Kevzara

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 
 
 
 
 



 
 

 
 

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This medicinal product is subject to additional monitoring. This will allow quick identification of 
new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions. 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
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 
Kevzara 200 mg solution for injection in pre-filled pen  
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
150 mg solution for injection 
Each single-dose pre-filled syringe contains 150 mg sarilumab in 1.14 ml solution (131.6 mg/ml). 
Each single-dose pre-filled pen contains 150 mg sarilumab in 1.14 ml solution (131.6 mg/ml). 
 
200 mg solution for injection 
Each single-dose pre-filled syringe contains 200 mg sarilumab in 1.14 ml solution (175 mg/ml). 
Each single-dose pre-filled pen contains 200 mg sarilumab in 1.14 ml solution (175 mg/ml). 
 
Sarilumab is a human monoclonal antibody selective for the interleukin-6 (IL-6) receptor, produced in 
Chinese Hamster Ovary cells by recombinant DNA technology. 
For the full list of excipients see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for injection (injection) 
 
Clear, colourless to pale yellow sterile solution of approximately pH 6.0. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
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). 
 
4.2 Posology and method of administration 
 
Treatment should be initiated and supervised by healthcare professionals experienced in the diagnosis 
and treatment of rheumatoid arthritis. Patients treated with Kevzara should be given the patient alert 
card. 
 
Posology 
The recommended dose of Kevzara is 200 mg once every 2 weeks administered as a subcutaneous 
injection. 



 
 

 
 

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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. 
 
Dose modification: 
Treatment with Kevzara should be withheld in patients who develop a serious infection until the 
infection is controlled. 
 
Initiating treatment with Kevzara is not recommended in patients with a low neutrophil count, i.e., 
absolute neutrophil count (ANC) less than 2 x 109/L. 
 
Initiating treatment with Kevzara is not recommended in patients with a platelet count below 
150 x 103/µL. 
 
Recommended dose modifications in case of neutropenia, thrombocytopenia, or liver enzyme 
elevations (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 Kevzara should be maintained. 
ANC 0.5-1 Treatment with Kevzara should be withheld until >1 x 109/L.   

Kevzara 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 Kevzara should be discontinued. 
 
Low Platelet Count  
Lab Value (cells x 
103/µL) 

Recommendation  

50 to 100 Treatment with Kevzara should be withheld until >100 x 103/µL.   
Kevzara 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 Kevzara 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 to 5 x ULN Treatment with Kevzara should be withheld until < 3 x ULN.    
Kevzara 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 Kevzara should be discontinued. 
 
Missed dose  
If a dose of Kevzara 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. 
 
Special Populations 
Renal impairment:  
No dose adjustment is required in patients with mild to moderate renal impairment. Kevzara has not 
been studied in patients with severe renal impairment (see section 5.2). 
 



 
 

 
 

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Hepatic impairment: 
The safety and efficacy of Kevzara 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). 
 
Elderly:  
No dose adjustment is required in patients over 65 years of age (see section 4.4). 
 
Paediatric population:  
The safety and efficacy of Kevzara in children up to 18 years of age have not been established. No 
data are available.  
 
Method of Administration 
Subcutaneous use. 
 
The total content (1.14 ml) of the pre-filled syringe/pre-filled pen should be administered as a 
subcutaneous injection. Injection sites (abdomen, thigh and upper arm) should be rotated with each 
injection. Kevzara should not be injected into skin that is tender, damaged, or has bruises or scars. 
 
A patient may self-inject Kevzara or the patient's caregiver may administer Kevzara 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 Kevzara prior to use. 
 
For further details on administration of this medicinal product see section 6.6. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or any of the excipients listed in section 6.1.  
Active, severe infections (see section 4.4). 
 
4.4 Special warnings and precautions for use 
 
Traceability of Kevzara 
In order to improve the traceability of biological medicinal products, the name and the batch number 
of the administered product should be clearly recorded. 
 
Serious infections  
Patients should be closely monitored for the development of signs and symptoms of infection during 
treatment with Kevzara (see sections 4.2 and 4.8). As there is a higher incidence of infections in the 
elderly population in general, caution should be used when treating the elderly.  
 
Kevzara should not be administered in patients with an active infection, including localised infections. 
Consider the risks and benefits of treatment prior to initiating Kevzara 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 Kevzara should be withheld if a patient develops a serious infection or an 
opportunistic infection.  
 
A patient who develops an infection during treatment with Kevzara 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. 
 



 
 

 
 

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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 
Kevzara for RA. The most frequently observed serious infections with Kevzara included pneumonia 
and cellulitis (see section 4.8). Among opportunistic infections, tuberculosis, candidiasis, and 
pneumocystis were reported with Kevzara. 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 should be evaluated for tuberculosis risk factors and tested for latent infection prior to 
initiating treatment with Kevzara. Patients with latent or active tuberculosis should be treated with 
standard antimycobacterial therapy before initiating Kevzara. Consider anti-tuberculosis therapy prior 
to initiation of Kevzara in patients with a past history of latent or active tuberculosis in whom an 
adequate course of treatment cannot be confirmed, and for patients with a negative test for latent 
tuberculosis but having risk factors for tuberculosis infection. When considering anti-tuberculosis 
therapy, consultation with a physician with expertise in tuberculosis may be appropriate. 
 
Patients should be closely monitored for the development of signs and symptoms of tuberculosis 
including patients who tested negative for latent tuberculosis infection prior to initiating therapy. 
 
Viral reactivation 
Viral reactivation has been reported with immunosuppressive biologic therapies. Cases of herpes 
zoster were observed in clinical studies with Kevzara. No cases of Hepatitis B reactivation were 
reported in the clinical studies; however patients who were at risk for reactivation were excluded. 
 
Laboratory parameters 
Neutrophil count 
Treatment with Kevzara was associated with a higher incidence of decrease in ANC. Decrease in ANC 
was not associated with higher incidence of infections, including serious infections.  

• Initiating treatment with Kevzara is not recommended in patients with a low neutrophil count, 
i.e., ANC less than 2 x 109/L. In patients who develop an ANC less than 0.5 x 109/L, treatment 
with Kevzara should be discontinued. 

• Neutrophil count should be monitored 4 to 8 weeks after start of therapy and according to 
clinical judgment thereafter. For recommended dose modifications based on ANC results see 
section 4.2. 

• Based on the pharmacodynamics of the changes in ANC, use results obtained at the end of the 
dosing interval when considering dose modification (see section 5.1).  

 
Platelet count 
Treatment with Kevzara was associated with a reduction in platelet counts in clinical studies. 
Reduction in platelets was not associated with bleeding events (see section 4.8). 

• Initiating treatment with Kevzara is not recommended in patients with a platelet count below 
150 x103/µL. In patients who develop a platelet count less than 50 x 103/ µL, treatment with 
Kevzara should be discontinued. 

• Platelet count should be monitored 4 to 8 weeks after start of therapy and according to clinical 
judgment thereafter. For recommended dose modifications based on platelet counts see section 
4.2. 

 
Liver enzymes 
Treatment with Kevzara was associated with a higher incidence of transaminase elevations. These 
elevations were transient and did not result in any clinically evident hepatic injury in clinical studies 
(see section 4.8). Increased frequency and magnitude of these elevations were observed when 
potentially hepatotoxic medicinal products (e.g., MTX) were used in combination with Kevzara. 
 
Initiating treatment with Kevzara is not recommended in patients with elevated transaminases, ALT or 
AST greater than 1.5 x ULN. In patients who develop elevated ALT greater than 5 x ULN, treatment 
with Kevzara should be discontinued (see section 4.2). 



 
 

 
 

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ALT and AST levels should be monitored 4 to 8 weeks after start of therapy and every 3 months 
thereafter. When clinically indicated, consider other liver function tests such as bilirubin. For 
recommended dose modifications based on transaminase elevations see section 4.2.  
 
Lipid abnormalities 
Lipid levels may be reduced in patients with chronic inflammation. Treatment with Kevzara was 
associated with increases in lipid parameters such as LDL cholesterol, HDL cholesterol, and/or 
triglycerides (see section 4.8). 
 
Lipid parameters should be assessed approximately 4 to 8 weeks following initiation of treatment with 
Kevzara, then at approximately 6 month intervals. 
 
Patients should be managed according to clinical guidelines for the management of hyperlipidaemia. 
 
Gastrointestinal perforation 
Gastrointestinal perforation has been reported in association with Kevzara in patients with and without 
diverticulitis. Use Kevzara with caution in patients with previous history of intestinal ulceration or 
diverticulitis. Patients presenting with new onset abdominal symptoms such as persistent pain with 
fever should be evaluated promptly (see section 4.8).  
 
Malignancies  
Treatment with immunosuppressants may result in an increased risk of malignancies. The impact of 
treatment with Kevzara on the development of malignancies is not known but malignancies were 
reported in clinical studies (see section 4.8).  
 
Hypersensitivity reactions 
Hypersensitivity reactions have been reported in association with Kevzara (see section 4.8). Injection 
site rash, rash, and urticaria were the most frequent hypersensitivity reactions. Patients should be 
advised to seek immediate medical attention if they experience any symptoms of a hypersensitivity 
reaction. If anaphylaxis or other hypersensitivity reaction occurs, administration of Kevzara should be 
stopped immediately. Kevzara should not be administered to patients with known hypersensitivity to 
sarilumab (see section 4.3). 
 
Hepatic impairment  
Treatment with Kevzara is not recommended in patients with active hepatic disease or hepatic 
impairment (see sections 4.2 and 4.8). 
 
Vaccinations 
Avoid concurrent use of live vaccines as well as live attenuated vaccines during treatment with 
Kevzara as clinical safety has not been established. No data are available on the secondary 
transmission of infection from persons receiving live vaccines to patients receiving Kevzara. Prior to 
initiating Kevzara, it is recommended that all patients be brought up to date with all immunisations in 
agreement with current immunisation guidelines. The interval between live vaccinations and initiation 
of Kevzara therapy should be in accordance with current vaccination guidelines regarding 
immunosuppressive agents (see section 4.5). 
 
Cardiovascular risk 
RA patients have an increased risk for cardiovascular disorders and risk factors (e.g. hypertension, 
hyperlipidaemia) should be managed as part of usual standard of care. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Sarilumab exposure was not affected when coadministered with MTX based on the population 
pharmacokinetic analyses and across study comparisons. MTX exposure is not expected to be changed 
by sarilumab coadministration; however, no clinical data was collected. Kevzara has not been 



 
 

 
 

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investigated in combination with Janus kinase (JAK) inhibitors or biological DMARDs such as Tumor 
Necrosis Factor (TNF) antagonists.  
 
Various in vitro and limited in vivo human studies have shown that cytokines and cytokine modulators 
can influence the expression and activity of specific cytochrome P450 (CYP) enzymes (CYP1A2, 
CYP2C9, CYP2C19, and CYP3A4) and therefore have the potential to alter the pharmacokinetics of 
concomitantly administered medicinal products that are substrates of these enzymes. Elevated levels of 
interleukin-6 (IL-6) may down-regulate CYP activity such as in patients with RA and hence increase 
drug levels compared to subjects without RA. Blockade of IL-6 signalling by IL-6Rα antagonists such 
as sarilumab might reverse the inhibitory effect of IL-6 and restore CYP activity, leading to altered 
medicinal products concentrations.  
 
The modulation of IL-6 effect on CYP enzymes by sarilumab may be clinically relevant for CYP 
substrates with a narrow therapeutic index, where the dose is individually adjusted. Upon initiation or 
discontinuation of Kevzara in patients being treated with CYP substrate medicinal products, 
therapeutic monitoring of effect (e.g., warfarin) or drug concentration (e.g., theophylline) should be 
performed and the individual dose of the medicinal product should be adjusted as needed.  
 
Caution should be exercised in patients who start Kevzara treatment while on therapy with CYP3A4 
substrates (e.g., oral contraceptives or statins), as Kevzara may reverse the inhibitory effect of IL-6 
and restore CYP3A4 activity, leading to decreased exposure and activity of CYP3A4 substrate. (see 
section 5.2).Interaction of sarilumab with substrates of other CYPs (CYP2C9, CYP 2C19, CYP2D6) 
has not been studied.  
 
4.6 Fertility, pregnancy and lactation 
 
Women of childbearing potential 
Women of childbearing potential should use effective contraception during and up to 3 months after 
treatment. 
 
Pregnancy 
There are no or limited amount of data from the use of sarilumab in pregnant women.  
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity 
(see section 5.3). 
 
Kevzara should not be used during pregnancy unless the clinical condition of the woman requires 
treatment with sarilumab. 
 
Breast-feeding 
It is unknown whether sarilumab is excreted in human milk or absorbed systemically after ingestion. 
The excretion of sarilumab in milk has not been studied in animals (see section 5.3). 
Because IgG1 are excreted in human milk, a decision should be made whether to discontinue breast-
feeding or to discontinue sarilumab therapy taking into account the benefit of breast-feeding for the 
child and the benefit of therapy for the woman. 
 
