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Another NameLitfulo、甲苯磺酸利特昔替尼胶囊、LuciRit
IndicationsSuitable for treating severe alopecia areata in adults and adolescents aged 12 and above.
Reg No.10 L 1035/23
Inspection NO.2581-23
Litexitinib is a medication used to treat alopecia areata in adolescents and adults aged 12 and above. It is an oral medication belonging to the Janus kinase inhibitor and can promote hair regeneration by inhibiting specific signaling pathways.
Ritlecitinib can block the adenosine triphosphate (ATP) binding site, irreversibly inhibiting tyrosine kinases expressed in Janus kinase 3 (JAK3) and hepatocellular carcinoma (TEC) kinase families, thereby inhibiting cytokine signaling pathways associated with hair loss.
ritlecitinib
Adults and adolescents aged 12 and above.
The existing data on clinical trials of rituxantinib for pregnant women is insufficient to determine the risk of significant birth defects, miscarriages, or other adverse maternal or fetal outcomes associated with the drug. Therefore, it is recommended that pregnant women use this product under the guidance of a doctor.
Due to the possibility of serious adverse reactions in breastfed children, it is recommended that women refrain from breastfeeding during the use of Vineclavone treatment and within one week after the last dose, and use it under the guidance of a doctor.
The safety and efficacy of rituxantinib in treating alopecia areata have been confirmed in children aged 12 years and above. The safety and efficacy of rituxantinib in children under 12 years old have not been determined.
Patients aged ≥ 65 do not need to adjust their dosage. However, due to the generally high incidence of infections in the elderly population, caution should be exercised when treating the elderly.
Patients with mild or moderate liver function impairment do not need to adjust the dosage. It is not recommended to use rituxantinib in patients with severe liver damage.
There is no specific antidote for excessive use of ritlecitinib. Treatment should be symptomatic and supportive, and monitor the signs and symptoms of adverse reactions in patients. If overdose occurs, it is recommended to consult a doctor for treatment.
Store ritlecitinib at a temperature of 20 ° C-25 ° C, allowing for variations between 15 ° C-30 ° C. Keep in the original packaging.
The absolute oral bioavailability of rituxantinib is approximately 64%. The plasma peak concentration was reached within 1 hour after oral administration of rituxantinib.
from FDA，2023.06
