Tascenso Odt
Fingolimod Lauryl Sulfate · Tablet, Orally Disintegrating · Oral
Uses
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 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 with ECG until resolved. Continue overnight if intervention is required; repeat first-dose monitoring for second dose. ( 2.4 ) Observe patients overnight if at higher risk of symptomatic bradycardia, heart block, prolonged QTc interval, or if taking drugs with known risk of torsades de pointes. ( 2.4 , 7.1 ) 2.1 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 [alanine transaminase (ALT) and aspartate transferase (AST)] and total bilirubin levels [see Warnings and Precautions (5.5) ] . Ophthalmic Assessment Obtain a baseline evaluation of the fundus, including the macula, near the start of treatment with TASCENSO ODT [see Warnings and Precautions ( 5.4 )]. 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 [see Warnings and Precautions ( 5.12 )]. 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. 2.2 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: Store the orally disintegrating tablet (ODT) in the sealed blister until ready to administer. Do not push the ODT through the lidding foil. Use dry hands when opening the blister pack. Peel back the lidding foil from one blister, then push the underside of the foil packet to release the ODT and gently remove the ODT. Take the ODT immediately after opening the blister pack. Place the ODT on the tongue and allow it to dissolve before swallowing. The ODT may be taken with or without water. 2.3 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. 2.4 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.
Dosage forms and strengths
3 DOSAGE FORMS AND STRENGTHS TASCENSO ODT is available as: 0.25 mg orally disintegrating tablets are white to off white, round tablets debossed with . 0.5 mg orally disintegrating tablets are white to off white, round tablets debossed with . Orally disintegrating tablets: 0.25 mg and 0.5 mg ( 3 ) image image description
Contraindications
4 CONTRAINDICATIONS 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 [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) ]. 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 treatment with Class Ia or Class III anti-arrhythmic drugs. ( 4 ) Hypersensitivity to fingolimod or its excipients. ( 4 )
Warnings and precautions
Bradyarrhythmia and Atrioventricular Blocks : Because of a risk for bradyarrhythmia and AV blocks, monitor during initiation of treatment ( 2.4 , 5.1 ) 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. ( 5.2 ) Progressive Multifocal Leukoencephalopathy (PML) : Withhold TASCENSO ODT at the first sign or symptom suggestive of PML. ( 5.3 ) 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. Consider discontinuing TASCENSO ODT if macular edema develops. Diabetes mellitus and uveitis increase the risk. ( 5.4 ) Liver Injury : Obtain liver enzyme results before initiation and periodically during treatment. Closely monitor patients with severe hepatic impairment. Discontinue if evidence of liver injury without other cause. ( 5.5 , 8.6 , 12.3 ) Posterior Reversible Encephalopathy Syndrome (PRES) : If suspected, discontinue TASCENSO ODT. ( 5.6 ) Respiratory Effects : Evaluate when clinically indicated. ( 5.7 ) Fetal Risk : May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for 2 months after stopping TASCENSO ODT. ( 5.8 , 8.1 , 8.3 ) Severe Increase in Disability After Stopping TASCENSO ODT: Monitor for development of severe increase in disability following discontinuation and begin appropriate treatment as needed. ( 5.9 ) Tumefactive MS : Consider when severe MS relapse occurs during treatment or after discontinuation. Obtain imaging and begin treatment as needed. ( 5.10 ) Increased Blood Pressure (BP) : Monitor BP in adult and pediatric patients during treatment. ( 5.11 ) Malignancies : Skin examination prior to or shortly after the start of treatment and periodically