Cinqaero

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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 
 
CINQAERO 10 mg/mL concentrate for solution for infusion 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each mL of concentrate contains 10 mg of reslizumab (10 mg/mL). 
 
Each vial of 2.5 mL contains 25 mg of reslizumab. 
Each vial of 10 mL contains 100 mg of reslizumab. 
 
Reslizumab is a humanised monoclonal antibody produced in mouse myeloma cells (NS0) by 
recombinant DNA technology. 
 
Excipient with known effect 
Each vial of 2.5 mL contains 0.05 mmol (1.15 mg) of sodium. 
Each vial of 10 mL contains 0.20 mmol (4.6 mg) of sodium. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Concentrate for solution for infusion (sterile concentrate). 
 
Clear to slightly hazy opalescent, colourless to slightly yellow solution with pH 5.5. Proteinaceous 
particles might be present. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
CINQAERO is indicated as add-on therapy in adult patients with severe eosinophilic asthma 
inadequately controlled despite high-dose inhaled corticosteroids plus another medicinal product for 
maintenance treatment (see section 5.1). 
 
4.2 Posology and method of administration 
 
CINQAERO should be prescribed by physicians experienced in the diagnosis and treatment of the 
above-mentioned indication (see section 4.1). 
 
Posology 
CINQAERO is given as intravenous infusion once every four weeks.  
 
Patients below 35 kg or above 199 kg 
The recommended dose is 3 mg/kg body weight. The volume (in mL) required from the vial(s) should 
be calculated as follows: 0.3 x patient body weight (in kg). 
 



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Patients between 35 kg and 199 kg 
The recommended dose is achieved using the vial-based dosing scheme in Table 1 below. The 
recommended dose is based on patient body weight and should only be adjusted for significant 
changes in body weight. 
 
Table 1: Vial-based dosing scheme* for patients with body weight between 35 kg and 199 kg 
Body weight 
(kg) 

Reslizumab total dose 
(mg) 

Numbers of each vial** 
Vials with 10 mL 
concentrate 
(100 mg reslizumab) 

Vials with 2.5 mL 
concentrate 
(25 mg reslizumab) 

35-41 100 1 0 
42-49 125 1 1 
50-58 150 1 2 
59-66 175 1 3 
67-74 200 2 0 
75-83 225 2 1 
84-91 250 2 2 
92-99 275 2 3 
100-108 300 3 0 
109-116 325 3 1 
117-124 350 3 2 
125-133 375 3 3 
134-141 400 4 0 
142-149 425 4 1 
150-158 450 4 2 
159-166 475 4 3 
167-174 500 5 0 
175-183 525 5 1 
184-191*** 550 5 2 
192-199*** 575 5 3 
* This dosing scheme is based on a maximum dose of 3 mg/kg. 
** The nominal volume of the vials (10 mL or 2.5 mL for each vial) has to be used. 
*** Patients weighing more than 188 kg were not studied. 
 
 
Treatment duration 
CINQAERO is intended for long-term treatment. 
 
A decision to continue the therapy should be made at least annually based on disease severity and 
level of exacerbation control. 
 
Missed dose 
If a reslizumab infusion is missed on the planned date, dosing should resume as soon as possible on 
the indicated dose and regimen. A double dose must not be administered to make up for a missed dose. 
 
Special populations 
 
Elderly 
There are limited data available on the use of reslizumab in patients older than 75 years of age. Based 
on the similar reslizumab exposure observed in patients older than 65 years of age as compared to 
patients 18 to <65 years of age, no dose adjustment is recommended (see section 5.2). 
 
Renal impairment 
No dose adjustment is required in patients with renal impairment (see section 5.2). 
 



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Hepatic impairment 
No dose adjustment is required in patients with hepatic impairment (see section 5.2). 
 
Paediatric population 
The safety and efficacy of CINQAERO in children and adolescents aged up to 17 years have not been 
established for the indication of CINQAERO. No data are available for children aged up to 11 years. 
Currently available data in adolescents from 12 to 17 years are described in sections 4.8, 5.1 and 5.2, 
but no recommendation on a posology can be made. 
 
Method of administration 
Intravenous use. 
 
CINQAERO is for intravenous infusion only. It must not be administered by the subcutaneous, oral or 
intramuscular route. 
 
The appropriate volume of CINQAERO should be dispensed into an infusion bag containing 50 mL 
sodium chloride 9 mg/mL (0.9%) solution for infusion. 
 
The diluted medicinal product should then be administered as a 20 – 50-minute intravenous infusion 
through a sterile, non-pyrogenic infusion, single-use, low protein binding filter (0.2 µm). CINQAERO 
must not be administered as a bolus injection or as undiluted concentrate. 
 
The infusion must be discontinued immediately if the patient experiences a hypersensitivity reaction to 
reslizumab or to any of the excipients (see section 4.4). 
 
For instructions on dilution of the medicinal product before administration, see section 6.6. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
Reslizumab should not be used to treat acute asthma exacerbations. 
 
Asthma-related symptoms or exacerbations may occur during treatment. Patients should be instructed 
to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment. 
 
Traceability 
In order to improve the traceability of biological medicinal products, the name and the batch number 
of the administered product should be clearly recorded. 
 
Hypersensitivity and administration-related reactions 
Acute systemic reactions, including anaphylactic reactions, have been reported in association with 
reslizumab (see section 4.8). These adverse reactions were observed during or within 20 minutes after 
completion of the infusion. Patients should be monitored during and for an appropriate time after 
administration of reslizumab. If an anaphylactic reaction occurs, administration of reslizumab should 
be stopped immediately and appropriate medical treatment should be provided; reslizumab must be 
discontinued permanently (see section 4.3). 
 
Parasitic (helminth) infections 
Eosinophils may be involved in the immunological response to some helminth infections. Patients 
with pre-existing helminth infections should be treated before starting reslizumab therapy. If patients 
become infected whilst receiving treatment with reslizumab and do not respond to anti-helminth 
treatment, temporary discontinuation of therapy should be considered. 
 
