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

Interactions
PK
Renal impairment
References

Tocilizumab

Generic name
Tocilizumab
Brand name
ATC Code
L04AC07

Pharmacokinetics in children

The pharmacokinetics of tocilizumab in sJIA patients was determined using population pharmacokinetic analysis.

  < 30 kg: 12 mg/kg every 2 weeks ≥ 30 kg: 8 mg/kg every 2 weeks
Cmax (mcg/ml) 274 ± 63,8 256 ± 60,8
Vd ss (l) 4,01 4,01
Cl (ml/h) 5,7 4,7
T1/2 16 days 16 days

The pharmacokinetics of tocilizumab in pJIA patients was determined using population pharmacokinetic analysis.

  < 30 kg: 10 mg/kg every 2 weeks  ≥ 30 kg: 8 mg/kg every 2 weeks
Cmax (mcg/ml) 168 ± 24,8 183 ± 42,3
T1/2 16 days 16 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

Cytokine Release Syndroom (CRS)
  • Intravenous
    • ≥ 2 years and < 30 kg
      • 12 mg/kg/dose, as required, max. Repeat three times with a dose interval of 8 hours. Max: 800 mg/dose.
    • ≥ 2 years and ≥ 30 kg
      • 8 mg/kg/dose, as required, max. Repeat three times with a dose interval of 8 hours. Max: 800 mg/dose.
Systemic juvenile idiopathic arthritis (sJIA)
  • Subcutaneous
    • 1 year up to 18 years and 10 up to 30 kg
      • 162 mg/dose every 2 weeks.
        • Only for patients who have previously responded insufficiently to treatment with NSAIDs and systemic corticosteroids.
        • As a monotherapy (in cases of intolerance of MTX or when treatment with MTX is not suitable) or combined with MTX.
        • Prescription by a treating physician who has experience of diagnosing and treating JIA.
        ...read more
    • 1 year up to 18 years and ≥ 30 kg
      • 162 mg/dose once a week.
        • Only for patients who have previously responded insufficiently to treatment with NSAIDs and systemic corticosteroids.
        • As a monotherapy (in cases of intolerance of MTX or when treatment with MTX is not suitable) or combined with MTX.
        • Prescription by a treating physician who has experience of diagnosing and treating JIA.
        ...read more
Polyarticular juvenile idiopathic arthritis
  • Subcutaneous
    • 2 years up to 18 years and < 30 kg
      [2]
      • 162 mg/dose every 3 weeks.
        • Only for patients who have previously responded insufficiently to treatment with MTX.
        • As a monotherapy (in cases of intolerance of MTX or when treatment with MTX is not suitable) or combined with MTX.
        • Prescription by a treating physician who has experience of diagnosing and treating JIA.
        ...read more
    • 2 years up to 18 years and ≥ 30 kg
      [2]
      • 162 mg/dose every 2 weeks.
        • Only for patients who have previously responded insufficiently to treatment with MTX.
        • As a monotherapy (in cases of intolerance of MTX or when treatment with MTX is not suitable) or combined with MTX.
        • Prescription by a treating physician who has experience of diagnosing and treating JIA.
        ...read more
    • 2 years up to 18 years and < 30 kg
      • 162 mg/dose every 3 weeks.
        • Only for patients who have previously responded insufficiently to treatment with MTX.
        • As a monotherapy (in cases of intolerance of MTX or when treatment with MTX is not suitable) or combined with MTX.
        • Prescription by a treating physician who has experience of diagnosing and treating JIA.
        ...read more
    • 2 years up to 18 years and ≥ 30 kg
      • 162 mg/dose every 2 weeks.
        • Only for patients who have previously responded insufficiently to treatment with MTX.
        • As a monotherapy (in cases of intolerance of MTX or when treatment with MTX is not suitable) or combined with MTX.
        • Prescription by a treating physician who has experience of diagnosing and treating JIA.
        ...read more
    • 2 years up to 18 years and < 30 kg
      • 162 mg/dose every 3 weeks.
        • Only for patients who have previously responded insufficiently to treatment with MTX.
        • As a monotherapy (in cases of intolerance of MTX or when treatment with MTX is not suitable) or combined with MTX.
        • Prescription by a treating physician who has experience of diagnosing and treating JIA.
        ...read more
    • 2 years up to 18 years and ≥ 30 kg
      • 162 mg/dose every 2 weeks.
        • Only for patients who have previously responded insufficiently to treatment with MTX.
        • As a monotherapy (in cases of intolerance of MTX or when treatment with MTX is not suitable) or combined with MTX.
        • Prescription by a treating physician who has experience of diagnosing and treating JIA.
        ...read more
Treatment of moderate to severe symptoms of COVID-19
  • Intravenous
    • 12 years up to 18 years
      • 600 mg/dose, once only.

      • In the event of (imminent) severe IL-6 inhibitor shortages, an alternative, lower dose of tocilizumab may be considered (once-daily 400 mg i.v. or a starting dose of 200 mg i.v. followed by a 2nd dose of 200 mg after 7 days).

        There are no scientific studies (yet) for the use of tocilizumab in adolescents with COVID-19. The dosage is derived from the adult dosage.

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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

Very common: upper respiratory tract infections, nasopharyngitis, headache, decreased neutrophil count.

Common: Nausea, diarrhea, infusion-related reactions. Increase in liver transaminases. Lowering of platelet count. Increased cholesterol.

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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 in children

Active, serious infections

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

Patients weighing < 30 kg: dilute aseptically to 50 ml with 0.9% NaCl. Patients weighing ≥ 30 kg: dilute aseptically to 100 ml with 0.9% NaCl. Allow the infusion to run in over 1 hour.

Macrophage activation syndrome (MAS) is a serious, life-threatening condition that can arise in sJIA patients. Tocilizumab has not been studied in clinical investigations during episodes of active MAS.

Tocilizumab is an interleukin inhibitor, directed against IL-6. When an infection occurs with the use of tocilizumab, tocilizumab will capture the produced IL-6, preventing the CRP to increase or not to increase as much. CRP assessment, and to a lesser extent the sedimentation, will therefore be less reliable in patients using tocilizumab.

Check the ALAT and ASAT levels every 4-8 weeks for the first 6 months and then every 12 weeks. With an ALAT or ASAT increase> 3-5 x ULN, treatment with tocilizumab must be interrupted.

It is recommended to determine the number of neutrophils and platelets before starting treatment and upon second administration and then periodically. Adjust the dosage in case of liver impairment.

Determine lipid parameters in RA, sJIA and pJIA patients 4–8 weeks after initiation of treatment. 

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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
L04AC03
L04AC02
L04AC08
L04AC13
L04AC19
L04AC10
L04AC22
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. Roche Registration GmHb, SmPC RoActemra (EU/1/08/492/001-006) Rev 44; 26-06-2024, www.ema.europe.eu
  2. Roche Registration GmbH, SmPC RoActemra SC (EU/1/08/492/009-010) Rev 44; 26-06-2024, www.ema.europa.eu
  3. SWAB in samenwerking met het CIB, NVZA, NVMM, NVII, NVIC, NVK en NVALT., Medicamenteuze behandelopties bij patiënten met COVID-19 (infecties met SARS-CoV-2), 1 dec 2021

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Changes

Changes