Fertility 
No data are available on the effect of sarilumab on human fertility. Animal studies showed no 
impairment of male or female fertility (see section 5.3).  
4.7 Effects on ability to drive and use machines 
 
Kevzara has no or negligible influence on the ability to drive or operate machinery. 
 



 
 

 
 

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4.8 Undesirable effects 
 
Summary of the safety profile 
 
The most frequent adverse reactions observed with Kevzara in clinical studies were neutropenia, 
increased ALT, injection site erythema, upper respiratory infections, and urinary tract infections. The 
most common serious adverse reactions were infections (see section 4.4). 
 
Tabulated list of adverse reactions 
 
The safety of Kevzara in combination with DMARDs was evaluated based on data from seven clinical 
studies, of which two were placebo-controlled, consisting of 2887 patients (long- term safety 
population). Of these, 2170 patients received Kevzara for at least 24 weeks, 1546 for at least 48 weeks, 
1020 for at least 96 weeks, and 624 for at least 144 weeks.  
 
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). Within each frequency grouping, undesirable effects 
are presented in order of decreasing seriousness. 
 
Table 1: List of ADRs* 
System Organ Class Frequency Adverse Reaction  
Infections and Infestations Common Upper respiratory tract infection  

Urinary tract infection  
Nasopharyngitis  
Oral herpes  

Uncommon Pneumonia 
Cellulitis 

Blood and Lymphatic System 
Disorders 

Very Common Neutropenia  

Common Thrombocytopenia  

Metabolism and Nutrition 
Disorders 

Common Hypercholesterolemia 

Hypertriglyceridemia 

Gastrointestinal disorders Rare Gastrointestinal perforation 

Hepatobiliary Disorders Common Transaminases increased 

General Disorders and 
Administration Site Conditions 

Common Injection site erythema  
Injection site pruritus 

* Adverse reactions listed in the table have been reported in controlled clinical studies. 
 
Description of selected adverse reactions  
Infections 
In the placebo-controlled population, the rates of infections were 84.5, 81.0, and 75.1 events per 100 
patient-years, in the 200 mg and 150 mg Kevzara + DMARDs and placebo + DMARDs groups 
respectively. The most commonly reported infections (5% to 7% of patients) were upper respiratory 
tract infections, urinary tract infections, and nasopharyngitis.  The rates of serious infections were 4.3, 
3.0, and 3.1 events per 100 patient-years, in the 200 mg, 150 mg Kevzara + DMARDs, and placebo + 
DMARDs groups, respectively. 
 
In the Kevzara +DMARDs long-term safety population, the rates of infections and serious infection 
were 57.3 and 3.4 events per 100-patient years, respectively.   
 



 
 

 
 

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The most frequently observed serious infections included pneumonia and cellulitis. Cases of 
opportunistic infection have been reported (see section 4.4). 
 
The overall rates of infections and serious infections in the Kevzara monotherapy population were 
consistent with rates in the Kevzara + DMARDs population. 
 
Gastrointestinal perforation 
Gastrointestinal perforation was reported in patients with and without diverticulitis. Most patients who 
developed gastrointestinal perforations were taking concomitant nonsteroidal anti-inflammatory 
medications (NSAIDs), corticosteroids, or methotrexate. The contribution of these concomitant 
medications relative to Kevzara in the development of gastrointestinal perforations is not known (see 
section 4.4). 
 
Hypersensitivity reactions 
In the placebo-controlled population, the proportion of patients who discontinued treatment due to 
hypersensitivity reactions was higher among those treated with Kevzara (0.9% in 200 mg group, 0.5% 
in 150 mg group) than placebo (0.2%). The rates of discontinuations due to hypersensitivity in the 
Kevzara + DMARDs long-term safety population and the Kevzara monotherapy population were 
consistent with the placebo-controlled population. In the placebo-controlled population, 0.2% of the 
patients treated with Kevzara 200 mg q2w + DMARD reported serious adverse events of 
hypersensitivity reactions, and none from Kevzara 150 mg q2w + DMARD group. 
 
Injection site reactions 
In the placebo-controlled population, injection site reactions were reported in 9.5%, 8%, and 1.4% of 
patients receiving Kevzara 200 mg, 150 mg, and placebo respectively.  These injection site reactions 
(including erythema and pruritus) were mild in severity for the majority of patients.  Two patients on 
Kevzara (0.2%) discontinued treatment due to injection site reactions.  
 
Laboratory abnormalities 
To allow for a direct comparison of frequency of laboratory abnormalities between placebo and active 
treatment, data from weeks 0-12 were used as this was prior to patients being permitted to switch from 
placebo to Kevzara. 
 
Neutrophil count 
Decreases in neutrophil counts below 1 x 109/L occurred in 6.4% and 3.6% of patients in the 200 mg 
and 150 mg Kevzara + DMARDs group, respectively, compared to no patients in the placebo + 
DMARDs group. Decreases in neutrophil counts below 0.5 x 109/L occurred in 0.8% and 0.6% of 
patients in the 200 mg and 150 mg Kevzara+ DMARDs groups, respectively. In patients experiencing 
a decrease in absolute neutrophil count (ANC), modification of treatment regimen such as interruption 
of Kevzara or reduction in dose resulted in an increase or normalization of ANC (see section 4.2).  
Decrease in ANC was not associated with higher incidence of infections, including serious infections. 
 
In the Kevzara + DMARDs long-term safety population and the Kevzara monotherapy population, the 
observations on neutrophil counts were consistent with those seen in the placebo-controlled population 
(see section 4.4).  
 
Platelet count 
Decreases in platelet counts below 100 x 103/µL occurred in 1.2% and 0.6% of patients on 200 mg and 
150 mg Kevzara + DMARDs, respectively, compared to no patients on placebo + DMARDs. 
 
In the Kevzara + DMARDs long-term safety population and the Kevzara monotherapy population, the 
observations on platelet counts were consistent with those seen in the placebo-controlled population.  
 
There were no bleeding events associated with decreases in platelet count. 
 



 
 

 
 

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Liver enzymes 
Liver enzyme abnormalities are summarised in Table 2. In patients experiencing liver enzyme 
elevation, modification of treatment regimen, such as interruption of Kevzara or reduction in dose, 
resulted in decrease or normalization of liver enzymes (see section 4.2). These elevations were not 
associated with clinically relevant increases in direct bilirubin, nor were they associated with clinical 
evidence of hepatitis or hepatic insufficiency (see section 4.4). 
 
Table 2: Incidence of liver enzyme abnormalities in controlled clinical studies 
 
 Placebo + 

DMARD 
N = 661 

Kevzara 150 mg 
+ DMARD 

N = 660 

Kevzara 200 mg 
+ DMARD 

N = 661 

Kevzara Monotherapy 
Any Dose 
N = 467 

AST      
>3 x ULN –  
5 x ULN 

0% 1.2% 1.1% 1.1% 

>5 x ULN 0% 0.6% 0.2% 0% 
ALT      
>3 x ULN –  
5 x ULN 

0.6% 3.2% 2.4% 1.9% 

>5 x ULN 0% 1.1% 0.8% 0.2% 
 
Lipids 
Lipid parameters (LDL, HDL, and triglycerides) were first assessed at 4 weeks following initiation of 
Kevzara+ DMARDs in the placebo-controlled population. At Week 4 the mean LDL increased by 14 
mg/dL; mean triglycerides increased by 23 mg/dL; and mean HDL increased by 3 mg/dL. After Week 
4 no additional increases were observed. There were no meaningful differences between doses.  
 
In the Kevzara + DMARDs long-term safety population and the Kevzara monotherapy population, the 
observations in lipid parameters were consistent with those seen in the placebo-controlled population.  
 
Immunogenicity 
As with all therapeutic proteins, there is a potential for immunogenicity with Kevzara.  
 
In the placebo-controlled population, 4.0%, 5.6%, and 2.0% of patients treated with Kevzara 200 mg + 
DMARDs, Kevzara 150 mg + DMARDs and placebo + DMARDs respectively, exhibited a positive 
response in the anti-drug antibody (ADA) assay. Positive responses in the neutralizing antibody (NAb) 
assay were detected in 1.0%, 1.6%, and 0.2% of patients on Kevzara 200 mg, Kevzara 150 mg, and 
placebo respectively.  
 
In the Kevzara monotherapy population, observations were consistent with the Kevzara + DMARDs 
population.    
 
Anti Drug Antibody (ADA) formation may affect pharmacokinetics of Kevzara. No correlation was 
observed between ADA development and either loss of efficacy or adverse events. 
 
The detection of an immune response is highly dependent on the sensitivity and specificity of the 
assays used and testing conditions. For these reasons, comparison of the incidence of antibodies to 
Kevzara with the incidence of antibodies to other products may be misleading. 
 
Malignancies 
In the placebo-controlled population, malignancies occurred at the same rate in patients receiving 
either Kevzara + DMARDs or placebo + DMARDs (1.0 events per 100 patient-years).  
 
In the Kevzara + DMARDs long-term safety population and the Kevzara monotherapy population, the 
rates of malignancies were consistent with the rate observed in the placebo-controlled population (see 
section 4.4). 



 
 

 
 

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Reporting of suspected adverse reactions  
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V.  
 
4.9 Overdose 
 
There are limited data available on overdose with Kevzara. 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. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Immunosupressants, Interleukin inhibitors, ATC code: L04AC14 
 
Mechanism of action  
Sarilumab is a human monoclonal antibody (IgG1 subtype) that specifically binds to both soluble and 
membrane-bound IL-6 receptors (IL-6Rα), and inhibits IL-6-mediated signalling which involves 
ubiquitous signal-transducing glycoprotein 130 (gp130) and the Signal Transducer and Activator of 
Transcription-3 (STAT-3).  
 
In functional human cell-based assays, sarilumab was able to block the IL-6 signalling pathway, 
measured as STAT-3 inhibition, only in the presence of IL-6.  
 
IL-6 is a pleiotropic cytokine that stimulates diverse cellular responses such as proliferation, 
differentiation, survival, and apoptosis and can activate hepatocytes to release acute-phase proteins, 
including C-reactive protein (CRP) and serum amyloid A. Elevated levels of IL-6 are found in the 
synovial fluid of patients with rheumatoid arthritis and play an important role in both the pathologic 
inflammation and joint destruction which are hallmarks of RA. IL-6 is involved in diverse 
physiological processes such as migration and activation of T-cells, B-cells, monocytes, and 
osteoclasts leading to systemic inflammation, synovial inflammation, and bone erosion in patients with 
RA. 
 
The activity of sarilumab in reducing inflammation is associated with laboratory changes such as 
decrease in ANC and elevation in lipids (see section 4.4). 
Pharmacodynamic effects 
Following single-dose subcutaneous (SC) administration of sarilumab 200 mg and 150 mg in patients 
with RA rapid reduction of CRP levels was observed. Levels were reduced to normal as early as 4 
days after treatment initiation. Following single-dose sarilumab administration, in patients with RA, 
ANC decreased to the nadir between 3 to 4 days and thereafter recovered towards baseline (see section 
4.4). Treatment with sarilumab resulted in decreases in fibrinogen and serum amyloid A, and increases 
in haemoglobin and serum albumin. 
 
Clinical efficacy 
The efficacy and safety of Kevzara were assessed in three randomised, double-blind, controlled 
multicentre studies (MOBILITY and TARGET were placebo-controlled studies and MONARCH was 
an active comparator-controlled study) in patients older than 18 years with moderately to severely 
active rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria. 
Patients had at least 8 tender and 6 swollen joints at baseline.  
 

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Placebo-controlled studies  
MOBILITY evaluated 1197 patients with RA who had inadequate clinical response to MTX. Patients 
received Kevzara 200 mg, Kevzara 150 mg, or placebo every 2 weeks with concomitant MTX. The 
primary endpoints were the proportion of patients who achieved an ACR20 response at Week 24, 
changes from baseline in Health Assessment Questionnaire – Disability Index (HAQ-DI) score at 
Week 16, and change from baseline in van der Heijde-modified Total Sharp Score (mTSS) at Week 
52.  
 
TARGET evaluated 546 patients with RA who had an inadequate clinical response or were intolerant 
to one or more TNF-α antagonists. Patients received Kevzara 200 mg, Kevzara 150 mg, or placebo 
every 2 weeks with concomitant conventional DMARDs (cDMARDs). The primary endpoints were 
the proportion of patients who achieved an ACR20 response at Week 24 and the changes from 
baseline HAQ-DI score at Week 12. 
 
Clinical response 
The percentages of Kevzara + DMARDs-treated patients achieving ACR20, ACR50, and ACR70 
responses in MOBILITY and TARGET are shown Table 3. In both studies, patients treated with either 
200 mg or 150 mg of Kevzara + DMARDs every two weeks had higher ACR20, ACR50, and ACR70 
response rates versus placebo-treated patients at Week 24.  These responses persisted through 3 years 
of therapy in an open-label extension study. 
 
