Gilenya is a prescription drug that is used to treat the relapsing-remitting forms of multiple sclerosis (MS) — an immune-mediated neurological disorder that occurs due to nerve damage in the brain and spinal cord.
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This medication belongs to the immunosuppressants drug class, which suppresses the immune system at specific points to prevent or reduce nerve damage. It was the first disease-modifying therapy (DMT) approved by the FDA in 2010 to reduce relapses and delay disease progression in relapsing-remitting multiple sclerosis (RRMS) patients.
The generic name of Gilenya is fingolimod.
What Forms of Multiple Sclerosis (MS) Is Gilenya Used To Treat?
Gilenya is used to treat the relapsing forms of multiple sclerosis (MS), which includes:
Relapsing-Remitting MS (RRMS)
In this form, a patient has flare-ups (relapses) of symptoms followed by a period with milder or no symptoms (remission phase).
Clinically Isolated Syndrome (CIS)
This condition refers to an episode of one or two neurological symptoms that indicate the onset of MS.
Active Secondary Progressive MS
Active secondary progressive MS develops after the relapsing-remitting phase of MS. In this stage, patients experience fewer relapses than they would with RRMS, but their symptoms get worse over time despite the treatment.
Gilenya is used in adults and children over 10 years of age with a relapsing form of MS.
When Is Gilenya Prescribed to Patients?
Gilenya is generally prescribed to patients under the following conditions:
- When other disease-modifying therapies (DMTs) do not work, and patients still experience more than two disabling relapses in one year
- When your MRI scan shows an increased number of lesions in the brain
- When you have highly active relapsing MS or severe relapsing-remitting MS
How Does It Work?
In MS, immune cells such as T and B cells (made in lymph nodes) travel to the brain and spinal cord and destroy the protective coating (myelin sheath) of nerve cells. Gilenya works to reduce this nerve damage by limiting the movement of these immune cells to the brain.
Mechanism of Action
The active ingredient of Gilenya, fingolimod, is a sphingosine-1-phosphate receptor modulator that binds and blocks the action of the sphingosine-1-phosphate receptor (S1P) on lymphocytes (T & B-cells). S1P receptors mainly control the movement of lymphocytes in the body.
With SIP receptor blockage, Gilenya prevents lymphocytes from leaving the lymph nodes and attacking nerve cells. This helps reduce the severity of symptoms and slow down the disease progression.
In What Drug Form Is Gilenya Available?
Gilenya is available as oral hard capsules in strengths of 0.5 and 0.25 mg.
What Is the Recommended Dose?
The dose of Gilenya is adjusted based on the patient’s weight (kg). It is taken once a day.
Recommended Dose for Adults
For an adult patient weighing more than 40 kg, 0.5 mg (one oral capsule) of Gilenya should be taken once a day.
Recommended Dose for Pediatric Patients
If a pediatric patient (10 years of age or older) weighs more than 40 kg, 0.5 mg (one oral capsule) of Gilenya is recommended.
However, if their weight is less than or equal to 40 kg, then a dose of 0.25 mg (one oral capsule) of Gilenya is recommended.
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About Copay AssistanceHow Is Gilenya Taken?
Gilenya is taken orally with or without food. It is recommended that you take your first dose of Gilenya in a medical setting, as this drug can slow the heart rate. The healthcare provider monitors your condition for 6 hours after taking the medication for any problems.
Side Effects?
Gilenya can cause mild and potentially serious side effects.
Common or Mild Side Effects
The most common side effects include:
- Headache
- Increased liver enzymes
- Diarrhea
- Cough
- Influenza
- Sinusitis
- Back pain
- Abdominal pain and pain in the extremities (arms or legs)
- Nausea
These side effects are generally temporary and last a few days to weeks.
Serious Side Effects
It is less common, but Gilenya causes some serious side effects as well, which are as follows:
- Serious heart rhythm problem (slow heart rate)
- Brain infections such as progressive multifocal leukoencephalopathy (PML)
- Hypertension (high blood pressure)
- Macular edema
- Liver damage
- Skin malignancies such as melanoma and basal cell carcinoma
- Allergic reaction
- Swelling in the brain (a condition known as posterior reversible encephalopathy syndrome)
- Tumefactive MS (a rare form of MS that causes tumor-like mass/lesions in the brain)
- Trouble breathing (respiratory issues)
If you experience any of the above side effects, visit your healthcare provider immediately.
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What Special Precautions Should You Follow Before Taking Gilenya?
Before you take Gilenya, it is important to tell your healthcare provider if you have certain medical conditions or are taking any other medications. It is especially important to inform your doctor if you:
- Are pregnant or plan to become pregnant
- Are nursing or planning to breastfeed
- Have a history of heart problems such as such as a heart attack, heart failure, stroke, or arrhythmia (irregular heart rate or rhythm)
- Have a history of liver problems
- Have diabetes or skin cancer
- Have uveitis (a form of eye inflammation)
- Have a fever or active serious infection
- Have received a live vaccine (such as the measles, mumps, and rubella vaccine) within the last 2 months
- Are taking over-the-counter medications, supplements, or herbal products
- Are allergic to any component of Gilenya
What You Should Avoid When Taking Gilenya
You should avoid taking drugs like systemic Ketoconazole when taking Gilenya, as it can increase your risk of heart problems. Furthermore, avoid live vaccines during and for 2 months following the discontinuation of Gilenya as they can increase the risk of infection.
Gilenya can also increase your risk of skin cancer. Therefore, it is important to avoid sunlight or tanning beds and always use sunscreen (SPF 30 or higher) when you go outside.
Cost
Gilenya is a branded medication that can be a bit expensive. One 0.5 mg capsule costs around $373, and a supply of 30 capsules costs around $11,204.
The cost can vary depending on the pharmacy you visit. Patients with low incomes or who are uninsured can participate in patient assistance programs to lower the treatment cost.
REFERENCES:
- US Food and Drug Administration (FDA). Gilenya ((fingolimod) Prescribing Information: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022527s031lbl.pdf
- European Medicines Agency (EMC). Gilenya (fingolimod) Prescribing Information: https://www.ema.europa.eu/en/medicines/human/EPAR/fingolimod-mylan-0
- Roy, R., Alotaibi, A. A., & Freedman, M. S. (2021). Sphingosine 1-Phosphate receptor modulators for multiple sclerosis. CNS Drugs, 35(4), 385–402. https://doi.org/10.1007/s40263-021-00798-w
- Mao-Draayer, Y., Sarazin, J., Fox, D., & Schiopu, E. (2017). The sphingosine-1-phosphate receptor: A novel therapeutic target for multiple sclerosis and other autoimmune diseases. Clinical Immunology, 175, 10-15. https://doi.org/10.1016/j.clim.2016.11.008
- Chun, J., Kihara, Y., Jonnalagadda, D., & Blaho, V. A. (2019). FinGoliMod: Lessons learned and new opportunities for treating multiple sclerosis and other disorders. Annual Review of Pharmacology and Toxicology, 59(1), 149–170. https://doi.org/10.1146/annurev-pharmtox-010818-021358
