ARCALYST (rilonacept)
safety and

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 RHAPSODY trial, injection-site reactions and upper respiratory tract infections were the most common adverse events associated with use of ARCALYST, which were mild to moderate in severity.2

Safety table
Safety table

                      *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 patient-administered 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 total

given as two 2-mL injections of 160 mg each

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)

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

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

• Each vial contains 220 mg rilonacept, a
   sterile, white to off-white, preservative
   -free, lyophilized powder

• Reconstitution with 2.3 mL of
  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

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

how-to-guide-thumb copy.png

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


In the Phase 3 trial RHAPSODY, a total of 86 patients received at least 1 dose of ARCALYST with a median treatment duration of 9 months.1



Some patients could receive treatment for up to an additional 2 years in the long-term extension treatment period.3