Tascenso ODT

Generic name: fingolimod (oral route)
Drug class: Selective immunosuppressants

Medically reviewed by  A Ras MD.

What is Tascenso ODT?

Tascenso ODT is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in children 10 years of age and older and weighing less than or equal to 40 kg.

It is not known if Tascenso ODT is safe and effective in children under 10 years of age. Tascenso ODT is not approved for use in adults.

Description

Fingolimod is a sphingosine 1-phosphate receptor modulator.

Chemically, fingolimod is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride. Its structure is shown below:

Fingolimod hydrochloride, USP is a white to off white powder that is freely soluble in water and alcohol and soluble in propylene glycol. It has a molecular weight of 343.93 g/mol.

Fingolimod is provided as 0.5 mg hard gelatin capsules for oral use.

Each 0.5 mg capsule contains 0.56 mg of fingolimod hydrochloride, USP equivalent to 0.5 mg of fingolimod.

Each fingolimod 0.5 mg capsule contains the following inactive ingredients: gelatin, magnesium stearate, microcrystalline cellulose, titanium dioxide and iron oxide yellow.

The imprinting ink contains shellac, black iron oxide and trace amount (less than 1 ppb) of Potassium salts of potassium hydroxides.

 Mechanism of Action

Fingolimod is metabolized by sphingosine kinase to the active metabolite, fingolimod-phosphate. Fingolimod-phosphate is a sphingosine 1-phosphate receptor modulator, and binds with high affinity to sphingosine 1-phosphate receptors 1, 3, 4, and 5. Fingolimod-phosphate blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood. The mechanism by which fingolimod exerts therapeutic effects in multiple sclerosis is unknown, but may involve reduction of lymphocyte migration into the central nervous system.

What is the most important information I should know about Tascenso ODT?

Tascenso ODT may cause serious side effects, including:

1. Slow heart rate (bradycardia or bradyarrhythmia) when your child starts taking Tascenso ODT.
Tascenso ODT can cause your child’s heart rate to slow down, especially after your child takes the first dose. Your child will have a test, called an electrocardiogram (ECG), to check the electrical activity of your child’s heart before your child takes the first dose of Tascenso ODT. All children will be observed by a healthcare professional for at least 6 hours after taking their first dose of Tascenso ODT.

All children should also be observed by a healthcare professional for at least 6 hours after taking their first increased dose of any fingolimod product approved for use at a higher dose when switching from the 0.25 mg dose.

After a child takes the first dose of Tascenso ODT or an increased dose of any fingolimod product approved for use at a higher dose:

• Your child’s pulse and blood pressure should be checked every hour.
• Your child should be observed by a healthcare professional to see if your child has any serious side effects. If the heart rate slows down too much, your child may have symptoms, such as:
  • dizziness
  • tiredness
  • feeling like your heart is beating slowly or skipping beats
  • chest pain
• If your child has any symptoms of slow heart rate, the symptoms will usually happen during the first 6 hours after the first dose of Tascenso ODT. Symptoms can happen up to 24 hours after a child takes a first dose of Tascenso ODT.
• 6 hours after your child takes the first dose of Tascenso ODT your child will have another ECG. If the ECG shows any heart problems or if the heart rate is still too low or continues to decrease, your child will continue to be observed.
• If your child has any serious side effects after a first dose of Tascenso ODT, especially those that require treatment with other medicines, your child will stay in the medical facility to be observed overnight. Your child will also be observed for any serious side effects for at least 6 hours after taking a second dose of Tascenso ODT the next day.
• If your child has certain types of heart problems, or if your child is taking certain types of medicines that can affect your heart, your child will be observed overnight after taking the first dose of Tascenso ODT.

A slow heart rate will usually return to normal within 1 month after your child starts taking Tascenso ODT. Call your child’s doctor or go to the nearest hospital emergency room right away if your child has any symptoms of a slow heart rate.

If your child misses 1 or more doses of Tascenso ODT, your child may need to be observed by a healthcare professional when your child takes the next dose. Call your child’s doctor if your child misses a dose of Tascenso ODT. See “How should I take Tascenso ODT?”

2. Infections.
Tascenso ODT can increase your child’s risk of serious infections that can be life-threatening and cause death. Your child should not receive live vaccines during treatment with Tascenso ODT and for 2 months after your child stops taking Tascenso ODT. Talk to your child’s doctor before your child receives a vaccine during treatment and for 2 months after treatment with Tascenso ODT. If your child receives a live vaccine, your child may get the infection the vaccine was meant to prevent. Vaccines may not work as well when given during treatment with Tascenso ODT.

