TASCENSO ODT is a sphingosine 1-phosphate receptor modulator 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.

• Patients who in the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure with hospitalization, or Class III/IV heart failure.
• Patients with a history or presence of Mobitz Type II 2nd degree or 3rd degree AV block or sick sinus syndrome, unless patient has a functioning pacemaker.
• Patients with a baseline QTc interval ≥ 500 msec.
• Patients with cardiac arrhythmias requiring anti-arrhythmic treatment with Class Ia or Class III anti-arrhythmic drugs.
• Patients who had a hypersensitivity to fingolimod or any excipients in TASCENSO ODT.
• Concomitant use with other products containing fingolimod.

Warnings and Precautions:

Due to a risk for bradyarrhythmia and AV blocks patients should be monitored during TASCENSO ODT treatment initiation. TASCENSO ODT may increase blood pressure, risk of infections and may cause fetal harm. Cases of Progressive Multifocal Leukoencephalopathy and of clinically significant liver injury have occurred in patients treated with fingolimod in the postmarketing setting. TASCENSO ODT increases risk of macular edema. Rare cases of Posterior Reversible Encephalopathy Syndrome in adults have been reported with fingolimod.  Fingolimod can have respiratory effects. Severe increase in disability accompanied by multiple new lesions on MRI has been reported following discontinuation of fingolimod. MS relapses with tumefactive demyelinating lesions on imaging have been observed during fingolimod therapy and after discontinuation. The risk of basal cell carcinoma and melanoma is increased in patients treated with fingolimod. Cases of lymphoma have been reported in patients receiving fingolimod. The reporting rate of non-Hodgkin lymphoma with fingolimod is greater than that expected in the general population. Fingolimod remains in the blood and has pharmacodynamic effects, including decreased lymphocyte counts for up to 2 months following the last dose. Hypersensitivity reactions including rash, urticaria, and angioedema have been reported with fingolimod. Cases of seizures, including status epilepticus, have been reported with the use of fingolimod.

Adverse Reactions:

In clinical trials, the most common adverse reactions (incidence ≥ 10% and >placebo) are headache, liver transaminase elevation, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain, and pain in extremity.

Drug Interactions:

Patients on QT prolonging drugs with a known risk of torsades de pointes should be monitored during initiation of treatment with TASCENSO ODT. Monitor patients during use of systemic ketoconazole. Use of live attenuated vaccines during, and for 2 months after stopping TASCENSO ODT, should be avoided.

For more detailed information, please refer to the full Prescribing Information at www.tascenso.com/PI.

To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals Ltd at 1-888-533-1625 or the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.