Monograph Details
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Immune System
> Immunomodulators
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ARCALYST |
| Manufacturer |
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Regeneron |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Interleukin-1 (IL-1) blocker. |
| Generic Name |
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Rilonacept 220mg; per vial; pwd for SC inj after reconstitution; preservative-free. |
| Indications |
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Cryopyrin-associated periodic syndromes (CAPS) including familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS). |
| Children |
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Give by SC inj into abdomen, thigh, or upper arm; rotate sites. <12yrs: not recommended. 12–17yrs: Loading dose: 4.4mg/kg (max 320mg) in 1 or 2 inj (max 2mL/inj) on day 1; may split loading dose into 2 inj at different sites. Maintenance: 2.2mg/kg (max 160mg) once weekly. |
| Adults |
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Give by SC inj into abdomen, thigh, or upper arm; rotate sites. ≥18yrs: Loading dose: 320mg on day 1 (split dose into 2x160mg at different sites), then 160mg as single dose once weekly. |
| Precautions |
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Discontinue if serious infection develops. Do not start treatment with active or chronic infection. Before starting therapy: complete recommended immunization schedules (including pneumococcal and influenza), and evaluate and treat possible latent tuberculosis. Asthma. Diabetes. HIV, hep B, or hep C infection. Renal or hepatic impairment. Monitor lipid profile. Patients <18yrs: monitor growth and development. Pregnancy (Cat.C): not recommended (may cause fetal harm). Nursing mothers. |
| Interactions |
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Avoid concurrent live vaccines. Infection risk with concomitant TNF blockers (eg etanercept, infliximab, adalimumab) or other IL-1 blockers (eg, anakinra): not recommended. Monitor drugs that affect or are affected by CYP450 (eg, warfarin). Caution with other immunosuppressants (eg, corticosteroids). |
| Adverse Reactions |
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Inj site reactions, infections (eg, URI; may be serious/fatal); possible increased risk of malignancies, antibody formation, changes in lipid profile. |
| How Supplied |
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Single-dose vial—4 |
| Additional Resources |
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• Related Prescribing Note |
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