Tascenso ODT lowers the number of white blood cells (lymphocytes) in your child’s blood. This will usually go back to normal within 2 months of stopping treatment. Your child’s doctor may do a blood test to check your child’s white blood cells before a child starts taking Tascenso ODT. Call your child’s doctor right away if your child has any of these symptoms of an infection during treatment with Tascenso ODT, and for 2 months after your child’s last dose of Tascenso ODT:

• fever
• tiredness
• body aches
• chills
• nausea
• vomiting
• headache with fever, neck stiffness, sensitivity to light, nausea, or confusion (these may be symptoms of meningitis, an infection of the lining around your brain and spine)

3. Progressive multifocal leukoencephalopathy (PML).
PML is a rare brain infection that usually leads to death or severe disability. If PML happens, it usually happens in people with weakened immune systems but has happened in people who do not have weakened immune systems. Symptoms of PML get worse over days to weeks. Call your child’s doctor right away if your child has any new or worsening symptoms of PML, that have lasted several days, including:

• weakness on 1 side of the body
• loss of coordination in arms and legs
• decreased strength
• problems with balance
• changes in vision
• changes in thinking or memory
• confusion
• changes in personality

4. A problem with vision called macular edema.
Macular edema can cause some of the same vision symptoms as a multiple sclerosis (MS) attack (optic neuritis). Your child may not notice any symptoms with macular edema. If macular edema happens, it usually starts in the first 3 to 4 months after a child starts taking fingolimod, the active ingredient in Tascenso ODT. Your child’s doctor should test your child’s vision before your child starts taking Tascenso ODT and 3 to 4 months thereafter, or any time your child notice vision changes during treatment with Tascenso ODT. Your child’s risk of macular edema is higher if your child has diabetes or has had an inflammation of the eye called uveitis.
Call your child’s doctor right away if your child has any of the following:

• blurriness or shadows in the center of vision
• a blind spot in the center of vision
• sensitivity to light
• unusually colored (tinted) vision

Who should not take Tascenso ODT?

Do not take Tascenso ODT if your child:

• has had a heart attack, unstable angina, stroke or mini-stroke (transient ischemic attack or TIA) or certain types of heart failure in the last 6 months.
• has certain types of irregular or abnormal heartbeat (arrhythmia), including patients in whom a heart finding called prolonged QT is seen on ECG before starting Tascenso ODT.
• has a heart rhythm problem that needs treatment with certain medicines.
• is allergic to fingolimod or any of the ingredients in Tascenso ODT. See the end of this guide for a complete list of ingredients in Tascenso ODT. Symptoms of an allergic reaction may include rash, itchy hives, or swelling of the lips, tongue or face.
• taking other products containing fingolimod, the active ingredient in Tascenso ODT.

Talk to your child’s doctor before taking Tascenso ODT if your child has any of these conditions, or do not know if your child has any of these conditions.

What should I tell my healthcare provider before taking Tascenso ODT?

Before your child takes Tascenso ODT, tell your child’s doctor about all your child’s medical conditions, including:

• an irregular or abnormal heartbeat (arrhythmia).
• a history of stroke or mini-stroke.
• heart problems, including heart attack or angina.
• a history of repeated fainting (syncope).
• a fever or infection, or your child is unable to fight infections due to a disease or take or have taken medicines that lower your immune system.
• recently received a vaccine or are scheduled to receive a vaccine.
• chickenpox or have received the vaccine for chickenpox. Your child’s doctor may do a blood test for chickenpox virus. Your child may need to get the full course of the vaccine for chickenpox and then wait 1 month before your child starts taking Tascenso ODT.
• your child has completed their vaccination schedule. Your child needs to have completed their vaccination schedule before starting treatment with Tascenso ODT.
• eye problems, especially an inflammation of the eye called uveitis.
• diabetes.
• breathing problems, including during your sleep.
• liver problems.
• high blood pressure.
• types of skin cancer called basal cell carcinoma (BCC) or melanoma.
• are pregnant. Tascenso ODT may harm your child’s unborn baby. Tell your child’s doctor right away if your child becomes pregnant while taking Tascenso ODT or if your child becomes pregnant within 2 months after your child stops taking Tascenso ODT.
  • If your child is a female who can become pregnant, your child should use effective birth control during treatment with Tascenso ODT and for at least 2 months after your child stops taking Tascenso ODT.
• are breastfeeding or plan to breastfeed. It is not known if Tascenso ODT passes into your child’s breast milk. Talk to your child’s doctor about the best way to feed your child’s baby if your child takes Tascenso ODT.

Tell your child’s doctor about all the medicines your child takes or has recently taken, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your child’s doctor if your child takes medicines that affect the immune system, including corticosteroids, or have taken them in the past.

Know the medicines your child takes. Keep a list of your child’s medicines to show your child’s doctor and pharmacist when your child gets a new medicine.

Using Tascenso ODT and other medicines together may affect each other causing serious side effects.

Do not take Tascenso ODT with Gilenya or other medicines containing fingolimod.

How should I take Tascenso ODT?

