Anakinra

Generic name
Anakinra
Brand name
ATC Code
L04AC03
Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

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

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

No information is present at this moment.

Available formulations

No information is present at this moment.

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

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.

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.

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].

Interactions

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

IMMUNOSUPPRESSANTS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

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

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

Changes

Therapeutic Drug Monitoring


Overdose