thereafter is recommended. Suspicious skin lesions should be evaluated. ( 5.12 ) 5.1 Bradyarrhythmia and Atrioventricular Blocks Because of a risk for bradyarrhythmia and AV blocks, patients should be monitored during TASCENSO ODT treatment initiation [see Dosage and Administration (2.4) ] . Reduction in Heart Rate After the first dose of TASCENSO ODT, the heart rate decrease starts within an hour. On Day 1, the maximum decline in heart rate generally occurs within 6 hours and recovers, although not to baseline levels, by 8 to 10 hours postdose. Because of physiological diurnal variation, there is a second period of heart rate decrease within 24 hours after the first dose. In some patients, heart rate decrease during the second period is more pronounced than the decrease observed in the first 6 hours. Heart rates below 40 beats per minute (bpm) in adults, and below 50 bpm in pediatric patients occurred rarely. In controlled clinical trials in adult patients, adverse reactions of symptomatic bradycardia following the first dose were reported in 0.6% of patients receiving fingolimod 0.5 mg and in 0.1% of patients on placebo. Patients who experienced bradycardia were generally asymptomatic, but some patients experienced hypotension, dizziness, fatigue, palpitations, and/or chest pain that usually resolved within the first 24 hours on treatment. Patients with some preexisting conditions (e.g., ischemic heart disease, history of myocardial infarction, congestive heart failure, history of cardiac arrest, cerebrovascular disease, uncontrolled hypertension, history of symptomatic bradycardia, history of recurrent syncope, severe untreated sleep apnea, AV block, sinoatrial heart block) may poorly tolerate the TASCENSO ODT-induced bradycardia, or experience serious rhythm disturbances after the first dose of TASCENSO ODT. Prior to treatment with TASCENSO ODT, these patients should have a cardiac evaluation by a physician appropriately trained to conduct such evaluation, and if treated with TASCENSO ODT, should be monitored overnight with continuous ECG in a medical facility after the first dose. Since initiation of TASCENSO ODT treatment results in decreased heart rate and may prolong the QT interval, patients with a prolonged QTc interval (> 450 msec adult and pediatric males, > 470 msec adult females, or > 460 msec pediatric females) before dosing or during 6-hour observation, or at additional risk for QT prolongation (e.g., hypokalemia, hypomagnesemia, congenital long- QT syndrome), or on concurrent therapy with 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. Following the second fingolimod dose, a further decrease in heart rate may occur when compared to the heart rate prior to the second dose, but this change is of a smaller magnitude than that observed following the first dose. With continued fingolimod dosing, the heart rate returns to baseline within 1 month of chronic treatment. Clinical data indicate effects of TASCENSO ODT on heart rate are maximal after the first dose although milder effects on heart rate may persist for, on average, 2 to 4 weeks after initiation of therapy at which time heart rate generally returns to baseline. Physicians should continue to be alert to patient reports of cardiac symptoms. Atrioventricular Blocks Initiation of TASCENSO ODT treatment has resulted in transient AV conduction delays. In controlled clinical trials in adult patients, first-degree AV block after the first dose occurred in 4.7% of patients receiving fingolimod capsules and 1.6% of patients on placebo.
Side effects
