Active Ingredient: Tocilizumab
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:
Intravenous
8 - 10 mg per kg of body weight
From 8 To 10 mg per kg of body weight once every 28 day(s)
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 Value | Action |
|---|---|
| >1 to 3 x ULN | Modify 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 ULN | Modify 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 ULN | Discontinue 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 >1 | Maintain dose |
| ANC 0.5 to 1 | Interrupt tocilizumab dosing. When ANC increases to >1 × 109/l resume tocilizumab |
| ANC <0.5 | Discontinue 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/µl) | Action |
|---|---|
| 50 to 100 | Modify the dose of the concomitant MTX if appropriate. Interrupt tocilizumab dosing. When platelet count is >100 × 103/µl resume tocilizumab |
| <50 | Discontinue 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.
It should be administered as an intravenous infusion over 1 hour.
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