Sodium content 



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This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 
‘sodium-free’. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No formal clinical drug interaction studies have been performed with reslizumab. In vitro data indicate 
that IL-5 and reslizumab are unlikely to affect CYP1A2, 3A4 or 2B6 activity. Based on the 
characteristics of reslizumab, drug-drug interactions are not expected. Results of population 
pharmacokinetic analysis confirm that concomitant use of either leukotriene antagonists or systemic 
corticosteroids does not affect the pharmacokinetics of reslizumab (see section 5.2). 
 
Reslizumab has not been studied in patients concurrently taking immunosuppressant medicinal 
products other than oral corticosteroids (OCS); therefore, the safety and efficacy profile of reslizumab 
in these patients is unknown. 
 
Reslizumab has not been studied in patients receiving live vaccines. No data are available on the 
secondary transmission of infection from persons receiving live vaccines to patients receiving 
reslizumab or the response to new immunisations in patients receiving reslizumab. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of reslizumab 
in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to 
reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of CINQAERO 
during pregnancy. Reslizumab has a long half-life (see section 5.2). This should be taken into 
consideration. 
 
Breast-feeding 
It is unknown whether reslizumab is excreted in human milk. Available 
pharmacodynamic/toxicological data in animals have shown excretion of reslizumab in milk. In 
humans, during the first few days after birth antibodies may be transferred to the newborns through 
milk. In this short period, a risk to the suckling child cannot be excluded. Afterwards, CINQAERO 
could be used during breast-feeding if appropriate. 
 
Fertility 
There are no fertility data in humans. Available non-clinical data do not suggest an effect on fertility. 
 
4.7 Effects on ability to drive and use machines 
 
CINQAERO has no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
The most frequently reported adverse reaction during treatment was increased blood creatine 
phosphokinase, which occurred in approximately 2% of patients. Anaphylactic reaction (see 
section 4.4) occurred in less than 1% of patients. 
 
During controlled clinical studies, the proportion of patients who discontinued due to any adverse 
event was 5% for both the 3 mg/kg reslizumab and placebo groups. 
 
Tabulated list of adverse reactions 
Overall, 2,195 subjects received at least one dose of reslizumab. Of these subjects, 1,006 asthma 
patients were exposed for at least 6 months, 759 exposed for at least 1 year and 237 exposed for longer 
than 2 years (up to 3 years).The following adverse reactions have been reported with reslizumab 
during placebo-controlled asthma studies for up to 52 weeks of treatment with a 3 mg/kg dose given 



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intravenously (1,028 patients). Adverse reactions are listed below in Table 2 by system organ class 
and frequency (frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), 
uncommon (≥ 1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known 
(cannot be estimated from the available data). 
 
Table 2: Adverse reactions 
System organ class Frequency Adverse reaction 
Immune system disorders Uncommon Anaphylactic reaction* 
Musculoskeletal and connective 
tissue disorders 

Uncommon Myalgia* 

Investigations Common Blood creatine phosphokinase 
increased* 

*See subsection “Description of selected adverse reactions” below 
 
Description of selected adverse reactions 
 
Anaphylactic reaction 
The serious adverse reaction of anaphylactic reaction was reported and considered related to 
reslizumab in 3 patients (0.19%) during placebo-controlled and open-label asthma studies. These 
reactions were observed during or within 20 minutes after completion of the reslizumab infusion and 
were reported as early as the second dose of reslizumab. They were fully resolved with standard 
treatment with no residual effect. Manifestations included skin or mucosal involvement, dyspnoea, 
wheezing, gastrointestinal symptoms and chills. These cases resulted in the discontinuation of 
treatment. Due to an overlap in signs and symptoms, it was not possible to distinguish between an 
anaphylactic reaction, another hypersensitivity reaction and an infusion-related reaction in all cases 
(see section 4.4). 
 
Myalgia 
Myalgia was reported in 0.97% of patients (10 out of 1,028) in the 3 mg/kg reslizumab group of the 
placebo-controlled asthma studies compared with 0.55% of patients (4 out of 730) in the placebo 
group. 
 
Blood creatine phosphokinase increased 
Blood creatine phosphokinase elevations were transient and asymptomatic, and did not lead to 
treatment discontinuation. 
 
Malignancies 
In placebo-controlled clinical studies, 6 out of 1,028 patients (0.6%) receiving 3 mg/kg reslizumab had 
at least one malignant neoplasm reported compared to 2 out of 730 patients (0.3%) in the placebo 
group. The malignancies observed in reslizumab-treated patients were diverse in nature and without 
clustering of any particular tissue type. 
 
Paediatric population 
Experience in paediatric patients is limited (see section 5.1). The data did not indicate a difference in 
the safety profile of reslizumab in paediatric patients compared with that in adult patients. 
 
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 
 
The highest single dose administered intravenously was reported at 12.1 mg/kg and had no clinical 
consequences for the patient. In case of overdose, it is recommended that the patient be monitored for 
any signs or symptoms of adverse effects and given appropriate symptomatic treatment. 

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


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5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Drugs for obstructive airway diseases, other systemic drugs for 
obstructive airway diseases; ATC code: R03DX08 
 
Mechanism of action 
Reslizumab is a humanised monoclonal antibody (IgG4, κ) against the human interleukin-5 (IL-5). 
Reslizumab binds specifically to IL-5 and interferes with IL-5 binding to its cell-surface receptor. IL-5 
is a key cytokine responsible for the differentiation, maturation, recruitment and activation of human 
eosinophils. Reslizumab binds human IL-5 with picomolar affinity blocking its biological function; 
consequently survival and activity of eosinophils are reduced. 
 
