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Arcalyst Generic Name & Formulations
Legal Class
Rx
General Description
Rilonacept 220mg; per vial; lyophilized pwd for SC inj after reconstitution; preservative-free.
Pharmacological Class
Interleukin-1 (IL-1) blocker.
How Supplied
Single-dose vials—4
Manufacturer
Generic Availability
NO
Arcalyst Indications
Indications
Recurrent pericarditis (RP) and reduction in risk of recurrence.
Arcalyst Dosage and Administration
Adults and Children
<12yrs: not established. Give by SC inj into abdomen, thigh, or upper arm; rotate sites. 12–17yrs: Loading dose: 4.4mg/kg (max 320mg) in 1 or 2 inj (max 2mL/inj/site); if dose is given as 2 inj, administer on the same day at different sites. Continue with 2.2mg/kg (max 160mg) as single dose once weekly. ≥18yrs: Loading dose: 320mg (give as 2 inj of 160mg on the same day at different sites), then continue with 160mg as single dose once weekly. Switching from another IL-1 blocker: discontinue IL-1 blocker, then begin Arcalyst at the time of next dose.
Arcalyst Contraindications
Not Applicable
Arcalyst Boxed Warnings
Not Applicable
Arcalyst Warnings/Precautions
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 Pharmacokinetics
See Literature
Arcalyst Interactions
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).
Arcalyst Adverse Reactions
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.
Arcalyst Clinical Trials
See Literature
Arcalyst Note
Not Applicable
Arcalyst Patient Counseling
See Literature
Arcalyst Generic Name & Formulations
Legal Class
Rx
General Description
Rilonacept 220mg; per vial; lyophilized pwd for SC inj after reconstitution; preservative-free.
Pharmacological Class
Interleukin-1 (IL-1) blocker.
How Supplied
Single-dose vials—4
Manufacturer
Generic Availability
NO
Arcalyst Indications
Indications
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).
Arcalyst Dosage and Administration
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 (12–17yrs): Loading dose: 4.4mg/kg (max 320mg) in 1 or 2 inj (max 2mL/inj/site); if dose is given as 2 inj, administer on the same day at different sites. Continue with 2.2mg/kg (max 160mg) as single dose once weekly; (≥18yrs): Loading dose: 320mg (give as 2 inj of 160mg on the same day at different sites), then continue with 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 Contraindications
Not Applicable
Arcalyst Boxed Warnings
Not Applicable
Arcalyst Warnings/Precautions
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 Pharmacokinetics
See Literature
Arcalyst Interactions
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).
Arcalyst Adverse Reactions
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.
Arcalyst Clinical Trials
See Literature
Arcalyst Note
Not Applicable
Arcalyst Patient Counseling
See Literature
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