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🏅 FDA Orphan Designation

Arcalyst

rilonacept

Manufacturer: Kiniksa Pharmaceuticals, Ltd.

Indicated for:
NLRP3-associated autoinflammatory diseaseOrphanIdiopathic recurrent pericarditisOrphanFamilial cold urticariaMuckle-Wells syndromeSterile multifocal osteomyelitis with periostitis and pustulosis

FDA-Approved Indications (5)

Treatment of Cryopyrin-Assisted Periodic Syndromes (CAPS)

Treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and pediatric patients 12 years and older

Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS), and Muckle-Wells Syndrome (MWS)

Population: adults and children 12 years and older

Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS), and Muckle-Wells Syndrome (MWS)

Population: adults and children 12 years and older

Maintenance of remission of Deficiency of Interleukin-1 Receptor Antagonist (DIRA)

Population: adults and pediatric patients weighing 10 kg or more

Indications & Usage

1 INDICATIONS AND USAGE ARCALYST (rilonacept) is an interleukin-1 blocker indicated for: Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS), and Muckle-Wells Syndrome (MWS) in adults and children 12 years and older ( 1.1 , 14.1 ) Maintenance of remission of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) in adults and pediatric patients weighing 10 kg or more ( 1.2 , 14.2 ) Treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and children 12 years and older ( 1.3 , 14.3 ) 1.1 Cryopyrin-Associated Periodic Syndromes, Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome 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. 1.2 Deficiency of IL-1 Receptor Antagonist 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. 1.3 Recurrent Pericarditis 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.

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Medical disclaimer: This information is for educational purposes only. Always consult a qualified healthcare provider before making treatment decisions. Data sourced from FDA and current as of our last update.