Pharmacodynamic effects 
 
Effect on sputum eosinophils 
The effect of reslizumab in patients with asthma and elevated sputum eosinophil counts (at least 3%) 
was evaluated in a 15-week, phase 2, randomised, double-blind, placebo-controlled clinical study with 
reslizumab 3 mg/kg. Sputum eosinophils were measured in a subset of 38 adult patients at the end of 
therapy. In this study, the percentage of sputum eosinophils was reduced from a mean baseline value 
of 17.4% (standard deviation: 15.9%) by 82% at end of therapy in the reslizumab group. 
 
Effect on blood eosinophils 
In clinical Studies I and II with reslizumab 3 mg/kg, decreases in blood eosinophil counts were seen 
following the first dose and maintained through 52 weeks of treatment with no signs of tachyphylaxis. 
In pooled data, mean eosinophil counts were 655 µL-1 (n=476) and 654 µL-1 (n=477) for the placebo 
and reslizumab treatment groups at baseline and were 514 µL-1 (n=405) and 61 µL-1 (n=407) at 
week 52. Eosinophils began to return towards baseline in those reslizumab patients completing a 
90-day follow-up assessment (394 µL-1, n=36). Decreases in blood eosinophils were related to 
reslizumab levels. 
 
The reduction in blood eosinophil counts by reslizumab in anti-reslizumab antibody-positive patients 
was not different from patients who were anti-reslizumab antibody-negative. 
 
Clinical efficacy and safety 
 
Overview of clinical efficacy 
The efficacy of reslizumab in eosinophilic asthma (blood eosinophils ≥400 µL-1) was evaluated in 
three randomised, double-blind, placebo-controlled studies (Studies I to III) from 16 to 52 weeks’ 
duration involving 1268 patients with moderate to severe asthma inadequately controlled on medium- 
to high-dose inhaled corticosteroids (ICS) (at least 440 μg of fluticasone propionate daily or 
equivalent) with or without other controllers; prior stable allergen immunotherapy was allowed. 
 
Studies I and II were 52-week, randomised, placebo-controlled studies in patients who had at least one 
asthma exacerbation requiring systemic corticosteroid use over the past twelve months. Maintenance 
OCS (up to 10 mg per day prednisone equivalent) were allowed. The patients received either 13 doses 
of placebo or reslizumab 3 mg/kg administered once every 4 weeks. 
 
Study III was a 16-week, randomised, placebo-controlled study. There was no prior asthma 
exacerbation requirement for this study. Maintenance OCS was not allowed. The patients received 
either four doses of placebo or reslizumab 0.3 mg/kg or 3 mg/kg administered once every 4 weeks. 
 
Table 3 presents the demographics and baseline characteristics of Studies I, II and III. 
 



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Table 3: Demographics and baseline characteristics of asthma studies I - III 
Demographic or 
baseline characteristic 

Study I 
(n=489) 

Study II 
(n=464) 

Study III 
(n=315) 

Demographics    
Age, mean in years 46.65 46.97 43.89 
Asthma duration, 
mean in years 

19.28 18.41 20.35 

Pulmonary function 
tests 

   

Pre-bronchodilator 
FEV1a, mean % 
predicted 

64.31 69.21 70.14 

Eosinophil counts    
Baseline mean blood 
eosinophil count, µL-1 

660 649 614 

Exacerbation history    
Mean number of 
exacerbations in 
previous year 

1.99 1.94 2.03 

Proportions of 
patients in GINA 
steps 4 and 5c 

   

GINA 4, % 68 70 79 
GINA 5, % 13 9 <1 

Patients with 
refractory asthmad 

   

% 34 31 NAb 
a FEV1=forced expiratory volume in 1 second 
b NA=not available 
c The GINA classification is based on the Global Initiative for Asthma (GINA) definition: 
 GINA step 4 patients received medium- to high-dose ICS plus another controller. 
 GINA step 5 patients received in addition, as an add-on, maintenance OCS. 
d The percentage of patients with refractory asthma (based on the American Thoracic Society 

[ATS]/European Respiratory Society [ERS] 2000 workshop definition for refractory asthma) from 
Studies I and II was analysed post hoc. 

 
Studies I and II 
The primary efficacy measure for both Studies I and II was the frequency of asthma exacerbations for 
each patient during the 52-week treatment period. In both studies, an asthma exacerbation was defined 
as a worsening of asthma that required the following medical intervention:  
1) use of systemic corticosteroids or an increase in the use of ICS treatment for 3 or more days, and/or  
2) asthma-related emergency treatment including at least one of the following: an unscheduled visit to 
their healthcare professional for nebuliser treatment or other urgent treatment to prevent worsening of 
asthma symptoms; a visit to the emergency room for asthma-related treatment; or asthma-related 
hospitalisation. 
 
Overall population 
In Studies I and II, patients receiving reslizumab 3 mg/kg had significant reductions in asthma 
exacerbations (50% and 59%, respectively) compared to placebo (see Table 4). The overall reduction 
was 54%. 
 



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Table 4: Frequency of asthma exacerbations during the 52-week treatment period – Studies I 
and II, integrated data (Studies I and II) for the overall population and subgroup GINA 4 and 5 
 Treatment arms 

(n) 
Asthma exacerbation 
ratea 

% reduction 

Data by study    
Study I Reslizumab 3 mg/kg 

(n=245) 
0.90 

50% 
(p<0.0001) Placebo 

(n=244) 
1.80 

Study II  Reslizumab 3 mg/kg 
(n=232) 

0.86 
59% 

(p<0.0001) Placebo 
(n=232) 

2.12 

Integrated Studies I 
and II 

   

Overall population Reslizumab 3 mg/kg 
(n=477) 

0.84 
54% 

(p<0.0001) Placebo 
(n=476) 

1.81 

Subgroup 
GINA 4 and 5 

Reslizumab 3 mg/kg 
(n=383) 
95% CIb 

0.85 
 

(0.64, 1.12) 56% Placebo 
(n=380) 
95% CI 

1.95 
 

(1.50, 2.53) 
a Rate adjusted for stratification factors (baseline usage of OCS and geographical region). 
b CI = Confidence interval 
 
In the subset of patients requiring courses of OCS treatment for management of their asthma 
exacerbation, reslizumab was shown to reduce the frequency of asthma exacerbations by 56% 
(p<0.0001) and 60% (p<0.0001) in Study I and Study II, respectively. A reduction in asthma 
exacerbations resulting in hospitalisation or an emergency room visit was observed with reslizumab 
3 mg/kg that was not statistically significant (34% [p=0.2572] and 31% [p=0.4020] in Study I and 
Study II, respectively). 
 
