Cinqaero · 4.8 Undesirable effects · 1

HOS-097325 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile The most frequently reported adverse reactions are increased blood creatine phosphokinase (approximately 2% of patients) and anaphylactic reaction (see section 4.4) (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). Table 2: Adverse reactions System organ class Frequency Adverse reaction Immune system disorders Uncommon Anaphylactic reaction* Musculoskeletal and connective Uncommon Myalgia* tissue disorders 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%

Auszug; vollständigen Abschnitt im Original lesen.

HOS-097321 · has-contraindication-information · PDF-Seite 4

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-097320 · has-indication-information · PDF-Seite 2

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).

HOS-097323 · has-interaction-information · PDF-Seite 5

No formal clinical 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, 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.

HOS-097324 · has-pregnancy-information · PDF-Seite 5

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 5 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.

HOS-097322 · has-warning-information · PDF-Seite 4

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 4 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 This medicinal product contains 4.6 mg sodium per vial of 10 mL (1.15 mg sodium per vial of 2.5 mL), equivalent to 0.23% (0.06%) of the WHO recommended maximum daily intake of 2 g sodium for an adult.