Patient Information

What your patients should know
about treatment with
ARCALYST® (rilonacept)

Injection and
Self-Injection Instructions

The first injection of ARCALYST® (rilonacept) should be performed under the supervision of a qualified healthcare professional.

  • If a patient or caregiver is to administer ARCALYST, he/she should be instructed on aseptic reconstitution of the lyophilized product and injection technique
  • The ability to inject subcutaneously should be assessed to ensure proper administration of ARCALYST, including rotation of injection sites (see the Patient Prescribing Information in the Full Prescribing Information)
  • ARCALYST should be reconstituted with preservative-free sterile water for injection
  • A puncture-resistant container for disposal of vials, needles, and syringes should be used. Patients or caregivers should be instructed in proper vial, syringe, and needle disposal and should be cautioned against reuse of these items

Injection-site reactions: healthcare providers should explain to patients that almost half the patients in the clinical trials experienced a reaction at the injection site.

  • Injection-site reactions may include pain, erythema, swelling, pruritis, bruising, mass, inflammation, dermatitis,edema, urticaria, vesicles, warmth, and hemorrhage
  • Patients should be cautioned to avoid injecting into an area that is already swollen or red
  • Any persistent reaction should be brought to the attention of the prescribing physician

Infections: patients should be cautioned that ARCALYST has been associated with serious, life-threatening infections and not to initiate treatment with ARCALYST if they have a chronic or active infection.

  • Patients should be counseled to contact their healthcare provider immediately if they develop an infection after starting ARCALYST
  • Treatment with ARCALYST should be discontinued if a patient develops a serious infection
  • Patients should be counseled not to take any IL-1-blocking drug, including ARCALYST, if they are also taking a drug that blocks TNF, such as etanercept, infliximab, or adalimumab
  • Use of ARCALYST with other IL-1-blocking agents, such as anakinra, is not recommended

Vaccinations: prior to initiation of therapy with ARCALYST, healthcare providers should review with adult and pediatric patients their vaccination history relative to current medical guidelines for vaccine use, including taking into account the potential of increased risk of infection during treatment with ARCALYST.

Additional assistance for patients taking ARCALYST, as well as their caregivers and healthcare providers, is available by calling Regeneron Pharmaceuticals Medical Information at 1-877-REGN-777 (1-877-734-6777).

Dosage & Administration

View the dosing instructions for adult patients and pediatric patients aged 12 to 17 years.

Review the Information

Important Safety Information

  • IL-1 blockade may interfere with immune response to infections. Serious, life-threatening infections have been reported in patients taking ARCALYST. ARCALYST should be discontinued if a patient develops a serious infection. Taking ARCALYST with TNF inhibitors is not recommended because this may increase the risk of serious infections
  • Patients should not receive a live vaccine while taking ARCALYST. It is recommended that prior to initiation of therapy with ARCALYST patients receive all recommended vaccinations, as appropriate, including pneumococcal vaccine and inactivated influenza vaccine
  • In the initial development program for ARCALYST, six serious adverse reactions were reported by four patients: Mycobacterium intracellulare infection, gastrointestinal bleeding and colitis, sinusitis and bronchitis, and Streptococcus pneumoniae meningitis
  • The most commonly reported adverse reactions associated with ARCALYST were injection site reaction and upper respiratory tract infection
  • Patients should be monitored for changes in their lipid profiles and provided with medical treatment if warranted
  • Treatment with immunosuppressants, including ARCALYST, may result in an increase in risk of malignancies
  • Hypersensitivity reactions associated with ARCALYST administration in clinical studies have been rare. If a hypersensitivity reaction occurs, administration of ARCALYST should be discontinued and appropriate therapy initiated

IMPORTANT PRESCRIBING INFORMATION

ARCALYST® (rilonacept), an interleukin-1 blocker, is indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children age 12 and over. It has not been studied in patients with Neonatal-Onset Multisystem Inflammatory Disease (NOMID).

Please see the full Prescribing Information for ARCALYST.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

The information provided in this site is intended only for healthcare professionals in the United States. The products discussed herein may have different product labeling in different countries.

Copyright © 2018,
Regeneron Pharmaceuticals, Inc. May 2018 US-ARC-13325(1)

Important Safety Information
and Indication

IL-1 blockade may interfere with immune response to infections. Serious, life-threatening infections have been reported in patients taking ARCALYST. ARCALYST should be discontinued if a patient develops a serious infection. Taking ARCALYST with TNF inhibitors is not recommended because this may increase the risk of serious infections.