In MOBILITY, a greater proportion of patients treated with Kevzara 200 mg or 150 mg every two 
weeks plus MTX achieved remission, defined as Disease Activity Score 28-C-Reactive Protein 
(DAS28-CRP) < 2.6 compared with placebo + MTX at Week 52. Results at 24 weeks in TARGET 
were similar to the results at 52 weeks in MOBILITY (see Table 3). 
 



 
 

 
 

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Table 3: Clinical Response at Weeks 12, 24, and 52 in Placebo-Controlled Studies, MOBILITY and 
TARGET 
 

 Percentage of Patients 

 

MOBILITY 
MTX Inadequate Responders 

TARGET 
TNF Inhibitor Inadequate Responders  

Placebo 
+ MTX 
N = 398 

Kevzara 
150 mg 
+ MTX 
N = 400 

Kevzara 
200 mg 
+ MTX 
N = 399 

Placebo 
+ cDMA

RDs* 
N = 181 

Kevzara 
150 mg 

+ cDMARD
s* 

N = 181 

Kevzara 
200 mg 

+ cDMARD
s* 

N = 184 
Week 12       

DAS28-CRP 
remission (< 2.6) 4.8% 18.0%††† 23.1%††† 3.9% 17.1%††† 17.9%††† 
ACR20 34.7% 54.0%††† 64.9%††† 37.6% 54.1%† 62.5%††† 
ACR50 12.3% 26.5%††† 36.3%††† 13.3% 30.4%††† 33.2%††† 
ACR70 4.0% 11.0%†† 17.5%††† 2.2% 13.8%††† 14.7%††† 

Week 24       
DAS28-CRP 
remission (< 2.6) 10.1% 27.8%††† 34.1%††† 7.2% 24.9%††† 28.8%††† 
ACR20‡ 33.4% 58.0%††† 66.4%††† 33.7% 55.8%††† 60.9%††† 
ACR50 16.6% 37.0%††† 45.6%††† 18.2% 37.0%††† 40.8%††† 
ACR70 7.3% 19.8%††† 24.8%††† 7.2% 19.9%†† 16.3%† 

Week 52       
DAS28-CRP 
remission (< 2.6) 8.5% 31.0%††† 34.1%††† NA§ NA§ NA§ 
ACR20 31.7% 53.5%††† 58.6%†††    
ACR50 18.1% 40.0%††† 42.9%†††    
ACR70 9.0% 24.8% 26.8%    
Major clinical 
response¶ 3.0% 12.8%††† 14.8%†††    

*cDMARDs in TARGET included MTX, sulfasalazine, leflunomide and hydroxychloroquine 
† p-value <0.01 for difference from placebo 
††p-value <0.001 for difference from placebo 
†††p-value <0.0001 for difference from placebo 
‡ Primary endpoint 
§ NA=Not Applicable as TARGET was a 24-week study 
¶ Major clinical response = ACR70 for at least 24 consecutive weeks during the 52-week period   



 
 

 
 

14 

In both MOBILITY and TARGET, higher ACR20 response rates were observed within 2 weeks 
compared to placebo and were maintained for the duration of the studies (see Figures 1 and 2). 
 

Figure 1: Percent of ACR20 Response by Visit for MOBILITY 
 

 
Figure 2: Percent of ACR20 Response by Visit for TARGET 

 

 
 
The results of the components of the ACR response criteria at Week 24 for MOBILITY and TARGET 
are shown in Table 4. Results at 52 weeks in MOBILITY were similar to the results at 24 weeks for 
TARGET. 



 
 

 
 

15 

Table 4: Mean reductions from baseline to Week 24 in components of ACR score 

 
Radiographic response 
In MOBILITY, structural joint damage was assessed radiographically and expressed as change in van 
der Heijde-modified Total Sharp Score (mTSS) and its components, the erosion score, and joint space 
narrowing score at Week 52. Radiographs of hands and feet were obtained at baseline, 24 weeks, and 
52 weeks and scored independently by at least two well-trained readers who were blinded to treatment 
group and visit number.  
 
Both doses of Kevzara + MTX were superior to placebo + MTX in the change from baseline in mTSS 
at 24 and 52 weeks (see Table 5). Less progression of both erosion and joint space narrowing scores at 
24 and 52 weeks was reported in the sarilumab treatment groups compared to the placebo group. 
 
Treatment with Kevzara + MTX was associated with significantly less radiographic progression of 
structural damage as compared with placebo. At Week 52, 55.6% of patients receiving Kevzara 
200 mg and 47.8% of patients receiving Kevzara 150 mg had no progression of structural damage (as 
defined by a change in the TSS of zero or less) compared with 38.7% of patients receiving placebo. 
 
Treatment with Kevzara 200 mg and 150 mg + MTX inhibited the progression of structural damage by 
91% and 68%, respectively, compared to placebo + MTX at Week 52.  
 
The efficacy of sarilumab with concomitant DMARDs on inhibition of radiographic progression that 
was assessed as part of the primary endpoints at Week 52 in MOBILITY was sustained up to three 
years from the start of treatment.  
 

 MOBILITY TARGET 

Component 
(range) 

Placebo  
+ MTX 

(N = 
398) 

KEVZARA  
150 mg 
q2w* + 
MTX 

(N = 400) 

KEVZARA  
200 mg 
q2w* + 
MTX 

(N = 399) 

Placebo  
+ 

cDMARDs  
(N = 181) 

KEVZARA  
150 mg q2w* 
+ cDMARDs 

(N = 181) 

KEVZARA  
200 mg q2w* 
+ cDMARDs 

(N = 184) 

Tender 
Joints  
(0-68) 

-14.38 -19.25††† -19.00††† -17.18  -17.30†  -20.58†††  

Swollen 
Joints  
(0-66) 

-8.70 -11.84††† -12.43††† -12.12  -13.04†† -14.03††† 

Pain VAS†  
(0-100 mm) -19.43 -30.75††† -34.35††† -27.65 -36.28†† -39.60††† 

Physician 
global VAS‡ 

(0-100 mm) 
-32.04 -40.69†††  -42.65††† -39.44 -45.09††† -48.08††† 

Patient 
global VAS‡ 
(0-100 mm) 

-19.55 -30.41††† -35.07††† -28.06 -33.88†† -37.36†††  

HAQ-DI 
(0-3) -0.43 -0.62†††  -0.64†††  -0.52  -0.60†  -0.69†† 

CRP -0.14 -13.63††† -18.04††† -5.21 -13.11††† -29.06†††  
* q2w = every 2 weeks 
‡ Visual analogue scale 
†p-value <0.01 for difference from placebo 
††p-value <0.001 for difference from placebo 
†††p-value <0.0001 for difference from placebo 



 
 

 
 

16 

Table 5: Mean Radiographic Change from Baseline at Week 24 and Week 52 in MOBILITY 
 

  

MOBILITY 
MTX Inadequate Responders 

Placebo  
+ MTX 

(N = 398) 

Kevzara  
150 mg q2w*  

+ MTX 
(N = 400) 

Kevzara 
200 mg q2w*  

+ MTX 
(N = 399) 

Mean change at Week 24       
Modified Total Sharp Score (mTSS) 1.22 0.54† 0.13†† 

Erosion score (0-280) 0.68 0.26† 0.02†† 
Joint space narrowing score 0.54 0.28 0.12† 

Mean change at Week 52  
   

Modified Total Sharp Score (mTSS) ‡ 2.78 0.90†† 0.25†† 
Erosion score (0-280) 1.46 0.42†† 0.05†† 
Joint space narrowing score 1.32  0.47† 0.20†† 

* q2w=every two weeks 
† p-value <0.001 
††p-value <0.0001 
‡ Primary end point  
 
Physical function response 
In MOBILITY and TARGET, physical function and disability were assessed by the Health 
Assessment Questionnaire Disability Index (HAQ-DI). Patients receiving Kevzara 200 mg or 150 mg 
+ DMARDs every two weeks demonstrated greater improvement from baseline in physical function 
compared to placebo at Week 16 and Week 12 in MOBILITY and TARGET, respectively.  
 
MOBILITY demonstrated significant improvement in physical function, as measured by the HAQ-DI 
at Week 16 compared to placebo (-0.58, -0.54, and -0.30 for Kevzara 200 mg + MTX, Kevzara 
150 mg + MTX, and placebo + MTX, every two weeks, respectively). TARGET demonstrated 
significant improvement in HAQ-DI scores at Week 12 compared to placebo (-0.49, -0.50, and -0.29 
for Kevzara 200 mg + DMARDs, Kevzara 150 mg + DMARDs, and placebo + DMARDs, every two 
weeks, respectively). 
 
In MOBILITY, the improvement in physical functioning as measured by HAQ-DI was maintained up 
to Week 52 (-0.75, -0.71, and -0.46 for Kevzara 200 mg + MTX, Kevzara 150 mg + MTX, and 
placebo + MTX treatment groups, respectively).  
 
Patients treated with Kevzara + MTX (47.6% in the 200 mg treatment group and 47.0% in the 150 mg 
treatment group) achieved a clinically relevant improvement in HAQ-DI (change from baseline of 
≥0.3 units) at Week 52 compared to 26.1% in the placebo + MTX treatment group.  
 
Patient reported outcomes 
General health status was assessed by the Short Form health survey (SF-36). In MOBILITY and 
TARGET, patients receiving Kevzara 200 mg + DMARDs every two weeks or Kevzara 150 mg + 
DMARDs every two weeks demonstrated greater improvement from baseline compared to placebo + 
DMARDs in physical component summary (PCS) and no worsening on the mental component 
summary (MCS) at Week 24. Patients receiving Kevzara 200 mg + DMARDs reported greater 
improvement relative to placebo in the domains of Physical Functioning, Role Physical, Bodily Pain, 
General Health Perception, Vitality, Social Functioning, and Mental Health. 
 
Fatigue was assessed by the FACIT-Fatigue scale. In MOBILITY and TARGET, patients receiving 
sarilumab 200 mg + DMARDs every two weeks or sarilumab 150 mg + DMARDs every two weeks 
demonstrated greater improvement from baseline compared to placebo + DMARDs. 



 
 

 
 

17 

 
Active Comparator-controlled Study  
MONARCH was a 24 –week randomised double-blind, double-dummy study that compared Kevzara 
200 mg monotherapy with adalimumab 40 mg monotherapy administered subcutaneously every two 
weeks in 369 patients with moderately to severely active RA who were inappropriate for treatment 
with MTX including those who were intolerant of or inadequate responders to MTX.  
 
Kevzara 200 mg was superior to adalimumab 40 mg in reducing disease activity and improving 
physical function, with more patients achieving clinical remission over 24 weeks (see Table 6). 
 
Table 6: Efficacy results for MONARCH 
  

Adalimumab  
40 mg q2w* 

(N=185) 

Kevzara  
200 mg q2w 

 (N=184) 

DAS28-ESR (primary endpoint) 
      p-value versus adalimumab  

-2.20 (0.106) -3.28 (0.105) 
< 0.0001 

DAS28-ESR remission (< 2.6), n (%) 
      p-value versus adalimumab 

13 (7.0%) 49 (26.6%) 
< 0.0001 

ACR20 response, n (%) 
      p-value versus adalimumab 

108 (58.4%) 132 (71.7%) 
0.0074 

ACR50 response, n (%) 
      p-value versus adalimumab 

55 (29.7%) 84 (45.7%) 
0.0017 

ACR70 response, n (%) 
      p-value versus adalimumab 

22 (11.9%) 43 (23.4%) 
0.0036 

HAQ-DI  
      p-value versus adalimumab 

-0.43(0.045) -0.61(0.045)  
0.0037 

*Includes patients who increased the frequency of dosing of adalimumab 40 mg to every week 
because of an inadequate response 

 
Paediatric population 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
Kevzara (sarilumab) in one or more subsets of the paediatric population in chronic idiopathic arthritis 
(including rheumatoid arthritis, spondylarthritis, psoriatic arthritis and juvenile idiopathic arthritis) 
(see section 4.2 for information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
The pharmacokinetics of sarilumab were characterised in 2186 patients with RA treated with 
sarilumab which included 751 patients treated with 150 mg and 891 patients treated with 200 mg 
subcutaneous doses every two weeks for up to 52 weeks.  
 
Absorption 
The absolute bioavailability for sarilumab after SC injection was estimated to be 80% by population 
PK analysis. The median tmax after a single subcutaneous dose was observed in 2 to 4 days. After 
multiple dosing of 150 to 200 mg every two weeks, steady state was reached in 12 to 16 weeks with a 
2- to 3-fold accumulation compared to single dose exposure. 
 
For the 150 mg every two weeks dose regimen, the estimated mean (± standard deviation, SD) steady-
state area under curve (AUC), Cmin, and Cmax of sarilumab were 210 ± 115 mg.day/L, 6.95 ± 
7.60 mg/L, and 20.4 ± 8.27 mg/L, respectively. 
 
