Arcalyst

(rilonacept)
rilonacept 220 MG Injection [Arcalyst]
NO BOXED WARNING

Dosage & administration

Administer by subcutaneous injection

drug label

Arcalyst prescribing information

prior authorization

Arcalyst prior authorization resources

Most recent Arcalyst prior authorization forms

View By Payer
Verified: Feb 07, 2024Kaiser Foundation Health Plan - Chronic High-Dose Opioid Therapy Prior Authorization Form Washington
Verified: Feb 01, 2024Highmark BCBS Northeastern NY - Medical Injectable Specialty Drug Prior Authorization Form
Verified: Feb 01, 2024Highmark BCBS Northeastern NY - Outpatient Chemotherapy Prior Authorization Form (Medical Benefit)
Verified: Feb 01, 2024Highmark BCBS Northeastern NY - Specialty Drug Prior Authorization Form
Verified: Feb 01, 2024Highmark BCBS Northeastern NY - Non-Formulary Drug Coverage Prior Authorization Form

Most recent state uniform prior authorization forms

Verified: Jan 28, 2024Oregon - Uniform Prior Authorization Form
Verified: Jan 28, 2024Colorado - Uniform Prior Authorization Form
Verified: Jan 28, 2024Michigan - Uniform Prior Authorization Form
Verified: Jan 28, 2024Hawaii - Uniform Prior Authorization Form
Verified: Jan 28, 2024Minnesota - Uniform Prior Authorization Form
Verified: Jan 28, 2024New Hampshire - Uniform Prior Authorization Form
Verified: Jan 28, 2024New Mexico - Uniform Prior Authorization Form
Verified: Jan 28, 2024Texas - Uniform Prior Authorization Form
Verified: Jan 28, 2024Louisiana - Uniform Prior Authorization Form
Verified: Jan 28, 2024Arizona - Uniform Prior Authorization Form
Verified: Jan 28, 2024Indiana - Uniform Prior Authorization Form
Verified: Jan 28, 2024Illinois - Uniform Prior Authorization Form
Complete Letter of Medical Necessity
Coverage Authorization Appeal
Appeal Letter Guide
Letter of Medical Neccessity Guide
Tiering Exception Letter
Tiering Exception Letter Guide
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Benefits investigation

Kinisa OneConnect Enrollment Form: Recurrent Pericarditis
Kinisa OneConnect Enrollment Form (Spanish): Recurrent Pericarditis
Kinisa OneConnect Enrollment Form: CAPS & DIRA
Kinisa OneConnect Enrollment Form (Spanish): CAPS & DIRA
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pharmacy

Arcalyst preferred pharmacy

Pharmacy List

financial assistance

Arcalyst financial assistance options

Co-pay savings program

commercial only
Kinisa OneConnect Enrollment Form: Recurrent Pericarditis
Kinisa OneConnect Enrollment Form (Spanish): Recurrent Pericarditis
Enroll in Patient Savings Program
Kinisa OneConnect Enrollment Form: CAPS & DIRA
Kinisa OneConnect Enrollment Form (Spanish): CAPS & DIRA
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Bridge program

commercial only
Kinisa OneConnect Enrollment Form: CAPS & DIRA
Kinisa OneConnect Enrollment Form (Spanish): CAPS & DIRA
Quick Start Program: CAPS & DIRA
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Foundation programs

under insured
no insurance
goverment insurance
65+
Kinisa OneConnect Enrollment Form: Recurrent Pericarditis
Kinisa OneConnect Enrollment Form (Spanish): Recurrent Pericarditis
Patient Assistance Program
Kinisa OneConnect Enrollment Form: CAPS & DIRA
Kinisa OneConnect Enrollment Form (Spanish): CAPS & DIRA
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PubMed™ | Arcalyst

Arcalyst PubMed™ News

patient education

Arcalyst patient education

Getting started on Arcalyst

Instructions For Use (Video): Recurrent Pericarditis
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Instructions For Use: All Indications
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Instructions For Use (Video): DIRA
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Instructions For Use (Video): CAPS
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To share resource; ask patient to:
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2.Open camera
3.Scan QR code with camera
4.Tap link

