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(ri-lon-a-sept) ,


(trade name)


Therapeutic: orphan drugs
Pharmacologic: fusion proteins
Pregnancy Category: C


Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS).


Modulates cryopyrin by blocking interleukin-1 beta (IL-1β) preventing its interaction with surface receptors.

Therapeutic effects

Decreased inflammatory manifestations of CAPS including fever, rash, arthralgia, myalgia, fatigue and conjunctivitis.


Absorption: Absorbed following subcutaneous administration.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: Unknown.

Time/action profile (improvement in symptoms)

Subcutwithin several daysunknownunknown


Contraindicated in: Active or chronic infections; Obstetric: May cause fetal harm.
Use Cautiously in: Patients at risk of infections; Lactation: Use cautiously; Pediatric: Safety and effectiveness have not been established in children <12 yr.

Adverse Reactions/Side Effects


  • upper respiratory tract infections (most frequent)
  • cough


  • injection site reactions (most frequent)


  • changes in lipid profile


  • hypoesthesia


  • serious life-threatening infections (life-threatening)
  • hypersensitivity reactions


Drug-Drug interaction

May decrease the antibody response to and ↑ adverse reactions from live vaccines ; vaccination should take place prior to initiation of treatment.Concurrrent use with TNF inhibitors ↑ risk of serious infections and is not recommended.Medications that are substrates of the CYP450 enzyme system, especially those with narrow therapeutic indices such as warfarin should be monitored carefully as enzyme activity may increase (normalize) as a result of treatment.


Subcutaneous (Adults ≥18 yr) 320 mginitially, followed by 160 mg weekly.
Subcutaneous (Children and adolescents 12–17 yr) 4.4 mg/kg (not to exceed 320 mg) initially, followed by 2.2 mg/kg (not to exceed 160 mg) weekly.


Powder for subcutaneous administration (requires reconstitution): 220 mg/20 mL vial

Nursing implications

Nursing assessment

  • Assess for signs of infections. Discontinue therapy if serious infection occurs. Do not administer to patients with active or chronic infections.
  • Assess for signs of hypersensitivity reactions; institute symptomatic therapy.
  • .
  • Lab Test Considerations: Monitor lipid profiles every 2–3 mo during therapy. May cause ↑total cholesterol, HDL, LDL, and triglycerides. Consider lipid lowering therapies as needed.

Potential Nursing Diagnoses

Risk for infection (Adverse Reactions)


  • Administer all recommended adult and pediatric vaccinations, including pneumococcal vaccine and inactivated influenza vaccine, prior to starting rilonacept therapy.
  • Administer first dose under supervision of health care professional.
  • Loading dose in adults is given as two 2 mL injections on the same day in 2 different injection sites. In pediatric patients 1 or 2 injections may be used. Do not administer more than once weekly or more then 2 mL/injection site.
  • Reconstitute with 2.3 mL of Sterile water for injection using a 27-gauge 1/2 inch needle for a concentration of 80 mg/mL. Discard needle and syringe after reconstitution. Shake vial for 1 min and allow to sit for 1 min. Solution is viscous, clear, colorless to pale yellow. Do not administer solutions that are discolored, contain particulate matter, or are passed the expiration date. Withdraw recommended dose up to 2 mL with new 27-gauge 1/2 inch needle. Vials are single use; discard unused solution. Rilonacept must be refrigerated and protected from light. Reconstituted solution is stable for 3 hrs at room temperature.
  • Subcutaneous: Inject subcut into abdomen (avoid area within 2 inches of navel), thigh or upper arm by pinching skin and injecting at a 90° (45° angle for small children or persons with little fat). May require 30 seconds to inject entire dose. Pull needle out of skin and hold gauze over site for several seconds. Rotate sites and avoid sites that are bruised, red, tender or hard.

Patient/Family Teaching

  • Instruct patient or family on correct technique for preparing and administering injection, and disposing of equipment. If a dose is missed, administer up to the day before next scheduled dose. Take next dose at regularly scheduled time. Advise patient to read Patient Information prior to starting therapy and with each Rx refill in case of new information.
  • Advise patient to notify health care professional immediately if signs of infection (fever, cough, flu-like symptoms, open sores) occur during therapy.
  • Instruct patient to notify health care professional or seek emergency care if signs of allergic reaction (rash, swollen face, difficulty breathing) occur.
  • Advise patient that injection site reactions (erythema, swelling pruritus, bruising, inflammation, pain, edema, dermatitis, urticaria, vesicles, warmth, and hemorrhage) may occur; usually resolve in 1–2 days. Notify health care professional if reaction is persistent.
  • Instruct patient to consult health care professional prior to taking other Rx, OTC, or herbal products.
  • Advise female patients to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

  • Decrease in symptoms (rash, joint pain, fever, tiredness), decrease in and normalization of serum Amyloid A (SAA) and C-Reactive Protein (CRP) levels.
Drug Guide, © 2015 Farlex and Partners
References in periodicals archive ?
(Regeneron) and is approved by the FDA under the brand name ARCALYST for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), which includes Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome.
Biopharmaceutical company Regeneron Pharmaceuticals Inc (NasdaqGS:REGN) reported on Monday the receipt of a Complete Response Letter for the supplemental biologics license application (sBLA) for ARCALYST (rilonacept) Injection for Subcutaneous Use for the prevention of gout flares in patients initiating uric acid-lowering therapy.
Currently, ARCALYST is indicated in the US for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older.
23 November 2011 - The US Food and Drug Administration (FDA) has agreed to review the Regeneron Pharmaceuticals' (NASDAQ:REGN) supplemental Biologics License Application (sBLA) for ARCALYST (rilonacept) for Subcutaneous Use for the prevention of gout flares in patients initiating uric acid-lowering therapy.
The sBLA filing for ARCALYST is based on positive efficacy results from two Phase III trials, North America's PRE-SURGE 1 and the global study PRE-SURGE 2.
Already approved for cryopyrin-associated periodic syndromes, the anti-inflammatory interleukin-1 inhibitors rilonacept (Arcalyst) and canakinumab (Ilaris) are being studied both for acute gout and for prophylaxis.
The gout drug Arcalyst, subject of the trial results reported last week, may help generate $500 million a year in additional revenue, said Joseph Pantginis, an analyst with Roth Capital Partners in New York.
A once-weekly dose of 160 mg of Arcalyst cut the recurrence of painful flare-ups of gout by 80%, the study showed.
Regeneron's only marketed product is Arcalyst, a treatment for rare inflammatory conditions.
The annual wholesale acquisition cost of Arcalyst is about $250,000; the company has a program to help with payment.