For the 200 mg every two weeks dose regimen, the estimated mean (± SD) steady-state AUC, Cmin and 
Cmax of sarilumab were 396 ± 194 mg.day/L, 16.7 ± 13.5 mg/L, and 35.4 ± 13.9 mg/L, respectively. 
In a usability study sarilumab exposure after 200 mg Q2W was slightly higher (Cmax + 24-34%, 
AUC(0-2w) +7-21%) after use of a pre-filled pen compared to the pre-filled syringe. 



 
 

 
 

18 

 
Distribution 
In patients with RA, the apparent volume of distribution at steady state was 8.3 L. 
 
Biotransformation 
The metabolic pathway of sarilumab has not been characterised. As a monoclonal antibody sarilumab 
is expected to be degraded into small peptides and amino acids via catabolic pathways in the same 
manner as endogenous IgG.  
 
Elimination 
Sarilumab is eliminated by parallel linear and non-linear pathways. At higher concentrations, the 
elimination is predominantly through the linear, non-saturable proteolytic pathway, while at lower 
concentrations, non-linear saturable target-mediated elimination predominates. These parallel 
elimination pathways result in an initial half-life of 8 to 10 days, and at steady-state an effective half-
life of 21 days is estimated.  
 
After the last steady state dose of 150 mg and 200 mg sarilumab, the median times to non-detectable 
concentration are 30 and 49 days, respectively. 
Monoclonal antibodies are not eliminated via renal or hepatic pathways. 
 
Linearity/non-linearity 
A more than dose-proportional increase in pharmacokinetic exposure was observed in patients with 
RA. At steady state, exposure over the dosing interval measured by AUC increased approximately 2-
fold with a 1.33-fold increase in dose from 150 to 200 mg every two weeks. 
 
Interactions with CYP450 substrates 
Simvastatin is a CYP3A4 and OATP1B1 substrate. In 17 patients with RA, one week following a 
single 200-mg subcutaneous administration of sarilumab, exposure of simvastatin and simvastatin acid 
decreased by 45% and 36%, respectively (see section 4.5). 
 
Special populations 
Age, gender, ethnicity and body weight  
Population pharmacokinetic analyses in adult patients with RA (ranging in age from18 to 88 years 
with 14% over 65 years) showed that age, gender and race did not meaningfully influence the 
pharmacokinetics of sarilumab. 
Body weight influenced the pharmacokinetics of sarilumab. In patients with higher body weight (>100 
Kg) both 150 mg and 200 mg doses demonstrated efficacy; however, patients weighing >100 Kg had 
greater therapeutic benefit with the 200 mg dose. 
 
Renal impairment 
No formal study of the effect of renal impairment on the pharmacokinetics of sarilumab was 
conducted. Mild to moderate renal impairment did not affect the pharmacokinetics of sarilumab. No 
dosage adjustment is required in patients with mild to moderate renal impairment. Patients with severe 
renal impairment were not studied. 
 
Hepatic impairment 
No formal study of the effect of hepatic impairment on the pharmacokinetics of sarilumab was 
conducted (see section 4.2). 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on repeated-dose toxicity studies, 
carcinogenic risk assessment and reproductive and developmental toxicity studies. 
 
No long-term animal studies have been performed to establish the carcinogenicity potential of 
sarilumab. The weight of evidence for IL-6Rα inhibition mainly indicates anti-tumour effects 
mediated by multiple mechanisms predominantly involving STAT-3 inhibition. In vitro and in vivo 



 
 

 
 

19 

studies with sarilumab using human tumour cell lines showed inhibition of STAT-3 activation and 
inhibition of tumour growth in human tumour xenograft animal models. 
 
Fertility studies conducted in male and female mice using a murine surrogate antibody against mouse 
IL-6Rα showed no impairment of fertility.  
 
In an enhanced pre-/postnatal developmental toxicity study, pregnant Cynomolgus monkeys were 
administered sarilumab once-weekly intravenously from early gestation to natural birth 
(approximately 21 weeks) Maternal exposure up to approximately 83 times the human exposure based 
on AUC after subcutaneous doses of 200 mg every 2 weeks, did not cause any maternal or embryo-
fetal effects. Sarilumab had no effect on maintenance of pregnancy or on the neonates evaluated up to 
1 month after birth in body weight measurements, in parameters of functional or morphological 
development including skeletal evaluations, in immunophenotyping of peripheral blood lymphocytes, 
and in microscopic evaluations. Sarilumab was detected in the serum of neonates up to 1 month. The 
excretion of sarilumab in Cynomolgus monkey’s milk has not been studied. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Histidine  
Arginine  
Polysorbate 20  
Sucrose  
Water for injections 
 
6.2 Incompatibilities 
 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products. 
 
6.3 Shelf life 
 
36 months. 
 
Once removed from the refrigerator, Kevzara should be administered within 14 days and should not be 
stored above 25 ºC. 
 
6.4 Special precautions for storage 
 
Store in a refrigerator (2ºC - 8ºC). Do not freeze.  
 
Store pre-filled syringe/pre-filled pen in the original carton in order to protect from light. 
 
6.5 Nature and contents of container 
 
All presentations contain a 1.14 ml solution in a syringe (type 1 glass) equipped with a stainless steel 
staked needle and an elastomer plunger stopper.  
 
Pre-filled syringe 150 mg: 
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. 
 



 
 

 
 

20 

Pre-filled syringe 200 mg: 
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. 

 
Pre-filled pen 150 mg: 
The syringe components are pre-assembled into a single-use pre-filled pen with a yellow needle cover 
and light-orange cap. 
 
Pre-filled pen 200 mg: 
The syringe components are pre-assembled into a single-use pre-filled pen with a yellow needle cover 
and dark-orange cap. 
 
Pack sizes:  

• 1 pre-filled syringe 
• 2 pre-filled syringes 
• Multipack containing 6 (3 packs of 2) pre-filled syringes  
• 1 pre-filled pen 
• 2 pre-filled pens  
• Multipack containing 6 (3 packs of 2) pre-filled pens 

 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
The pre-filled syringe/pre-filled pen 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) before injecting Kevzara.  
Comprehensive instructions for the administration of Kevzara in a pre-filled syringe/pre-filled pen are 
given in the package leaflet.  
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. After use, place the pre-filled syringe/ pre-filled pen into a puncture-resistant container 
and discard as required by local regulations. Do not recycle the container. Keep the container out of 
sight and reach of children. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
sanofi-aventis groupe 
54, rue La Boétie 
75008 Paris  
France 
 
 
8. MARKETING AUTHORISATION NUMBERS 
 
EU/1/17/1196/001 
EU/1/17/1196/002 
EU/1/17/1196/003 
EU/1/17/1196/004 
EU/1/17/1196/005 
EU/1/17/1196/006 
EU/1/17/1196/007 
EU/1/17/1196/008 



 
 

 
 

21 

EU/1/17/1196/009 
EU/1/17/1196/010 
EU/1/17/1196/011 
EU/1/17/1196/012 
 
 
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 23 June 2017 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu  

http://www.ema.europa.eu/


 
 

 
 

22 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 

MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE  
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
D.  CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
 
 

 



 
 

 
 

23 

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
MANUFACTURERS  RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer of the biological active substance  
Regeneron Pharmaceuticals Inc. 
81 Columbia Turnpike 
Rensselaer 
12144 
United States 
 
Name and address of the manufacturer(s) responsible for batch release 
Sanofi Winthrop Industrie  
Boulevard Industriel, Zone Industrielle, 
Le Trait, 76580,  
France 
 
Sanofi-Aventis Deutschland GmbH 
Brueningstrasse 50 
Industriepark Hochst 
65926 Frankfurt am Main 
Germany 
 
Genzyme Ireland Ltd 
IDA Industrial Park 
Old Kilmeaden Road 
Waterford,  
Ireland 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2). 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION  
 
• Periodic safety update reports  
 
The requirements for submission of periodic safety update reports for this medicinal product are set 
out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 
2001/83/EC and any subsequent updates published on the European medicines web-portal. 
The marketing authorisation holder shall submit the first periodic safety update report for this 
product within 6 months following authorisation. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk Management Plan (RMP) 
 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 



 
 

 
 

24 

agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed  subsequent 
updates of the RMP. 
 
An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new 

information being received that may lead to a significant change to the benefit/risk profile or 
as the result of an important (pharmacovigilance or risk minimisation) milestone being 
reached.  

 
• Additional risk minimisation measures  

 
Prior to launch of Kevzara in each Member State the Marketing Authorisation Holder (MAH) must 
agree about the content and format of patient alert card, including communication media, 
distribution modalities, and any other aspects, with the National Competent Authority.  
 
The MAH shall ensure that in each Member State where Kevzara is marketed, all healthcare 
professionals who are expected to prescribe Kevzara have access to the patient alert card. 
 
The patient alert card shall contain the following key messages:  

• A warning message for HCPs treating the patient at any time, including in conditions of 
emergency, that the patient is using Kevzara.  

• That Kevzara treatment may increase the risks of serious infections, neutropenia and 
intestinal perforation.  

• Educate patients on signs or symptoms that could represent serious infections or 
gastrointestinal perforations to seek for medical attention immediately.  

• Contact details of the prescriber for Kevzara. 
 

 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 



 
 

 
 

25 

 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



 
 

 
 

26 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



 
 

 
 

27 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON - PACK OF 2 PRE-FILLED SYRINGES 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
KEVZARA 150 mg solution for injection in pre-filled syringe 
sarilumab  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled syringe contains 150 mg sarilumab in 1.14 ml solution (131.6 mg/ml). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: histidine, arginine, polysorbate 20, sucrose, water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
solution for injection  
2 pre-filled syringes 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Subcutaneous use 
For single use only  
Read the package leaflet before use. 
Open here 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Store in the original carton in order to protect from light. 



 
 

 
 

28 

 
Date of removal from the refrigerator: .../.../... 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
sanofi-aventis groupe: 
54, rue la Boétie 
75008 Paris 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/17/1196/001 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE  
 
kevzara 150 mg syringe 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



 
 

 
 

29 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON with the Blue Box – MULTIPACK OF 6 (3 PACKS OF 2) PRE-FILLED 
SYRINGES 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
KEVZARA 150 mg solution for injection in pre-filled syringe 
sarilumab  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled syringe contains 150 mg sarilumab in 1.14 ml solution (131.6 mg/ml). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: histidine, arginine, polysorbate 20, sucrose, water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
solution for injection  
Multipack: 6 (3 packs of 2) pre-filled syringes. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Subcutaneous use 
For single use only  
Read the package leaflet before use. 
Open here 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Store in the original carton in order to protect from light. 



 
 

 
 

30 

 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
sanofi-aventis groupe: 
54, rue la Boétie 
75008 Paris 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/17/1196/002 6 pre-filled syringes (3 packs of 2) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE  
 
kevzara 150 mg syringe 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
 



 
 

 
 

31 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
INNER CARTON without Blue Box – 2 PRE-FILLED SYRINGES (MULTIPACK 
PRESENTATION) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
KEVZARA 150 mg solution for injection in pre-filled syringe 
sarilumab  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled syringe contains 150 mg sarilumab in 1.14 ml solution (131.6 mg/ml). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: histidine, arginine, polysorbate 20, sucrose, water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
2 pre-filled syringes. Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Subcutaneous use 
For single use only  
Read the package leaflet before use. 
Open here 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Store in the original carton in order to protect from light. 



 
 

 
 

32 

 
Date of removal from the refrigerator: .../.../... 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
sanofi-aventis groupe: 
54, rue la Boétie 
75008 Paris 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/17/1196/002 6 pre-filled syringes (3 packs of 2) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE  
 
kevzara 150 mg syringe 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 



 
 

 
 

33 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON - PACK OF 2 PRE-FILLED SYRINGES 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
KEVZARA 200 mg solution for injection in pre-filled syringe 
sarilumab  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled syringe contains 200 mg sarilumab in 1.14 ml solution (175 mg/ml). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: histidine, arginine, polysorbate 20, sucrose, water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
solution for injection  
2 pre-filled syringes 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Subcutaneous use 
For single use only  
Read the package leaflet before use. 
Open here 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Store in the original carton in order to protect from light. 



 
 

 
 

34 

 
Date of removal from the refrigerator: .../.../... 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
sanofi-aventis groupe: 
54, rue la Boétie 
75008 Paris 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/17/1196/003 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE  
 
kevzara 200 mg syringe 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
 



 
 

 
 

35 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON with the Blue Box – MULTIPACK OF 6 (3 PACKS OF 2) PRE-FILLED 
SYRINGES 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
KEVZARA 200 mg solution for injection in pre-filled syringe 
sarilumab  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled syringe contains 200 mg sarilumab in 1.14 ml solution (175 mg/ml). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: histidine, arginine, polysorbate 20, sucrose, water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
solution for injection  
Multipack: 6 (3 packs of 2) pre-filled syringes. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Subcutaneous use 
For single use only  
Read the package leaflet before use. 
Open here 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Store in the original carton in order to protect from light. 



