Active Ingredient: Sarilumab
Sarilumab in combination with methotrexate (MTX) is indicated for the treatment of moderately to severely active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Sarilumab can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Subcutaneous, 200 milligrams sarilumab, once every 2 weeks.
The recommended dose of sarilumab is 200 mg once every 2 weeks administered as a subcutaneous injection.
Reduction of dose from 200 mg once every 2 weeks to 150 mg once every 2 weeks is recommended for management of neutropenia, thrombocytopenia, and liver enzyme elevations.
Reduction of dose from 200 mg once every 2 weeks to 150 mg once every 2 weeks is recommended for management of neutropenia, thrombocytopenia, and liver enzyme elevations.
Treatment with sarilumab must be withheld in patients who develop a serious infection until the infection is controlled.
Initiating treatment with sarilumab is not recommended in patients with a low neutrophil count, i.e. absolute neutrophil count (ANC) less than 2 × 109/L.
Initiating treatment with sarilumab is not recommended in patients with a platelet count below 150 × 103/μL.
Table 1. Recommended dose modifications in case of neutropenia, thrombocytopenia, or liver enzyme elevations for rheumatoid arthritis:
| Low Absolute Neutrophil Count | |
| Lab Value (cells x 109/L) | Recommendation |
| ANC greater than 1 | Current dose of sarilumab to be maintained. |
| ANC 0.5-1 | Treatment with sarilumab to be withheld until >1 × 109/L. Sarilumab can then be resumed at 150 mg every 2 weeks and increased to 200 mg every 2 weeks as clinically appropriate. |
| ANC less than 0.5 | Treatment with sarilumab to be discontinued. |
| Low Platelet Count | |
| Lab Value (cells x 103/μL) | Recommendation |
| 50 to 100 | Treatment with sarilumab to be withheld until >100 × 103/μL. Sarilumab can then be resumed at 150 mg every 2 weeks and increased to 200 mg every 2 weeks as clinically appropriate. |
| Less than 50 | If confirmed by repeat testing, treatment with sarilumab to be discontinued |
| Liver Enzyme Abnormalities | |
| Lab Value | Recommendation |
| ALT > 1 to 3 x Upper Limit of Normal (ULN) | Clinically appropriate dose modification of concomitant DMARDs or immunomodulatory agents to be considered. |
| ALT > 3 to 5 x ULN | Treatment with sarilumab to be withheld until < 3 x ULN. Sarilumab can then be resumed at 150 mg every 2 weeks and increased to 200 mg every 2 weeks as clinically appropriate. |
| ALT > 5 x ULN | Treatment with sarilumab to be discontinued. |
If a dose of sarilumab is missed and it has been 3 days or less since the missed dose, the next dose should be administered as soon as possible. The subsequent dose should be administered at the regularly scheduled time. If it has been 4 days or more since the missed dose, the subsequent dose should be administered at the next regularly scheduled time, the dose should not be doubled.
Injection sites (abdomen, thigh and upper arm) should be rotated with each injection. Sarilumab should not be injected into skin that is tender, damaged, or has bruises or scars.
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