Estats Units - anglès - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - tildrakizumab (unii: dew6x41bek) (tildrakizumab - unii:dew6x41bek) - ilumya® is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. ilumya is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any of the excipients [see warnings and precautions (5.1) ]. risk summary limited available data with ilumya use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. human igg is known to cross the placental barrier; therefore, ilumya may be transferred from the mother to the fetus. an embryofetal developmental study conducted with tildrakizumab in pregnant monkeys revealed no treatment-related effects to the developing fetus when tildrakizumab was administered subcutaneously during organogenesis to near parturition at doses up to 159 times the maximum recommended human dose (mrhd). when dosing was continued until parturition, an increase in neonatal death was observed at 59 times the mrhd [ see data below ] . the clinical significance of this nonclinical finding is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data in an embryofetal developmental study, subcutaneous doses up to 300 mg/kg tildrakizumab were administered to pregnant cynomolgus monkeys once every two weeks during organogenesis to gestation day 118 (22 days from parturition). no maternal or embryofetal toxicities were observed at doses up to 300 mg/kg (159 times the mrhd of 100 mg, based on auc comparison). tildrakizumab crossed the placenta in monkeys. in a pre- and postnatal developmental study, subcutaneous doses up to 100 mg/kg tildrakizumab were administered to pregnant cynomolgus monkeys once every two weeks from gestation day 50 to parturition. neonatal deaths occurred in the offspring of one control monkey, two monkeys at 10 mg/kg dose (6 times the mrhd based on auc comparison), and four monkeys at 100 mg/kg dose (59 times the mrhd based on auc comparison). the clinical significance of these nonclinical findings is unknown. no tildrakizumab-related adverse effects were noted in the remaining infants from birth through 6 months of age. risk summary there are no data on the presence of tildrakizumab in human milk, the effects on the breastfed infant, or the effects on milk production. human igg is known to be present in human milk. tildrakizumab was detected in the milk of monkeys [ see data ] . the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ilumya and any potential adverse effects on the breastfed child from ilumya or from the underlying maternal condition. data animal data tildrakizumab was detected in breast milk of monkeys in the pre- and postnatal developmental study described in 8.1. the mean tildrakizumab concentrations in milk were approximately 0.09 – 0.2% of that in serum on postpartum days 28 and 91. safety and effectiveness of ilumya in pediatric patients (<18 years of age) have not been established. a total of 1083 subjects were exposed to ilumya 100 mg during phase 2 and 3 trials. a total of 92 subjects were 65 years or older, and 17 subjects were 75 years or older. although no differences in safety or efficacy were observed between older and younger subjects, the number of subjects aged 65 and over is not sufficient to determine whether they responded differently from younger subjects [see clinical pharmacology (12.3) ] .

Unió Europea - anglès - EMA (European Medicines Agency)

almirall s.a - tildrakizumab - psoriasis - immunosuppressants, interleukin inhibitors, - ilumetri is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.

Israel - anglès - Ministry of Health

taro international ltd, israel - tildrakizumab - solution for injection - tildrakizumab 100 mg/ml - tildrakizumab - treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy

Canadà - anglès - Health Canada

sun pharmaceutical industries limited - tildrakizumab - solution - 100mg - tildrakizumab 100mg - misc. skin and mucous membrane agents

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

sun pharma anz pty ltd - tildrakizumab, quantity: 100 mg/ml - injection, solution - excipient ingredients: histidine; sucrose; water for injections; polysorbate 80; histidine hydrochloride monohydrate - ilumya is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.

Regne Unit - anglès - MHRA (Medicines & Healthcare Products Regulatory Agency)

almirall ltd - tildrakizumab - solution for injection - 100mg/1ml

Aràbia Saudita - anglès - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

jazeera pharmaceutical industries (jpi), saudi arabia - tildrakizumab - solution for injection in pre-filled syringe - 100 mg/ml

Jordània - anglès - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

شركة أدوية الحكمة - hikma pharmaceuticals - tildrakizumab 100 mg/1 ml syr - 100 mg/1 ml syr

Filipines - anglès - FDA (Food And Drug Administration)

sun pharma philippines, inc.; distributor: sun pharma philippines, inc. - tildrakizumab - solution for injection (s.c.) - 100 mg/ml

Japó - anglès - すりの適正使用協議会 RAD-AR Council, Japan

sun pharma japan limited - tildrakizumab(genetical recombination) - injection