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, sinusitis, back pain, abdominal pain, and pain in extremity. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals Ltd at 1-888-533-1625 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adults In clinical trials (Studies 1, 2, and 3), a total of 1212 patients with relapsing forms of multiple sclerosis received fingolimod 0.5 mg capsules. This included 783 patients who received fingolimod 0.5 mg in the 2-year placebo-controlled trials (Studies 1 and 3) and 429 patients who received fingolimod 0.5 mg in the 1-year active-controlled trial (Study 2). The overall exposure in the controlled trials was equivalent to 1716 person-years. Approximately 1000 patients received at least 2 years of treatment with fingolimod 0.5 mg capsules. In all clinical studies, including uncontrolled extension studies, the exposure to fingolimod 0.5 mg capsules was approximately 4119 person-years. In placebo-controlled trials, the most frequent adverse reactions (incidence ≥ 10% and greater than placebo) for fingolimod 0.5 mg capsules were headache, liver transaminase elevation, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain, and pain in extremity. Adverse events that led to treatment discontinuation and occurred in more than 1% of patients taking fingolimod 0.5 mg capsules, were serum transaminase elevations (4.7% compared to 1% on placebo) and basal cell carcinoma (1% compared to 0.5% on placebo). Table 1 lists adverse reactions in clinical studies in adults that occurred in ≥ 1% of fingolimod-treated patients and ≥ 1% higher rate than for placebo. Table 1: Adverse Reactions Reported in Adult Studies 1 and 3 (Occurring in ≥ 1% of Patients and Reported for Fingolimod 0.5 mg Capsules at ≥ 1% Higher Rate than for Placebo) Fingolimod 0.5 mg Capsules N = 783 Placebo N = 773 Adverse Drug Reactions % % Infections Influenza 11 8 Sinusitis 11 8 Bronchitis 8 5 Herpes zoster 2 1 Tinea versicolor 2 < 1 Cardiac disorders Bradycardia 3 1 Nervous system disorders Headache 25 24 Migraine 6 4 Gastrointestinal disorders Nausea 13 12 Diarrhea 13 10 Abdominal pain 11 10 General disorders and administration-site conditions Asthenia 2 1 Musculoskeletal and connective tissue disorders Back pain 10 9 Pain in extremity 10 7 Skin and subcutaneous tissue disorders Alopecia 3 2 Actinic keratosis 2 1 Investigations Liver transaminase elevations (ALT/GGT/AST) 15 4 Blood triglycerides increased 3 1 Respiratory, thoracic, and mediastinal disorders Cough 12 11 Dyspnea 9 7 Eye disorders Vision blurred 4 2 Vascular disorders Hypertension 8 4 Blood and lymphatic system disorders Lymphopenia 7 < 1 Leukopenia 2 < 1 Neoplasms benign, malignant, and unspecified (including cysts and polyps) Skin papilloma 3 2 Basal cell carcinoma 2 1 Abbreviations: ALT, alanine transaminase; AST, aspartate transferase; GGT, gamma-glutamyl transferase. Adverse reactions of seizure, dizziness, pneumonia, eczema, and pruritus were also reported in Studies 1 and 3 but did not meet the reporting rate criteria for inclusion in Table 1 (difference was less than 1%). Adverse reactions with fingolimod 0.5 mg in Study 2, the 1-year active-controlled (versus interferon beta-1a) study were generally similar to those in Studies 1 and 3. Vascular Events Vascular events, including ischemic and hemorrhagic strokes, and peripheral arterial occlusive disease were reported in premarketing clinical trials in patients who received fingolimod doses (1.25 mg to 5 mg) higher than recommended for use in MS. Similar events have been reported with fingolimod treatment in the postmarketing setting although a causal relationship has not been established. Seizure Cases of seizures, including status epilepticus, have been reported with the use of fingolimod capsules in clinical trials and in the postmarketing setting in adults [see Adverse Reactions (6.2) ]. In adult clinical trials, the rate of seizures was 0.9% in fingolimod - treated patients and 0.3% in placebo-treated patients. It is unknown whether these events were related to the effects of multiple sclerosis alone, to fingolimod, or to a combination of both. Pediatric Patients 10 Years of Age and Older In the controlled pediatric trial (Study 4), the safety profile in pediatric patients receiving fingolimod 0.25 mg or 0.5 mg capsules daily was similar to that seen in adult patients.