 
 

 
 

36 

 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
sanofi-aventis groupe: 
54, rue la Boétie 
75008 Paris 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/17/1196/004 6 pre-filled syringes (3 packs of 2) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE  
 
kevzara 200 mg syringe 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
 



 
 

 
 

37 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
INNER CARTON without Blue Box – 2 PRE-FILLED SYRINGES (MULTIPACK 
PRESENTATION) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
KEVZARA 200 mg solution for injection in pre-filled syringe 
sarilumab  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled syringe contains 200 mg sarilumab in 1.14 ml solution (175 mg/ml). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: histidine, arginine, polysorbate 20, sucrose, water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
solution for injection  
2 pre-filled syringes. Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Subcutaneous use 
For single use only  
Read the package leaflet before use. 
Open here 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Store in the original carton in order to protect from light. 



 
 

 
 

38 

 
Date of removal from the refrigerator: .../.../... 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
sanofi-aventis groupe: 
54, rue la Boétie 
75008 Paris 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/17/1196/004 6 pre-filled syringes (3 packs of 2) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE  
 
kevzara 200 mg syringe 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
  



 
 

 
 

39 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON - PACK OF 2 PRE-FILLED PENS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
KEVZARA 150 mg solution for injection in pre-filled pen 
sarilumab  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled pen contains 150 mg sarilumab in 1.14 ml solution (131.6 mg/ml). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: histidine, arginine, polysorbate 20, sucrose, water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
solution for injection  
2 pre-filled pens 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Subcutaneous use 
For single use only  
Read the package leaflet before use. 
Open here 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Store in the original carton in order to protect from light. 



 
 

 
 

40 

 
Date of removal from the refrigerator: .../.../... 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
sanofi-aventis groupe: 
54, rue la Boétie 
75008 Paris 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/17/1196/005 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE  
 
kevzara 150 mg pen 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
 



 
 

 
 

41 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON with the Blue Box – MULTIPACK OF 6 (3 PACKS OF 2) PRE-FILLED 
PENS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
KEVZARA 150 mg solution for injection in pre-filled pen 
sarilumab  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled pen contains 150 mg sarilumab in 1.14 ml solution (131.6 mg/ml). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: histidine, arginine, polysorbate 20, sucrose, water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
solution for injection  
Multipack: 6 (3 packs of 2) pre-filled pens. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Subcutaneous use 
For single use only  
Read the package leaflet before use. 
Open here 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Store in the original carton in order to protect from light. 



 
 

 
 

42 

 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
sanofi-aventis groupe: 
54, rue la Boétie 
75008 Paris 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/17/1196/006 6 pre-filled pens (3 packs of 2) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE  
 
kevzara 150 mg pen 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
 



 
 

 
 

43 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
INNER CARTON without Blue Box – 2 PRE-FILLED PENS (MULTIPACK 
PRESENTATION) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
KEVZARA 150 mg solution for injection in pre-filled pen 
sarilumab  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled pen contains 150 mg sarilumab in 1.14 ml solution (131.6 mg/ml). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: histidine, arginine, polysorbate 20, sucrose, water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
solution for injection  
2 pre-filled pens. Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Subcutaneous use 
For single use only  
Read the package leaflet before use. 
Open here 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Store in the original carton in order to protect from light. 



 
 

 
 

44 

 
Date of removal from the refrigerator: .../.../... 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
sanofi-aventis groupe: 
54, rue la Boétie 
75008 Paris 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/17/1196/006 6 pre-filled pens (3 packs of 2) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE  
 
kevzara 150 mg pen 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 



 
 

 
 

45 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON - PACK OF 2 PRE-FILLED PENS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
KEVZARA 200 mg solution for injection in pre-filled pen 
sarilumab  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled pen contains 200 mg sarilumab in 1.14 ml solution (175 mg/ml). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: histidine, arginine, polysorbate 20, sucrose, water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
solution for injection  
2 pre-filled pens 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Subcutaneous use 
For single use only  
Read the package leaflet before use. 
Open here 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Store in the original carton in order to protect from light. 



 
 

 
 

46 

 
Date of removal from the refrigerator: .../.../... 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
sanofi-aventis groupe: 
54, rue la Boétie 
75008 Paris 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/17/1196/007 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE  
 
kevzara 200 mg pen 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
 



 
 

 
 

47 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON with the Blue Box – MULTIPACK OF 6 (3 PACKS OF 2) PRE-FILLED 
PENS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
KEVZARA 200 mg solution for injection in pre-filled pen 
sarilumab  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled pen contains 200 mg sarilumab in 1.14 ml solution (175 mg/ml). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: histidine, arginine, polysorbate 20, sucrose, water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
solution for injection  
Multipack: 6 (3 packs of 2) pre-filled pens. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Subcutaneous use 
For single use only  
Read the package leaflet before use. 
Open here 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Store in the original carton in order to protect from light. 



 
 

 
 

48 

 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
sanofi-aventis groupe: 
54, rue la Boétie 
75008 Paris 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/17/1196/008 6 pre-filled pens (3 packs of 2) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE  
 
kevzara 200 mg pen 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
 



 
 

 
 

49 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
INNER CARTON without Blue Box – 2 PRE-FILLED PENS (MULTIPACK 
PRESENTATION) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
KEVZARA 200 mg solution for injection in pre-filled pen 
sarilumab  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled pen contains 200 mg sarilumab in 1.14 ml solution (175 mg/ml). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: histidine, arginine, polysorbate 20, sucrose, water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
solution for injection  
2 pre-filled pens. Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Subcutaneous use 
For single use only  
Read the package leaflet before use. 
Open here 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Store in the original carton in order to protect from light. 



 
 

 
 

50 

 
Date of removal from the refrigerator: .../.../... 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
sanofi-aventis groupe: 
54, rue la Boétie 
75008 Paris 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/17/1196/008 6 pre-filled pens (3 packs of 2) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE  
 
kevzara 200 mg pen 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
  



 
 

 
 

51 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON - PACK OF 1 PRE-FILLED SYRINGE 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
KEVZARA 150 mg solution for injection in pre-filled syringe 
sarilumab  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled syringe contains 150 mg sarilumab in 1.14 ml solution (131.6 mg/ml). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: histidine, arginine, polysorbate 20, sucrose, water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
solution for injection  
1 pre-filled syringe 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Subcutaneous use 
For single use only  
Read the package leaflet before use. 
Open here 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Store in the original carton in order to protect from light. 



 
 

 
 

52 

 
Date of removal from the refrigerator: .../.../... 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
sanofi-aventis groupe: 
54, rue la Boétie 
75008 Paris 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/17/1196/009 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE  
 
kevzara 150 mg syringe 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



 
 

 
 

53 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON - PACK OF 1 PRE-FILLED SYRINGE 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
KEVZARA 200 mg solution for injection in pre-filled syringe 
sarilumab  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled syringe contains 200 mg sarilumab in 1.14 ml solution (175 mg/ml). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: histidine, arginine, polysorbate 20, sucrose, water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
solution for injection  
1 pre-filled syringe 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Subcutaneous use 
For single use only  
Read the package leaflet before use. 
Open here 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Store in the original carton in order to protect from light. 



 
 

 
 

54 

 
Date of removal from the refrigerator: .../.../... 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
sanofi-aventis groupe: 
54, rue la Boétie 
75008 Paris 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/17/1196/010 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE  
 
kevzara 200 mg syringe 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
 



 
 

 
 

55 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON - PACK OF 1 PRE-FILLED PEN 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
KEVZARA 150 mg solution for injection in pre-filled pen 
sarilumab  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled pen contains 150 mg sarilumab in 1.14 ml solution (131.6 mg/ml). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: histidine, arginine, polysorbate 20, sucrose, water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
solution for injection  
1 pre-filled pen 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Subcutaneous use 
For single use only  
Read the package leaflet before use. 
Open here 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Store in the original carton in order to protect from light. 



 
 

 
 

56 

 
Date of removal from the refrigerator: .../.../... 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
sanofi-aventis groupe: 
54, rue la Boétie 
75008 Paris 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/17/1196/011 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE  
 
kevzara 150 mg pen 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
 



 
 

 
 

57 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON - PACK OF 1 PRE-FILLED PEN 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
KEVZARA 200 mg solution for injection in pre-filled pen 
sarilumab  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled pen contains 200 mg sarilumab in 1.14 ml solution (175 mg/ml). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: histidine, arginine, polysorbate 20, sucrose, water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
solution for injection  
1 pre-filled pen 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Subcutaneous use 
For single use only  
Read the package leaflet before use. 
Open here 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Store in the original carton in order to protect from light. 



 
 

 
 

58 

 
Date of removal from the refrigerator: .../.../... 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
sanofi-aventis groupe: 
54, rue la Boétie 
75008 Paris 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/17/1196/012 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE  
 
kevzara 200 mg pen 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
 



 
 

 
 

59 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
KEVZARA 150 mg injection 
sarilumab 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Lot  
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1.14 ml 
 
 
6. OTHER 
 
 



 
 

 
 

60 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
KEVZARA 200 mg injection 
sarilumab 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Lot  
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1.14 ml 
 
 
6. OTHER 
 
 
 
 
 
 
 
 



 
 

 
 

61 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED PEN 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
KEVZARA 150 mg injection 
sarilumab 
Subcutaneous use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Lot  
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1.14 ml 
 
 
6. OTHER 
 
 
 
 



 
 

 
 

62 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED PEN 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
KEVZARA 200 mg injection 
sarilumab 
Subcutaneous use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Lot  
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1.14 ml 
 
 
6. OTHER 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 



 
 

 
 

63 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



 
 

 
 

64 

Package leaflet: Information for the patient 
 

Kevzara 150 mg solution for injection in pre-filled syringe 
Kevzara 200 mg solution for injection in pre-filled syringe 

Sarilumab 
 

This medicine is subject to additional monitoring. This will allow quick identification of new 
safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
• Keep this leaflet. You may need to read it again.  
• If you have any further questions, ask your doctor, pharmacist, or nurse. 
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours.  
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 
In addition to this leaflet, you will be given a patient alert card, which contains important safety 
information that you need before and during treatment with Kevzara. 

 
 
What is in this leaflet 
1. What Kevzara is and what it is used for  
2. What you need to know before you use Kevzara  
3. How to use Kevzara 
4. Possible side effects  
5. How to store Kevzara  
6. Contents of the pack and other information 
 
 
1. What Kevzara is and what it is used for 
 
What Kevzara is 
Kevzara contains the active substance sarilumab. It is a type of protein called a monoclonal antibody. 
 
What Kevzara is used for 
Kevzara is used to treat adults with moderately to severely active rheumatoid arthritis if previous 
therapy did not work well enough or was not tolerated. Kevzara can be used alone or together with a 
medicine called methotrexate. 
It may help you by: 
• slowing down damage to joints 
• improving your ability to perform daily activities. 

 
How Kevzara works 
• Kevzara attaches to another protein called interleukin-6 (IL-6) receptor and blocks its action. 
• IL-6 plays a major role in the symptoms of rheumatoid arthritis such as pain, swollen joints, 

morning stiffness, and fatigue. 
 
 
2. What you need to know before you use Kevzara  
 
Do not use Kevzara: 
• if you are allergic to sarilumab or any of the other ingredients of this medicine (listed in 

section 6).  
• if you have an active severe infection. 



 
 

 
 

65 

 
Warnings and precautions  
Talk to your doctor, pharmacist, or nurse if:  
• you have any infection or you get a lot of infections. Kevzara can lower your body's ability to 

fight infection: this means it can make you more likely to get infections or make your infection 
worse. 

• you have tuberculosis (TB), symptoms of TB (persistent cough, weight loss, listlessness, mild 
fever), or have been in close contact with someone with TB. Before you are given Kevzara, your 
doctor will check you for TB. 

• you have had viral hepatitis or other liver disease. Before you use Kevzara, your doctor will do a 
blood test to check your liver function. 

• you have had diverticulitis (a condition of the lower bowel) or ulcers in your stomach or 
intestines, or develop symptoms such as fever and stomach (abdominal) pain that does not go 
away. 

• you have ever had any type of cancer. 
• you have recently had any vaccination or are going to have a vaccination.  

 
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before 
using Kevzara. 
 
You will have blood tests before you are given Kevzara. You will also have the tests during your 
treatment. This is to check for low blood cell count, liver problems, or changes in your cholesterol 
levels. 
 
Children and adolescents 
Kevzara is not recommended in children and adolescents under 18 years of age. 
 
Other medicines and Kevzara 
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. 
This is because Kevzara can affect the way some other medicines work. Also some other medicines 
can affect the way Kevzara works. 
 
In particular, do not use Kevzara and tell your doctor or pharmacist if you are using: 
• a group of medicines called “Janus kinase (JAK) inhibitors” (used for diseases like rheumatoid 

 arthritis and cancer) 
• other biological medicines used in the treatment of rheumatoid arthritis  

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist. 
 
Kevzara can affect the way some medicines work: this means the dose of other medicines may need 
changing. If you are using any of the following medicines, tell your doctor or pharmacist before using 
Kevzara: 
• statins, used to reduce cholesterol level 
• oral contraceptives 
• theophylline, used to treat asthma 
• warfarin, used to prevent blood clots.  

