New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - siltuximab 100mg;  ;   - powder for infusion concentrate - 100 mg - active: siltuximab 100mg     excipient: histidine polysorbate 80 sucrose - sylvant is indicated for the treatment of adult patients with multicentric castleman's disease (mcd) who are human immunodeficiency virus (hiv) negative and human herpesvirus-8 (hhv-8) negative.

United States - English - NLM (National Library of Medicine)

janssen biotech, inc. - siltuximab (unii: t4h8fma7im) (siltuximab - unii:t4h8fma7im) - siltuximab 100 mg - sylvant is indicated for the treatment of patients with multicentric castleman's disease (mcd) who are human immunodeficiency virus (hiv) negative and human herpesvirus-8 (hhv-8) negative. limitations of use sylvant was not studied in patients with mcd who are hiv positive or hhv-8 positive because sylvant did not bind to virally produced il-6 in a nonclinical study. severe hypersensitivity reaction to siltuximab or any of the excipients in sylvant [see warnings and precautions (5.3)] . hypersensitivity reactions, including anaphylactic reaction, hypersensitivity, and drug hypersensitivity have been reported in patients treated with siltuximab. pregnancy category c risk-summary there are no adequate or well-controlled studies in pregnant women. in animal reproduction studies, administration of a human antibody to il-6 to pregnant cynomolgus monkeys caused decreases in globulin levels in pregnant animals and in the offspring. siltuximab crossed the placenta in monkeys. infants born to pregnant women treated wi

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

janssen-cilag ltd - siltuximab - powder for solution for infusion - 100mg

Israel - English - Ministry of Health

medison pharma ltd - siltuximab - powder for concentrate for solution for infusion - siltuximab 100 mg - siltuximab - sylvant is indicated for the treatment of adult patients with multicentric castleman’s disease (mcd) who are human immunodeficiency virus (hiv) negative and human herpesvirus-8 (hhv-8) negative.

Australia - English - Department of Health (Therapeutic Goods Administration)

recordati rare diseases australia pty ltd - siltuximab, quantity: 100 mg - injection, powder for - excipient ingredients: histidine; polysorbate 80; sucrose - sylvant is indicated for the treatment of patients with multicentric castleman's disease (mcd) who are human immunodeficiency virus (hiv) negative and human herpesvirus-8 (hhv-8) negative.

Canada - English - Health Canada

eusa pharma (uk) limited - siltuximab - powder for solution - 100mg - siltuximab 100mg - immunosuppressive agents

Australia - English - Department of Health (Therapeutic Goods Administration)

recordati rare diseases australia pty ltd - siltuximab, quantity: 400 mg - injection, powder for - excipient ingredients: polysorbate 80; sucrose; histidine - sylvant is indicated for the treatment of patients with multicentric castleman's disease (mcd) who are human immunodeficiency virus (hiv) negative and human herpesvirus-8 (hhv-8) negative.

United States - English - NLM (National Library of Medicine)

