Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, France
Kevzara 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). Kevzara can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate (see section 5.1).
Kevzara is indicated for the treatment of polymyalgia rheumatica (PMR) in adult patients who have had an inadequate response to corticosteroids or who experience a relapse during corticosteroid taper.
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 dose of sarilumab is 200 mg once every 2 weeks administered as a subcutaneous injection.
The recommended dose of sarilumab is 200 mg once every 2 weeks administered as a subcutaneous injection, in combination with a tapering course of systemic corticosteroids, after which sarilumab can be continued as monotherapy.
Data are available in patients that were treated for up to 1 year. Therefore treatment beyond 52 weeks should be guided by disease activity, physician discretion, and patient choice.
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 (see sections 4.4 and 4.8):
| Low Absolute Neutrophil Count (see section 5.1) | |
| 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. |
Laboratory Abnormalities: Discontinue sarilumab in patients with PMR who develop the following laboratory abnormalities (see section 4.4 and 5.1):
Dosage modifications have not been studied in patients with PMR with these conditions. For treatment initiation criteria, refer to the posology for PMR.
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 pre-filled syringe and pre-filled pen in children less than 18 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 total content (1.14 ml) of the pre-filled syringe/pre-filled pen should be administered as a subcutaneous injection.
For the pre-filled syringe/pre-filled pen, a patient may self-inject sarilumab or the patient’s caregiver may administer sarilumab if their healthcare professional determines that it is appropriate. Proper training should be provided to patients and/or caregivers on the preparation and administration of sarilumab prior to use.
The pre-filled syringe or pen has not been studied in paediatric patients.
Comprehensive instructions for administration of this medicinal product are given in the package leaflet.
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 150 mg solution for injection in pre-filled syringe, Kevzara 150 mg solution for injection in pre-filled pen, Kevzara 200 mg solution for injection in pre-filled syringe, and Kevzara 200 mg solution for injection in pre-filled pen
3 years.
Once removed from the refrigerator, Kevzara should be administered within 14 days and should not be stored above 25ºC.
Store in a refrigerator (2°C-8°C). Do not freeze.
Store in the original carton in order to protect from light.
The pre-filled pen and pre-filled syringes contain a 1.14 ml solution in a syringe (type 1 glass) equipped with a stainless steel staked needle and an elastomer plunger stopper.
Kevzara 150 mg solution for injection in pre-filled syringe:
The single-use pre-filled syringe has a styrene-butadiene elastomer needle cap and is equipped with a white polystyrene plunger rod and a light-orange polypropylene finger flange.
Kevzara 200 mg solution for injection in pre-filled syringe:
The single-use pre-filled syringe has a styrene-butadiene elastomer needle cap and is equipped with a white polystyrene plunger rod and a dark-orange polypropylene finger flange.
Kevzara 150 mg solution for injection in pre-filled pen:
The syringe components are pre-assembled into a single-use pre-filled pen with a yellow needle cover and light-orange cap.
Kevzara 200 mg solution for injection in pre-filled pen:
The syringe components are pre-assembled into a single-use pre-filled pen with a yellow needle cover and dark-orange 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.
After removing the pre-filled syringe/pre-filled pen from the refrigerator, it should be allowed to reach room temperature (<25°C) by waiting 30 minutes for the pre-filled syringe or 60 minutes for the pre-filled pen as applicable, before injecting Kevzara.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements. After use, the pre-filled syringe/pre-filled pen should be placed into a puncture-resistant container and discarded as required by local regulations.
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