Juvenile idiopathic polyarthritis

Active Ingredient: Tocilizumab

Indication for Tocilizumab

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old)

Tocilizumab in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. Tocilizumab can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.

For this indication, competent medicine agencies globally authorize below treatments:

8-10 mg/kg once every 4 weeks

Route of admnistration

Intravenous

Defined daily dose

8 - 10 mg per kg of body weight

Dosage regimen

From 8 To 10 mg per kg of body weight once every 28 day(s)

Detailed description

The recommended posology in patients above 2 years of age is 8 mg/kg once every 4 weeks in patients weighing greater than or equal to 30 kg or 10 mg/kg once every 4 weeks in patients weighing less than 30 kg. The dose should be calculated based on the patient’s body weight at each administration. A change in dose should only be based on a consistent change in the patient’s body weight over time.

The safety and efficacy of intravenous tocilizumab in children below 2 years of age has not been established.

Dose interruptions of tocilizumab for the following laboratory abnormalities are recommended in pJIA patients in the tables below. If appropriate, the dose of concomitant MTX and/or other medications should be modified or dosing stopped and tocilizumab dosing interrupted until the clinical situation has been evaluated. As there are many co-morbid conditions that may effect laboratory values in pJIA, the decision to discontinue tocilizumab for a laboratory abnormality should be based upon the medical assessment of the individual patient.

Liver enzyme abnormalities:

Laboratory ValueAction
>1 to 3 x ULNModify the dose of the concomitant MTX if appropriate. For persistent increases in this range, interrupt tocilizumab until ALT/AST have normalized.
>3 x ULN to 5x ULNModify the dose of the concomitant MTX if appropriate. Interrupt tocilizumab dosing until <3x ULN and follow recommendations above for >1 to 3x ULN
>5 x ULNDiscontinue tocilizumab. The decision to discontinue tocilizumab in pJIA for a laboratory abnormality should be based on the medical assessment of the individual patient.

Low absolute neutrophil count (ANC):

Laboratory Value (cells x 109/l)Action
ANC >1Maintain dose
ANC 0.5 to 1Interrupt tocilizumab dosing. When ANC increases to >1 × 109/l resume tocilizumab
ANC <0.5Discontinue tocilizumab. The decision to discontinue tocilizumab in pJIA for a laboratory abnormality should be based on the medical assessment of the individual patient.

Low platelet count:

Laboratory Value (cells x 103/ยตl)Action
50 to 100Modify the dose of the concomitant MTX if appropriate. Interrupt tocilizumab dosing. When platelet count is >100 × 103/ยตl resume tocilizumab
<50Discontinue tocilizumab. The decision to discontinue tocilizumab in pJIA for a laboratory abnormality should be based on the medical assessment of the individual patient.

Reduction of tocilizumab dose due to laboratory abnormalities has not been studied in pJIA patients.

Available data suggest that clinical improvement is observed within 12 weeks of initiation of treatment with tocilizumab. Continued therapy should be carefully reconsidered in a patient exhibiting no improvement within this timeframe.

Dosage considerations

It should be administered as an intravenous infusion over 1 hour.

Active ingredient

Tocilizumab

Tocilizumab binds specifically to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R). IL-6 is involved in diverse physiological processes such as T-cell activation, induction of immunoglobulin secretion, induction of hepatic acute phase protein synthesis and stimulation of haemopoiesis. IL-6 has been implicated in the pathogenesis of diseases including inflammatory diseases, osteoporosis and neoplasia.

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