ARCALYST (rilonacept)

For the maintenance of remission of Deficiency of Interleukin 1 (IL-1)
Receptor Antagonist (DIRA)

What is DIRA

DIRA is an autoinflammatory disease first reported in 2009 that is characterized by the absence of functional interleukin-1 receptor antagonist (IL-1Ra) protein.1,2 Patients with DIRA have life-threatening systemic inflammation with skin and bone involvement.1 DIRA is a genetic disorder inherited in an autosomal recessive manner, meaning that a mutation in both copies of a gene is needed to cause the disease.2,3

DIRA is a very rare disease with fewer than 50 patients worldwide.4 Cases have been identified in families originating in Puerto Rico, Newfoundland (Canada), The Netherlands, Palestine/Lebanon, Germany, Turkey, India, and Brazil.2,5,6 In Puerto Rico, the incidence of DIRA in some regions may be as high as 1 in 6300 births.1 Although difficult to estimate, mortality is approximately 30% in early infancy.4

DIRA is characterized by a neonatal onset, with patients presenting at birth or in the first days of life with prominent skin and bone manifestations.1,2,5 Generalized skin pustulosis, joint swelling, and painful osteolytic lesions are some of the more distinctive clinical features of the disease.2

Children with DIRA experience intense chronic pain.7 This pain may lead to feeding challenges and subsequent growth delays.7 If left untreated, DIRA can escalate to life-threatening inflammation, with the development of systemic inflammatory response syndrome (SIRS), multiorgan failure, and death in early childhood.4,5

ABOUT ARCALYST
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ARCALYST is indicated for the maintenance of remission of DIRA in adults and pediatric patients weighing at least 10 kg.8

DOSING AND ADMINISTRATION

ARCALYST is a patient-administered
once-weekly subcutaneous therapy.8

Weekly Dose

Maintenance dose

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

Adults
(18 years and older)

320 mg

injection given once weekly as 2 subcutaneous injections, administered:

 

  • On the same day
  • At 2 different sites
  • With a maximum single-injection volume of 3 mL

Pediatric Patients
(weighing at least 10 kg)

4.4 mg/kg

up to maximum at 320 mg administered once-weekly as 1-2 subcutaneous  injections. If the dose is given as 2 injections, it should be administered:

 

  • On the same day
  • At 2 different sites
  • With a maximum single-injection volume of 3 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.8

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ARCALYST is supplied in sterile, single-use, 20-mL glass vials.8

  • 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 a 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 One Connect at (781) 609-7826.

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

 

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

 

Step 3

FULFILLMENT

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

Kiniksa One Connect 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 One Connect 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
Kiniksa one connect white small

 

Kiniksa One Connect 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 One Connect, 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