The proportion of patients who did not experience an asthma exacerbation during the 52-week 
treatment period was higher in the reslizumab 3 mg/kg group (62% and 75%) compared with the 
placebo group (46% and 55%), in Studies I and II, respectively. 
 
Patients with severe eosinophilic asthma 
In Studies I and II, severe eosinophilic asthma is defined as any patients falling into GINA 
steps 4 and 5 (medium- to high-dose ICS [≥ 440 µg fluticasone propionate] plus another controller, 
with or without maintenance OCS) with a blood eosinophil count of ≥400 µL-1 at start of treatment. A 
cohort of 763 patients within Studies I and II met this criterion; the primary efficacy outcome is 
presented in Table 4. In integrated Studies I and II, patients receiving reslizumab 3 mg/kg had 
significant reductions in asthma exacerbations (56% for subgroup GINA 4 and 5) compared to 
placebo. 
 
The effect of reslizumab 3 mg/kg administered once every 4 weeks on secondary endpoints, including 
FEV1, Asthma Quality of Life Questionnaire (AQLQ), Asthma Control Questionnaire (ACQ) and 
Asthma Symptom Utility Index (ASUI), further supports the efficacy of reslizumab 3 mg/kg compared 
to placebo. Improvements were observed as early as 4 weeks following the first dose of reslizumab 
(AQLQ at 16 weeks) and sustained through week 52. 
 
Results for FEV1, ACQ and AQLQ are shown in Table 5 below for the overall population, and 
subgroup GINA 4 and 5. 
 



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Table 5: Treatment difference in mean change from baseline for selected secondary efficacy 
variables – Integrated data (Studies I and II) for the overall population and subgroup 
GINA 4 and 5  
 Overall population Subgroup GINA 4 and 5 
Efficacy 
variablea 

Over 16 weeks Over 52 weeks Over 16 weeks Over 52 weeks 

FEV1 (mL)     
Mean diff 
(95% CIb) 
(p-value) 

117 
(73, 160) 

(p<0.0001) 

110 
(66, 154) 

(p<0.0001) 

143 
(94, 192) 

 

129 
(80, 179) 

 
ACQ     

Mean diff 
(95% CI) 
(p-value) 

-0.232 
(-0.325, -0.139) 

-0.250 
(-0.343, -0.156) 

-0.321 
(-0.424, -0.218) 

 

-0.330 
(-0.433, -0.226) 

 
AQLQ     

Mean diff 
(95% CI) 
(p-value) 

0.226 
(0.094, 0.359) 

(p<0.0001) 

0.272 
(0.155, 0.388) 

(p<0.0001) 

0.295 
(0.151, 0.438) 

 

0.346 
(0.219, 0.473) 

 
a  The values represent the treatment difference between placebo and reslizumab 3 mg/kg based on 

adjusted means over the specified time period for each treatment group, except for the change to 
week 16 for AQLQ, which was the first timepoint where AQLQ was assessed. 

b CI = Confidence interval. 
 
Patients with severe refractory eosinophilic asthma 
Reslizumab produced significant reductions in asthma exacerbations relative to placebo in the 
refractory population (59%) and non-refractory population (49%). Results were supported by the 
secondary efficacy endpoints and were in line with the overall population. 
 
Study III 
The primary endpoint was the change from baseline over 16 weeks in FEV1. In Study III, patients 
receiving reslizumab 3 mg/kg had significantly larger increases in FEV1 from baseline compared to 
placebo (treatment difference: 160 mL, p=0.0018). Improvements were noted in FEV1 at 4 weeks 
following the first dose of reslizumab. 
 
Immunogenicity 
In phase 3 placebo-controlled studies with a duration of 16 to 52 weeks, low-titre, frequently transient 
anti-reslizumab antibodies were detected in 53 out of 983 asthma patients (5%) receiving reslizumab 
at 3 mg/kg. In an open-label phase 3 extension study, low-titre, frequently transient anti-reslizumab 
antibodies were detected in 49 out of 1,014 asthma patients (5%) who received 3 mg/kg reslizumab for 
up to 36 months. Systemic exposure to reslizumab appears to be unaffected by anti-reslizumab 
antibodies. The antibodies had no impact on clinical pharmacodynamics, efficacy or safety. 
 
Ethnicity 
Population pharmacokinetic analyses indicated that the pharmacokinetics of reslizumab is not 
significantly different between ethnic groups (white, black and Asian). There are limited safety data in 
non-white ethnic populations. 
 
Paediatric population 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
CINQAERO in one or more subsets of the paediatric population in asthma (see section 4.2 for 
information on paediatric use). 
 
39 paediatric asthma patients from 12 to 17 years were randomised to reslizumab 0.3 mg/kg, 
reslizumab 3 mg/kg or placebo as part of two 52-week exacerbation studies (Studies I and II) and one 
16-week lung function study (Study III). In Studies I and II only, patients were required to have at 
least one asthma exacerbation requiring systemic corticosteroid use in the year prior to study entry. 
Asthma exacerbations were evaluated only in the exacerbation studies (Studies I and II: reslizumab 



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3 mg/kg [n=14] and placebo [n=11]). No treatment effect on asthma exacerbations was observed for 
this age group (asthma exacerbation rate ratio [reslizumab/placebo] of 2.09). Given the small sample 
size and baseline imbalances resulting from subgroup analysis, no conclusion can be drawn regarding 
asthma efficacy in the paediatric population. 
 
