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ARCALYST
Miscellaneous immune disorders
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Drug Name:

ARCALYST Rx

Generic Name and Formulations:
Rilonacept 220mg; per vial; pwd for SC inj after reconstitution; preservative-free.

Company:
Regeneron

Therapeutic Use:

Indications for ARCALYST:

Cryopyrin-associated periodic syndromes (CAPS) including familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS).

Adult:

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.

Children:

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.

Warnings/Precautions:

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:

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).

Pharmacological Class:

Interleukin-1 (IL-1) blocker.

Adverse Reactions:

Inj site reactions, infections (eg, URI; may be serious/fatal); possible increased risk of malignancies, antibody formation, changes in lipid profile.

How Supplied:

Single-dose vial—4

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