Gilenya, a S1P-receptor modulator, traps certain T and B cells in the lymph nodes and prevents them from attacking the central nervous system.
Capsule taken orally
Once per day; 0.5 mg capsule for adults
In pediatric patients 10 years of age and older weighing less than or equal to 40 kg, the recommended dosage is 0.25 mg orally once daily
Relapsing forms of multiple sclerosis in adults and children ages 10 and older, including clinically isolated syndrome, relapsing-remitting MS, and active secondary-progressive MS
- 48-54% reduction in relapses compared to placebo over 2 years. 41 and 52% reduction in relapses vs. Copaxone and Avonex, respectively
- New or enlarging T2 lesions were reduced 74% and T1 contrast-enhancing lesions reduced 82% on Gilenya vs placebo in 2 year trial.
- 30% reduction in 3-month confirmed disability progression in a 2 year trial
- Reduction in brain volume loss 33-38% compared to placebo over 2 years
Common Potential Side Effects
Liver function test abnormalities, high blood pressure, respiratory infections.
For assistance finding additional resources that might help cover the costs of your prescription, contact MSAA.
NEW FORMULATION OF FINGOLIMOD
Tascenso ODT® (fingolimod)
This is the first orally disintegrating version of fingolimod to be approved by the FDA. This is the same medication that is found with the brand name of Gilenya®, but rather than a solid pill that needs to be swallowed, Tascenso ODT is given by a pill that immediately dissolves on the tongue and does not require water. Clinical data shows that it has the same efficacy (effectiveness), safety, and purity as the original medication.
This new formulation became available in early 2023. For more information, the Cycle Vita patient-support team may be contacted by calling 1-888-360-VITA (1-888-360- 8482) or visiting www.cyclevita.life.
HOW Gilenya® WORKS
Gilenya® traps lymphocytes, a type of white blood cell, in the lymph nodes to keep them out of the brain and spinal cord. Gilenya may also have direct effects on cells in the central nervous system as well. Like Mayzent®, Zeposia® and Ponvory®, Gilenya® is a sphingosine 1-phosphate (S1P) receptor modulator.
Gilenya, FDA-approved in 2010, is indicated for relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary-progressive disease, in adults and children 10 years of age and older.
Potential Side Effects
Headache, flu, diarrhea, back pain, respiratory infections, abnormal liver tests and cough.
Possible adverse events include a reduction in heart rate (dose-related and transient); infrequent transient atrioventricular (AV) conduction block of the heart; increase in blood pressure; macular edema (swelling behind the eye); elevation of liver enzymes; and a slight increase in respiratory infections (including bronchitis). Rare serious infections include Progressive multifocal leukoencephalopathy (PML), a rare brain infection that usually leads to death or severe disability over a period of weeks or months, and fungal meningitis.
OTHER KEY INFORMATION
Testing completed prior to starting Gilenya® includes:
- Baseline ECG.
- Eye exam.
- Blood tests including liver test, blood count and varicella (chickenpox) antibodies.
- 6-hour monitoring of heart rate and blood pressure with first dose.
Patient advocates talk about
their treatment experience
Kristie Salerno Kent“I have had situations where treatments aren’t approved at first. My doctors, nurses, they actually go to bat for me and made it happen.”
Azure Antoinette"I will be undergoing my first disease-modifying therapy to help treat multiple sclerosis in my body and while I’m very nervous, I am equally as excited and looking forward to the positive effects of how I will feel physically, and mentally, and emotionally."
Damian Washington“Nobody’s going to be looking out for your best interests better than you.”
Cathy Chester“I think it’s really important to talk about how to age with this illness.”
Lauren Hutton-Work“Just because you have this disease does not mean that your work life should be awkward or uncomfortable.”
Chernise Joseph“My first neurologist was a frontline neurologist, he wasn’t an MS specialist.”
Julian Gamboa“If you’re newly diagnosed with multiple sclerosis remember it’s always okay to get a second opinion.”
Lauren and Sam Alcorn“Our future is uncertain and we have to enjoy each other and love each other in the present.”
Shawn Feliciano“I want to know what medications might work best for someone who’s Hispanic.”
Darlene Feigen“The sooner you get on a therapy the better it is in the long run.”
Birgit Bauer“At the end of the appointment you should have an answer to the most important questions.”
Ellen Tutton“I looked up all the different disease-modifying therapies and compared them to my lifestyle.”
Victoria Marie Reese“I’m trying to show my daughter that taking care of yourself is cool.”