A proven treatment
with established safety1


A proven treatment
with established safety1

Safety profile

Safety and tolerability data reflect exposure to ARCALYST in more than 2000 patients.1

These included patients with cryopyrin-associated periodic syndromes (CAPS) and recurrent pericarditis, patients with other diseases, and healthy volunteers.

  • Included approximately 151 patients exposed for at least 6 months1
  • Included 111 patients exposed for at least 1 year1

In the Phase 3 trial, RHAPSODY, injection-site reactions* and upper respiratory tract infections were the most common adverse events associated with use of ARCALYST.2

Safety table
Safety table

*Including erythema, swelling, pruritus, mass, bruising, inflammation, pain, edema, dermatitis, discomfort, urticaria, vesicles, warmth and hemorrhage.1
Patients with multiple events were counted once in each appropriate category.
Counted once, according to the maximum severity of the adverse event.
§Cancer was an event of special interest.


ARCALYST is a once-weekly subcutaneous therapy.1

Loading dose

Loading dose

ARCALYST should be initiated with a loading dose that is 2x the dose of the following weekly maintenance doses.

The loading dose of ARCALYST should be performed under the supervision of a healthcare professional.

Maintenance dose

Maintenance dose

The weekly maintenance dose can be self-administered by the patient.

Adults (18 years and older)

Loading dose:

320 mg

given as two 160-mg (2 mL) injections

Weekly maintenance dose:

160 mg

given as a once-weekly 2-mL injection

Adolescents (12 to 17 years)

Loading dose:

4.4 mg/kg

given as 1 or 2 injections, up to a maximum of 320 mg (up to 2 mL)

Weekly maintenance dose:

2.2 mg/kg

given as a once-weekly injection, up to a maximum of 160 mg (up to 2 mL)


ARCALYST reconstitution and injection
follow a step-by-step process.

Patients should receive training from a healthcare professional before self-administering
ARCALYST for the first time.


Arcalyst Bottle

ARCALYST is supplied in sterile, single-use, 20-mL glass vials.1

  • Each vial contains 220 mg rilonacept, a sterile, white to off-white, lyophilized powder
  • Reconstitution with 2.3 mL of preservative-free Sterile Water for Injection is required prior to subcutaneous administration of the drug
  • The reconstituted ARCALYST is a viscous, clear, colorless to pale yellow, free from particulates, 80-mg/mL preservative-free solution

The video below can give your patients a step-by-step tutorial for administering ARCALYST.

How to use  Arcalyst guide

Take an in-depth look at
how to use ARCALYST.


The duration of a patient's ARCALYST treatment will be determined by the prescribing physician.



Real-world evidence indicates that the mean duration of recurrent pericarditis could be up to 3 to 4 years from the first episode—longer in patients with a greater burden of recurrences3

  • In RHAPSODY, the mean duration of disease at study entry was 2.4 years1

In RHAPSODY, the median duration of rilonacept treatment was 9 months2

  • At the completion of the RW period, 74 of 75 eligible patients chose to enroll in the ongoing long-term extension (LTE) treatment period.2

At the 1-year anniversary of the start of the LTE treatment period, the median duration of continuous rilonacept therapy was approximately 20 months4

A majority of ARCALYST prescriptions have been written for a duration of 12 months*

*From approval in March 2021 to November 1, 2021.