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 inappropriat.
For this indication, competent medicine agencies globally authorize below treatments:
Subcutaneous
150 - 200 mg
From 150 To 200 mg once every 14 day(s)
200 mg
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.
Treatment with sarilumab should 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.
Recommended dose modifications in case of neutropenia, thrombocytopenia, or liver enzyme elevations:
Low Absolute Neutrophil Count:
| Lab Value (cells x 109/L) | Recommendation |
|---|---|
| ANC greater than 1 | Current dose of sarilumab should be maintained. |
| ANC 0,5-1 | Treatment with sarilumab should 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 should be discontinued. |
Low Platelet Count:
| Lab Value (cells x 103/µL) | Recommendation |
|---|---|
| 50 έως 100 | Treatment with sarilumab should 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 should 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 should be considered. |
| ALT >3 έως 5 x ULN | Treatment with sarilumab should 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 should 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.
Liability Disclaimer : RxReasoner has utilized reasonable care in providing content and services that are accurate, complete and up to date. However, RxReasoner does not accept any responsibility or liability about it. The content and services of RxReasoner are for informational purposes only and they are not intended to be a substitute for the knowledge, expertise, skill, and judgment of physicians, pharmacists, nurses, or other healthcare professionals involved in patient care. RxReasoner offers no medical advice. Users are responsible for the use of the provided content. A shown indication or treatment should not be construed to indicate that the medication is safe, appropriate, or effective in any given patient or under any particular circumstances. The absence of an indication or treatment should not roule out the existence of other appropriate medications. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition or medicament. RxReasoner is not liable for any damages allegedly sustained arising out of the use of its content and services.
