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 Aug 17, 2023.

Assessment Prior to Initiating TASCENSO ODT

Cardiac Evaluation

Obtain a cardiac evaluation in patients with certain preexisting conditions [see Dosage and Administration (2.4) and Warnings and Precautions (5.1)].

Prior to starting treatment, determine whether patients are taking drugs that could slow heart rate or atrioventricular (AV) conduction [see Dosage and Administration (2.4), Drug Interactions (7.5)].

Complete Blood Count (CBC)

Review results of a recent CBC [see Warnings and Precautions (5.2), Drug Interactions (7.6)].

Serum transaminases (ALT and AST) and Total Bilirubin Levels

Prior to starting treatment with TASCENSO ODT (i.e., within 6 months), review serum transaminases (ALT and AST) and total bilirubin levels [see Warnings and Precautions (5.5)].

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 [see Warnings and Precautions (5.2), Drug Interactions (7.4)].

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 [see Warnings and Precautions (5.2)]. 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) [see Dosage and Administration (2.4, 2.5)].

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.
Peel back the foil covering of one blister and gently remove the orally disintegrating tablet (ODT). Do not push the ODT through the foil.
As soon as the blister is opened, remove the ODT and 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 [see Warnings and Precautions (5.1), Clinical Pharmacology (12.2)]. 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 [see Warnings and Precautions (5.1)]
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 [see Warnings and Precautions (5.1), Drug Interactions (7.1)]
in patients receiving concurrent therapy with drugs that slow heart rate or AV conduction [see Drug Interactions (7.5)].

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 [see Dosage and Administration (2.4)]. 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.