Tascenso ODT (fingolimod) is a sphingosine 1-phosphate receptor modulator for the treatment of relapsing forms of multiple sclerosis (MS) in adults and children aged 10 years and older. ODT stands for orally disintegrating tablet.

This medicine will not cure MS, but it may slow some disabling effects and decrease the number of relapses in the relapsing forms of MS (such as clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease).

Exactly how Tascenso ODT works to treat MS is unknown, but it may involve a decrease in the migration of lymphocytes into the brain and spinal cord (central nervous system). This reduces nerve inflammation and damage. Inside the body, Tascenso ODT is metabolized by sphingosine kinase to form fingolimod phosphate, which binds to the sphingosine 1-phosphate receptors, blocking the capacity of lymphocytes to exit lymph nodes, and reducing the number of lymphocytes in peripheral blood.

Tascenso ODT was first approved on December 23, 2021.

Tascenso ODT should not be used with other products containing fingolimod or by people with the following conditions:

• Recent myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure with hospitalization, or Class III/IV heart failure
• A history of Mobitz Type II 2nd-degree or 3rd-degree AV block or sick sinus syndrome, unless the person has a pacemaker
• A baseline QTc interval of ≥ 500 msec
• Cardiac arrhythmias requiring anti-arrhythmic treatment with Class Ia or Class III anti-arrhythmic drugs
• Known hypersensitivity to fingolimod or its excipients.

Other warnings and precautions associated with Tascenso ODT include an 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.

Pregnancy

May cause fetal harm when administered to pregnant women. Tascenso ODT should be stopped at least 2 months before a planned conception.

Lactation

There is no data about the presence of fingolimod in human milk but based on animal data it is likely to be present.

Tascenso ODT is taken orally, once daily.

• Use dry hands when you open the blister pack. Remove the tablet from the pack by gently pulling back the foil covering one blister, rather than pushing the tablet through the foil.
• Place the tablet on the tongue and allow it to dissolve before swallowing.
• The orally disintegrating tablet (ODT) can be taken with or without water and dissolves on the tongue within seconds.

Eligible patients prescribed Tascenso ODT will have access to patient support from Cycle Vita™, Cycle’s in-house patient support hub.

First dose monitoring

The first time you take Tascenso ODT, or if you reinitiate it after a break of more than 14 days, or if your dose is increased, you will need to be observed in a doctor’s office or another facility for at least 6 hours and have your pulse and blood pressure monitored. An ECG is also required before dosing and at the end of the observation period. If your heart rate or blood pressure drops below a certain level, you may need to stay overnight until it has resolved.

• Adults and children aged 10 years and older weighing more than 40kg: 0.5 mg orally once daily
• Adults and children aged 10 years and older weighing less than or equal to 40kg: 0.25 mg orally once daily.

Dosages of Tascenso ODT higher than 0.5 mg are associated with a greater incidence of side effects without any additional benefits.

Before starting treatment, your doctor may need to conduct the following investigations:

• Cardiac evaluation in people with certain pre-existing conditions
• Medication check to determine if any of the other medicines you take could slow your heart rate or atrioventricular conduction, or if you take any other medications that may suppress your immune system or increase your infection risk such as antineoplastics, immunosuppressive or immunomodulating treatments, or if there is a history of prior use of these drugs
• A complete blood count if a recent one is not available
• Liver function tests that include serum transaminases (ALT and AST) and total bilirubin levels if one has not been done less than 6 months prior
• An assessment of your antibody levels to varicella zoster virus (VZV). Some people may require VZV vaccination and pediatric patients should have completed all other recommended childhood immunizations before starting Tascenso ODT.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Do not stop taking Tascenso ODT without first talking to your doctor about it.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Common adverse reactions include back pain, abdominal pain, pain in the extremities, cough, diarrhea, headache, high blood pressure, infections, influenza, and sinusitis

Common laboratory abnormalities include elevated liver transaminases.

Fingolimod persists in the blood for up to 2 months and it may take this long for lymphocyte counts to return to normal. Because of these continuing pharmacodynamic effects be cautious when initiating other drugs, such as immunosuppressants because of additive effects.

Tascenso ODT has the potential to interact with many medications including:

• Ketoconazole
• Medications that slow your heart rate, and atrioventricular conduction, suppress your immune system, or increase your infection risk
• QT-prolonging drugs such as citalopram, chlorpromazine, or haloperidol
• Vaccines.

Tascenso ODT may interfere with the results of peripheral blood lymphocyte counts because it redistributes lymphocytes into secondary lymphoid organs.

This list is not complete. Many other drugs may interact with atorvastatin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed and you should refer to the product information for a full list.