Patient toolkit

About Arcalyst: Recurrent Pericarditis
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Patient Stories
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Patient Brochure
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About Arcalyst: CAPS
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About Arcalyst: DIRA
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people also ask

Arcalyst FAQs

What are the risks of ARCALYST during pregnancy?There have been rare pregnancy outcomes reported postmarketing and from clinical trials, with very limited use of ARCALYST in pregnant women, so there is insufficient information to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In an animal reproduction study, subcutaneous administration of rilonacept to pregnant monkeys during the period of organogenesis was associated with a dose-related increase in exposure but no treatment-related effects on fetal survival or development of malformations with doses up to 11 times the maximum recommended human dose (MRHD). Increased incidences of lumbar ribs, a skeletal variation, were observed in fetuses at doses approximately 2 times the MRHD and higher, and there were findings of multiple fusion and absence of the ribs and thoracic vertebral bodies and arches in one fetus of the only pregnant monkey with exposure to rilonacept during the later period of gestation associated with a dose approximately 6 times the MRHD. The relationship of these findings in a single fetus to drug treatment was unclear, as these findings were not evident in fetuses from pregnant monkeys that had higher exposures to rilonacept during the period of organogenesis associated with a dose approximately 11 times the MRHD. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2%–4% and of miscarriage is 15%–20%, respectively.
What should I consider if I am breastfeeding while using ARCALYST?There is no information on the presence of rilonacept in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ARCALYST and any potential adverse effects on the breastfed child from ARCALYST or from the underlying maternal condition.
Is ARCALYST safe and effective for pediatric patients with CAPS and RP below the age of 12 years?No, safety and effectiveness in pediatric patients with CAPS and RP below the age of 12 years have not been established for ARCALYST.
What subcutaneous dose of ARCALYST was used to treat pediatric patients with CAPS in the open-label extension phase?Six pediatric patients with CAPS between the ages of 12 and 16 were treated with ARCALYST at a weekly subcutaneous dose of 2.2 mg/kg (up to a maximum of 160 mg) for 24 weeks during the open-label extension phase.
What were the results of treating pediatric patients with ARCALYST?Pediatric patients with CAPS treated with ARCALYST showed improvement from baseline in their symptom scores and in objective markers of inflammation (e.g., Serum Amyloid A and C-Reactive Protein). The adverse reactions included injection-site reactions and upper respiratory symptoms as were commonly seen in adult patients.
What is the recommended monitoring for pediatric patients treated with ARCALYST?Pediatric patients treated with ARCALYST should undergo appropriate monitoring for growth and development.
Is ARCALYST safe and effective for pediatric patients with DIRA weighing less than 10 kg?No, safety and effectiveness of ARCALYST have not been established in pediatric patients weighing less than 10 kg for maintenance of remission of DIRA.
What is known about the safety and effectiveness of ARCALYST in geriatric patients?In the placebo-controlled clinical studies, 78 patients randomized to treatment with ARCALYST were  65 years of age, and 6 were  75 years of age. In the CAPS clinical trial, efficacy, safety, and tolerability were generally similar in elderly patients as compared to younger adults; however, only ten patients  65 years old participated in the trial. In an open-label extension study of CAPS, a 71-year-old woman developed bacterial meningitis and died. Age did not appear to have a significant effect on steady-state trough concentrations in the clinical study.
Has the pharmacokinetics of rilonacept administered subcutaneously been evaluated in patients with renal impairment?No, no studies have been conducted to evaluate the pharmacokinetics of rilonacept administered subcutaneously in patients with renal impairment.
Has the pharmacokinetics of rilonacept administered subcutaneously been evaluated in patients with hepatic impairment?No, no studies have been conducted to evaluate the pharmacokinetics of rilonacept administered subcutaneously in patients with hepatic impairment.
FAQ Data Source