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

Interactions
PK
Renal impairment
References

Golimumab

Generic name
Golimumab
Brand name
ATC Code
L04AB06

Pharmacokinetics in children

In 173 children pJIA 2-17 years, 30 mg/m2 (maximum 50 mg) SC every 4 weeks: median steady-state trough golimumab concentrations are similar across different age groups and are also similar to or slightly higher than those seen in adult RA patients who received 50 mg golimumab every 4 weeks.

Population pharmacokinetic/pharmacodynamic modelling and simulation in children with pJIA confirmed  that the dosing regimen of golimumab 50 mg every 4 weeks in children with pJIA of at least 40 kg achieves similar exposures to those shown to be efficacious in adults. [SmPC]

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

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

No information is present at this moment.

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

Available formulations

No information is present at this moment.

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

Dosages

Polyarticular juvenile idiopathic arthritis
  • Subcutaneous
    • 2 years up to 18 years and < 40 kg
      • (Golimumab) 30 mg/m²/dose once every 4 weeks. Max: 40 mg/dose.

      • Clinical response is usually achieved within 12 to 14 weeks of treatment (after 3-4 doses). Continued therapy should be reconsidered in children who show no evidence of therapeutic benefit within this time period.

    • 2 years up to 18 years and ≥ 40 kg
      • (Golimumab) 50 mg/dose once every 4 weeks.

      • Clinical response is usually achieved within 12 to 14 weeks of treatment
        (after 3-4 doses). Continued therapy should be reconsidered in children who show no evidence of therapeutic benefit within this time period.
Ulcerative colitis
  • Subcutaneous
    • ≥ 2 years and 15 up to 40 kg
      • Initial dose: Week 0: 100 mg/dose, once only.
      • Maintenance dose: From week 2 onwards: 50 mg/dose every 4 weeks.

      • For patients who have been in remission since week 54, consideration may be given to reducing the dosage to 25 mg/dose every 4 weeks.

    • ≥ 2 years and 40 up to 80 kg
      • Initial dose: Week 0: 200 mg/dose, once only.
      • Maintenance dose: From week 2 onwards: 100 mg/dose every 4 weeks.

      • For patients who have been in remission since week 54, consideration may be given to reducing the dosage to 50 mg/dose every 4 weeks.

    • ≥ 2 years and ≥ 80 kg
      • Initial dose: 200 mg/day, once only.
      • Maintenance dose: 100 mg/day every 4 weeks.

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

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

The type and frequency of adverse events reported in paediatric pJIA and CU studies were generally similar to those seen in adult RA studies.

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

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

If possible, administer vaccinations to pediatric patients in accordance with current guidelines before starting treatment with golimumab. See also the section on Interactions.

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

Interactions

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

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

Selective immunosuppressants
L04AA24
L04AA32
L04AA13
L04AA02
L04AA06
L04AA31
L04AA04
L04AA44
Other immunosuppressants
L04AX01
L04AX03
Tumor necrosis factor alpha (TNF-alpha) inhibitors
L04AB04
L04AB01
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

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

References

  1. Janssen Biologics B.V., SmPC Simponi 45 mg/0,45 ml solution for injection in pre-filled pen (EU/1/09/546/009) Rev 45, 22-03-2023
  2. Janssen Biologics B.V., SmPC Simponi® 50 mg solution for injection in pre-filled pen/syringe (EU/1/09/546/001) Rev 45, 22-03-2023
  3. Janssen Biologics B.V., SmPC Simponi 45 mg/0,45 ml solution for injection in pre-filled pen (EU/1/09/546/009) Rev 54, 30-01-2026, www.ema.europa.eu
  4. Janssen Biologics B.V., SmPC Simponi® 50 mg solution for injection in pre-filled pen/syringe (EU/1/09/546/001) Rev 54, 30-01-2026, www.ema.europa.eu

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

Changes

Changes