5.2 Pharmacokinetic properties 
 
Peak serum concentrations of approximately 80 µg/mL are typically observed at the end of the 
infusion. Serum reslizumab concentrations generally decline from peak in a biphasic manner. 
Following multiple doses, serum concentrations of reslizumab accumulate approximately 1.5- to 
1.9-fold. No apparent deviation from dose-proportional reslizumab pharmacokinetics was noted over 
the dose range of 0.3 mg/kg to 3.0 mg/kg. Inter-individual variability in peak and overall exposure is 
approximately 20-30% 
 
Based on population pharmacokinetic analysis, systemic exposure to reslizumab appears to be 
unaffected by circulating anti-reslizumab antibodies. 
 
Distribution 
Reslizumab has a volume of distribution of approximately 5 L, suggesting minimal distribution to the 
extravascular tissues. 
 
Biotransformation 
In common with other monoclonal antibodies, reslizumab is believed to be degraded by enzymatic 
proteolysis into small peptides and amino acids. As reslizumab binds to a soluble target, linear 
non-target-mediated clearance is expected. 
 
Elimination 
Reslizumab clearance is approximately 7 mL/hour. Reslizumab has a half-life of about 24 days. 
 
Special populations 
 
Elderly 
The pharmacokinetics of reslizumab was similar in adults (18-65 years of age; n=759) and elderly 
patients (greater than 65 years of age; n=30). 
 
Paediatric population 
The range of systemic exposures in patients from 12 to less than 18 years of age (n=15) overlapped 
that in the other groups although the median value was slightly lower than in adult patients 
(18-65 years of age; n=759) and elderly patients (greater than 65 years of age; n=30). 
 
Gender 
The pharmacokinetics of reslizumab was not significantly different between males and females. 
 
Ethnicity 
Population pharmacokinetic analyses indicated that the pharmacokinetics of reslizumab is not 
significantly different between ethnic groups (white, black and Asian). 
 
Hepatic Impairment 
Reslizumab has not been studied in patients with hepatic impairment. No direct effect of hepatic 
function on the pharmacokinetics of reslizumab is expected because antibodies are principally cleared 
by catabolism. In a population pharmacokinetic analysis, patients were classified by baseline liver 
function levels. Most patients had normal liver function tests (n=766, approximately 95%) or mildly 
increased liver function tests (either, in the first case, total bilirubin above the upper limit of normal 
[ULN] but less than or equal to 1.5 times the ULN or, in the second case, aspartate aminotransferase 
greater than the ULN and total bilirubin less than or equal to the ULN; n=35, approximately 4%). No 
significant difference in the pharmacokinetics of reslizumab was observed across these groups. 
 



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Renal Impairment 
Reslizumab is an antibody with a molecular mass of 147 kDaltons and is therefore not expected to be 
excreted in urine. Most patients in the population pharmacokinetic analysis had normal renal function 
(estimated glomerular filtration rate [eGFR]) greater than or equal to 90 mL/min/1.73 m2; n=294, 
approximately 37%), mild renal impairment (eGFR 60-89 mL/min/1.73 m2; n=446, approximately 
56%), or moderate renal impairment (eGFR 30-59 mL/min/1.73 m2; n=63, approximately 8%). No 
noteworthy differences in the pharmacokinetics of reslizumab were observed across these renal 
function groups. Reslizumab has not been studied in patients with severe renal impairment or end 
stage renal disease. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to 
reproduction and development. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Sodium acetate trihydrate 
Acetic acid glacial 
Sucrose 
Water for injections 
 
6.2 Incompatibilities 
 
This medicinal product must not be mixed with other medicinal products except those mentioned in 
section 6.6. 
 
6.3 Shelf life 
 
3 years 
 
Diluted medicinal product 
Chemical and physical in-use stability has been demonstrated at 2 °C-8 °C and at 25 °C in sodium 
chloride 9 mg/mL (0.9%) solution for infusion protected from light for up to 16 hours. 
 
From a microbiological point of view, the product should be used immediately. If not used 
immediately, in-use storage times and conditions prior to use are the responsibility of the user and 
would normally not be longer than 16 hours at 2 °C-8 °C, unless dilution has taken place in controlled 
and validated aseptic conditions. 
 
6.4 Special precautions for storage 
 
Store in a refrigerator (2 °C-8 °C). 
Do not freeze. 
Keep the vial in the outer carton in order to protect from light. 
 
For storage conditions after dilution of the medicinal product, see section 6.3. 
 
6.5 Nature and contents of container 
 
2.5 mL of concentrate in a clear type I glass vial closed by a 
poly(ethylene-co-tetrafluoroethylene)-coated butyl rubber stopper covered with a crimped-on 
aluminium ring and a white plastic flip-off cap. 



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10 mL of concentrate in a clear type I glass vial closed by a 
poly(ethylene-co-tetrafluoroethylene)-coated butyl rubber stopper covered with a crimped-on 
aluminium ring and a blue plastic flip-off cap. 
 
Pack sizes: 
1 vial of 2.5 mL 
2 vials of 2.5 mL 
1 vial of 10 mL 
2 vials of 10 mL 
 
Not all pack sizes may be marketed. 
 
 
6.6 Special precautions for disposal and other handling 
 
CINQAERO is provided as a concentrate for solution for infusion in a single-use vial. The solution for 
infusion is intended only for intravenous use after dilution and should be prepared using aseptic 
technique as follows: 
 
Preparation of solution for infusion 
1. Remove CINQAERO from the refrigerator. Do not shake the vial. 
2. The medicinal product should be inspected visually before use. The concentrate is clear to 

slightly hazy opalescent, colourless to slightly yellow. Proteinaceous particles may be present in 
the concentrate that appear as translucent to white, amorphous particles, some of which may 
look fibrous. This is not unusual for proteinaceous solutions. The concentrate must not be used 
if coloured (except slightly yellow) or if foreign particles are present. 

