Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Anakinra

Generic name
Anakinra
Brand name
ATC Code
L04AC03

Pharmacokinetics in children

The following parameters were calculated using a pharmacokinetic model [Urien]:
Cl: 0.089 l/hour/kg
Vd: 65.2 l

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

Cryopyrin-associated periodic syndromes (CAPS), Familial Mediterranean Fever (FMS),systemic juvenile idiopathic arthritis (sJIA), other autoinflammatory conditions that do not respond to conventional therapy
  • Subcutaneous
    • ≥ 8 months and ≥ 10 kg
      • Initial dose 1 - 2 mg/kg/day in 1 dose. Max: 100 mg/day. In the event of little effect or in severe forms, increase to 3-4 mg/kg/day in a single dose, max 100 mg/day. .
      • Dose titration:

        Dose depending on therapeutic response.  In very exceptional cases, increase to 8 mg/kg/day, but not more than 200 mg/day

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Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2
Dose adjustment is not required
GFR 30-50 ml/min/1.73 m2
Dose adjustment is not required
GFR 10-30 ml/min/1.73 m2
Contraindicated
GFR < 10 ml/min/1.73 m2
Contraindicated
Clinical consequences

The half-life of anakinra is increased in cases of reduced renal function.

Patients on dialysis

Generalized recommendations cannot be given.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Reaction at the injection site, infections (especially in children aged < 2 years), headaches, vomiting, abdominal pain and skin lesions.

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

When the arthritis is in remission, anakinra can be reduced by dosing every other day for 4 weeks. After that, anakinra can be discontinued [Urien 2013]. Macrophage activation syndrome (MAS) can occur during treatment of sJIA. Temporarily increasing anakinra can be useful [Ravelli 2012].

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Selective immunosuppressants
L04AA24
L04AA32
L04AA13
L04AA02
L04AA06
L04AA31
L04AA04
L04AA44
Other immunosuppressants
L04AX01
L04AX03
Tumor necrosis factor alpha (TNF-alpha) inhibitors
L04AB04
L04AB01
L04AB06
L04AB02
Interleukin inhibitors
L04AC02
L04AC08
L04AC13
L04AC19
L04AC10
L04AC22
L04AC07
L04AC05
Calcineurin inhibitors
L04AD01
L04AD02
Sphingosine-1-phosphate (S1P) receptor modulators
L04AE01
Janus-associated kinase (JAK) inhibitors
L04AF02
L04AF02
L04AF08
L04AF01
Monoclonal antibodies
L04AG04
Mammalian target of rapamycin (mTOR) kinase inhibitors
L04AH02
L04AH01
Complement inhibitors
L04AJ01
L04AJ02
Dihydroorotate dehydrogenase (DHODH) inhibitors
L04AK02

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References

  1. DeWitt EM et al., Consensus treatment plans for new-onset systemic juvenile idiopathic arthritis., Arthritis Care Res (Hoboken)., 2012, Jul;64(7):, 1001-10
  2. ter Haar N et al., Treatment of autoinflammatory diseases: results from the Eurofever Registry and a literature review., Ann Rheum Dis., 2013, 72, 678-85
  3. Lequerré T et al. 2008 , Interleukin-1 receptor antagonist (anakinra) treatment in patients with systemic-onset juvenile idiopathic arthritis or adult onset Still disease: preliminary experience in France., Ann Rheum Dis., 2008, Mar;67(3), 302-8
  4. Manger B et al. , Recommendations on therapy using interleukin-1beta-blocking agents. , Z Rheumatol., 2009, Nov;68(9), 766-71
  5. Moll M et al., Inflammasome and cytokine blocking strategies in autoinflammatory disorders., Clin Immunol., 2013, Jun;147(3), 242-75
  6. Nigrovic PA et al., Review: is there a window of opportunity for treatment of systemic juvenile idiopathic arthritis?, Arthritis Rheumatol., 2014, Jun;66(6), 1405-13
  7. Picco P et al., Successful treatment of idiopathic recurrent pericarditis in children with interleukin-1beta receptor antagonist (anakinra): an unrecognized autoinflammatory disease?, Arthritis Rheum., 2009, Jan;60(1), 264-8
  8. Quartier P et al., A multicentre, randomised, double-blind, placebo-controlled trial with the interleukin-1 receptor antagonist anakinra in patients with systemic-onset juvenile idiopathic arthritis (ANAJIS trial)., Ann Rheum Dis., 2011, May;70(5), 747-54
  9. Ravelli A et al., Macrophage activation syndrome as part of systemic juvenile idiopathic arthritis: diagnosis, genetics, pathophysiology and treatment., Genes Immun., 2012, Jun;13(4):, 289-98
  10. Swedish Orphan Biovitrum AB (publ)., SPC Kineret (EU/1/02/203/001) 14-05-2018, www.geneesmiddeleninformatiebank.nl
  11. Urien S et al., Anakinra pharmacokinetics in children and adolescents with systemic-onset juvenile idiopathic arthritis and autoinflammatory syndromes., BMC Pharmacol Toxicol., 2013, Aug 5;14, 40
  12. Vastert SJ et al., Effectiveness of first-line treatment with recombinant interleukin-1 receptor antagonist in steroid-naive patients with new-onset systemic juvenile idiopathic arthritis: results of a prospective cohort study., Arthritis Rheumatol, 2014, Apr;66(4):, 1034-43
  13. Kostjukovits S et al., Treatment of hyperimmunoglobulinemia D syndrome with biologics in children: review of the literature and Finnish experience., Eur J Pediatr., 2015, Jun;174(6), 707-14
  14. Lequerré T et al. 2008, Interleukin-1 receptor antagonist (anakinra) treatment in patients with systemic-onset juvenile idiopathic arthritis or adult onset Still disease: preliminary experience in France., Ann Rheum Dis., 2008, Mar;67(3), 302-8
  15. Manger B et al., Recommendations on therapy using interleukin-1beta-blocking agents., Z Rheumatol., 2009, Nov;68(9), 766-71
  16. Swedish Orphan Biovitrum AB (publ)., SPC Kineret (EU/1/02/203/001) 14-05-2018, www.geneesmiddeleninformatiebank.nl

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Changes

Changes