Miscellaneous immune disorders:

Indications for ARCALYST:

Cryopyrin-associated periodic syndromes (CAPS) including familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS). Maintenance of remission of deficiency of interleukin-1 receptor antagonist (DIRA).

Adults and Children:

CAPS (<12yrs): not established. DIRA (<10kg): not established. Give by SC inj into abdomen, thigh, or upper arm; rotate sites. CAPS, FCAS, MWS (≥18yrs): Loading dose: 320mg (give as 2 inj of 160mg on the same day at different sites), then 160mg as single dose once weekly; (12–17yrs): Loading dose: 4.4mg/kg (max 320mg) in 1 or 2 inj (max 2mL/inj); if dose is given as 2 inj, administer on the same day at different sites. Maintenance: 2.2mg/kg (max 160mg) as single dose once weekly. DIRA (≥18yrs): 320mg once weekly (given as 2 inj on the same day at different sites); (pediatrics ≥10kg): 4.4mg/kg (max 320mg) in 1 or 2 inj (max 2mL/inj) once weekly; if dose is given as 2 inj, administer on the same day at different sites. Switching from another IL-1 blocker: discontinue IL-1 blocker, then begin Arcalyst at the time of next dose.

ARCALYST Warnings/Precautions:

Discontinue if serious infection develops. Active or chronic infection: do not initiate therapy. Prior to initiation: complete recommended immunizations (including pneumococcal, inactivated influenza), and evaluate and treat possible latent tuberculosis. Discontinue if hypersensitivity reactions occur. Asthma. Diabetes. HIV, hep B, or hep C infection. Renal or hepatic impairment. Monitor lipid profile. Pediatrics: monitor growth and development. Pregnancy. Nursing mothers.

ARCALYST Classification:

Interleukin-1 (IL-1) blocker.

ARCALYST Interactions:

Avoid concurrent live vaccines. Increased risk of infection 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:

Inj site reactions, infections (eg, URI; may be serious/fatal); also DIRA: rash, otitis media, pharyngitis, rhinorrhea; possible increased risk of malignancies, changes in lipid profile.

Generic Drug Availability:

NO

How Supplied:

Single-dose vials—4