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 vaccination. Vaccination may be less effective during and for up to 2 months after discontinuation of treatment with TASCENSO ODT [see Clinical Pharmacology (12.2) ] . Avoid the use of live attenuated vaccines during and for 2 months after treatment with TASCENSO ODT because of the risk of infection. It is recommended that pediatric patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating TASCENSO ODT therapy. 7.4 Antineoplastic, Immunosuppressive, or Immune-Modulating Therapies Antineoplastic, immune-modulating, or immunosuppressive therapies, (including corticosteroids) are expected to increase the risk of immunosuppression, and the risk of additive immune system effects must be considered if these therapies are coadministered with TASCENSO ODT. When switching from drugs with prolonged immune effects, such as natalizumab, teriflunomide or mitoxantrone, the duration and mode of action of these drugs must be considered to avoid unintended additive immunosuppressive effects when initiating TASCENSO ODT [see Warnings and Precautions (5.2) ]. 7.5 Drugs That Slow Heart Rate or Atrioventricular Conduction (e.g., beta blockers or diltiazem) Experience with fingolimod in patients receiving concurrent therapy with drugs that slow the heart rate or AV conduction (e.g., beta blockers, digoxin, or heart rate-slowing calcium channel blockers such as diltiazem or verapamil) is limited. Because initiation of TASCENSO ODT treatment may result in an additional decrease in heart rate, concomitant use of these drugs during TASCENSO ODT initiation may be associated with severe bradycardia or heart block. Seek advice from the physician prescribing these drugs regarding the possibility to switch to drugs that do not slow the heart rate or atrioventricular conduction before initiating TASCENSO ODT. Patients who cannot switch should have overnight continuous ECG monitoring after the first dose [see Dosage and Administration (2.4) , Warnings and Precautions (5.1) ]. 7.6 Laboratory Test Interaction Because fingolimod reduces blood lymphocyte counts via redistribution in secondary lymphoid organs, peripheral blood lymphocyte counts cannot be utilized to evaluate the lymphocyte subset status of a patient treated with fingolimod. A recent CBC should be available before initiating treatment with TASCENSO ODT.
Use in specific populations
8.1 Pregnancy Risk Summary Available observational pregnancy registry data suggest that use of TASCENSO ODT is associated with an increased prevalence of major birth defects in comparison to the general population. However, limitations in the number of exposed pregnant women and in the study design preclude definitive conclusions (see Data ) . Data from prospective reports to the fingolimod pregnancy registry are currently not sufficient to allow for an adequate assessment of the drug-associated risk for miscarriage. Based on findings from animal studies, TASCENSO ODT may cause fetal harm when administered to a pregnant woman. In oral studies conducted in rats and rabbits, fingolimod demonstrated developmental toxicity, including an increase in malformations (rats) and embryolethality, when given to pregnant animals. In rats, the highest no-effect dose was less than the recommended human dose of 0.5 mg/day on a body surface area (mg/m 2 ) basis. The most common fetal visceral malformations in rats were persistent truncus arteriosus and ventricular septal defect. The receptor affected by fingolimod (sphingosine 1-phosphate receptor) is known to be involved in vascular formation during embryogenesis (see Data ). Advise pregnant women of the potential risk to a fetus. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Clinical Considerations In females planning to become pregnant, TASCENSO ODT should be stopped 2 months before planned conception. The possibility of severe increase in disability should be considered in women who discontinue or are considering discontinuation of TASCENSO ODT because of pregnancy or planned pregnancy. In many of the cases in which increase in disability was reported after stopping fingolimod, the active moiety in TASCENSO ODT, patients had stopped fingolimod because of pregnancy or planned pregnancy [see Warnings and Precautions (5.9 ] . Data Human Data In a prospective observational fingolimod pregnancy registry (2011 - 2024), the rate of major birth defects among 147 live births, stillbirths, or terminations of pregnancy due to fetal anomalies from women who were administered fingolimod during the first trimester was 8.2% (95% CI: 4.3-13.8) using the European Registration of Congenital Anomalies and Twin classification and 10.9% (95% CI: 6.4-17.1) using the Metropolitan Atlanta Congenital Defects Program classification. The most frequent major birth defects were congenital heart