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist. 
 
Pregnancy and breast-feeding 
Talk to your doctor before using Kevzara if you are pregnant or breast-feeding, think you may be 
pregnant  or are planning to have a baby. 
• Do not take Kevzara if you are pregnant unless your doctor specifically recommends it. 
• The effects of Kevzara on an unborn baby are not known. 
• You and your doctor should decide if you should use Kevzara if you are breast-feeding. 

 



 
 

 
 

66 

Driving and using machines 
The use of Kevzara is not expected to affect your ability to drive or use machines.  However, if you 
are feeling tired or unwell after you use Kevzara, you should not drive or use machines. 
 
 
3. How to use Kevzara 
 
Treatment should be started by a doctor experienced in the diagnosis and treatment of rheumatoid 
arthritis. Always use this medicine exactly as your doctor or pharmacist has told you. Check with your 
doctor or pharmacist if you are not sure.  
 
Kevzara is given as an injection under the skin (called “subcutaneous” injection). 
 
The recommended dose is one 200 mg injection every two weeks.  
• Your doctor may adjust the dose of your medicine based on results of blood tests.  

 
Learning how to use the pre-filled syringe  
• Your doctor, pharmacist, or nurse will show you how to inject Kevzara. Following these 

instructions, Kevzara can be self-injected or administered by a care-giver.  
• Carefully follow the “Instructions for Use” provided in the carton.  
• Use the pre-filled syringe exactly as described in the “Instructions for Use”. 

 
If you use more Kevzara than you should 
If you have used more Kevzara than you should, talk to your doctor, pharmacist or nurse.  
 
If you miss a dose of Kevzara 
If it has been 3 days or less since the missed dose: 
• inject your missed dose as soon as you can.  
• then inject your next dose at your regular time.  

 
If it has been 4 days or more, inject the next dose at your regular time. Do not inject a double dose to 
make up for a forgotten injection.   
If you are unsure when to inject your next dose: ask your doctor, pharmacist or nurse for instructions.  
 
If you stop using Kevzara 
Do not stop using Kevzara without talking to your doctor.  
 
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.  
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Serious side effect  
Tell your doctor straight away if you think you have an infection (which may affect up to 1 in every 
10 people). The symptoms may include fever, sweats, or chills.  
 
Other side effects 
Tell your doctor, pharmacist, or nurse if you notice any of the following side effects: 
Very Common (may affect more than 1 in 10 people): 
• Low white blood cell counts shown by blood tests 

 
Common (may affect up to 1 in 10 people): 
• infections in your sinuses or throat, blocked or runny nose and sore throat  (upper respiratory 

tract infection) 



 
 

 
 

67 

• urinary tract infection 
• cold sores (oral herpes) 
• low platelet counts shown by blood tests 
• high cholesterol, high triglycerides shown by blood tests 
• abnormal liver function tests 
• injection-site reactions (including redness and itching). 

 
Uncommon (may affect up to 1 in 100 people): 
• infection of the lungs 
• inflammation of the deep skin tissue 

 
Rare (may affect up to 1 in 1000 people): 
• perforation in stomach or intestines (a hole that develops in the wall of the gut) 

 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Kevzara 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date 
refers to the last day of that month. 
 
Store in a refrigerator (2°C to 8°C).  
• Do not freeze or heat the syringe.  
• Once taken out of the refrigerator, do not store Kevzara above 25 ºC.  
• Write down the date of removal from the refrigerator in the space provided on the outer carton. 
• Use the syringe within 14 days after taking it out of the refrigerator or the insulated bag.  
• Keep the syringe in the original carton in order to protect it from light. 

 
Do not use this medicine if the solution in the syringe is cloudy, discoloured or contains particles, or if 
any part of the pre-filled syringe looks damaged. 
 
After use, put the syringe into a puncture-resistant container. Always keep the container out of the 
sight and reach of children. Ask your doctor, pharmacist, or nurse how to throw away the container. 
Do not recycle the container. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Kevzara contains  
• The active substance is sarilumab.  
• The other ingredients are arginine, histidine, polysorbate 20, sucrose, and water for injections.  

 
What Kevzara looks like and contents of the pack 
Kevzara is a clear, colourless to pale yellow solution for injection that comes in a pre-filled syringe. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 
 

 
 

68 

Each pre-filled syringe contains 1.14 ml of solution delivering one single dose. It is available in pack 
sizes of 1 or 2 or a multipack of 6 pre-filled syringes (3 packs of 2). 
 
Not all pack sizes may be marketed. 
 
Kevzara is available as 150 mg or 200 mg pre-filled syringes.  
 
Marketing Authorisation Holder  
sanofi-aventis groupe 
54, rue La Boétie 
F-75008 Paris  
France 
 
Manufacturer 
Sanofi Winthrop Industrie 
1051 Boulevard Industriel 
76580 Le Trait,  
France 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Sanofi Belgium 
Tél/Tel: +32 (0)2 710 54 00 
 

Lietuva 
UAB "SANOFI-AVENTIS LIETUVA"  
Tel: +370 5 2755224 
 

България 
SANOFI BULGARIA EOOD 
Тел.: +359 (0)2 970 53 00 
 

Luxembourg/Luxemburg 
Sanofi Belgium  
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien) 
 

Česká republika 
sanofi-aventis, s.r.o. 
Tel: +420 233 086 111 
 

Magyarország 
SANOFI-AVENTIS Zrt. 
Tel.: +36 1 505 0050 
 

Danmark 
Sanofi A/S 
Tlf: +45 45 16 70 00 
 

Malta 
Sanofi S.r.l. 
Tel: +39. 02 39394275 
 

Deutschland 
Sanofi-Aventis Deutschland GmbH 
Telefon: 0800 04 36 996 
Telefon aus dem Ausland: +49 69 305 70 13 
 

Nederland 
Genzyme Europe B.V. 
Tel: +31 20 245 4000 

Eesti 
sanofi-aventis Estonia OÜ 
Tel: +372 627 34 88 
 

Norge 
sanofi-aventis Norge AS 
Tlf: +47 67 10 71 00 
 

Ελλάδα 
sanofi-aventis AEBE 
Τηλ: +30 210 900 16 00 
 

Österreich 
sanofi-aventis GmbH 
Tel: +43 1 80 185 – 0 
 

España 
sanofi-aventis, S.A.  
Tel: +34 93 485 94 00 
 

Polska 
sanofi-aventis Sp. z o.o. 
Tel.: +48 22 280 00 00 
 



 
 

 
 

69 

 
France 
sanofi-aventis france 
Tél: 0 800 222 555 
Appel depuis l’étranger : +33 1 57 63 23 23 
 

Portugal 
Sanofi - Produtos Farmacêuticos, Lda 
Tel: +351 21 35 89 400 
 

Hrvatska  
sanofi-aventis Croatia d.o.o.  
Tel: +385 1 600 34 00 
 

România 
Sanofi Romania SRL 
Tel: +40 (0) 21 317 31 36 
 

Ireland 
sanofi-aventis Ireland Ltd. T/A SANOFI 
Tel: +353 (0) 1 403 56 00 
 

Slovenija 
sanofi-aventis d.o.o. 
Tel: +386 1 560 48 00 
 

Ísland 
Vistor hf. 
Sími: +354 535 7000 
 

Slovenská republika 
sanofi-aventis Slovakia s.r.o. 
Tel: +421 2 33 100 100 
 

Italia 
Sanofi S.r.l. 
Tel: 800 13 12 12 (domande di tipo tecnico)  
800 536389 (altre domande) 
 

Suomi/Finland 
Sanofi Oy 
Puh/Tel: +358 (0) 201 200 300 
 

Κύπρος 
sanofi-aventis Cyprus Ltd. 
Τηλ: +357 22 871600 
 

Sverige 
Sanofi AB 
Tel: +46 (0)8 634 50 00 
 

Latvija 
sanofi-aventis Latvia SIA 
Tel: +371 67 33 24 51 
 

United Kingdom 
Sanofi 
Tel: +44 (0) 845 372 7101 
 

 
This leaflet was last revised in . 
 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.  
 
--------------------------------------------------------------------------------------------------------------------------- 

http://www.ema.europa.eu/


 
 

 
 

70 

Kevzara 150 mg solution for injection in a pre-filled syringe 
sarilumab 

 
Instructions for use 

 
The parts of the Kevzara pre-filled syringe are shown in this picture.  
 

 
 
Important information 
 
This device is a single-dose pre-filled syringe (called “syringe” in these instructions). It contains 
150 mg of Kevzara for injection under the skin (subcutaneous injection) once every two weeks. 
 
Ask your healthcare professional to show you the right way to use the syringe before your first 
injection. 
 
Do 
 Read all of the instructions carefully before using a syringe. 
 Check that you have the correct medicine and the correct dose. 
 Keep unused syringes in the original carton and store in the refrigerator between 2ºC and 8ºC.  
 Keep the carton in an insulated bag with an ice pack when travelling. 
 Let the syringe warm up to room temperature for at least 30 minutes before using. 
 Use the syringe within 14 days after taking it out of the refrigerator or insulated bag. 
 Keep the syringe out of the sight and reach of children. 
 



 
 

 
 

71 

Do not  
 Do not use the syringe if it has been damaged or the needle cap is missing or not attached.  
 Do not remove the needle cap until just before you are ready to inject. 
 Do not touch the needle. 
 Do not try to put the cap back on the syringe. 
 Do not re-use the syringe. 
 Do not freeze or heat the syringe. 
 Once removed from the refrigerator, do not store the syringe above 25ºC.  
 Do not expose the syringe to direct sunlight. 
 Do not inject through your clothes. 

 
If you have any further questions, ask your doctor, pharmacist or nurse or call the sanofi 
number on the package leaflet. 
 
Step A: Get ready for an injection 
 
1. Prepare all the equipment you will need on a clean, flat working surface. 

• You will need an alcohol wipe, a cotton ball or gauze, and a puncture-resistant container. 
• Take one syringe out of the packaging by holding the middle of the syringe body. Keep the 

remaining syringe in the carton in the refrigerator. 
 
2. Look at the label. 

• Check that you have the correct medicine and the correct dose. 
• Check the expiry date (EXP). 

 Do not use the syringe if the date has passed. 
 

 
 
3. Look at the medicine. 

• Check that the liquid is clear and colourless to pale yellow. 
• You may see an air bubble, this is normal. 

 Do not inject if the liquid is cloudy, discoloured or contains particles.  

 
 



 
 

 
 

72 

4. Lay the syringe on a flat surface and allow it to warm up to room temperature (<25°C) for at 
least 30 minutes. 

• Using the syringe at room temperature may make the injection more comfortable. 
 Do not use the syringe if it has been out of the refrigerator for more than 14 days. 
 Do not heat the syringe; let it warm up on its own. 
 Do not expose the syringe to direct sunlight. 

 

 
 
5. Select the injection site. 

• You can inject into your thigh or belly (abdomen) except for the 5 cm around your belly button 
(navel).  If somebody else gives you the injection, you can also use the outer area of the upper 
arm. 

• Change injection site each time you inject. 
 Do not inject into skin that is tender, damaged or has bruises or scars. 

 

 
 
6. Prepare the injection site. 

• Wash your hands. 
• Clean skin with an alcohol wipe. 

 Do not touch the injection site again before the injection. 
 
Step B: Perform the injection – Perform Step B only after completing Step A “Get ready for an 

injection” 
 
1. Pull off the needle cap. 

• Hold the syringe in the middle of the syringe body with the needle pointing away from you. 
• Keep your hand away from the plunger. 

 Do not get rid of any air bubbles in the syringe. 



 
 

 
 

73 

 Do not pull off the needle cap until you are ready to inject. 
 Do not put the needle cap back on. 

 
 
2. Pinch the skin.  

• Use your thumb and first (index) finger to pinch a fold of skin at the injection site. 

 
 
3. Insert the needle into the fold of skin at roughly a 45º angle. 

 
 
4. Push the plunger down. 

• Slowly push the plunger down as far as it will go until the syringe is empty. 
 

 



 
 

 
 

74 

 
 
5. Before you remove the needle, check that the syringe is empty. 

• Pull the needle out at the same angle it was injected. 
• If you see any blood, press a cotton ball or gauze on the site. 

 Do not rub your skin after the injection. 
 

 
 
6. Put your used syringe and the cap into a puncture-resistant container right away after use. 

• Always keep the container out of the sight and reach of children. 
 Do not put the needle cap back on. 
 Do not throw the used syringe in household waste.  
 Do not recycle your used puncture-resistant container. 
 Do not dispose of your used puncture-resistant container in your household waste unless your 

local guidelines permit this. Ask your doctor, pharmacist or nurse how to throw away the 
container. 
 



 
 

 
 

75 

 

 



 
 

 
 

76 

Kevzara 200 mg solution for injection in a pre-filled syringe 
sarilumab 

 
Instructions for use 

 
The parts of the Kevzara pre-filled syringe are shown in this picture.  
 

