ARCALYST  (rilonacept)

A treatment for Cryopyrin-Associated Periodic Syndromes (CAPS)

WHAT ARE CAPS?

CAPS are a group of rare, hereditary autoinflammatory disorders.1,2 They are inherited in an autosomal dominant pattern, which means that a mutation in 1 copy of the gene is enough to cause the disorder.2,3

  • Both males and females are equally affected.4
  • The estimated incidence in the United States is 1 to 2 cases per million people.2

 

CAPS are characterized by lifelong recurrent symptoms of rash, fever/chills, joint pain, eye redness/pain, and fatigue.4

  • The symptoms of CAPS may be challenging to diagnose.
  • The diagnosis may be delayed because CAPS are rare and the symptoms often resemble those of other disorders.
  • Intermittent symptom flares may be triggered anytime by cooling temperatures, stress, exercise, or unidentified causes. Some patients may try to reduce their symptoms by avoiding things that trigger the disease.
About ARCALYST
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ARCALYST is a targeted inhibitor of IL-1, the key driver of inflammation in Cryopyrin-Associated Periodic Syndromes (CAPS). It is approved for the treatment of CAPS, including Familial Cold Auto-inflammatory Syndrome (FCAS), and Muckle-Wells Syndrome (MWS) in adults and children 12 and older.4

Dosing and administration

ARCALYST is a patient-administered
once-weekly subcutaneous therapy.4

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 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. 
Step-by-step administration

ARCALYST reconstitution and injection follow a step-by-step process.4

 

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

 

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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 solution


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

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

Initiating treatment

Steps to initiate ARCALYST treatment

Follow these steps to begin your patient’s ARCALYST treatment process. Please remember that each patient has unique needs and additional steps may be required.

 

 

Step 1

PRE-ENROLLMENT

Ensure your patient’s vaccination history is up to date, including their pneumonia and flu vaccines.

 

Step 2

ENROLLMENT FORM COMPLETION

The Enrollment Form will be provided by your Kiniksa Sales Specialist or is available for download below.

Fax completed Enrollment Form to Kiniksa OneConnect at (781) 609-7826.

 

 

Enrollment Form
(English)
Enrollment
Enrollment Form
(Spanish)
Enrollment

Fax completed Enrollment Form to Kiniksa OneConnect at
(781) 609-7826.

 

 

Step 3

FULFILLMENT

Your patient will be contacted by Kiniksa OneConnect to help arrange delivery from select specialty pharmacies.

Kiniksa OneConnect will work with your patients to set up one-on-one injection training sessions with either virtual support from an ARCALYST Nurse Educator or a combination of virtual/in-person training support that includes virtual support from an ARCALYST Nurse Educator and in-person support from a healthcare professional.

 

Kiniksa OneConnect can help your patients with their treatment needs. 

TREATMENT RESOURCES

There may be several steps to obtaining approval for your patient’s treatment with ARCALYST. The downloadable resources below were developed to help simplify this process by providing information about gaining access to ARCALYST, understanding reimbursement claims, and working with a
specialty pharmacy.

 

Access

The following downloadable resources can help guide you through the steps to product access.

 

 

Tiering Exception Letter Guide and Template
Tiering Guide
Tiering Exception Letter Template
Tiering Sample

Financial assistance

Resources for information about access to ARCALYST and navigating the reimbursement process.

 

 

Access & Reimbursement Guide
Access Guide
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Kiniksa OneConnect is a support program made up of a team of experienced individuals, known as Patient Access Leads, with knowledge of insurance plans and healthcare networks.

Patient Access Leads

Once enrolled in Kiniksa OneConnect, your patient will be paired with a dedicated Patient Access Lead who will work to provide personalized one-on-one support throughout your patient's entire treatment experience.

 

ARCALYST Nurse Educators

ARCALYST Nurse Educators can conduct sessions to help provide your patients with training on the injection process.

Starting treatment
 

Beginning treatment

 By helping to navigate your patients through their insurance coverage and partnering with your practice, we make getting your patient on treatment a seamless experience in a variety of ways: 

  • We coordinate, verify, and explain the benefits verification process
  • We assist with the prior authorization and appeals processes if required
  • When it's time for your patients to begin treatment, we help coordinate delivery of your patient’s therapy 

 

 

KOC-Finance

 

Financial assistance

Our programs help identify possible sources of financial support for eligible patients. 

  • The Kiniksa Copay Assistance Program can offer copays as low as $10 per month* 
  • The Quick Start Program supports qualified patients with delay in coverage for treatment initiation while awaiting prior authorization
  • The Patient Assistance Program supports qualified patients with no coverage for treatment

 

*To be eligible for the Kiniksa Copay Assistance Program, your patients must have commercial insurance, must not have Medicare, Medicaid, or other government insurance, and must meet other eligibility criteria. Your patient also must agree to the rules set forth in the terms and conditions for the program. Please visit kiniksapolicies.com/copay to review additional eligibility criteria.
Program offered for up to 60 days. To be eligible for the Kiniksa Quick Start Program, your patient must meet certain financial eligibility requirements. Please visit kiniksapolicies.com/qstart to review additional eligibility criteria.
Program offered for up to 12 months. To be eligible for the Kiniksa Patient Assistance Program, your patient must meet certain financial eligibility requirements. Please visit kiniksapolicies.com/pap to review additional eligibility criteria.

 

KOC-treatment-support
 

Treatment support

We provide access to Registered Nurses and Licensed Practical Nurses who are trained in both disease state and ARCALYST administration to maximize the patient experience. There are multiple injection training options including:

  • In-office training by you or your office staff
  • One-on-one injection training sessions with an ARCALYST Nurse Educator
KOC Brochure

Help your patients learn more about our services.

Call

 

Call 1-833-KINIKSA (1-833-546-4572)
Monday through Friday, 8 AM to 8 PM ET