defects, renal/urinary malformations, and limb/musculoskeletal malformations. Study limitations include no adjustment for confounders, no re-adjudication in case of spontaneous resolution, lack of an internal comparator cohort, and small sample size. In fingolimod prospective pharmacovigilance data, the most frequent major birth defect types were similar to those reported in the fingolimod pregnancy registry. The pattern of malformations reported for fingolimod is similar to that observed in the general population. There is no evidence of clustering of specific birth defects with fingolimod. Animal Data When fingolimod was orally administered to pregnant rats during the period of organogenesis (0, 0.03, 0.1, and 0.3 mg/kg/day or 0, 1, 3, and 10 mg/kg/day), increased incidences of fetal malformations and embryofetal deaths were observed at all but the lowest dose tested (0.03 mg/kg/day), which is less than the recommended human dose (RHD) on a mg/m 2 basis. Oral administration to pregnant rabbits during organogenesis (0, 0.5, 1.5, and 5 mg/kg/day) resulted in increased incidences of embryofetal mortality and fetal growth retardation at the mid and high doses. The no-effect dose for these effects in rabbits (0.5 mg/kg/day) is approximately 20 times the RHD on a mg/m 2 basis. When fingolimod was orally administered to female rats during pregnancy and lactation (0, 0.05, 0.15, and 0.5 mg/kg/day), pup survival was decreased at all doses and a neurobehavioral (learning) deficit was seen in offspring at the high dose. The low-effect dose of 0.05 mg/kg/day is similar to the RHD on a mg/m 2 basis. 8.2 Lactation Risk Summary There are no data on the presence of fingolimod in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. Fingolimod is excreted in the milk of treated rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for TASCENSO ODT and any potential adverse effects on the breastfed infant from TASCENSO ODT or from the underlying maternal condition. 8.3 Females and Males of Reproductive Potential Pregnancy Testing The pregnancy status of females of reproductive potential should be verified prior to starting treatment with TASCENSO ODT [see Use in Specific Populations (8.1) ]. Contraception Before initiation of TASCENSO ODT, females of reproductive potential should be counseled on the potential for a serious risk to the fetus and the need for effective contraception during treatment with TASCENSO ODT [see Warnings and Precautions (5.9) and Use in Specific Populations (8.1) ] . Since it takes approximately 2 months to eliminate the compound from the body after stopping treatment, the potential risk to the fetus may persist and women should use effective contraception during this period [see Warnings and Precautions (5.8 , 5.13) ] .
Pregnancy
8.1 Pregnancy Risk Summary Available observational pregnancy registry data suggest that use of TASCENSO ODT is associated with an increased prevalence of major birth defects in comparison to the general population. However, limitations in the number of exposed pregnant women and in the study design preclude definitive conclusions (see Data ) . Data from prospective reports to the fingolimod pregnancy registry are currently not sufficient to allow for an adequate assessment of the drug-associated risk for miscarriage. Based on findings from animal studies, TASCENSO ODT may cause fetal harm when administered to a pregnant woman. In oral studies conducted in rats and rabbits, fingolimod demonstrated developmental toxicity, including an increase in malformations (rats) and embryolethality, when given to pregnant animals. In rats, the highest no-effect dose was less than the recommended human dose of 0.5 mg/day on a body surface area (mg/m 2 ) basis. The most common fetal visceral malformations in rats were persistent truncus arteriosus and ventricular septal defect. The receptor affected by fingolimod (sphingosine 1-phosphate receptor) is known to be involved in vascular formation during embryogenesis (see Data ). Advise pregnant women of the potential risk to a fetus. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Clinical Considerations In females planning to become pregnant, TASCENSO ODT should be stopped 2 months before planned conception. The possibility of severe increase in disability should be considered in women who discontinue or are considering discontinuation of TASCENSO ODT because of pregnancy or planned pregnancy. In many of the cases in which increase in disability was reported after stopping fingolimod, the active moiety in TASCENSO ODT, patients had stopped fingolimod because of pregnancy or planned pregnancy [see Warnings and Precautions (5.9 ] . Data Human Data In a prospective observational fingolimod pregnancy registry (2011 - 2024), the rate of major birth defects among 147 live births, stillbirths, or terminations of pregnancy due to fetal anomalies from women who were administered fingolimod during the first trimester was 8.2% (95% CI: 4.3-13.8) using the European Registration of Congenital Anomalies and Twin classification and 10.9% (95% CI: 6.4-17.1) using the Metropolitan Atlanta Congenital Defects Program classification. The most frequent major birth defects were congenital heart defects, renal/urinary malformations, and limb/musculoskeletal malformations. Study limitations include no adjustment for confounders, no re-adjudication in case of spontaneous resolution, lack of an internal comparator cohort, and small sample size. In fingolimod prospective pharmacovigilance data, the most frequent major birth defect types were similar to those reported in the fingolimod pregnancy registry. The pattern of malformations reported for fingolimod is similar to that observed in the general population. There is no evidence of clustering of specific birth defects with fingolimod. Animal Data When fingolimod was orally administered to pregnant rats during the period of organogenesis (0, 0.03, 0.1, and 0.3 mg/kg/day or 0, 1, 3, and 10 mg/kg/day), increased incidences of fetal malformations and embryofetal deaths were observed at all but the lowest dose tested (0.03 mg/kg/day), which is less than the recommended human dose (RHD) on a mg/m 2 basis. Oral administration to pregnant rabbits during organogenesis (0, 0.5, 1.5, and 5 mg/kg/day) resulted in increased incidences of embryofetal mortality and fetal growth retardation at the mid and high doses. The no-effect dose for these effects in rabbits (0.5 mg/kg/day) is approximately 20 times the RHD on a mg/m 2 basis. When fingolimod was orally administered to female rats during pregnancy and lactation (0, 0.05, 0.15, and 0.5 mg/kg/day), pup survival was decreased at all doses and a neurobehavioral (learning) deficit was seen in offspring at the high dose. The low-effect dose of 0.05 mg/kg/day is similar to the RHD on a mg/m 2 basis.
Pediatric use
8.4 Pediatric Use Safety and effectiveness of fingolimod for the treatment of relapsing forms of multiple sclerosis in pediatric patients 10 to less than 18 years of age were established in one randomized, double-blind clinical study in 215 patients (fingolimod n = 107; intramuscular interferon (IFN) beta-1a n = 108) [see Clinical Studies (14.2) ] . In the controlled pediatric study, the safety profile in pediatric patients (10 to less than 18 years of age) receiving fingolimod 0.25 mg or 0.5 mg capsules daily was similar to that seen in adult patients. In the pediatric study, cases of seizures were reported in 5.6% of fingolimod-treated patients and 0.9% of interferon beta-1a-treated patients. It is recommended that pediatric patients, if possible, complete all immunizations in accordance with current immunization guidelines prior to initiating TASCENSO ODT therapy. Safety and effectiveness of TASCENSO ODT in pediatric patients below the age of 10 years have not been established. Juvenile Animal Toxicity Data In a study in which fingolimod (0.3, 1.5, or 7.5 mg/kg/day) was orally administered to young rats from weaning through sexual maturity, changes in bone mineral density and persistent neurobehavioral impairment (altered auditory startle) were observed at all doses. Delayed sexual maturation was noted in females at the highest dose tested and in males at all doses. The bone changes observed in fingolimod-treated juvenile rats are consistent with a reported role of S1P in the regulation of bone mineral homeostasis. When fingolimod (0.5 or 5 mg/kg/day) was orally administered to rats from the neonatal period through sexual maturity, a marked decrease in T-cell dependent antibody response was observed at both doses. This effect had not fully recovered by 6 to 8 weeks after the end of treatment. Overall, a no-effect dose for adverse developmental effects in juvenile animals was not identified.
Geriatric use
8.5 Geriatric Use Clinical MS studies of fingolimod capsules did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently than younger patients. TASCENSO ODT should be used with caution in patients aged 65 years and over, reflecting the greater frequency of decreased hepatic, or renal, function and of concomitant disease or other drug therapy.
Overdosage
Fingolimod, the active moiety in TASCENSO ODT, can induce bradycardia as well as AV conduction blocks (including complete AV block). The decline in heart rate usually starts within 1 hour of the first dose and is maximal within 6 hours in most patients [see Warnings and Precautions (5.1) ]. In case of TASCENSO ODT overdosage, observe patients overnight with continuous ECG monitoring in a medical facility, and obtain regular measurements of blood pressure. [see Dosage and Administration (2.4) ]. Neither dialysis nor plasma exchange results in removal of fingolimod from the body.
Description
Fingolimod is a sphingosine 1-phosphate receptor modulator. Chemically, fingolimod lauryl sulfate is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol lauryl sulfate. Its structure is shown below: Fingolimod lauryl sulfate is a white to practically white powder that is practically insoluble in water. It has a molecular weight of 573.87 g/mol. TASCENSO ODT is provided as 0.25 mg and 0.5 mg orally disintegrating tablets for oral use. Each orally disintegrating tablet contains 0.25 mg or 0.5 mg of fingolimod (equivalent to 0.47 mg or 0.93 mg of fingolimod lauryl sulfate) and the following inactive ingredients: gelatin, mannitol, medium-chain triglycerides, sodium chloride, and sodium lauryl sulfate. Chemical Structure
Mechanism of action
12.1 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.
How supplied
16.1 How Supplied 0.25 mg TASCENSO ODT orally disintegrating tablets are supplied as follows: White to off-white, round, orally disintegrating tablet debossed with . Carton of 30 orally disintegrating tablets containing 3 blister cards of 10 orally disintegrating tablets per blister card NDC 70709-062-30 0.5 mg TASCENSO ODT orally disintegrating tablets are supplied as follows: White to off-white, round, orally disintegrating tablet debossed with . Carton of 30 orally disintegrating tablets containing 3 blister cards of 10 orally disintegrating tablets per blister card NDC 70709-065-30 image description image description 16.2 Storage and Handling 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. Do not open blister until ready to administer.
Storage
16.1 How Supplied 0.25 mg TASCENSO ODT orally disintegrating tablets are supplied as follows: White to off-white, round, orally disintegrating tablet debossed with . Carton of 30 orally disintegrating tablets containing 3 blister cards of 10 orally disintegrating tablets per blister card NDC 70709-062-30 0.5 mg TASCENSO ODT orally disintegrating tablets are supplied as follows: White to off-white, round, orally disintegrating tablet debossed with . Carton of 30 orally disintegrating tablets containing 3 blister cards of 10 orally disintegrating tablets per blister card NDC 70709-065-30 image description image description 16.2 Storage and Handling 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. Do not open blister until ready to administer.
Patient information
Advise the patient to read the FDA-approved patient labeling (Medication Guide). Administration Tell patients not to discontinue TASCENSO ODT without first discussing this with the prescribing healthcare provider. Advise patients to contact their healthcare provider if they accidently take more TASCENSO ODT than prescribed. Advise patients to use dry hands when opening the blister pack. Instruct patients to not push the ODT through the lidding foil, but to peel back the lidding foil and then push the underside [see Dosage and Administration ( 2.2 )]. Cardiac Effects Advise patients that initiation of TASCENSO ODT treatment results in a transient decrease in heart rate. Inform patients that they will need to be observed in the healthcare professional's office or other facility for at least 6 hours after the first dose, after reinitiation if treatment is interrupted or discontinued for certain periods, and after the dosage is increased [see Dosage and Administration (2.4) , Warnings and Precautions (5.1) ]. Risk of Infections Inform patients that they may have an increased risk of infections, some of which could be life-threatening, when taking TASCENSO ODT, and that they should contact their healthcare provider if they develop symptoms of infection. Advise patients that the use of some vaccines should be avoided during treatment with TASCENSO ODT and for 2 months after discontinuation. Recommend to patients that they delay treatment with TASCENSO ODT until after VZV vaccination if they have not had chickenpox or a previous VZV vaccination. Inform patients that prior or concomitant use of drugs that suppress the immune system may increase the risk of infection [see Warnings and Precautions (5.2)]. Progressive Multifocal Leukoencephalopathy Inform patients that cases of progressive multifocal leukoencephalopathy (PML) have occurred in patients who received fingolimod, the active moiety in TASCENSO ODT. Inform the patient that PML is characterized by a progression