Tascenso ODT FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 9, 2023.
FDA Approved: Yes (First approved December 23, 2021)
Brand name: Tascenso ODT
Generic name: fingolimod lauryl sulfate
Dosage form: Orally Disintegrating Tablets
Company: Cycle Pharmaceuticals Ltd.
Treatment for: Multiple Sclerosis
Tascenso ODT (fingolimod) is a sphingosine 1-phosphate receptor modulator for the treatment of relapsing forms of multiple sclerosis (MS).
- Tascenso ODT is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.
- The way in which fingolimod works to treat multiple sclerosis is unknown, but may involve reduction of lymphocyte migration into the central nervous system. Fingolimod is metabolized by sphingosine kinase to form fingolimod phosphate, which binds to the sphingosine 1-phosphate receptors, blocking the capacity of lymphocytes to egress from lymph nodes, and reducing the number of lymphocytes in peripheral blood.
- Fingolimod was first approved in an oral capsule dosage form under the brand name Gilenya (fingolimod hydrochloride) in 2010.
- Tascenso ODT is administered orally, once daily. The orally disintegrating tablet (ODT) can be taken with or without water and dissolves on the tongue within seconds.
- The launch of Tascenso ODT in Q1 2023 aims to address the withdrawal of the Gilenya® (fingolimod) capsules patient support program (Go Program®) on March 31, 2023. Eligible patients prescribed Tascenso ODT will have access to patient support from Cycle Vita™, Cycle’s in-house patient support hub.
- Warnings and precautions associated with Tascenso ODT include increased risk of bradyarrhythmia and atrioventricular blocks, infections, progressive multifocal leukoencephalopathy (PML), macular edema, liver injury, posterior reversible encephalopathy syndrome (PRES), respiratory effects, fetal harm, severe increase in disability after discontinuation of treatment, tumefactive MS, increased blood pressure, and skin cancer.
- Common adverse reactions include headache, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain, and pain in extremities.
Common laboratory abnormalities include elevated liver transaminases.
Development timeline for Tascenso ODT
Further information
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