3. A suitable injection syringe should be used to withdraw the needed amount of the concentrate 
from the vial(s) (see section 4.2).  

4. Slowly dispense the contents of the syringe(s) into an infusion bag containing 50 mL of sodium 
chloride 9 mg/mL (0.9%) solution for infusion. Gently invert the bag to mix the solution. This 
medicinal product must not be mixed with other medicinal products except sodium chloride 
9 mg/mL (0.9%) solution for infusion. 

5. The concentrate does not contain any preservatives. Any concentrate remaining in the vial must 
be discarded. 

6. It is recommended that the solution for infusion be administered immediately after preparation. 
Solutions of CINQAERO diluted in sodium chloride 9 mg/mL (0.9%) solution for infusion may 
be stored refrigerated at 2 °C-8 °C (or not above 25 °C if dilution has taken place in controlled 
and validated aseptic conditions), protected from light for up to 16 hours. 

7. CINQAERO is compatible with polyvinylchloride (PVC) or polyolefin (PO) infusion bags. 
 
Instructions for administration 
1. CINQAERO should be administered by a healthcare professional prepared to manage 

hypersensitivity reactions including anaphylaxis (see section 4.4). The patient has to be 
observed over the duration of the infusion and for an appropriate period afterwards. Patients 
should be instructed on how to recognise symptoms of serious allergic reactions. 

2. If the solution for infusion has been stored in a refrigerator, allow it to reach room temperature 
(15 °C-25 °C). 

3. The solution for infusion should be infused intravenously over 20 – 50 minutes. Infusion time 
may vary depending on the total volume to be infused. 

4. The solution for infusion should not be infused concomitantly in the same intravenous line with 
other medicinal products. No physical or biochemical compatibility studies have been 
conducted to evaluate the co-administration of reslizumab with other medicinal products. 

5. An infusion set with an in-line, sterile, non-pyrogenic, low-protein-binding filter (pore size of 
0.2 µm) should be used for infusion. CINQAERO is compatible with polyethersulfone (PES), 
polyvinylidene fluoride (PVDF), nylon, cellulose acetate (CA) low protein binding in-line 
infusion filters. 



14 

6. Upon completion of the infusion, flush the infusion set with sterile sodium chloride 9 mg/mL 
(0.9%) solution for infusion to ensure that all of the CINQAERO solution for infusion has been 
administered. 

 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Teva B.V. 
Swensweg 5 
2031 GA Haarlem 
The Netherlands 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/16/1125/001 1 vial of 10 mL 
EU/1/16/1125/002 - 1 vial of 2.5 mL 
EU/1/16/1125/003 - 2 vials of 10 mL 
EU/1/16/1125/004 - 2 vials of 2.5 mL 
 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 16 August 2016. 
 
 
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/


15 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
MANUFACTURER 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 

 



16 

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

 
Name and address of the manufacturer of the biological active substance 
 
Lonza Biologics Inc. 
101 International Drive 
Portsmouth 
NH 03801-2815 
United States of America 
 
Name and address of the manufacturer responsible for batch release 
 
UAB Teva Baltics 
Molėtų pl. 5 
LT-08409 Vilnius 
Lithuania 
 
Merckle GmbH 
Graf-Arco-Str. 3 
89079 Ulm 
Germany 
 
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 (PSURs) 
 
The requirements for submission of PSURs 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 (MAH) shall submit the first PSUR 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 marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities 
and interventions detailed in the 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; 



17 

● 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.  



18 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



19 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
  



20 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
CINQAERO 10 mg/mL concentrate for solution for infusion 
reslizumab 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each mL of concentrate contains 10 mg of reslizumab. 
 
One vial of 2.5 mL contains 25 mg reslizumab. 
One vial of 10 mL contains 100 mg reslizumab. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium acetate trihydrate, acetic acid glacial, sucrose, water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Concentrate for solution for infusion 
 
1 vial 
2 vials 
 
25 mg/2.5 mL 
100 mg/10 mL 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
Intravenous use, after dilution only. 
 
 
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 
 



21 

 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Keep the vial in the outer carton in order to protect from light. 
 
 
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 
 
Teva B.V. 
Swensweg 5 
2031 GA Haarlem 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/16/1125/001 1 vial of 10 mL 
EU/1/16/1125/002 1 vial of 2.5 mL 
EU/1/16/1125/003 2 vials of 10 mL 
EU/1/16/1125/004 2 vials of 2.5 mL 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN:  



22 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
CINQAERO 10 mg/mL sterile concentrate 
reslizumab 
 
Intravenous use, after dilution only. 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
2.5 mL 
25 mg/2.5 mL 
 
10 mL 
100 mg/10 mL 
 
 
6. OTHER 
 
 
  



23 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



24 

Package leaflet: Information for the patient 
 

CINQAERO 10 mg/mL concentrate for solution for infusion 
reslizumab 

 
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 are given 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. 
- 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. 
 
What is in this leaflet 
 
1. What CINQAERO is and what it is used for 
2. What you need to know before you are given CINQAERO 
3. How CINQAERO is given 
4. Possible side effects 
5. How to store CINQAERO 
6. Contents of the pack and other information 
 
 
1. What CINQAERO is and what it is used for 
 
What CINQAERO is 
CINQAERO is a medicine containing the active substance reslizumab, a monoclonal antibody, a type 
of protein that recognises and binds to a specific target substance in the body. 
 
How CINQAERO works 
CINQAERO blocks interleukin-5 activity and reduces the number of eosinophils in your blood and 
lungs. Eosinophils are white blood cells involved in asthma inflammation. Interleukin-5 is a protein 
your body makes that plays a key role in inflammation in asthma by activating eosinophils. 
 
