Tascenso ODT Dosage
Generic name: Fingolimod Lauryl Sulfate 0.25mg
Dosage form: tablet, orally disintegrating
Drug class: Selective immunosuppressants
Medically reviewed by Drugs.com. Last updated on Jul 30, 2024.
Assessment Prior to Initiating TASCENSO ODT
Cardiac Evaluation
Obtain a cardiac evaluation in patients with certain preexisting conditions.
Prior to starting treatment, determine whether patients are taking drugs that could slow heart rate or atrioventricular (AV) conduction.
Serum Transaminases (ALT and AST) and Total Bilirubin Levels
Prior to starting treatment with TASCENSO ODT (i.e., within 6 months), review serum transaminases [alanine transaminase (ALT) and aspartate transferase (AST)] and total bilirubin levels.
Ophthalmic Assessment
Obtain a baseline evaluation of the fundus, including the macula, near the start of treatment with TASCENSO ODT.
Skin Examination
Obtain a baseline skin examination prior to or shortly after initiation of TASCENSO ODT. If a suspicious skin lesion is observed, it should be promptly evaluated.
Prior Medications
If patients are taking antineoplastic, immunosuppressive, or immune-modulating therapies, or if there is a history of prior use of these drugs, consider possible unintended additive immunosuppressive effects prior to initiating treatment with TASCENSO ODT.
Vaccinations
Prior to initiating TASCENSO ODT, test patients for antibodies to varicella zoster virus (VZV). VZV vaccination of antibody- negative patients is recommended prior to commencing treatment with TASCENSO ODT. It is recommended that pediatric patients if possible, complete all other immunizations in accordance with current immunization guidelines prior to initiating TASCENSO ODT.
Important Administration Instructions
Patients who initiate TASCENSO ODT, and those who reinitiate treatment after discontinuation for longer than 14 days, require first- dose monitoring. This monitoring is also recommended when the dose is increased in pediatric patients. Patients who are currently treated with another fingolimod product and underwent first-dose monitoring at initiation may be switched to TASCENSO ODT at the same daily dose without a need to repeat first-dose monitoring (unless the previous treatment was discontinued more than 14 days prior).
TASCENSO ODT can be taken with or without food.
Inform the patient about the following administration instructions for TASCENSO ODT:
- Use dry hands when opening the blister pack.
- Do not push the orally disintegrating tablet (ODT) through the lidding foil.
- Peel back the lidding foil from one blister, push the underside of the foil packet to release the ODT and gently remove.
- As soon as the blister is opened, remove the ODT, place on the tongue and allow it to dissolve before swallowing.
- The ODT may be taken with or without water.
- Take the ODT immediately after opening the blister pack. Do not store the ODT outside the blister pack for future use.
Recommended Dosage
In adults and pediatric patients 10 years of age and older weighing more than 40 kg, the recommended dosage of TASCENSO ODT is 0.5 mg orally once-daily.
In pediatric patients 10 years of age and older weighing less than or equal to 40 kg, the recommended dosage of TASCENSO ODT is 0.25 mg orally once daily.
Fingolimod doses higher than 0.5 mg are associated with a greater incidence of adverse reactions without additional benefit.
First-Dose Monitoring
Initiation of TASCENSO ODT treatment results in a decrease in heart rate, for which monitoring is recommended. Prior to dosing and at the end of the observation period, obtain an electrocardiogram (ECG) in all patients.
First 6-Hour Monitoring
Administer the first dose of TASCENSO ODT in a setting in which resources to appropriately manage symptomatic bradycardia are available. Monitor all patients for 6 hours after the first dose for signs and symptoms of bradycardia with hourly pulse and blood pressure measurement.
Additional Monitoring after 6-Hour Monitoring
Continue monitoring until the abnormality resolves if any of the following is present (even in the absence of symptoms) after 6 hours:
- The heart rate 6 hours postdose is less than 45 bpm in adults, less than 55 bpm in pediatric patients 12 years of age and older, or less than 60 bpm in pediatric patients 10 or 11 years of age
- The heart rate 6 hours postdose is at the lowest value postdose suggesting that the maximum pharmacodynamic effect on the heart may not have occurred
- The ECG 6 hours postdose shows new onset second degree or higher AV block.
If postdose symptomatic bradycardia occurs, initiate appropriate management, begin continuous ECG monitoring, and continue monitoring until the symptoms have resolved if no pharmacological treatment is required. If pharmacological treatment is required, continue monitoring overnight and repeat 6-hour monitoring after the second dose.
Overnight Monitoring
Continuous overnight ECG monitoring in a medical facility should be instituted:
- in patients that require pharmacologic intervention for symptomatic bradycardia. In these patients, the first-dose monitoring strategy should be repeated after the second dose of TASCENSO ODT
- in patients with some preexisting heart and cerebrovascular conditions
- in patients with a prolonged QTc interval before dosing or during 6-hour observation, or at additional risk for QT prolongation, or on concurrent therapy with QT prolonging drugs with a known risk of torsades de pointes
- in patients receiving concurrent therapy with drugs that slow heart rate or AV conduction.
Monitoring After Reinitiation of Therapy Following Discontinuation
When restarting TASCENSO ODT treatment after discontinuation for more than 14 days after the first month of treatment, perform first-dose monitoring, because effects on heart rate and AV conduction may recur on reintroduction of TASCENSO ODT treatment. The same precautions (first-dose monitoring) as for initial dosing are applicable. Within the first 2 weeks of treatment, first-dose procedures are recommended after interruption of 1 day or more; during Weeks 3 and 4 of treatment, first-dose procedures are recommended after treatment interruption of more than 7 days.
Frequently asked questions
- Gilenya vs Tecfidera. How do they compare?
- What are the new drugs used for multiple sclerosis (MS)?
- How much does Gilenya cost?
- What happens when you stop taking Gilenya?
- Does Gilenya suppress the immune system?
- Where is Gilenya manufactured and by whom?
- How long does it take Gilenya to work?
- Does Gilenya cause hair loss?
- What does Gilenya do for multiple sclerosis (MS)?
More about Tascenso ODT (fingolimod)
- Check interactions
- Compare alternatives
- Pricing & coupons
- Imprints, shape & color data
- Side effects
- During pregnancy
- FDA approval history
- Drug class: selective immunosuppressants
- Breastfeeding
- En español
Patient resources
Other brands
Professional resources
Other brands
Related treatment guides
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.