European Union - English - EMA (European Medicines Agency)

regeneron uk limited - rilonacept - cryopyrin-associated periodic syndromes - immunosuppressants - rilonacept regeneron is indicated for the treatment of cryopyrin-associated periodic syndromes (caps) with severe symptoms, including familial cold auto-inflammatory syndrome (fcas) and muckle-wells syndrome (mws), in adults and children aged 12 years and older.

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

regeneron pharmaceuticals, inc. - rilonacept (unii: 8k80yb5gmg) (rilonacept - unii:8k80yb5gmg) - rilonacept 160 mg in 2 ml - arcalyst® (rilonacept) is an interleukin-1 blocker indicated for the treatment of cryopyrin-associated periodic syndromes (caps), including familial cold autoinflammatory syndrome (fcas), and muckle-wells syndrome (mws) in adults and pediatric patients 12 years and older. arcalyst is indicated for the maintenance of remission of deficiency of interleukin-1 receptor antagonist (dira) in adults and pediatric patients weighing at least 10 kg. arcalyst is indicated for the treatment of recurrent pericarditis (rp) and reduction in risk of recurrence in adults and pediatric patients 12 years and older. none. risk summary rare pregnancy outcomes reported postmarketing and from clinical trials, with very limited use of arcalyst in pregnant women, are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there may be risks to the mother and fetus associated with cryopyrin associated periodic syndromes (caps) (see clinical considerations) . in an

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

kiniksa pharmaceuticals (uk), ltd. - rilonacept (unii: 8k80yb5gmg) (rilonacept - unii:8k80yb5gmg) - arcalyst® (rilonacept) is an interleukin-1 blocker indicated for the treatment of cryopyrin-associated periodic syndromes (caps), including familial cold autoinflammatory syndrome (fcas), and muckle-wells syndrome (mws) in adults and pediatric patients 12 years and older. arcalyst is indicated for the maintenance of remission of deficiency of interleukin-1 receptor antagonist (dira) in adults and pediatric patients weighing at least 10 kg. arcalyst is indicated for the treatment of recurrent pericarditis (rp) and reduction in risk of recurrence in adults and pediatric patients 12 years and older. none. risk summary rare pregnancy outcomes reported postmarketing and from clinical trials, with very limited use of arcalyst in pregnant women, are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there may be risks to the mother and fetus associated with cryopyrin associated periodic syndromes (caps) (see clinical considerations) . in an

Israel - English - Ministry of Health

neopharm (israel) 1996 ltd - rilonacept - lyophilized powder for solution for injection - rilonacept 80 mg/ml - rilonacept - arcalyst (rilonacept) is an interleukin-1 blocker indicated for the treatment of cryopyrin-associated periodic syndromes (caps), including familial cold autoinflammatory syndrome (fcas) and muckle-wells syndrome (mws) in adults and children 12 and older.

Israel - English - Ministry of Health

neopharm (israel) 1996 ltd - rilonacept - lyophilized powder for solution for injection - rilonacept 80 mg/ml - rilonacept - arcalyst (rilonacept) is an interleukin-1 blocker indicated for the treatment of cryopyrin-associated periodic syndromes (caps), including familial cold autoinflammatory syndrome (fcas) and muckle-wells syndrome (mws) in adults and children 12 and older.

Canada - English - Health Canada

novartis pharmaceuticals canada inc - canakinumab - powder for solution - 150mg - canakinumab 150mg - immunosuppressive agents

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

novartis pharmaceuticals corporation - canakinumab (unii: 37cq2c7x93) (canakinumab - unii:37cq2c7x93) - canakinumab 150 mg in 1 ml - ilaris® (canakinumab) is an interleukin-1β (il-1β) blocker indicated for the treatment of the following autoinflammatory periodic fever syndromes: cryopyrin-associated periodic syndromes (caps) ilaris is indicated for the treatment of cryopyrin-associated periodic syndromes (caps), in adults and pediatric patients 4 years of age and older, including: - familial cold autoinflammatory syndrome (fcas) - muckle-wells syndrome (mws) tumor necrosis factor receptor (tnf) associated periodic syndrome (traps) ilaris is indicated for the treatment of tumor necrosis factor (tnf) receptor associated periodic syndrome (traps) in adult and pediatric patients. hyperimmunoglobulin d syndrome (hids)/mevalonate kinase deficiency (mkd) ilaris is indicated for the treatment of hyperimmunoglobulin d (hyper-igd) syndrome (hids)/mevalonate kinase deficiency (mkd) in adult and pediatric patients. familial mediterranean fever (fmf) ilaris is indicated for the treatment of familial mediterranean fever (fmf) in adult and pediatric pat

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

e.r. squibb & sons, l.l.c. - belatacept (unii: e3b2gi648a) (belatacept - unii:e3b2gi648a) - belatacept 250 mg - nulojix® (belatacept) is indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant. nulojix is to be used in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids. use nulojix only in patients who are ebv seropositive [see contraindications (4) and warnings and precautions (5.1)] . use of nulojix for the prophylaxis of organ rejection in transplanted organs other than kidney has not been established [see warnings and precautions (5.6)] . nulojix is contraindicated in transplant recipients who are epstein-barr virus (ebv) seronegative or with unknown ebv serostatus due to the risk of post-transplant lymphoproliferative disorder (ptld), predominantly involving the central nervous system (cns) [see boxed warning and warnings and precautions (5.1)] . to monitor maternal-fetal outcomes of pregnant women who have received immunosuppressants including nulojix or whose partners have received nulojix, healthcare providers are strongly encouraged to regis