Active Ingredient: Tocilizumab
Tocilizumab, in combination with methotrexate (MTX), is indicated for
In these patients, tocilizumab can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
Tocilizumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 8 milligrams tocilizumab per kilogram of body weight, once every 4 weeks.
The recommended posology is 8 mg/kg body weight, given once every four weeks.
For individuals whose body weight is more than 100 kg, doses exceeding 800 mg per infusion are not recommended.
Doses above 1.2 g have not been evaluated in clinical trials.
| Laboratory Value | Action |
|---|---|
| > 1 to 3 × Upper Limit of Normal (ULN) | Modify the dose of the concomitant MTX if appropriate. For persistent increases in this range, reduce tocilizumab dose to 4 mg/kg or interrupt treatment until alanine aminotransferase (ALT) or aspartate aminotransferase (AST) have normalised. Restart with 4 mg/kg or 8 mg/kg, as clinically appropriate. |
| > 3 to 5 × ULN (confirmed by repeat testing). | Interrupt tocilizumab dosing until < 3 × ULN and follow recommendations above for > 1 to 3 × ULN. For persistent increases > 3 × ULN, discontinue treatment. |
| > 5 × ULN | Discontinue treatment. |
In patients not previously treated with tocilizumab, initiation is not recommended in patients with an absolute neutrophil count (ANC) below 2 x 109/l.
| Laboratory Value (cells x 109/l) | Action |
|---|---|
| ANC >1 | Maintain dose |
| ANC 0.5 to 1 | Interrupt tocilizumab dosing. When ANC increases > 1 × 109/ L resume treatment at 4 mg/kg and increase to 8 mg/kg as clinically appropriate. |
| ANC < 0.5 | Discontinue treatment. |
| Laboratory Value (cells x 103/μL) | Action |
|---|---|
| 50 to 100 | Interrupt tocilizumab dosing. When platelet count > 100 × 10 3/μL resume treatment at 4 mg/kg and increase to 8 mg/kg as clinically appropriate. |
| < 50 | Discontinue treatment. |
It should be administered as an intravenous infusion over 1 hour. If signs and symptoms of an infusion-related reaction occur, the infusion needs to be slowed or stopped and appropriate medicinal product/supportive care must be administered immediately.
For:
Subcutaneous, 162 milligrams tocilizumab, once weekly.
The recommended posology is subcutaneous 162 mg once every week.
Limited information is available regarding switching patients from tocilizumab intravenous formulation to tocilizumab subcutaneous fixed dose formulation. The once every week dosing interval should be followed.
Patients transitioning from intravenous to subcutaneous formulation should administer their first subcutaneous dose instead of the next scheduled intravenous dose under the supervision of a qualified healthcare professional.
| Laboratory Value | Action |
|---|---|
| > 1 to 3 × Upper Limit of Normal (ULN) | Dose modify concomitant DMARDs (RA) or immunomodulatory agents (GCA) if appropriate. For persistent increases in this range, reduce tocilizumab dose frequency to every other week injection or interrupt treatment until alanine aminotransferase (ALT) or aspartate aminotransferase (AST) have normalised. Restart with weekly or every other week injection, as clinically appropriate. |
| > 3 to 5 × ULN | Interrupt treatment dosing until < 3 × ULN and follow recommendations above for > 1 to 3 × ULN. For persistent increases > 3 × ULN (confirmed by repeat testing), discontinue treatment. |
| > 5 × ULN | Discontinue treatment. |
In patients not previously treated with tocilizumab, initiation is not recommended in patients with an ANC below 2 × 109/L
| Laboratory Value (cells × 109/L) | Action |
|---|---|
| ANC > 1 | Maintain dose. |
| ANC 0.5 to 1 | Interrupt tocilizumab dosing. When ANC increases > 1 × 109/L resume treatment dosing every other week and increase to every week injection, as clinically appropriate. |
| ANC < 0.5 | Discontinue treatment. |
| Laboratory Value (cells × 103/μL) | Action |
|---|---|
| 50 to 100 | Interrupt tocilizumab dosing. When platelet count > 100 × 103/μL resume treatment dosing every other week and increase to every week injection as clinically appropriate. |
| < 50 | Discontinue treatment. |
If a patient misses a subcutaneous weekly injection of tocilizumab within 7 days of the scheduled dose, he/she should be instructed to take the missed dose on the next scheduled day. If a patient misses a subcutaneous once every other week injection of tocilizumab within 7 days of the scheduled dose, he/she should be instructed to take the missed dose immediately and the next dose on the next scheduled day.
After proper training in injection technique, patients may self-inject with this medicinal product if their physician determines that it is appropriate. The recommended injection sites (abdomen, thigh and upper arm) should be rotated and injections should never be given into moles, scars, or areas where the skin is tender, bruised, red, hard, or not intact.
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