rilonacept

(redirected from Arcalyst)

rilonacept

(ri-lon-a-sept) ,

Arcalyst

(trade name)

Classification

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

Indications

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

Action

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.

Pharmacokinetics

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

Time/action profile (improvement in symptoms)

ROUTEONSETPEAKDURATION
Subcutwithin several daysunknownunknown

Contraindications/Precautions

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

Respiratory

  • upper respiratory tract infections (most frequent)
  • cough

Local

  • injection site reactions (most frequent)

Metabolic

  • changes in lipid profile

Neurologic

  • hypoesthesia

Miscellaneous

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

Interactions

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.

Route/Dosage

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.

Availability

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)

Implementation

  • 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.
References in periodicals archive ?
Biological therapies used in treatment of JIA Generic name Trade name Mechanism Etanercept Enbrel TNF supression, fusion protein TNF receptor supression Infliximab Remicade TNF supression, anti TNF monoclonal chimeric antibody Adalimumab Humira TNF supression, anti TNF monoclonal antibody Anakinra Kineret IL1-receptor antagonist Kanakinumab Ilaris IL-1 inhibitor, anti IL-1 beta monoclonal antibody Rilonacept Arcalyst IL-1 supression; soluble fusion protein Tosilizumab Actemra Il-6 receptor antagonist Abatacept Orencia T cell costimulator; soluble fusion protein Rituximab MabThera CD20 antigen supression Generic name FDA approval Dose Etanercept Present 0.
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.
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 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.
Gain insight into Regeneron's other pipeline products, including: Arcalyst for prevention of gout flares and Zaltrap for second-line colorectal cancer
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.
Patient profiles for the marketed UALs as well as products in late stage clinical development for gout (Regeneron's Arcalyst, Ardea's RDEA594, Biocryst's BCX4208, Metabolex's MBX-102) are characterized.
There are several therapies for gout in development including Ardea Bioscience's RDEA594, BioCryst Pharmaceutical's BCX4208 and Regeneron's Arcalyst.
Emerging/off-label therapies: Remicade, Simponi, Cimzia, Rituxan/MabThera, Kineret, Ilaris (canakinumab), Arcalyst (rilonacept).
The Company currently projects shipments of ARCALYST to its U.