirect.com

Formulation of Gilenya

Gilenya is available in the following forms

• Capsule
• Tablet

Strength (power)

• 0.5 mg (milligram)
• 0.25 mg ²Dosage| Researched based study from Sciencedirect.com

Taking Gilenya

• One can swallow Gilenya tablets or capsules with a glass of plain water with or without food.
• However, always confirm with the doctor about taking the medication without food, as it might not suit everyone.

Missed dose

• One must take the Gilenya dose as directed. If one misses a dose by chance, call your doctor straightaway to know the second dose.
• However, you might need to visit the doctor’s clinic after taking the missed dose and stay there for around six to eight hours. The doctor will again recheck the heart rate as done for the first time dose to confirm any abnormality.

• Individuals with the condition experience multiple sclerosis symptoms that get better and get worse periodically.

Uses

Uses of Gilenya

The FDA has approved Gilenya to treat the following types of multiple sclerosis in adults and youngsters over ten years of age:

• Clinically isolated syndrome
• Relapsing-remitting multiple sclerosis
• Active secondary progressive multiple sclerosis ⁵Uses| Researched based study from Sciencedirect.com

Side effects

Side effects of Gilenya

Mild side effects

• Cough
• Headache
• Stomach pain
• Backache
• Leg pain
• Flu infection
• Diarrhea

Serious side effects

Liver failure

Symptoms are

• Abdominal pain
• Nausea and vomiting
• Extreme tiredness
• Appetite loss
• Jaundice( eyes and skin yellowing)
• Dark urine

Elevated blood pressure

Symptoms are

• Chest pain
• Lightheadedness
• Headache
• Trouble breathing

Decreased heart rate (Bradycardia)

Symptoms are

• Extreme tiredness
• Lightheadedness
• Reduced blood pressure
• Chest tightness and pain

Skin cancer

Symptoms are

• Change in shape and size of existing spot
• Skin changes
• Skin bruises
• Sores that do not heal

Allergic reaction

Symptoms are

• Hives (urticaria)
• Skin reaction
• Severe itching
• Swelling of face and mouth
• Shortness of breath

Tumefaction multiple sclerosis (a rare condition involving more brain masses)

Symptoms are

• Headaches
• Difficulty in talking
• Lowering in thinking ability
• Confusion
• Convulsions

Posterior reversible encephalopathy syndrome (PRES)(brain disease)

Symptoms are

• Intense headache
• Unclear vision
• Vision loss
• Confusion
• Convulsions (seizures)

Progressive multifocal leukoencephalopathy (rare infection in people with weakened immunity)

Symptoms are

• Muscle weakness
• Vision changes
• Difficulty maintaining balance
• Memory loss
• Lack of coordination ⁶Side effects| Researched based study from Sciencedirect.com

Overdose

Overdose toxicity of Gilenya

One taking the excess drug than the physician’s advised dose can lead to severe complications.

Some of the overdose symptoms are as follows:

• Tightening of the chest with pain
• Low blood pressure
• Reduced heart rate (bradycardia)
• Irregular heartbeat
• Lightheadedness
• Heart block ⁷Overdose| Researched based study from Nlm.nih.gov

One who feels he has taken excessive drugs by mistake can call the poison control center or emergency number based on the location. But if the symptoms are severe, accompanied by difficulty breathing, dial 911 or hurry to the nearest medical room immediately.

Precautions

Precautions

• In animal studies, Gilenya indicated fetal anomalies and death. But there is inadequate information to conclude whether Gilenya is safe or unsafe for humans. So, pregnant women should always discuss with the physician before taking Gilenya.
• In animal studies, researchers detected Gilenya in breast milk. But there need to be more research studies in humans to confirm that. So, nursing mothers should always take the doctor’s opinion before taking Gilenya ⁸Precautions| Researched based study from Nlm.nih.gov

Contraindications

Contraindications

Gilenya might not suit people with specific medical conditions.

Always consult with the physician if you have any of the health issues listed below:

• Allergic reaction to fingolimod or any other drug
• High sugar (diabetes)
• High blood pressure
• Heart disease
• Eye problem viz swelling of eyes (uveitis)
• Liver disease
• Abnormal heartbeat
• Weakened immune system
• Breathing problem viz; asthma
• Skin carcinoma (cancer)
• Tumefactive multiple sclerosis (a condition that attacks more brain masses)
• Recent vaccination
• Viral infections such as chickenpox, mumps
• Stroke history
• Pregnant or planning to conceive
• Nursing mothers ⁹Contraindications| Researched based study from Nlm.nih.gov

Interactions

Interactions of Gilenya

Live vaccines

• Gilenya is a drug that decreases the body’s immune response
• The live vaccine has infections in its weakened form
• So if one takes Gilenya and live vaccines viz; measles, rotavirus together, the body will not be able to combat the infection. Consequently, the person might get the illness instead of protection from the disease

High blood pressure medication

• Gilenya decreases the heart rate
• High blood pressure drugs viz; Lanoxin, Tenormin also reduce the heart rate. Taking both together might increase the risk of heart issues.

Corticosteroids

• Corticosteroids viz; prednisone, dexamethasone are drugs that weaken the immune system
• Gilenya also reduces the immune response. Taking both together might increase the infection chances

Some other drugs that can interact with Gilenya are as follows:

• Tegretol(Seizure medication)
• Ocrevus(immunosuppressant drug)
• EryPed(antibiotic)
• Ketoconazole(antifungal medication)
• Citalopam(antidepressant drug)
• Haloperidol(antidepressant drug)
• Verapamil(high blood pressure medication)
• Metoprolol(high blood pressure medication)
• Sotalol (heart medication) ¹⁰Interactions| Researched based study from Nlm.nih.gov

However, Gilenya might also interact with other drugs not mentioned above. Talk to your physician or pharmacist about more interactions that Gilenya might have.

Storage

Storage & Disposal of Gilenya

• Keep the drug out of reach of youngsters.
• Store the drug in a closed container and keep it at 20 to 25 degrees centigrade temperatures.
• Avoid keeping the drug in direct sunlight or wet places such as lavatories.

Disposal

• Throw the unused mediation in a thrash to avoid the causalities of animals and pets
• Dispose of the drugs whose expiration date is over.

Alternatives

Alternatives to Gilenya

Some other drugs other than Gilenya to treat multiple sclerosis are also available. Some may suit finer for you than others. Individuals interested in taking alternatives to Gilenya must speak to a healthcare professional to get the best fit.

Some examples of other drugs to treat multiple sclerosis are as follows:

• Aubagio
• Ocrevus
• Lemtrada
• Tysabri
• Tecfidera
• Avonex
• Copaxone ¹¹Alternatives| Researched based study from Nlm.nih.gov

Takeaway

Key takeaways

• Gilenya is a prescription drug for treating multiple sclerosis in adults and youngsters over ten years.
• Individuals with health issues must inform the physician before taking Gilenya to prevent potential complexity.
• Gilenya has probable adverse effects. So, always ensure to take the drug as the physician recommended