Tascenso
(fingolimod)Tascenso ODT 0.25 MG Disintegrating Oral TabletTascenso ODT 0.5 MG Disintegrating Oral Tablet
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Tascenso FAQs
What is the risk of using TASCENSO ODT during pregnancy?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. 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.
Should females planning to become pregnant use TASCENSO ODT?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.
What is the recommended contraception for females of reproductive potential taking TASCENSO ODT?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. 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.
Is TASCENSO ODT safe for 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. Safety and effectiveness of TASCENSO ODT in pediatric patients below the age of 10 years have not been established.
Is TASCENSO ODT safe for 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.
What is hepatic impairment?Hepatic impairment refers to a condition where the liver is not functioning properly. This can be caused by various factors such as liver disease, infections, alcohol abuse, or medications.
How does hepatic impairment affect fingolimod exposure?Fingolimod exposure is doubled in patients with severe hepatic impairment, but not in those with mild or moderate hepatic impairment. Therefore, patients with severe hepatic impairment should be closely monitored, as the risk of adverse reactions may be greater.
Is dose adjustment necessary for patients with hepatic impairment?No dose adjustment is needed in patients with mild or moderate hepatic impairment.
What is renal impairment?Renal impairment is a condition in which the kidneys are not functioning properly. This can be caused by various factors such as kidney disease, infections, diabetes, or medications.
How does renal impairment affect fingolimod metabolites?In patients with severe renal impairment, the blood level of some fingolimod metabolites is increased up to 13-fold. The toxicity of these metabolites has not been fully explored. The blood level of these metabolites has not been assessed in patients with mild or moderate renal impairment.
Is dose adjustment necessary for patients with renal impairment?There is no specific dose adjustment recommended for patients with renal impairment. However, close monitoring of patients with severe renal impairment is recommended.
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