rilonacept

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 ?
19) A current phase II/III trial of anakinra in refractory SJIA is underway, as well a trial using rilonacept, an IL-1 Trap.
Ophthalmologists and eye specialists from the US and Europe focus on recent innovative treatment options, but begin with an outline of treatment principles and the most conventional treatments, including corticosteroids and other immunosuppresant agents, then discuss the newer available agents for intraocular inflammation, such as drugs adopted from rheumatology, mycophenolate mofetil, anti-tumor necrosis factor-alpha agents, anti-interleuken therapy, interferon-alpha therapy, rituximab, intravitreal injection therapy, corticosteroid intravitreal implants, and calcineurin inhibitor voclosporin, mammalian target of rapamycin inhibitor sirolumus, and the IL-1 trap rilonacept.
Rilonacept (IL-1 Trap/Arcalyst) is a long-acting IL-1 blocker currently undergoing trials in children with SOJIA.
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.
Regeneron has no products on the market and its lead candidate, rilonacept for genetic inflammatory conditions, is scheduled to be reviewed by U.
Growth over the next decade is anticipated as a result of the planned launch of Rilonacept and Ilaris this year.
studies examining the efficacies of anakinra, canakinumab and rilonacept in gout.
Rilonacept has been approved for cryopyrin-associated periodic syndromes, but is clinically effective in only a few patients with the autoinflam-matory syndrome.
43) Similar studies have demonstrated the potential benefit of rilonacept as a prophylactic agent.
84) A current phase II/III trial of anakinra in refractory S-JIA is underway, as well a trial using rilonacept, an IL-1 Trap.
In July 2009, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) issued a positive opinion for the marketing authorization in the European Union of rilonacept for the treatment of CAPS with severe symptoms in adults and children aged 12 years and older.
anakinra, rilonacept, canakinumab, RDEA594 and tranilast.