FDA Approves Tascenso ODT® (fingolimod), similar to Gilenya, for Relapsing MS

The U.S. Food and Drug Administration recently approved Tascenso ODT^® (fingolimod, Cycle Pharmaceuticals) as an orally disintegrating tablet (ODT) disease-modifying therapy for people living with relapsing forms of MS who are 10 years of age or older.

• Relapsing forms of MS include clinically isolated syndrome (an initial neurological episode), relapsing-remitting MS, and active secondary progressive MS. People with active secondary progressive MS have had progression of disability but still experience acute relapses or new MRI activity.
• Tascenso ODT is a sphingosine 1-phosphate receptor modulator, which is thought to act by retaining certain white blood cells (lymphocytes) in the lymph nodes, thereby preventing those cells from crossing the blood-brain barrier in the central nervous system (CNS). Preventing the entry of these cells into the CNS reduces inflammatory damage to nerve cells.
• Tascenso ODT has the same mechanism of action and active ingredient as Gilenya, but comes as two different strengths in a tablet that dissolves on the tongue. Tascenso ODT is considered to be bioequivalent to Gilenya but is not a generic product; it is a brand name product.
  • Tascenso ODT has the same active ingredient (fingolimod) as brand name Gilenya and as the generic fingolimod products.
  • Tascenso ODT works in the body the same as Gilenya (fingolimod) capsules. It has the same safety, efficacy, and side effect profile as Gilenya, hence why it is considered bioequivalent.
  • The difference is in how the therapy is delivered: Gilenya and its generics are given as oral capsules, while Tascenso ODT is given as an oral tablet that dissolves in the mouth.
• Recommended dosing for Tascenso ODT:
  • 0.25mg orally once daily for individuals weighing less than or equal to 40kg (88 pounds)
  • 0.50mg orally once daily for individuals weighing more than 40kg (88 pounds)
  • Tablet is placed directly on tongue and allowed to dissolve (within seconds)
  • Monitoring in a healthcare setting for at least 6 hours upon initial dose or when restarting the medication after not taking for more than 14 days is required
• Side Effects: The most common adverse reactions reported from clinical trials were headache, elevated liver enzymes, diarrhea, cough, flu, stuffy nose, and body pains. Tascenso ODT may also cause serious side effects (see below under Potential Risks).
• Availability: Cycle Pharmaceuticals has announced that Tascenso ODT is available by prescription as of February 2023.
• Support Programs: The company has announced its intent to enable access to Tascenso ODT through support programs. For more information, individuals may call: 1-888-360-VITA (8482), email hello@cyclevita.life or visit www.tascenso.com/.
• Price: Cycle Pharmaceuticals has announced that Tascenso ODT will have an initial annual list price at parity with Gilenya; Gilenya currently costs approximately $10,138 per 30 days (as of February 15, 2023). The actual cost to an individual will depend on the provisions of their insurance coverage and the degree to which that individual will be eligible for programs designed to assist with out-of-pocket costs.

Read more about disease-modifying therapies and other treatments for MS and MS symptomsDownload prescribing information for Tascenso ODT (.pdf)Download the Tascenso ODT Medication Guide for people with MS(.pdf) FURTHER DETAILSPotential Risks: Prescribing information cautions that Tascenso ODT should not be administered in individuals with active infection. Individuals should not receive live vaccines during treatment with Tascenso ODT and for 2 months after treatment is stopped. Because of the risk for fetal harm, women of reproductive potential are cautioned to use birth control during and for 2 months after stopping Tascenso ODT. Individuals should be monitored for symptoms of progressive multifocal leukoencephalopathy (PML) as well as macular edema and the provider should be contacted right away at first signs of symptoms. For lists of possible symptoms to be aware of, see the Medication Guide. Pre-dosing Tests and Dosing: Individuals prescribed Tascenso ODT are required to have an electrocardiogram (ECG) test done to check the electrical activity of the heart before the first dose because this treatment can cause a slow heart rate. Individuals will be observed by a healthcare professional for at least 6 hours upon the initial dose. Taking a disease-modifying therapy is currently the best way to reduce MS disease activity, prevent accumulation of disability and protect the brain from damage due to MS. Selecting an MS therapy should be done by people with MS in collaboration with their MS healthcare provider. Important questions to be considered and discussed with your doctor in terms of Tascenso ODT include:

• How am I doing on my current therapy?
• What is my tolerance for the risk of known side effects?
• What is my tolerance for the risk of adverse consequences that might emerge with longer-term use?
• Does the administration schedule fit into my lifestyle?
• Will I remember to take it as prescribed?
• How will my medication choice affect my ability or plans to become pregnant (if applicable)?
• What are the comparative costs of my current therapy versus Tascenso ODT?

Avonex is a registered trademark of BiogenGilenya is a registered trademark of NovartisTascenso ODT is a registered trademark of Cycle Pharmaceuticals article source

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