eusa pharma (uk) ltd - siltuximab (unii: t4h8fma7im) (siltuximab - unii:t4h8fma7im) - sylvant is indicated for the treatment of patients with multicentric castleman's disease (mcd) who are human immunodeficiency virus (hiv) negative and human herpesvirus-8 (hhv-8) negative. limitations of use sylvant was not studied in patients with mcd who are hiv positive or hhv-8 positive because sylvant did not bind to virally produced il-6 in a nonclinical study. severe hypersensitivity reaction to siltuximab or any of the excipients in sylvant [see warnings and precautions (5.3)] . hypersensitivity reactions, including anaphylactic reaction, hypersensitivity, and drug hypersensitivity have been reported in patients treated with siltuximab. risk-summary in an animal reproduction study, intravenous administration of a human antibody to il-6 to pregnant monkeys from the onset of organogenesis through delivery caused functional impairment in pregnant animals and in the offspring. siltuximab and the human antibody to il-6 crossed the placenta in monkeys ( see data ). the limited available information on sylvant use during pregnancy is not sufficient to inform a drug-associated risk of major birth defects or miscarriage. infants born to pregnant women treated with sylvant may be at increased risk of infection (see clinical considerations). advise pregnant women of the potential risk to a fetus. the estimated background risk 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 is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. clinical considerations fetal/neonatal adverse reactions monoclonal antibodies are transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. infants born to pregnant women treated with sylvant may be at increased risk of infection. consider the risks and benefits of administering live or live-attenuated vaccines to infants exposed to sylvant in utero [see warnings and precautions (5.2)] . data animal data in an embryo-fetal development study in cynomolgus monkeys, pregnant animals received intravenous doses of siltuximab of 9.2 or 46 mg/kg/week during gestation days (gd) 20 to 118, which includes the period of organogenesis. fetuses were evaluated on gd 140, approximately 25 days prior to the natural birth. exposures at the low and high dose after the 25 th administration were approximately 3 and 7 times, respectively, the human exposure based on auc in patients with mcd at the recommended dose of 11 mg/kg every three weeks. no maternal or fetal structural abnormalities were observed. however, siltuximab crossed the placenta at both doses and when measured on gd 140, fetal serum concentrations of siltuximab were similar to maternal concentrations. in a combined embryofetal and pre- and post-natal development study in cynomolgus monkeys, pregnant animals received intravenous doses of 10 or 50 mg/kg/week of a human antibody to il-6 from gd 20 to natural delivery (gd 167). the offspring were evaluated up to 7 months after birth for developmental effects. no maternal or infant structural abnormalities were observed; however, globulin levels were decreased in pregnant animals (gd 34 through lactation day 30) and in the offspring (lactation days 30-120) at both doses. risk summary there are no data on the presence of siltuximab in human milk, the effects on the breastfed child, or the effects on milk production. however, low levels of the human antibody to il-6 was present in the milk of lactating cynomolgus monkeys. when a drug is present in animal milk, it is likely that the drug will be present in human milk. because of the potential for serious adverse reactions in the breastfed child including gastrointestinal perforations, advise patients that breastfeeding is not recommended during treatment with sylvant, and for 3 months after the last dose. contraception females sylvant may cause embryo-fetal harm when administered to pregnant women [see use in specific populations (8.1)] . advise female patients of reproductive potential to use effective contraception during treatment with sylvant and for 3 months after the last dose. the safety and efficacy of sylvant have not been established in pediatric patients. of the patients treated with sylvant monotherapy in clinical studies 127 (35%) were 65 years and older. no overall differences in safety profile were observed between these patients and younger patients, and other reported clinical experience has not identified differences in the safety profile between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. clinical studies did not include sufficient numbers of patients aged 65 years and older to determine the effect of age on efficacy in mcd population. based on a population pharmacokinetic analysis using data from clinical trials in patients, no significant difference in siltuximab clearance was observed in patients with pre-existing renal impairment (creatinine clearance (clcr) ≥ 15 ml/min) compared to patients with baseline normal renal function (clcr ≥ 90 ml/min). no initial dosage adjustment is necessary for patients with clcr ≥ 15 ml/min. the potential effect of end stage renal disease on siltuximab pharmacokinetics cannot be determined [see clinical pharmacology (12.3)]. based on a population pharmacokinetic analysis using data from clinical trials in patients, no significant difference in siltuximab clearance was observed in patients with pre-existing mild to moderate hepatic impairment (child-pugh class a and b, respectively) compared to patients with baseline normal hepatic function. no initial dosage adjustment is necessary for patients with mild to moderate hepatic impairment. patients with baseline severe hepatic impairment (child-pugh class c) were not included in clinical trials [see clinical pharmacology (12.3)].

European Union - English - EMA (European Medicines Agency)

recordati netherlands b.v. - siltuximab - giant lymph node hyperplasia - immunosuppressants - sylvant is indicated for the treatment of adult patients with multicentric castleman’s disease (mcd who are human immunodeficiency virus (hiv) negative and human herpesvirus-8 (hhv-8) negative.,

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

link healthcare sdn. bhd. - siltuximab -