What CINQAERO is used for 
CINQAERO is used to treat severe eosinophilic asthma in adult patients (18 years of age and over) 
when the condition is not well controlled despite treatment with high-dose inhaled corticosteroids 
together with another asthma medicine. Eosinophilic asthma is a type of asthma where patients have 
too many eosinophils in the blood or lungs. CINQAERO is used together with other medicines to treat 
asthma (inhaled corticosteroids plus other asthma medicines). 
 
What are the benefits of using CINQAERO 
CINQAERO reduces how often you have flare-ups of your asthma, helps you breathe better and 
decreases your asthma symptoms. 
 
 
2. What you need to know before you are given CINQAERO 
 
You must not receive CINQAERO: 
- if you are allergic to reslizumab or any of the other ingredients of this medicine (listed in 

section 6). 
 



25 

Warnings and precautions 
Talk to your doctor or nurse before you are given CINQAERO: 
- if you have a parasitic infection or if you live in an area where parasitic infections are common 

or if you are travelling to such a region, as this medicine may weaken your body’s ability to 
fight certain types of parasitic infections. 

 
Also, talk to your doctor or nurse when you are given CINQAERO: 
- if your asthma remains uncontrolled or worsens during treatment with this medicine; 
- if you have any of the symptoms of an allergic reaction (e.g. itching, trouble breathing, 

wheezing, fever, shivering, dizziness, headache, nausea, vomiting, abdominal discomfort, skin 
rash, redness or swelling). Serious allergic reactions have occurred in patients receiving this 
medicine (see section “4. Possible side effects”). 

 
Children and adolescents 
This medicine is NOT intended for use in children and adolescents below the age of 18 years. 
 
Other medicines and CINQAERO 
Tell your doctor if you are using, have recently used or might use any other medicines. 
 
This is particularly important: 
- if you are receiving other medicines which affect your immune system; 
- if you have recently received a vaccination or if you are likely to need a vaccination. 
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor for advice before you are given this medicine. 
 
The active substance in this medicine may pass into breast milk but only during the first few days after 
birth. 
 
Driving and using machines 
It is unlikely that CINQAERO will affect your ability to drive and use machines. 
 
CINQAERO contains sodium 
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’. 
 
 
3. How CINQAERO is given 
 
Always follow the instructions exactly as your doctor has told you. Check with your doctor if you are 
not sure. 
 
The dose depends on your body weight. Your doctor will work out the right dose for you. The 
maximum dose is 3 mg per kg of body weight. CINQAERO will be given every 4 weeks. You will be 
given CINQAERO by a doctor or nurse as an infusion (drip) into a vein. The infusion will take about 
20 to 50 minutes. 
 
It may take more than one dose before your asthma symptoms improve. 
 
Your doctor or nurse will watch you closely during and after your infusion for signs of an allergic 
reaction. 
 
If you miss your scheduled dose of CINQAERO 
If you miss a scheduled dose of CINQAERO, ask your doctor when to schedule your next treatment. 
 



26 

If you stop using CINQAERO 
Do NOT stop treatment with CINQAERO unless your doctor tells you to, even if you feel better. 
Interrupting or stopping treatment with this medicine may cause your asthma symptoms to come back. 
 
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 effects 
 
• Serious allergic reactions 

Serious allergic reactions can happen uncommonly (may affect up to 1 in 100 people) while 
receiving CINQAERO or afterwards. Your doctor or nurse will watch you closely for signs of a 
reaction. Tell your doctor or nurse straight away if you have any of the symptoms of an allergic 
reaction (e.g. itching, trouble breathing, wheezing, fever, shivering, dizziness, headache, nausea, 
vomiting, abdominal discomfort, skin rash, redness or swelling). 

 
Other side effects 
 
Common (may affect up to 1 in 10 people) 
• Increase of an enzyme in your blood (blood creatine phosphokinase). 
 
Uncommon (may affect up to 1 in 100 people) 
• Muscle pain (myalgia). 
 
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 CINQAERO 
 
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 outer carton and label after EXP. 
The expiry date refers to the last day of that month. 
 
Store in a refrigerator (2 °C-8 ºC). Do not freeze. 
Keep the vial in the outer carton in order to protect from light. 
 
Do not throw away any medicines via wastewater. 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 CINQAERO contains 
- The active substance is reslizumab. 

Each mL of concentrate contains 10 mg of reslizumab (10 mg/mL). Each vial of 2.5 mL 
contains 25 mg of reslizumab and each vial of 10 mL contains 100 mg of reslizumab. 

- The other excipients are sodium acetate, acetic acid glacial, sucrose and water for injections. 
 

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


27 

What CINQAERO looks like and contents of the pack 
CINQAERO is a clear to slightly hazy opalescent, colourless to slightly yellow concentrate for 
solution for infusion (sterile concentrate). Particles might be present. CINQAERO is supplied in glass 
vials containing 2.5 mL or 10 mL. 
 
CINQAERO is available in packs containing 1 or 2 vials with 2.5 mL and in packs containing 1 or 
2 vials with 10 mL. 
 
Not all pack sizes may be marketed. 
 
 
Marketing Authorisation Holder 
Teva B.V. 
Swensweg 5 
2031 GA Haarlem 
The Netherlands 
 
Manufacturer 
UAB Teva Baltics 
Molėtų pl. 5 
LT-08409 Vilnius 
Lithuania 
 
Merckle GmbH 
Graf-Arco-Str. 3 
89079 Ulm 
Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Teva Pharma Belgium N.V./S.A./AG 
Tél/Tel: +32 3 820 73 73 
 

Lietuva 
UAB Teva Baltics 
Tel: +370 5 266 0203 
 

България 
Актавис ЕАД 
Teл: +359 2 489 95 85 
 

Luxembourg/Luxemburg 
Teva Pharma Belgium N.V./S.A./AG, 
Belgique/Belgien 
Tél/Tel: +32 3 820 73 73 
 