• Children will be observed by a healthcare professional for at least 6 hours after taking their first dose of Tascenso ODT. Children should also be observed by a healthcare professional for at least 6 hours after taking their first increased dose of any fingolimod product approved for use at a higher dose when switching from the 0.25 mg dose. See “What is the most important information I should know about Tascenso ODT?”
• Take Tascenso ODT exactly as your child’s doctor tells your child to take it.
• Take Tascenso ODT 1 time each day.
• The ODT may be taken with or without water.
• Take Tascenso ODT with or without food.
• Take the Tascenso ODT immediately after opening the blister pack. Do not store the Tascenso ODT outside the blister pack for future use.
• Use dry hands when opening the blister pack.
• Peel back the foil covering of 1 blister pack and gently remove the orally disintegrating tablet (ODT). Do not push the ODT through the foil.
• As soon as the blister pack is opened, remove the ODT and place on the tongue and allow it to dissolve.
• If your child takes too much Tascenso ODT, call your child’s doctor or go to the nearest hospital emergency room right away.
• Do not stop taking Tascenso ODT without talking with your child’s doctor first.
• Call your child’s doctor right away if your child misses a dose of Tascenso ODT. Your child may need to be observed by a healthcare professional for at least 6 hours when your child takes the next dose. If your child needs to be observed by a healthcare professional when your child takes the next dose of Tascenso ODT your child will have:
  • an ECG before your child takes the dose
  • hourly pulse and blood pressure measurements after your child takes the dose
  • an ECG 6 hours after your child’s dose

See “What is the most important information I should know about Tascenso ODT?”

What are the possible side effects of Tascenso ODT?

• Tascenso ODT may cause serious side effects, including:
• See “What is the most important information I should know about Tascenso ODT?”
• swelling and narrowing of the blood vessels in your child’s brain. A condition called PRES (Posterior Reversible Encephalopathy Syndrome) has happened rarely in adults taking fingolimod, the active ingredient in Tascenso ODT. Symptoms of PRES usually get better when your child stops taking Tascenso ODT. However, if left untreated, it may lead to a stroke. Call your child’s doctor right away if your child has any of the following symptoms:
  • sudden severe headache
  • sudden confusion
  • sudden loss of vision or other changes in your child’s vision
  • seizure
• liver damage.​​​​​ Tascenso ODT may cause liver damage. Your child’s doctor should do blood tests to check your child’s liver before your child starts taking Tascenso ODT and periodically during treatment. Call your child’s doctor right away if your child has any of the following symptoms of liver damage:
  • nausea
  • vomiting
  • stomach pain
  • tiredness
  • loss of appetite
  • your child’s skin or the whites of your child’s eyes turn yellow
  • dark urine
• breathing problems. Some people who take Tascenso ODT have shortness of breath. Call your child’s doctor right away if your child has new or worsening breathing problems.
• severe worsening of multiple sclerosis after stopping Tascenso ODT. When Tascenso ODT is stopped, symptoms of MS can return and become worse compared to before or during treatment. Many people who have worsening of MS symptoms after stopping Tascenso ODT do not return to the level of function that they had before stopping Tascenso ODT. This worsening happens most often within 12 weeks after stopping Tascenso ODT but can happen later. Always talk to your child’s doctor before your child stops taking Tascenso ODT for any reason. Tell your child’s doctor if your child has worsening symptoms of MS after stopping Tascenso ODT.
• increased blood pressure. Your child’s doctor should check your child’s blood pressure during treatment with Tascenso ODT.
• types of skin cancer called basal cell carcinoma (BCC) and melanoma. Tell your child’s doctor if your child has any changes in the appearance of the skin, including changes in a mole, a new darkened area on your child’s skin, a sore that does not heal, or growths on the skin, such as a bump that may be shiny, pearly white, skin-colored, or pink. Your child’s doctor should check your child’s skin for any changes during treatment with Tascenso ODT. Limit the amount of time your child spends in sunlight and ultraviolet (UV) light. Your child should wear protective clothing and use a sunscreen with a high sun protection factor.
• allergic reactions. Call your child’s doctor if your child has symptoms of an allergic reaction, including a rash, itchy hives, or swelling of the lips, tongue or face.

The most common side effects of Tascenso ODT include:

• headache
• abnormal liver tests
• diarrhea
• cough
• flu
• inflammation of the sinuses (sinusitis)
• back pain
• stomach-area (abdominal) pain
• pain in arms or legs

Tell your child’s doctor if your child has any side effect that bothers your child or that does not go away. These are not all of the possible side effects of Tascenso ODT. For more information, ask your child’s doctor or pharmacist. Call your child’s doctor for medical advice about side effects. You may report side effects to FDA at 1-800- FDA-1088.

General information about the safe and effective use of Tascenso ODT

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Tascensov ODT for a condition for which it was not prescribed. Do not give Tascenso ODT to other people, even if they have the same symptoms that your child has. It may harm them. This Medication Guide summarizes the most important information about Tascenso ODT. If you would like more information, talk with your child’s healthcare provider. You can ask your child’s healthcare provider or pharmacist for information about Tascenso ODT that is written for health professionals.

How should I store Tascenso ODT?

• Store Tascenso ODT in the blister pack in a dry place.
• Store Tascenso ODT at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not open the blister pack until ready to take Tascenso ODT.
• Keep Tascenso ODT and all medicines out of the reach of children.

What are the ingredients in Tascenso ODT?

Active ingredient: fingolimod lauryl sulfate

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