Cinqaero

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. 3 x patient body weight (in kg). 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. 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.

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.

2). 2). 2). Paediatric population 4 The safety and efficacy of CINQAERO in children and adolescents aged up to 17 years have not been established. No data are available for children aged up to 11 years. 2, but no recommendation on a posology can be made.

Method of administration Intravenous use. This medicinal product is for intravenous infusion only. It must not be administered by the subcutaneous, oral or intramuscular route. 9%) solution for infusion. This medicinal product must not be administered as a bolus injection or as undiluted concentrate.

4). Instructions for administration 1. 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) (less than 1% of patients). During controlled clinical studies, the proportion of patients who discontinued due to any adverse reaction was 1% for both the 3 mg/kg reslizumab and placebo groups. Tabulated list of adverse reactions 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 intravenously.

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).

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. 4). 55% of patients (4 out of 730) in the placebo group. Blood creatine phosphokinase increased 7 Blood creatine phosphokinase elevations were transient and asymptomatic, and did not lead to treatment discontinuation.

3%) in the placebo group. The malignancies observed in reslizumab-treated patients were diverse in nature and without clustering of any particular tissue type. 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.

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 5 In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 8). 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. 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. 06%) of the WHO recommended maximum daily intake of 2 g sodium for an adult.

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