Tascenso ODT

Medically reviewed by Carmen Pope, BPharm. Last updated on Jun 20, 2024.

Pronunciation: tuh-SEN-soh O-D-T
Generic name: fingolimod
Brand name: Tascenso
Dosage forms: oral disintegrating tablet

What is Tascenso ODT?

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.

Warnings

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.

Before taking this medicine

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
• A skin cancer check
• 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.

Dosing information

• 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.

How should I take Tascenso ODT?

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.

Tascenso ODT side effects

Common side effects of Tascenso ODT include:

• back pain, abdominal pain, or pain in the extremities
• cough
• diarrhea
• headache
• high blood pressure
• infections
• influenza
• 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.

Serious side effects

Get emergency medical help if you have signs of an allergic reaction to Tascenso ODT: such as hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

Tascenso ODT may cause a rare brain infection called progressive multifocal leukoencephalopathy (PML) that can lead to disability or death. Tell your doctor if you have problems with speech, thought, vision, or muscle movement. These symptoms can get worse quickly. Longer treatment durations of Tascenso ODT (more than 18 months) increase the risk. 

Tascenso ODT can affect your immune system (even 2 months after you've taken this medicine). You may get infections more easily, even serious or fatal infections. Call your doctor if you have:

• signs of a new infection - fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Also, call your doctor at once if you have:

• new darkened area on your skin, a sore that does not heal, a mole that has changed in size or color, or a bump that looks shiny, pearly, or pink. The risk of certain skin cancers, such as basal cell carcinoma and melanoma, is increased in people who take S1P receptor modulators such as Tascenso ODT;

• vision problems such as increased sensitivity to light, blurred vision, having a blind spot or shadows in the center of your vision, or unusual color to your vision (may occur 3 to 4 months after you start taking Tascenso ODT). S1P receptor modulators, including Tascenso ODT, have been associated with an increased risk of macular edema. Your healthcare provider should send you for an eye examination before starting treatment, 3 to 4 months into treatment, periodically thereafter, and any time there is a vision change. Patients with diabetes or a history of uveitis are more at risk;

• new or worsened breathing problems;

• sores in your mouth and throat, cold sores, sores on your genital or anal area;

• new or worsening symptoms of multiple sclerosis at least 12 weeks after your last dose;

• sudden confusion, severe headache, weakness, vision loss, or seizure;

• increased blood pressure;

• a light-headed feeling, like you might pass out;

• heart problems - chest pain, slow or irregular heartbeats, and feeling dizzy or tired; or

• liver problems - nausea, loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What happens if I miss a dose?

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.

What happens if I overdose?

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

What other drugs will affect Tascenso ODT?

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.

Storage

Store at room temperature 20° to 25°C (68°F to 77°F) and protect from moisture. Store in the sealed blister pack until ready to take.

Ingredients

Active ingredients: Each ODT contains 0.25 mg or 0.5 mg of fingolimod (equivalent to 0.47 mg or 0.93 mg of fingolimod lauryl sulfate).

Inactive ingredients: gelatin, mannitol, medium-chain triglycerides, sodium chloride, and sodium lauryl sulfate.

Manufacturer

Cycle Pharmaceuticals.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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