Fingolimod lauryl

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.

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.

Assessments are required prior to initiating TASCENSO ODT. 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. 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. Administer TASCENSO ODT with or without water. Place tablet directly on the tongue and allow it to dissolve before swallowing. 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.

TASCENSO ODT is contraindicated in patients who have: In the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (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 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.

Bradyarrhythmia and Atrioventricular Blocks: Because of a risk for bradyarrhythmia and AV blocks, monitor during initiation of treatment. Infections: TASCENSO ODT may increase the risk. Obtain a complete blood count (CBC) before initiating TASCENSO ODT (i.e., within 6 months). Monitor for infection during treatment and for 2 months after discontinuation. Do not start in patients with active infections. Progressive Multifocal Leukoencephalopathy (PML): Withhold TASCENSO ODT at the first sign or symptom suggestive of PML. Macular Edema: Increases the risk of macular edema. Obtain a baseline evaluation of the fundus, including the macula, near the start of treatment with TASCENSO ODT. Conduct an evaluation of the fundus, including the macula, 3 to 4 months after treatment start, periodically while on therapy, and any time there is a change in vision.

The following serious adverse reactions are described elsewhere in labeling: Bradyarrhythmia and Atrioventricular Blocks Infections Progressive Multifocal Leukoencephalopathy Macular Edema Liver Injury Posterior Reversible Encephalopathy Syndrome Respiratory Effects Fetal Risk Severe Increase in Disability After Stopping TASCENSO ODT Tumefactive Multiple Sclerosis Increased Blood Pressure Malignancies Immune System Effects Following TASCENSO ODT Discontinuation Hypersensitivity Reactions Most common adverse reactions (incidence ≥ 10% and greater than placebo): Headache, liver transaminase elevation, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain, and pain in extremity.

Systemic Ketoconazole: Monitor during concomitant use. Vaccines: Avoid live attenuated vaccines during, and for 2 months after stopping TASCENSO ODT treatment.

TASCENSO ODT should be stored at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from moisture. Store in sealed blister pack.