Česká republika 
Teva Pharmaceuticals CR, s.r.o. 
Tel: +420 251 007 111 
 

Magyarország 
Teva Gyógyszergyár Zrt. 
Tel.: +36 1 288 64 00 
 

Danmark 
Teva Denmark A/S 
Tlf: +45 44 98 55 11 
 

Malta 
Teva Pharmaceuticals Ireland, L-Irlanda 
Tel: +353 51 321740 
 

Deutschland 
TEVA GmbH 
Tel: +49 731 402 08 
 

Nederland 
Teva Nederland B.V. 
Tel: +31 800 0228 400 
 

Eesti 
UAB Teva Baltics Eesti filiaal 
Tel: +372 661 0801 
 

Norge 
Teva Norway AS 
Tlf: +47 66 77 55 90 
 



28 

Ελλάδα 
Teva Ελλάς Α.Ε. 
Τηλ: +30 211 880 5000 
 

Österreich 
ratiopharm Arzneimittel Vertriebs-GmbH 
Tel: +43 1 97 007 
 

España 
Teva Pharma, S.L.U. 
Tel: +34 91 387 32 80 

Polska 
Teva Pharmaceuticals Polska Sp. z o.o. 
Tel.: +48 22 345 93 00 
 

France 
Teva Santé 
Tél: +33 1 55 91 78 00 
 

Portugal 
Teva Pharma - Produtos Farmacêuticos, Lda 
Tel: +351 21 476 75 50 
 

Hrvatska 
Pliva Hrvatska d.o.o. 
Tel: +385 1 37 20 000 
 

România 
Teva Pharmaceuticals S.R.L 
Tel: +40 21 230 65 24 
 

Ireland 
Teva Pharmaceuticals Ireland 
Tel: +353 51 321740 
 

Slovenija 
Pliva Ljubljana d.o.o. 
Tel: +386 1 58 90 390 
 

Ísland 
Actavis Pharmaceuticals Iceland ehf. 
Sími: +354 550 3300 
 

Slovenská republika 
TEVA Pharmaceuticals Slovakia s.r.o. 
Tel: +421 2 57 26 79 11 
 

Italia 
Teva Italia S.r.l. 
Tel: +39 02 89 17 98 1 
 

Suomi/Finland 
Teva Finland Oy 
Puh/Tel: +358 20 180 5900 
 

Κύπρος 
Teva Ελλάς Α.Ε., Ελλάδα 
Τηλ: +30 211 880 5000 
 

Sverige 
Teva Sweden AB 
Tel: +46 42 12 11 00 
 

Latvija 
UAB Teva Baltics filiāle Latvijā 
Tel: +371 673 23 666 
 

United Kingdom 
Teva UK Limited 
Tel: +44 1977 628500 
 

 
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. 
 
 
--------------------------------------------------------------------------------------------------------------------------- 
 
The following information is intended for healthcare professionals only: 
 
CINQAERO is provided as a concentrate for solution for infusion in a single-use vial. The solution for 
infusion is intended only for intravenous use after dilution and should be prepared using aseptic 
technique as follows: 
 
Preparation of solution for infusion 
1. Remove CINQAERO from the refrigerator. Do not shake the vial. 
2. The medicinal product should be inspected visually before use. The concentrate is clear to 

slightly hazy opalescent, colourless to slightly yellow. Proteinaceous particles may be present in 
the concentrate that appear as translucent to white, amorphous particles, some of which may 



29 

look fibrous. This is not unusual for proteinaceous solutions. The concentrate must not be used 
if coloured (except slightly yellow) or if foreign particles are present. 

3. A suitable injection syringe should be used to withdraw the needed amount of concentrate from 
the vial(s) (see section 4.2 of Summary of Product Characteristics). 

4. Slowly dispense the contents of the syringe(s) into an infusion bag containing 50 mL of sodium 
chloride 9 mg/mL (0.9%) solution for infusion. Gently invert the bag to mix the solution. This 
medicinal product must not be mixed with other medicinal products except sodium chloride 
9 mg/mL (0.9%) solution for infusion. 

5. The concentrate does not contain any preservatives. Any concentrate remaining in the vial must 
be discarded. 

6. It is recommended that the solution for infusion be administered immediately after preparation. 
Solutions of CINQAERO diluted in sodium chloride 9 mg/mL (0.9%) solution for infusion may 
be stored refrigerated at 2 °C-8 °C (or not above 25 °C if dilution has taken place in controlled 
and validated aseptic conditions), protected from light for up to 16 hours. 

7. CINQAERO is compatible with polyvinylchloride (PVC) or polyolefin (PO) infusion bags. 
 
Instructions for administration 
1. CINQAERO should be administered by a healthcare professional prepared to manage 

hypersensitivity reactions including anaphylaxis (see section 4.4 of Summary of Product 
Characteristics). The patient has to be observed over the duration of the infusion and for an 
appropriate period afterwards. Patients should be instructed on how to recognise symptoms of 
serious allergic reactions. 

2. If the solution for infusion has been stored in a refrigerator, allow it to reach room temperature 
(15 °C-25 °C). 

3. The solution for infusion should be infused intravenously over 20 – 50 minutes. Infusion time 
may vary depending on the total volume to be infused. 

4. The solution for infusion should not be infused concomitantly in the same intravenous line with 
other medicinal products. No physical or biochemical compatibility studies have been 
conducted to evaluate the co-administration of reslizumab with other medicinal products. 

5. An infusion set with an in-line, sterile, non-pyrogenic, low-protein-binding filter (pore size of 
0.2 µm) should be used for infusion. CINQAERO is compatible with polyethersulfone (PES), 
polyvinylidene fluoride (PVDF), nylon, cellulose acetate (CA) low protein binding in-line 
infusion filters. 

6. Upon completion of the infusion, flush the infusion set with sterile sodium chloride 9 mg/mL 
(0.9%) solution for infusion to ensure that all of the CINQAERO solution for infusion has been 
administered. 

 
For dosing instructions see section 4.2 of Summary of Product Characteristics. 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER 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