Kenja - Ingliż - Pharmacy and Poisons Board

f. hoffman-la roche ltd p.o. box 44212 - 00100 nairobi - tocilizumab - solution for infusion - tocilizumab 400mg - immunosuppressants: interleukininhibitors

Kenja - Ingliż - Pharmacy and Poisons Board

f. hoffman-la roche ltd p.o. box 44212 - 00100 nairobi - tocilizumab - solution for infusion - tocilizumab 80mg - immunosuppressants: interleukininhibitors

Ġappun - Ingliż - すりの適正使用協議会 RAD-AR Council, Japan

chugai pharmaceutical co., ltd. - tocilizumab(genetical recombination) - injectable preparation

Ġappun - Ingliż - すりの適正使用協議会 RAD-AR Council, Japan

chugai pharmaceutical co., ltd. - tocilizumab(genetical recombination) - injectable preparation

Għarabja Sawdita - Ingliż - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

boston oncology arabia, saudi arabia - tocilizumab - solution for injection - 180 mg/ml,

Stati Uniti - Ingliż - NLM (National Library of Medicine)

fresenius kabi usa, llc - tocilizumab (unii: i031v2h011) (tocilizumab - unii:i031v2h011) - tyenne® (tocilizumab-aazg) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (dmards). tyenne® (tocilizumab-aazg) is indicated for the treatment of giant cell arteritis (gca) in adult patients. tyenne® (tocilizumab-aazg) is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. tyenne® (tocilizumab-aazg) is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. tyenne is contraindicated in patients with known hypersensitivity to tocilizumab products [see warnings and precautions (5.6)]. risk summary the limited available data with tocilizumab products in pregnant women are not sufficient to determine whether there is a drug-associated risk for major birth defects and miscarriage. monoclonal antibodies, such as tocilizumab products, are actively transported across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant [see clinical considerations]. in animal reproduction studies, intravenous administration of tocilizumab to cynomolgus monkeys during organogenesis caused abortion/embryo-fetal death at doses 1.25 times and higher than the maximum recommended human dose by the intravenous route of 8 mg per kg every 2 to 4 weeks. the literature in animals suggests that inhibition of il-6 signaling may interfere with cervical ripening and dilatation and myometrial contractile activity leading to potential delays of parturition [see data] . based on the animal data, there may be a potential risk to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations fetal/neonatal adverse reactions monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to tyenne in utero [see warnings and precautions 5.9)]. data animal data an embryo-fetal developmental toxicity study was performed in which pregnant cynomolgus monkeys were treated intravenously with tocilizumab at daily doses of 2, 10, or 50 mg/ kg during organogenesis from gestation day (gd) 20-50. although there was no evidence for a teratogenic/dysmorphogenic effect at any dose, tocilizumab produced an increase in the incidence of abortion/embryo-fetal death at doses 1.25 times and higher the mrhd by the intravenous route at maternal intravenous doses of 10 and 50 mg/ kg. testing of a murine analogue of tocilizumab in mice did not yield any evidence of harm to offspring during the pre- and postnatal development phase when dosed at 50 mg/kg intravenously with treatment every three days from implantation (gd 6) until post-partum day 21 (weaning). there was no evidence for any functional impairment of the development and behavior, learning ability, immune competence and fertility of the offspring. parturition is associated with significant increases of il-6 in the cervix and myometrium. the literature suggests that inhibition of il-6 signaling may interfere with cervical ripening and dilatation and myometrial contractile activity leading to potential delays of parturition. for mice deficient in il-6 (ll6-/- null mice), parturition was delayed relative to wild-type (ll6+/+ ) mice. administration of recombinant il-6 to ll6-/- null mice restored the normal timing of delivery. risk summary no information is available on the presence of tocilizumab products in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. maternal immunoglobulin g (igg) is present in human milk. if tocilizumab products are transferred into human milk, the effects of local exposure in the gastrointestinal tract and potential limited systemic exposure in the infant to tocilizumab products are unknown. the lack of clinical data during lactation precludes clear determination of the risk of tocilizumab products to an infant during lactation; therefore the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tyenne and the potential adverse effects on the breastfed child from tyenne or from the underlying maternal condition. tyenne by intravenous use is indicated for the treatment of pediatric patients with: - active systemic juvenile idiopathic arthritis in patients 2 years of age and older - active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older tyenne by subcutaneous use is indicated for the treatment of pediatric patients with: - active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older - active systemic juvenile idiopathic arthritis in patients 2 years of age and older the safety and effectiveness of tyenne in pediatric patients with conditions other than pjia or sjia have not been established. the safety and effectiveness in pediatric patients below the age of 2 have not been established in pjia or sjia. systemic juvenile idiopathic arthritis – intravenous use a multicenter, open-label, single arm study to evaluate the pk, safety and exploratory pd and efficacy of tocilizumab over 12-weeks in sjia patients (n=11) under 2 years of age was conducted. patients received intravenous tocilizumab 12 mg/kg every two weeks. concurrent use of stable background treatment with corticosteroids, mtx, and/or non-steroidal anti-inflammatory drugs was permitted. patients who completed the 12-week period could continue to the optional extension period (a total of 52-weeks or until the age of 2 years, whichever was longer). the primary pk endpoints (cmax , ctrough and auc2weeks ) of tocilizumab at steady-state in this study were within the ranges of these parameters observed in patients with sjia aged 2 to 17 years. the safety and immunogenicity of tocilizumab for patients with sjia under 2 years of age was assessed descriptively. saes, aes leading to discontinuation, and infectious aes were reported by 27.3%, 36.4%, and 81.8% of patients. six patients (54.5%) experienced hypersensitivity reactions, defined as all adverse events occurring during or within 24 hours after an infusion considered related to tocilizumab. three of these patients experienced serious hypersensitivity reactions and were withdrawn from the study. three patients with hypersensitivity reactions (two with serious hypersensitivity reactions) developed treatment induced anti- tocilizumab antibodies after the event. there were no cases of mas based on the protocol-specified criteria, but 2 cases of suspected mas based on ravelli criteria1. of the 2644 patients who received tocilizumab in studies i to v [see clinical studies (14)] , a total of 435 rheumatoid arthritis patients were 65 years of age and older, including 50 patients 75 years and older. of the 1069 patients who received tocilizumab-sc in studies sc-i and sc-ii there were 295 patients 65 years of age and older, including 41 patients 75 years and older. the frequency of serious infection among tocilizumab treated subjects 65 years of age and older was higher than those under the age of 65. as there is a higher incidence of infections in the elderly population in general, caution should be used when treating the elderly. the safety and efficacy of tocilizumab products have not been studied in patients with hepatic impairment, including patients with positive hbv and hcv serology [see warnings and precautions 5.8)] . no dose adjustment is required in patients with mild or moderate renal impairment. tocilizumab products have not been studied in patients with severe renal impairment [see clinical pharmacology (12.3)] . no studies on the potential for tocilizumab products to cause dependence have been performed. however, there is no evidence from the available data that tocilizumab products treatment results in dependence.

Malasja - Ingliż - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

roche (malaysia) sdn. bhd. - tocilizumab -

Armenja - Ingliż - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

f. hoffmann-la roche ltd. - tocilizumab - concentrate for solution for i/v infusion - 20mg/ml

Armenja - Ingliż - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

f. hoffmann-la roche ltd. - tocilizumab - concentrate for solution for i/v infusion - 20mg/ml

Armenja - Ingliż - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

f. hoffmann-la roche ltd. - tocilizumab - concentrate for solution for i/v infusion - 20mg/ml