 
 

Important information 
 
This device is a single-dose pre-filled syringe (called “syringe” in these instructions). It contains 
200 mg of Kevzara for injection under the skin (subcutaneous injection) once every two weeks. 
 
Ask your healthcare professional to show you the right way to use the syringe before your first 
injection. 
 
Do 
 Read all of the instructions carefully before using a syringe. 
 Check that you have the correct medicine and the correct dose. 
 Keep unused syringes in the original carton and store in the refrigerator between 2ºC and 8ºC.  
 Keep the carton in an insulated bag with an ice pack when travelling. 
 Let the syringe warm up to room temperature for at least 30 minutes before using. 
 Use the syringe within 14 days after taking it out of the refrigerator or insulated bag. 
 Keep the syringe out of the sight and reach of children. 
 



 
 

 
 

77 

Do not  
 Do not use the syringe if it has been damaged or the needle cap is missing or not attached.  
 Do not remove the needle cap until just before you are ready to inject. 
 Do not touch the needle. 
 Do not try to put the cap back on the syringe. 
 Do not re-use the syringe. 
 Do not freeze or heat the syringe. 
 Once removed from the refrigerator, do not store the syringe above 25ºC. 
 Do not expose the syringe to direct sunlight. 
 Do not inject through your clothes. 

 
If you have any further questions, ask your doctor, pharmacist or nurse or call the sanofi 
number on the package leaflet. 
 
Step A: Get ready for an injection 
 
1. Prepare all the equipment you will need on a clean, flat working surface. 

• You will need an alcohol wipe, a cotton ball or gauze, and a puncture-resistant container. 
• Take one syringe out of the packaging by holding the middle of the syringe body. Keep the 

remaining syringe in the carton in the refrigerator. 
 
2. Look at the label. 

• Check that you have the correct medicine and the correct dose. 
• Check the expiry date (EXP). 

 Do not use the syringe if the date has passed. 
 

 
 
3. Look at the medicine. 

• Check that the liquid is clear and colourless to pale yellow. 
• You may see an air bubble, this is normal. 

 Do not inject if the liquid is cloudy, discoloured or contains particles.  

 



 
 

 
 

78 

 
4. Lay the syringe on a flat surface and allow it to warm up to room temperature (<25°C) for at 

least 30 minutes. 
• Using the syringe at room temperature may make the injection more comfortable. 

 Do not use the syringe if it has been out of the refrigerator for more than 14 days. 
 Do not heat the syringe; let it warm up on its own. 
 Do not expose the syringe to direct sunlight. 

 

 
 
5. Select the injection site. 

• You can inject into your thigh or belly (abdomen) except for the 5 cm around your belly button 
(navel).  If somebody else gives you the injection, you can also use the outer area of the upper 
arm. 

• Change injection site each time you inject. 
 Do not inject into skin that is tender, damaged or has bruises or scars. 

 

 
 
6. Prepare the injection site. 

• Wash your hands. 
• Clean skin with an alcohol wipe. 

 Do not touch the injection site again before the injection. 
 
Step B: Perform the injection – Perform Step B only after completing Step A “Get ready for an 

injection” 
 
1. Pull off the needle cap. 

• Hold the syringe in the middle of the syringe body with the needle pointing away from you. 



 
 

 
 

79 

• Keep your hand away from the plunger. 
 Do not get rid of any air bubbles in the syringe. 
 Do not pull off the needle cap until you are ready to inject. 
 Do not put the needle cap back on. 

 

 
 
2. Pinch the skin.  

• Use your thumb and first (index) finger to pinch a fold of skin at the injection site. 

 
 
3. Insert the needle into the fold of skin at roughly a 45º angle. 

 
 
4. Push the plunger down. 



 
 

 
 

80 

• Slowly push the plunger down as far as it will go until the syringe is empty. 
 

 
 
5. Before you remove the needle, check that the syringe is empty. 

• Pull the needle out at the same angle it was injected. 
• If you see any blood, press a cotton ball or gauze on the site. 

 Do not rub your skin after the injection. 
 
 

 
 
6. Put your used syringe and the cap into a puncture-resistant container right away after use. 

• Always keep the container out of the sight and reach of children. 
 Do not put the needle cap back on. 
 Do not throw the used syringe in household waste.  
 Do not recycle your used puncture-resistant container. 
 Do not dispose of your used puncture-resistant container in your household waste unless your 

local guidelines permit this. Ask your doctor, pharmacist or nurse how to throw away the 
container. 

 



 
 

 
 

81 

 



 
 

 
 

82 

Package leaflet: Information for the patient 
 

Kevzara 150 mg solution for injection in pre-filled pen 
Kevzara 200 mg solution for injection in pre-filled pen 

Sarilumab 
 

This medicine is subject to additional monitoring. This will allow quick identification of new 
safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
• Keep this leaflet. You may need to read it again.  
• If you have any further questions, ask your doctor, pharmacist, or nurse. 
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours.  
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 
In addition to this leaflet, you will be given a patient alert card, which contains important safety 
information that you need before and during treatment with Kevzara. 
 
 
What is in this leaflet 
1. What Kevzara is and what it is used for  
2. What you need to know before you use Kevzara  
3. How to use Kevzara 
4. Possible side effects  
5. How to store Kevzara  
6. Contents of the pack and other information 
 
 
1. What Kevzara is and what it is used for 
 
What Kevzara is 
Kevzara contains the active substance sarilumab. It is a type of protein - called a “monoclonal 
antibody”. 
 
What Kevzara is used for 
Kevzara is used to treat adults with moderately to severely active rheumatoid arthritis if previous 
therapy did not work well enough or was not tolerated. Kevzara can be used alone or together with a 
medicine called methotrexate. 
It may help you by: 
• slowing down damage to joints 
• improving your ability to perform daily activities. 

 
How Kevzara works 
• Kevzara attaches to another protein called interleukin-6 (IL-6) receptor and blocks its action. 
• IL-6 plays a major role in the symptoms of rheumatoid arthritis such as pain, swollen joints, 

morning stiffness, and fatigue. 
 
 



 
 

 
 

83 

2. What you need to know before you use Kevzara  
 
Do not use Kevzara: 
• if you are allergic to sarilumab or any of the other ingredients of this medicine (listed in 

section 6). 
• if you have an active severe infection.  

 
Warnings and precautions  
Talk to your doctor, pharmacist, or nurse if:  
• you have any infection or, you get a lot of infections. Kevzara can lower your body's ability to 

fight infection and this means it can make you more likely to get infections or make your 
infection worse. 

• you have tuberculosis (TB), symptoms of TB (persistent cough, weight loss, listlessness, mild 
fever), or have been in close contact with someone with TB. Before you are given Kevzara, your 
doctor will check you for TB. 

• you have had viral hepatitis or other liver disease. Before you use Kevzara, your doctor will do a 
blood test to check your liver function. 

• you have had diverticulitis (a condition of the lower bowel) or ulcers in your stomach or 
intestines, or develop symptoms such as fever and stomach (abdominal) pain that does not go 
away. 

• you have ever had any type of cancer. 
• you have recently had any vaccination or are going to have a vaccination. 

 
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before 
using Kevzara. 
 
You will have blood tests before you are given Kevzara. You will also have the tests during your 
treatment. This is to check if you have a low blood cell count,   liver problems, or changes in your 
cholesterol levels. 
 
Children and adolescents 
Kevzara is not recommended in children and adolescents under 18 years of age. 
 
Other medicines and Kevzara 
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. 
This is because Kevzara can affect the way some other medicines work. Also some other medicines 
can affect the way Kevzara works. 
 
In particular, do not use Kevzara and tell your doctor or pharmacist if you are using: 
• a group of medicines called “Janus kinase (JAK) inhibitors” (used for disease like rheumatoid 

arthritis and cancer) 
• other biological medicines used in the treatment of rheumatoid arthritis.  

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist. 
 
Kevzara can affect the way some medicines work: this means the dose of other medicines may need 
changing. If you are using any of the following medicines, tell your doctor or pharmacist before using 
Kevzara: 
• statins, used to reduce cholesterol level 
• oral contraceptives 
• theophylline, used to treat asthma 
• warfarin, used to prevent blood clots  

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist. 
 
Pregnancy and breast-feeding  
Talk to your doctor before using Kevzara if you are pregnant or breast feeding, think you may be 
pregnant  or are planning to have a baby. 



 
 

 
 

84 

• Do not take Kevzara if you are pregnant – unless your doctor specifically recommends it. 
• The effects of Kevzara on an unborn baby are not known. 
• You and your doctor should decide if you should use Kevzara if you are breast-feeding. 

 
Driving and using machines 
The use of Kevzara is not expected to affect your ability to drive or use machines.  However, if you 
are feeling tired or unwell after you use Kevzara, you should not drive or use machines. 
 
 
3. How to use Kevzara 
 
Treatment should be started by a doctor experienced in the diagnosis and treatment of rheumatoid 
arthritis. Always use this medicine exactly as your doctor or pharmacist has told you. Check with your 
doctor or pharmacist if you are not sure.  
 
Kevzara is given as an injection under the skin (called “subcutaneous” injection). 
 
The recommended dose is one 200 mg injection every two weeks.  
• Your doctor may adjust the dose of your medicine based on results of blood tests.  

 
Learning how to use the pre-filled pen  
• Your doctor, pharmacist, or nurse will show you how to inject Kevzara. Following these 

instructions Kevzara can be self-injected or administered by a care-giver. 
• Carefully follow the “Instructions for Use” provided in the carton.  
• Use the pre-filled pen exactly as described in the “Instructions for Use”. 

 
If you use more Kevzara than you should 
If you have used more Kevzara than you should, talk to your doctor, pharmacist or nurse.  
 
If you miss a dose of Kevzara 
If it has been 3 days or less since the missed dose: 
• inject your missed dose as soon as you can.  
• then inject your next dose at your regular time. 

 
If it has been 4 days or more, inject the next dose at your regular time. Do not inject a double dose to 
make up for a forgotten injection. 
If you are unsure when to inject your next dose: ask your doctor, pharmacist or nurse for instructions.  
 
If you stop using Kevzara 
Do not stop using Kevzara without talking to your doctor.  
 
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.  
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Serious side effect  
Tell your doctor straight away if you think you have an infection (which may affect up to 1 in every 
10 people). The symptoms may include fever, sweats, or chills.  
 
Other side effects 
Tell your doctor, pharmacist, or nurse if you notice any of the following side effects: 
Very Common (may affect more than 1 in 10 people): 
• Low white blood cell counts shown by blood tests 



 
 

 
 

85 

 
Common (may affect up to 1 in 10 people): 
• infections in your sinuses or throat, blocked or runny nose and  sore throat (“upper respiratory 

tract infection”) 
• urinary tract infection 
• cold sores (“oral herpes”) 
• low platelet counts shown by blood tests 
• high cholesterol, high triglycerides shown by blood tests 
• abnormal liver function tests 
• injection site reactions (including redness and itching) 

 
Uncommon (may affect up to 1 in 100 people): 
• infection of the lungs 
• inflammation of the deep skin tissue 

 
Rare (may affect up to 1 in 1000 people): 
• perforation in stomach or intestines (a hole that develops in the wall of the gut) 

 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Kevzara 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date 
refers to the last day of that month. 
 
Store in a refrigerator (2°C to 8°C).  
• Do not freeze or heat the pen.  
• Once taken out the refrigerator, do not store Kevzara above 25 ºC.  
• Write down the date of removal from the refrigerator in the space provided on the outer carton. 
• Use the pen within 14 days after taking it out of the refrigerator or the insulated bag.  
• Keep the pen in the original carton in order to protect it from light. 

 
Do not use this medicine if the solution in the pen is cloudy, discoloured or contains particles, or if any 
part of the pre-filled pen looks damaged. 
 
After use, put the pen into a puncture-resistant container. Always keep the container out of the sight 
and reach of children. Ask your doctor, pharmacist, or nurse how to throw away the container. Do not 
recycle the container. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Kevzara contains  
• The active substance is sarilumab.  
• The other ingredients are arginine, histidine, polysorbate 20, sucrose, and water for injections.  

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 
 

 
 

86 

 
What Kevzara looks like and contents of the pack 
Kevzara is a clear, colourless to pale yellow solution for injection that comes in a pre-filled pen. 
 
Each pre-filled pen contains 1.14 ml of solution delivering one single dose. It is available in pack sizes 
of 1 or 2 or a multipack of 6 pre-filled pens (3 packs of 2). 
 
Not all pack sizes may be marketed. 
 
Kevzara is available as 150 mg or 200 mg pre-filled pens. 
 
