Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, France
Kevzara is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA; rheumatoid factor positive or negative polyarthritis and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with conventional synthetic DMARDs (csDMARDs). Kevzara may be used as monotherapy or in combination with MTX.
Treatment should be initiated and supervised by healthcare professionals experienced in the diagnosis and treatment of the condition for which this medicinal product is intended (see section 4.1) Patients must be given the patient card.
The recommended posology in patients 2 years of age and older is 4 mg/kg subcutaneously once every 2 weeks in patients weighing 10 to less than 30 kg or 3 mg/kg subcutaneously once every 2 weeks in patients weighing greater than or equal to 30 kg.
Sarilumab can be used alone or in combination with MTX.
Sarilumab should be administered by subcutaneous injection and the dose should be calculated based on the patient’s body weight (kg) at each administration. A change in dose should only be based on a consistent change in the patient’s body weight over time (see Table 1).
Patients must have a minimum body weight of 10 kg when receiving sarilumab.
For patients who initially receive the 4 mg/kg dose and weigh between 27.5 to <39.5 kg, the 0.65 ml volume of injection must be maintained until the patient reaches 39.5 kg. At 39.5 kg, the patient must transition to the 3 mg/kg dose (see Table 1). The dose is capped at 200 mg given once every 2 weeks for patients weighing at or above 63 kg.
Table 1. Subcutaneous sarilumab doses based on body weight range:
| Body weight (kg) | Volume per injection (ml) |
| Patients 10 to less than 30 kg weight (4 mg/kg q2w) | |
| ≥10 and <12.5 | 0.25 |
| ≥12.5 and <14.5 | 0.30 |
| ≥14.5 and <16.5 | 0.35 |
| ≥16.5 and <19 | 0.40 |
| ≥19 and <21 | 0.45 |
| ≥21 and <23.5 | 0.50 |
| ≥23.5 and <25.5 | 0.55 |
| ≥25.5 and <27.5 | 0.60 |
| ≥27.5 and <30 | 0.65 |
| Patients at or above 30 kg weight (3 mg/kg q2w) | |
| ≥30 and <31 | 0.50 |
| ≥31 and <34 | 0.55 |
| ≥34 and <37 | 0.60 |
| ≥37 and <39.5 | 0.65 |
| ≥39.5 and <42.5 | 0.70 |
| ≥42.5 and <45 | 0.75 |
| ≥45 and <48.5 | 0.80 |
| ≥48.5 and <51.5 | 0.85 |
| ≥51.5 and <54.5 | 0.90 |
| ≥54.5 and <57 | 0.95 |
| ≥57 and <63 | 1.00 |
| ≥63 | 1.1 |
Table 2. Recommendation in case of neutropenia, thrombocytopenia, or liver enzyme elevations for pJIA (see sections 4.4 and 4.8):
| 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 with or without infection • ANC <0.5 without infection | Treatment with sarilumab to be withheld until clinical condition has been evaluated. |
| ANC <0.5 associated with infection | 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 and until clinical condition has been evaluated. |
| Less than 50 | 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 MTX and/or other medicinal products to be considered. |
| ALT >3 to 5 x ULN | Treatment with sarilumab to be withheld until <3 x ULN and until clinical condition has been evaluated. |
| ALT >5 x ULN | Treatment with sarilumab to be discontinued. |
Dose reduction of sarilumab has not been studied in the pJIA population. The decision to resume or discontinue sarilumab should be based upon the medical assessment of the individual patient. If appropriate, the dose of concomitant MTX and/or other treatment should be modified or stopped.
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.
No dose adjustment is required in patients with mild to moderate renal impairment. Sarilumab has not been studied in patients with severe renal impairment (see section 5.2).
The safety and efficacy of sarilumab have not been studied in patients with hepatic impairment, including patients with positive hepatitis B virus (HBV) or hepatitis C virus (HCV) serology (see section 4.4).
No dose adjustment is required in patients over 65 years of age (see section 4.4).
The safety and efficacy of sarilumab in children less than 2 years of age have not been established. No data are available.
Subcutaneous use.
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.
The vial is intended for administration by a healthcare professional only. The 175 mg/ml vial is a ready to use solution for injection which does not need to be diluted. Withdrawal of the dose from the vial using a sterile needle and syringe. The needle or syringe should not be re-used.
The contents of the sarilumab vial should not be mixed with, or transferred into, the content of another vial of sarilumab. The vial is for single use only. The unused portion must be discarded (see section 6.6).
There is no specific treatment for Kevzara overdose. In the event of an overdose, the patient should be closely monitored, treated symptomatically, and supportive measures instituted as required.
Kevzara 175 mg/ml solution for injection:
2 years.
Once removed from the refrigerator, Kevzara should be administered within 14 days and should not be stored above 25ºC.
Store in a refrigerator (2ºC–8ºC). Do not freeze.
Store in the original carton in order to protect from light.
Kevzara 175 mg/ml solution for injection:
The vial (type 1 glass) containing 1.54 ml solution is closed with ETFE-coated bromobutyl stoppers and crimped with an aluminium seal with a flip-off cap.
Pack sizes:
Not all pack sizes may be marketed.
The solution should be inspected before use. The solution should not be used if it is cloudy, discoloured, or contains particles, or if any part of the device appears to be damaged.
Each vial contains an overfill to ensure sufficient extractable volume.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements. After use, the syringe for the vial should be placed into a puncture-resistant container and discarded as required by local regulations.
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