TASCENSO ODT .25 mg/1
Fingolimod Lauryl Sulfate · TABLET, ORALLY DISINTEGRATING · Cycle Pharmaceuticals Ltd
TASCENSO ODT is a tablet, orally disintegrating containing fingolimod lauryl sulfate at .25 mg/1, taken oral. Manufactured by Cycle Pharmaceuticals Ltd.
Key Facts
- Brand Name
- TASCENSO ODT
- Generic Name
- Fingolimod Lauryl Sulfate
- NDC Code (Product)
70709-062- Manufacturer
- Cycle Pharmaceuticals Ltd
- Strength
- .25 mg/1
- Dosage Form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Marketing Status
- Application #
- NDA214962
- Marketing Start
- 02/01/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE TASCENSO ODT is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. TASCENSO ODT is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Assessments are required prior to initiating TASCENSO ODT ( 2.1 ) Recommended dosage for adults and pediatric patients (10 years of age and older) weighing more than 40 kg: 0.5 mg orally once daily, with or without food. ( 2.2 , 2.3 ) Recommended dosage for pediatric patients (10 years of age and older) weighing less than or equal to 40 kg: 0.25 mg orally once daily, with or without food ( 2.2 , 2.3 ). Administer TASCENSO ODT with or without water. Place tablet directly on the tongue and allow it to dissolve before swallowing. ( 2.2 ) First-Dose Monitoring (including reinitiation after discontinuation greater than 14 days and dose increases): Observe all patients for bradycardia for at least 6 hours; monitor pulse and blood pressure hourly. Electrocardiograms (ECGs) prior to dosing and at end of observation period required. ( 2.4 ) Monitor until resolution if heart rate < 45 beats per minute (bpm) in adults, < 55 bpm in patients aged 12 years and above, or < 60 bpm in pediatric patients aged 10 to below 12 years, atrioventricular (AV) block, or if lowest postdose heart rate is at the end of the observation period. ( 2.4 ) Monitor symptomatic bradycardia …
Contraindications
4 CONTRAINDICATIONS TASCENSO ODT is contraindicated in patients who have: In the last 6 months experienced myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization or Class III/IV heart failure. A history or presence of Mobitz Type II second-degree or third-degree AV block or sick sinus syndrome, unless patient has a functioning pacemaker [see Warnings and Precautions (5.1) ] A baseline QTc interval ≥ 500 msec Cardiac arrhythmias requiring anti-arrhythmic treatment with Class Ia or Class III anti-arrhythmic drugs Had a hypersensitivity reaction to fingolimod or any of the excipients in TASCENSO ODT. Observed reactions include rash, urticaria, and angioedema [see Warnings and Precautions (5.14) ]. Concomitant use with other products containing fingolimod Recent myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure with hospitalization, or Class III/IV heart failure. ( 4 ) History of Mobitz Type II 2 nd degree or 3 rd degree AV block or sick sinus syndrome, unless patient has a pacemaker. ( 4 ) Baseline QTc interval ≥ 500 msec. ( 4 ) Cardiac arrhythmias requiring anti-arrhythmic treatme…
Drug Interactions
7 DRUG INTERACTIONS Systemic Ketoconazole : Monitor during concomitant use. ( 7.2 , 12.3 ) Vaccines : Avoid live attenuated vaccines during, and for 2 months after stopping TASCENSO ODT treatment. ( 5.3 , 7.3 ) 7.1 QT Prolonging Drugs TASCENSO ODT has not been studied in patients treated with drugs that prolong the QT interval. Drugs that prolong the QT interval have been associated with cases of torsades de pointes in patients with bradycardia. Since initiation of TASCENSO ODT treatment results in decreased heart rate and may prolong the QT interval, patients on QT prolonging drugs with a known risk of torsades de pointes (e.g., citalopram, chlorpromazine, haloperidol, methadone, erythromycin) should be monitored overnight with continuous ECG in a medical facility [see Dosage and Administration (2.4) , Warnings and Precautions (5.1) ]. 7.2 Ketoconazole The blood levels of fingolimod and fingolimod-phosphate are increased by 1.7-fold when used concomitantly with ketoconazole. Patients who use TASCENSO ODT and systemic ketoconazole concomitantly should be closely monitored, as the risk of adverse reactions is greater. 7.3 Vaccines TASCENSO ODT reduces the immune response to vaccinat…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in labeling: Bradyarrhythmia and Atrioventricular Blocks [see Warnings and Precautions (5.1) ] Infections [see Warnings and Precautions (5.2) ] Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions (5.3) ] Macular Edema [see Warnings and Precautions (5.4) ] Liver Injury [see Warnings and Precautions (5.5) ] Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions (5.6) ] Respiratory Effects [see Warnings and Precautions (5.7) ] Fetal Risk [see Warnings and Precautions (5.8) ] Severe Increase in Disability After Stopping TASCENSO ODT [see Warnings and Precautions (5.9) ] Tumefactive Multiple Sclerosis [see Warnings and Precautions (5.10) ] Increased Blood Pressure [see Warnings and Precautions (5.11) ] Malignancies [see Warnings and Precautions (5.12) ] Immune System Effects Following TASCENSO ODT Discontinuation [see Warnings and Precautions (5.13) ] Hypersensitivity Reactions [see Warnings and Precautions (5.14) ] Most common adverse reactions (incidence ≥ 10% and greater than placebo): Headache, liver transaminase elevation, diarrhea, cough, influenza, sinusiti…
Frequently Asked Questions
What is TASCENSO ODT used for?
TASCENSO ODT contains Fingolimod Lauryl Sulfate. It is a tablet, orally disintegrating taken oral. Consult your doctor for specific uses.
Is TASCENSO ODT a controlled substance?
TASCENSO ODT is not classified as a controlled substance by the DEA.
What is the generic name for TASCENSO ODT?
The generic name for TASCENSO ODT is Fingolimod Lauryl Sulfate. There are no other listed brand versions of Fingolimod Lauryl Sulfate.
What is the NDC code for TASCENSO ODT .25 mg/1?
The NDC (National Drug Code) for TASCENSO ODT .25 mg/1 is 70709-062, listed by Cycle Pharmaceuticals Ltd.
Other TASCENSO ODT Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)