Marketing Authorisation Holder  
sanofi-aventis groupe 
54, rue La Boétie 
F-75008 Paris  
France 
 
Manufacturer 
Sanofi-Aventis Deutschland GmbH 
Brüningstraße 50 
Industriepark Höchst 
65926 Frankfurt am Main 
Germany 
 
Genzyme Ireland Ltd 
IDA Industrial Park 
Old Kilmeaden Road 
Waterford,  
Ireland 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Sanofi Belgium 
Tél/Tel: +32 (0)2 710 54 00 
 

Lietuva 
UAB "SANOFI-AVENTIS LIETUVA"  
Tel: +370 5 2755224 
 

България 
SANOFI BULGARIA EOOD 
Тел.: +359 (0)2 970 53 00 
 

Luxembourg/Luxemburg 
Sanofi Belgium  
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien) 
 

Česká republika 
sanofi-aventis, s.r.o. 
Tel: +420 233 086 111 
 

Magyarország 
SANOFI-AVENTIS Zrt. 
Tel.: +36 1 505 0050 
 

Danmark 
Sanofi A/S 
Tlf: +45 45 16 70 00 
 

Malta 
Sanofi S.r.l. 
Tel: +39. 02 39394275 
 

Deutschland 
Sanofi-Aventis Deutschland GmbH 
Telefon: 0800 04 36 996 
Telefon aus dem Ausland: +49 69 305 70 13 
 

Nederland 
Genzyme Europe B.V. 
Tel: +31 20 245 4000 



 
 

 
 

87 

 
Eesti 
sanofi-aventis Estonia OÜ 
Tel: +372 627 34 88 
 

Norge 
sanofi-aventis Norge AS 
Tlf: +47 67 10 71 00 
 

Ελλάδα 
sanofi-aventis AEBE 
Τηλ: +30 210 900 16 00 
 

Österreich 
sanofi-aventis GmbH 
Tel: +43 1 80 185 – 0 
 

España 
sanofi-aventis, S.A.  
Tel: +34 93 485 94 00 
 

Polska 
sanofi-aventis Sp. z o.o. 
Tel.: +48 22 280 00 00 
 

France 
sanofi-aventis france 
Tél: 0 800 222 555 
Appel depuis l’étranger : +33 1 57 63 23 23 

Portugal 
Sanofi - Produtos Farmacêuticos, Lda 
Tel: +351 21 35 89 400 
 

 
Hrvatska  
sanofi-aventis Croatia d.o.o.  
Tel: +385 1 600 34 00 
 

România 
Sanofi Romania SRL 
Tel: +40 (0) 21 317 31 36 
 

Ireland 
sanofi-aventis Ireland Ltd. T/A SANOFI 
Tel: +353 (0) 1 403 56 00 
 

Slovenija 
sanofi-aventis d.o.o. 
Tel: +386 1 560 48 00 
 

Ísland 
Vistor hf. 
Sími: +354 535 7000 
 

Slovenská republika 
sanofi-aventis Slovakia s.r.o. 
Tel: +421 2 33 100 100 
 

Italia 
Sanofi S.r.l. 
Tel: 800 13 12 12 (domande di tipo tecnico)  
800 536389 (altre domande) 
 

Suomi/Finland 
Sanofi Oy 
Puh/Tel: +358 (0) 201 200 300 
 

Κύπρος 
sanofi-aventis Cyprus Ltd. 
Τηλ: +357 22 871600 
 

Sverige 
Sanofi AB 
Tel: +46 (0)8 634 50 00 
 

Latvija 
sanofi-aventis Latvia SIA 
Tel: +371 67 33 24 51 
 

United Kingdom 
Sanofi 
Tel: +44 (0) 845 372 7101 
 

 
This leaflet was last revised in  
 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.  
 
 
 
--------------------------------------------------------------------------------------------------------------------------- 

http://www.ema.europa.eu/


 
 

 
 

88 

Kevzara 150 mg solution for injection in a pre-filled pen 
sarilumab 

 
Instructions for use 

 
The parts of the Kevzara pre-filled pen are shown in this picture.  
 

 

 
Important information 
 
This device is a single-dose pre-filled pen (called “pen” in these instructions). It contains 150 mg of 
Kevzara for injection under the skin (subcutaneous injection) once every two weeks. 
 
Ask your healthcare professional to show you the right way to use the pen before your first injection. 
 
Do 
 Read all of the instructions carefully before using a pen. 
 Check that you have the correct medicine and the correct dose. 
 Keep unused pens in the original carton and store in the refrigerator between 2ºC and 8ºC.  
 Keep the carton in an insulated bag with an ice pack when travelling. 
 Let the pen warm up to room temperature for at least 60 minutes before using. 
 Use the pen within 14 days after taking it out of the refrigerator or insulated bag. 
 Keep the pen out of the sight and reach of children. 
 
Do not  

 Do not use a pen if it has been damaged or the cap is missing or not attached.  
 Do not remove the cap until just before you are ready to inject. 



 
 

 
 

89 

 Do not press or touch the yellow needle cover with your fingers. 
 Do not try to put the cap back on a pen. 
 Do not re-use the pen. 
 Do not freeze or heat the pen. 
 Once removed from the refrigerator, do not store the pen above 25ºC. 
 Do not expose the pen to direct sunlight. 
 Do not inject through your clothes. 

 
If you have any further questions, ask your doctor, pharmacist or nurse or call the sanofi 
number on the package leaflet. 
 
Step A: Get ready for an injection 
 
1. Prepare all the equipment you will need on a clean, flat working surface. 

• You will need an alcohol wipe, a cotton ball or gauze, and a puncture-resistant container. 
• Take one pen out of the packaging by holding the middle of the pen body. Keep the remaining 

pen in the carton in the refrigerator. 
 
2. Look at the label. 

• Check that you have the correct medicine and the correct dose. 
• Check the expiry date (EXP), this is shown on the side of the pens. 

 Do not use the pen if the date has passed. 
 

 
 
3. Look at the window. 

• Check that the liquid is clear and colourless to pale yellow. 
• You may see an air bubble, this is normal. 

 Do not inject if the liquid is cloudy, discoloured or contains particles.  
 Do not use if the window is solid yellow. 

 

 
4. Lay the pen on a flat surface and allow it to warm up to room temperature (<25°C) for at least 

60 minutes. 



 
 

 
 

90 

• Using the pen at room temperature may make the injection more comfortable. 
 Do not use the pen if it has been out of the refrigerator for more than 14 days. 
 Do not heat the pen; let it warm up on its own. 
 Do not expose the pen to direct sunlight. 

 

 
 
5. Select the injection site. 

• You can inject into your thigh or belly (abdomen) except for the 5 cm around your belly button 
(navel).  If somebody else gives you the injection, you can also use the outer area of the upper 
arm. 

• Change injection site each time you inject. 
 Do not inject into skin that is tender, damaged or has bruises or scars. 

 

 
 
6. Prepare the injection site. 

• Wash your hands. 
• Clean skin with an alcohol wipe. 

 Do not touch the injection site again before the injection. 
 
Step B: Perform the injection – Perform Step B only after completing Step A “Get ready for an 

injection” 
 
1. Twist or pull off the orange cap. 

 Do not remove the cap until you are ready to inject. 
 Do not press or touch the yellow needle cover with your fingers. 



 
 

 
 

91 

 Do not put the cap back on. 
 

 
 
2. Put the yellow needle cover on your skin at roughly a 90° angle.  

• Make sure you can see the window. 
 

 



 
 

 
 

92 

3. Press down and hold the pen firmly against your skin. 
• There will be a “click” when the injection starts. 

 
 

4. Keep holding the pen firmly against your skin. 
• The window will start to turn yellow. 
• The injection can take up to 15 seconds. 

 

 
 
5. There will be a second click. Check to see if the entire window has turned yellow before you 
remove the pen. 

• If you do not hear the second click, you should still check to see if the window has turned fully 
yellow.  

 If the window does not turn fully yellow, do not give yourself a second dose without speaking 
to your healthcare provider. 

 



 
 

 
 

93 

 
 
6. Pull the pen away from your skin. 

• If you see any blood, press a cotton ball or gauze on the site. 
 Do not rub your skin after the injection. 

 

 
 
7. Put your used pen and the cap into a puncture-resistant container right away after use. 

• Always keep the container out of the sight and reach of children. 
 Do not put the cap back on. 
 Do not throw the used pens in household waste. 
 Do not recycle your used puncture-resistant container. 
 Do not dispose of your used puncture-resistant container in your household waste unless your 

local guidelines permit this. Ask your doctor, pharmacist or nurse how to throw away the 
container. 

 



 
 

 
 

94 

 



 
 

 
 

95 

Kevzara 200 mg solution for injection in a pre-filled pen 
sarilumab 

 
Instructions for use 

 
The parts of the Kevzara pre-filled pen are shown in this picture.  
 

 
 
Important information 
 
This device is a single-dose pre-filled pen (called “pen” in these instructions). It contains 200 mg of 
Kevzara for injection under the skin (subcutaneous injection) once every two weeks. 
 
Ask your healthcare professional to show you the right way to use the pen before your first injection. 
 
Do 
 Read all of the instructions carefully before using a pen. 
 Check that you have the correct medicine and the correct dose. 
 Keep unused pens in the original carton and store in the refrigerator between 2ºC and 8ºC.  
 Keep the carton in an insulated bag with an ice pack when travelling. 
 Let the pen warm up to room temperature for at least 60 minutes before using. 
 Use the pen within 14 days after taking it out of the refrigerator or insulated bag. 
 Keep the pen out of the sight and reach of children. 
 
Do not  

 Do not use a pen if it has been damaged or the cap is missing or not attached.  
 Do not remove the cap until just before you are ready to inject. 
 Do not press or touch the yellow needle cover with your fingers. 



 
 

 
 

96 

 Do not try to put the cap back on a pen. 
 Do not re-use the pen. 
 Do not freeze or heat the pen. 
 Once removed from the refrigerator, do not store the pen above 25ºC. 
 Do not expose the pen to direct sunlight. 
 Do not inject through your clothes. 

 
If you have any further questions, ask your doctor, pharmacist or nurse or call the sanofi 
number on the package leaflet. 
 
Step A: Get ready for an injection 
 
1. Prepare all the equipment you will need on a clean, flat working surface. 

• You will need an alcohol wipe, a cotton ball or gauze, and a puncture-resistant container. 
• Take one pen out of the packaging by holding the middle of the pen body. Keep the remaining 

pen in the carton in the refrigerator. 
 
2. Look at the label. 

• Check that you have the correct medicine and the correct dose. 
• Check the expiry date (EXP), this is shown on the side of the pens. 

 Do not use the pen if the date has passed. 
 

 
3. Look at the window. 

• Check that the liquid is clear and colourless to pale yellow. 
• You may see an air bubble, this is normal. 

 Do not inject if the liquid is cloudy, discoloured or contains particles.  
 Do not use if the window is solid yellow. 

 

 
 

 



 
 

 
 

97 

4. Lay the pen on a flat surface and allow it to warm up to room temperature (<25°C) for at least 
60 minutes. 

• Using the pen at room temperature may make the injection more comfortable. 
 Do not use the pen if it has been out of the refrigerator for more than 14 days. 
 Do not heat the pen; let it warm up on its own. 
 Do not expose the pen to direct sunlight. 

 

 
 
5. Select the injection site. 

• You can inject into your thigh or belly (abdomen) except for the 5 cm around your belly button 
(navel).  If somebody else gives you the injection, you can also use the outer area of the upper 
arm. 

• Change injection site each time you inject. 
 Do not inject into skin that is tender, damaged or has bruises or scars. 

 

 
 
6. Prepare the injection site. 

• Wash your hands. 
• Clean skin with an alcohol wipe. 

 Do not touch the injection site again before the injection. 
 
Step B: Perform the injection – Perform Step B only after completing Step A “Get ready for an 

injection” 
 
1. Twist or pull off the orange cap. 

 Do not remove the cap until you are ready to inject. 
 Do not press or touch the yellow needle cover with your fingers. 



 
 

 
 

98 

 Do not put the cap back on. 
 

 
2. Put the yellow needle cover on your skin at roughly a 90° angle.  

• Make sure you can see the window. 
 

 
 
3. Press down and hold the pen firmly against your skin. 

• There will be a “click” when the injection starts. 
 



 
 

 
 

99 

 
 
4. Keep holding the pen firmly against your skin. 

• The window will start to turn yellow. 
• The injection can take up to 15 seconds. 

 

 
5. There will be a second click. Check to see if the entire window has turned yellow before you 
remove the pen. 

• If you do not hear the second click, you should still check to see if the window has turned fully 
yellow.  

 If the window does not turn fully yellow, do not give yourself a second dose without speaking 
to your healthcare provider. 

 



 
 

 
 

100 

 
6. Pull the pen away from your skin. 

• If you see any blood, press a cotton ball or gauze on the site. 
 Do not rub your skin after the injection. 

 

 
 
7. Put your used pen and the cap into a puncture-resistant container right away after use. 

• Always keep the container out of the sight and reach of children. 
 Do not put the cap back on. 
 Do not throw the used pens in household waste. 
 Do not recycle your used puncture-resistant container. 
 Do not dispose of your used puncture-resistant container in your household waste unless your 

local guidelines permit this. Ask your doctor, pharmacist or nurse how to throw away the 
container. 



 
 

 
 

101 

 

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET