KEVZARA

1) Patients must be given the patient card. Posology pJIA 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. 5 kg. 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.

8): Low Absolute Neutrophil Count Lab Value (cells x 109/L) Recommendation ANC greater than 1 Current dose of sarilumab to be maintained. 5 without infection Treatment with sarilumab to be withheld until clinical condition has been evaluated.

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 x 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. Missed dose 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.

7%). 4%). Tabulated list of adverse reactions Adverse reactions listed in the table have been reported in a clinical study. The frequency of adverse reactions listed below is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000); not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 6 events per 100 patient-years. 0%). The majority of nasopharyngitis and URTI events were mild. 7%). The majority of these events were mild and none of the ISRs required patient withdrawal from treatment or dose interruption.

8%) patients weighing 10 to <30 kg. The frequency of decreased neutrophil count was higher until Week 12. Decrease in ANC was not associated with an occurrence of infections, including serious infections. 3%) patients and were mild in severity and non-serious.

1%) patient had ALT greater than 3 times the upper limit of normal (ULN). 7%) patients overall had ALT increase and majority were mild in severity and all were non-serious. 1%) patient. 2%) patients overall had elevation in triglycerides, and all were mild in severity and non-serious.

No significant changes in mean LDL, HDL or total cholesterol were observed during the entire 156-week treatment period. 3%) patients treated with the recommended dose exhibited an antidrug antibody (ADA) response. Neutralizing antibodies were detected in one pJIA patient with ADA response.

Because of the low occurrence of anti-drug antibodies, the effect of antibodies on the safety, and/or effectiveness of sarilumab is unknown. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 8). As there is a higher incidence of infections in the elderly population in general, caution should be used when treating the elderly.

Sarilumab must not be administered in patients with an active infection, including localised infections. The risks and benefits should be considered prior to initiating treatment in patients who have: • chronic or recurrent infection; • a history of serious or opportunistic infections; • HIV infection; • underlying conditions that may predispose them to infection; • been exposed to tuberculosis; or • lived in or travelled to areas of endemic tuberculosis or endemic mycoses.

Treatment with sarilumab must be withheld if a patient develops a serious infection or an opportunistic infection. Once the infection is controlled, treatment with sarilumab may be re-initiated at the discretion of the healthcare professional.

A patient who develops an infection during treatment should also undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient; appropriate antimicrobial therapy should be initiated, and the patient should be closely monitored.

Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients receiving immunosuppressive agents including sarilumab for RA. 8). Among opportunistic infections, tuberculosis, candidiasis, and pneumocystis were reported with sarilumab.

In isolated cases, disseminated rather than localised infections were observed in patients often taking concomitant immunosuppressants such as MTX or corticosteroids, which in addition to RA may predispose them to infections. Tuberculosis Patients must be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating treatment with sarilumab.

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