Fingolimod Lauryl Sulfate
Generic Name: fingolimod lauryl sulfate
Brand Names:
Tascenso Odt
11 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.
Overview
11 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.
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
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.
Side Effects
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 Wa...
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.
Warnings
5 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. 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 Warni...
Pregnancy
8.1 Pregnancy Risk Summary Based on findings from animal studies, TASCENSO ODT may cause fetal harm when administered to a pregnant woman. 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 birth defects and miscarriage in humans. 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.
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 .
Frequently Asked Questions
What is Fingolimod Lauryl Sulfate 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 (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. ( 1 )
What are the side effects of Fingolimod Lauryl Sulfate?▼
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 Wa...
Can I take Fingolimod Lauryl Sulfate during pregnancy?▼
8.1 Pregnancy Risk Summary Based on findings from animal studies, TASCENSO ODT may cause fetal harm when administered to a pregnant woman. 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 birth defects and miscarriage in humans. 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.
What are the important warnings for Fingolimod Lauryl Sulfate?▼
5 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. 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 Warni...
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.