canakinumab


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canakinumab

(kan-a-kin-u-mab) ,

Ilaris

(trade name)

Classification

Therapeutic: none assigned
Pharmacologic: interleukin antagonists
Pregnancy Category: C

Indications

Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) including Familial Cold Autoinflammatory Syndrome (FCAS) an Muckle-Wells Syndrome (MWS).Active systemic juvenile idiopathic arthritis.

Action

Binds and neutralizes the activity of excess interleukin associated with CAPS.

Therapeutic effects

Decreased symptoms of CAPS and systemic juvenile idiopathic arthritis.

Pharmacokinetics

Absorption: 70% absorbed following subcutaneous administration.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: 26 days.

Time/action profile

ROUTEONSETPEAKDURATION
Subcutwithin 8 days†7 days‡8 weeks
† Noted as normalization of markers of inflammation‡ Blood levels

Contraindications/Precautions

Contraindicated in: None noted.
Use Cautiously in: Active untreated infection, history of recurrent infections or conditions increasing the propensity of infections; Obstetric: Use only if clearly needed; Lactation: Use cautiously; Pediatric: Children <2 yr (safety not established).

Adverse Reactions/Side Effects

Central nervous system

  • headache (most frequent)
  • vertigo

Ear, Eye, Nose, Throat

  • nasopharyngitis (most frequent)

Respiratory

  • bronchitis

Gastrointestinal

  • diarrhea (most frequent)
  • nausea (most frequent)
  • gastroenteritis

Local

  • injection site reactions

Metabolic

  • weight gain

Musculoskeletal

  • musculoskeletal pain

Miscellaneous

  • infection (life-threatening)
  • macrophage activation syndrome (life-threatening)
  • influenza (most frequent)

Interactions

Drug-Drug interaction

Avoid concurrent use of live vaccines ; all vaccinations should be completed prior to treatment.Concurrent use with tumor necrosis factor (TNF) inhibitors may ↑ risk of serious infections.May alter activity of drugs metabolized by the CYP450 enzyme system including warfarin ; careful monitoring of such drugs with narrow therapeutic indices should be undertaken.

Route/Dosage

Cryopyrin-Associated Periodic Syndromes

Subcutaneous (Adults ≥ 40 kg) 150 mg every 8 wk.
Subcutaneous (Adults and Children 15–40 kg) 2 mg/kg; may be ↑ to 3 mg/kg every 8 wk.

Systemic Juvenile Idiopathic Arthritis

Subcutaneous (Children ≥2 yr and ≥7.5 kg) 4 mg/kg (max dose = 300 mg) every 4 wk

Availability

Lyophilized powder for solution for subcutaneous injection: 180 mg/vial

Nursing implications

Nursing assessment

  • Assess for symptoms of CAPS (fever, headache, urticaria-like rash, arthralgia, myalgia, fatigue, and conjunctivitis) prior to and periodically during therapy.

Potential Nursing Diagnoses

Risk for infection (Adverse Reactions)

Implementation

  • Test for latent tuberculosis before initiating therapy. If positive, treat prior to therapy.
    • Administer vaccines to bring all recommended vaccinations up to date prior to therapy, including pneumococcal vaccine and inactivated influenza vaccine.
  • Subcutaneous: Reconstitute each vial by slowly injecting 1 mL preservative-free Sterile Water for injection with a 1 mL syringe and an 18 G, 2 inch needle. Swirl vial slowly at a 45° angle for 1 min and allow to stand for 5 min. Then, gently turn vial upside down and back again 10 times. Avoid touching rubber stopper with fingers. Allow vial to stand for 15 min at room temperature to obtain clear solution. Do not shake. Tap side of vial to remove liquid from stopper. Solution is clear to opalescent; colorless or have a slight brownish-yellow tint. May foam slightly. Do not administer solutions that are discolored or contain particulate matter. Must be used within 60 min or refrigerated and used within 4 hr. Discard unused portions.
    • Inject subcut using a 27 gauge 0.5 inch needle. Avoid injection into scar tissue.

Patient/Family Teaching

  • Instruct patient to read Patient Information prior to starting therapy.
  • May cause vertigo. Caution patient to avoid driving and other activities requiring alertness until response to canakinumab is known.
  • Advise patient to notify health care professional immediately if signs of infection (fever, sore throat, dyspnea) or Macrophage Activation Syndrome (fever lasting longer than 3 days, persistent cough, redness in one part of body, warm feeling or swelling of skin) occur.
  • Inform patient to avoid receiving live vaccines during therapy.
  • May cause injection site reactions (pain, erythema, swelling, pruritus, bruising, mass, inflammation, dermatitis, edema, urticaria, vesicles, warmth, hemorrhage). Notify health care professional if reaction is persistent.
  • Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
  • Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

  • Improvement in signs and symptoms of CAPS.
  • Improvement in signs and symptoms of Systemic Juvenile Idiopathic Arthritis.
References in periodicals archive ?
Drugs Profiles discussed in this report includes BSN-908, canakinumab, CT-2009, ticagrelor, VTI-2000 Series and VTI-3000 Series.
An open-label, phase 2 trial of canakinumab, a fully humanized monoclonal antibody binding IL-1[beta], followed by a withdrawal phase in over 100 active SJIA patients, 2/3 who had previously taken biologics including anakinra, demonstrated that 73% of patients were able to achieve an ACR Pedi50, though seven patients developed MAS.
11) It has also been suggested that hopeful results might be obtained through IL-1 antagonists, for example anakinra, a human recombinant IL-1 receptor antagonist, and canakinumab, which can be used as a monoclonal antibody against IL-1beta.
Safety concerns have likely scuttled approval for now of the biologic canakinumab for management of flares of gouty arthritis.
In the "Effects of Canakinumab On The Progression of Type 1 Diabetes In New Onset Subjects" protocol, at least 1 islet autoantibody (other than IAA) must be present in an individual for study inclusion.
The immunomodulators are canakinumab (Ilaris; pregnancy class C), indicated for cryopyrin-associated periodic syndrome, and golimumab (Simponi; B), indicated (with or without methotrexate) for ankylosing spondylitis, active psoriatic arthritis, or rheumatoid arthritis.
Therapeutic use: Canakinumab (9, 10) is a human antiinterleukin-1 [beta] blocker indicated for the treatment of cryopyrin-associated periodic syndromes (i.
12] Refractory systemic JIA has shown good response to tocilizumab, and to IL-1 inhibitors including anakinra, canakinumab and rilonocept and encouraging study results have been reported with tofacitinib.
He led the design and execution of more than 70 early stage clinical studies at Novartis and BMS, including the development of secukinumab, canakinumab and several other biologic therapies for immune-mediated inflammatory diseases.
studies examining the efficacies of anakinra, canakinumab and rilonacept in gout.
Canakinumab (ACZ885) is a fully humanized mAb which binds specifically to the [beta] isoform of IL-1 (IL-1[beta]) and neutralizes the bioactivity of human IL-1[beta].