of deficits and usually leads to death or severe disability over weeks or months. Instruct the patient of the importance of contacting their healthcare provider if they develop any symptoms suggestive of PML. Inform the patient that typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes [see Warnings and Precautions (5.3) ] . Macular Edema Advise patients that TASCENSO ODT may cause macular edema, and that they should obtain an eye exam near the start of treatment with TASCENSO ODT, have their eyes monitored periodically by an eye care professional while receiving therapy, and contact their healthcare provider if they experience any changes in their vision while taking TASCENSO ODT. Inform patients with diabetes mellitus or a history of uveitis that their risk of macular edema is increased [see Warnings and Precautions ( 5.4 )]. Hepatic Effects Inform patients that TASCENSO ODT may cause liver injury. Advise patients that they should contact their healthcare provider if they have any unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine [see Warnings and Precautions (5.5) ]. Posterior Reversible Encephalopathy Syndrome Advise patients to immediately report to their healthcare provider any symptoms involving sudden onset of severe headache, altered mental status, visual disturbances, or seizure. Inform patients that delayed treatment could lead to permanent neurological sequelae [see Warnings and Precautions (5.6) ]. Respiratory Effects Advise patients that they should contact their healthcare provider if they experience new onset or worsening of dyspnea [see Warnings and Precautions (5.7) ] . Fetal Risk Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy [ see Warnings and Precautions (5.8) and Use in Specific Populations (8.1 , 8.3) ]. Advise female patients of reproductive potential to use effective contraception during treatment with TASCENSO ODT and for two months after the final dose [ see Use in Specific Populations (8.3) ]. Severe Increase in Disability After Stopping TASCENSO ODT Inform patients that severe increase in disability has been reported after discontinuation of fingolimod. Advise patients to contact their healthcare provider if they develop worsening symptoms of MS following discontinuation of TASCENSO ODT [see Warnings and Precautions (5.9) ] . Malignancies Advise patients that the risk of basal cell carcinoma and melanoma is increased with use of fingolimod, the active moiety in TASCENSO ODT, and that cases of squamous cell carcinoma, Merkel cell carcinoma, and Kaposi’s sarcoma have been reported. Advise patients that any suspicious skin lesions should be promptly evaluated. Advise patients to limit exposure to sunlight and ultraviolet light by wearing protective clothing and using a sunscreen with a high protection factor. Inform patients that lymphoma has also occurred in patients receiving fingolimod [see Warnings and Precautions ( 5.12 )]. Persistence of TASCENSO ODT Effects After Drug Discontinuation Advise patients that TASCENSO ODT remains in the blood and continues to have effects, including decreased blood lymphocyte counts, for up to 2 months following the last dose [see Warnings and Precautions (5.13) ]. Hypersensitivity Reactions Advise patients that TASCENSO ODT may cause hypersensitivity reactions including rash, urticaria, and angioedema. Advise patients to contact their healthcare provider if they have any symptoms associated with hypersensitivity [see Warnings and Precautions (5.14) ].
Label text from the FDA structured product label by Cycle Pharmaceuticals Ltd (revised Jan 20, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Fingolimod Lauryl Sulfate in 2 products
Tascenso Odt NDC products (2)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 70709-062 | Fingolimod Lauryl Sulfate .25 mg/1 Tablet, Orally Disintegrating | Cycle Pharmaceuticals Ltd | NDA |
| 70709-065 | Fingolimod Lauryl Sulfate .5 mg/1 Tablet, Orally Disintegrating | Cycle Pharmaceuticals Ltd | NDA |
Frequently asked questions
What is Tascenso Odt used for?
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…
What are the side effects of Tascenso Odt?
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) ]… See the full label for the complete list.
Who makes Tascenso Odt?
Tascenso Odt is listed by 1 labeler in the FDA NDC directory, including Cycle Pharmaceuticals Ltd.