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

Interactions
PK
Renal impairment
References

Abatacept

Generic name
Abatacept
Brand name
ATC Code
L04AA24

Pharmacokinetics in children

The following kinetic parameters have been observed after administering 10 mg/kg abatacept (to children aged 6-17 years, avg. 40 kg):
Cl: 0.4 ml/hour/kg,
Vd: 0.12 l/kg,
t½: 11.4 days.

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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

Juvenile idiopathic arthritis (JIA)
  • Intravenous
    • 2 years up to 6 years
      • Initial dose: 10 mg/kg/dose once every 2 weeks. in weeks 0, 2 and 4.
      • Maintenance dose: 10 mg/kg/dose once every 4 weeks.
      • Directions for administration:

        Administer as an intravenous infusion over 30 minutes

      • There is no evidence regarding the use of abatacept for JIA in children aged < 6 years. Treatment by or after consultations with a paediatric specialist (rheumatologist) who has experience using abatacept for this indication.

    • 6 years up to 18 years and < 75 kg
      • Initial dose: 10 mg/kg/dose once every 2 weeks. in weeks 0, 2 and 4.
      • Maintenance dose: 10 mg/kg/dose once every 4 weeks.
      • Directions for administration:

        Administer as an intravenous infusion over 30 minutes

  • Subcutaneous
    • ≥ 2 years and 10 up to 25 kg
      • 50 mg/dose once a week.
    • ≥ 2 years and 25 up to 50 kg
      • 87.5 mg/dose once a week.
    • ≥ 2 years and ≥ 50 kg
      • 125 mg/dose once a week.
Therapy-resistant focal segmental glomerulosclerosis (FSGS)
  • Intravenous
    • 6 years up to 18 years and 75 up to 100 kg
      • 750 mg/dose, once only. Multiple doses can be given if necessary; give the first 3 doses every second week and thereafter every four weeks..
      • Directions for administration:

        Administer as an intravenous infusion over 30 minutes.

      • There is little evidence regarding the use of abatacept in children with FSGS. Treatment by or after consultations with a paediatric specialist (nephrologist) who has experience using abatacept for this indication.

    • 6 years up to 18 years and ≥ 100 kg
      • 1.000 mg/dose, once only. Multiple doses can be given if necessary; give the first 3 doses every second week and thereafter every four weeks.
      • Directions for administration:

        Administer as an intravenous infusion over 30 minutes.

      • There is little evidence regarding the use of abatacept in children with FSGS. Treatment by or after consultations with a paediatric specialist (nephrologist) who has experience using abatacept for this indication.

    • 2 years up to 18 years and < 75 kg
      • 10 mg/kg/dose, once only. Multiple doses can be given if necessary; give the first 3 doses every second week and thereafter every four weeks.
      • Directions for administration:

        Administer as an intravenous infusion over 30 minutes.

      • There is little evidence regarding the use of abatacept in children with FSGS. Treatment by or after consultations with a paediatric specialist (nephrologist) who has experience using abatacept for this indication.

    • 6 years up to 18 years and 75 up to 100 kg
      [3]
      • 750 mg/dose, once only. Multiple doses can be given if necessary; give the first 3 doses every second week and thereafter every four weeks..
      • Directions for administration:

        Administer as an intravenous infusion over 30 minutes.

      • There is little evidence regarding the use of abatacept in children with FSGS. Treatment by or after consultations with a paediatric specialist (nephrologist) who has experience using abatacept for this indication.

    • 6 years up to 18 years and ≥ 100 kg
      [3]
      • 1.000 mg/dose, once only. Multiple doses can be given if necessary; give the first 3 doses every second week and thereafter every four weeks.
      • Directions for administration:

        Administer as an intravenous infusion over 30 minutes.

      • There is little evidence regarding the use of abatacept in children with FSGS. Treatment by or after consultations with a paediatric specialist (nephrologist) who has experience using abatacept for this indication.

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Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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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

Common: infection of the upper respiratory tract (including sinusitis, nasopharyngitis and rhinitis), middle and external ear inflammation, haematuria, pyrexia.

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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

No information available on specific warnings and precautions in children.

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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
L04AA32
L04AA13
L04AA02
L04AA06
L04AA31
L04AA04
L04AA44
Other immunosuppressants
L04AX01
L04AX03
Tumor necrosis factor alpha (TNF-alpha) inhibitors
L04AB04
L04AB01
L04AB06
L04AB02
Interleukin inhibitors
L04AC03
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. Bristol-Myers Squibb Pharma EEIG, SPC Orencia (EU/1/07/389/001->003) 21-5-2012, www.geneesmiddeleninformatiebank.nl
  2. A van Royen., Expert opinie sectie kinderreumatologie JIA 2-6 jaar., 9 april 2015
  3. Yu CC et al., Abatacept in B7-1-positive proteinuric kidney disease., N Engl J Med., 2013, 19;369(25), 2416-23

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Changes

Changes