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Nucala is a brand name for Mepolizumab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Severe eosinophilic asthma Nucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older (see section 5.1). 3 Chronic rhinosinusitis with nasal polyps (CRSwNP) Nucala is indicated as an add-on therapy with intranasal corticosteroids for…
Verbatim from this product's EMA label. Tap a section to expand.
It is recommended that Nucala is prescribed by physicians experienced in the diagnosis and treatment of severe refractory eosinophilic asthma, CRSwNP, COPD, EGPA or HES. Posology Severe eosinophilic asthma Adults and adolescents aged 12 years and over The recommended dose of mepolizumab is 100 mg administered subcutaneously once every 4 weeks.
Children aged 6 to 11 years old The recommended dose of mepolizumab is 40 mg administered subcutaneously once every 4 weeks. Nucala is intended for long-term treatment. The need for continued therapy is to be considered at least on an annual basis as determined by physician assessment of the patient’s disease severity and level of control of exacerbations.
CRSwNP Adults The recommended dose of mepolizumab is 100 mg administered subcutaneously once every 4 weeks. Nucala is intended for long-term treatment. Consideration can be given to alternative treatments in patients who have shown no response after 24 weeks of treatment for CRSwNP.
Some patients with initial partial response may subsequently improve with continued treatment beyond 24 weeks. 4 COPD Adults The recommended dose of mepolizumab is 100 mg administered subcutaneously once every 4 weeks. Nucala is intended for long-term treatment.
The need for continued therapy is to be considered at least on an annual basis as determined by physician assessment of the patient’s disease severity and level of control of exacerbations. EGPA Adults and adolescents aged 12 years and older The recommended dose of mepolizumab is 300 mg administered subcutaneously once every 4 weeks.
2). Children aged 6 to 11 years old weighing ≥ 40 kg The recommended dose of mepolizumab is 200 mg administered subcutaneously once every 4 weeks. Children aged 6 to 11 years old weighing < 40 kg The recommended dose of mepolizumab is 100 mg administered subcutaneously once every 4 weeks.
Nucala is intended for long-term treatment. The need for continued therapy is to be reviewed at least on an annual basis as determined by physician assessment of the patient’s disease severity and improvement of symptom control. Patients who develop life-threatening manifestations of EGPA must also be evaluated for the need for continued therapy, as Nucala has not been studied in this population.
HES Adults The recommended dose of mepolizumab is 300 mg administered subcutaneously once every 4 weeks. Nucala is intended for long-term treatment. The need for continued therapy is to be reviewed at least on an annual basis as determined by physician assessment of the patient’s disease severity and level of symptom control.
Summary of the safety profile Severe eosinophilic asthma In placebo-controlled studies in adult and adolescent patients with severe refractory eosinophilic asthma, the most commonly reported adverse reactions during treatment were headache (20%), injection site reactions (8%) and back pain (6%).
CRSwNP In a placebo-controlled study in patients with CRSwNP, the most commonly reported adverse reactions during treatment were headache (18%) and back pain (7%). COPD In three placebo-controlled studies in patients with COPD, the most commonly reported adverse reactions during treatment were headache (10%), back pain (7%) and arthralgia (5%).
EGPA In a placebo-controlled study in patients with EGPA, the most commonly reported adverse reactions during treatment were headache (32%), injection site reactions (15%) and back pain (13%). Systemic allergic/hypersensitivity reactions were reported by 4% of EGPA patients.
HES In a placebo-controlled study in patients with HES, the most commonly reported adverse reactions during treatment were headache (13%), urinary tract infection (9%), injection site reactions and pyrexia (7% each). Tabulated list of adverse reactions The table below presents the adverse reactions from placebo-controlled severe eosinophilic asthma studies from patients receiving mepolizumab 100 mg subcutaneously (SC) (n=263), from a 9 randomised, double-blind placebo-controlled 52-week study in patients with CRSwNP receiving mepolizumab 100 mg SC (n=206), in three double-blind placebo-controlled 52- to 104-week studies in patients with COPD receiving mepolizumab 100 mg SC (n=1043), in patients with EGPA receiving mepolizumab 300 mg SC (n=68), in a double-blind placebo-controlled 32-week study in patients with HES receiving mepolizumab 300 mg SC (n= 54), and from spontaneous post-marketing reports.
5 years). The safety profile of mepolizumab in HES patients (n=102) enrolled in a 20-week open label extension study was similar to the safety profile of patients in the pivotal placebo-controlled study. The frequency of adverse reactions 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); and not known (cannot be estimated from available data).
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. Asthma or COPD exacerbations Mepolizumab must not be used to treat acute asthma or COPD exacerbations.
Asthma-related or COPD-related adverse symptoms or exacerbations may occur during treatment. Patients must be instructed to seek medical advice if their asthma or COPD remains uncontrolled or worsens after initiation of treatment. Corticosteroids Abrupt discontinuation of corticosteroids after initiation of mepolizumab therapy is not recommended.
Reduction in corticosteroid doses, if required, must be gradual and performed under the supervision of a physician. g. anaphylaxis, urticaria, angioedema, rash, bronchospasm, hypotension), have occurred following administration of mepolizumab.
, typically within several days). 8). In the event of a hypersensitivity reaction, appropriate treatment as clinically indicated must be initiated. 7 Parasitic infections Eosinophils may be involved in the immunological response to some helminth infections.
Patients with pre-existing helminth infections should be treated before starting therapy. If patients become infected whilst receiving treatment with mepolizumab and do not respond to anti-helminth treatment, temporary discontinuation of therapy should be considered.
COPD patients with low blood eosinophil counts Data do not support the use of Nucala in patients with COPD with blood eosinophil count <150 cells/mcL and no evidence of blood eosinophil count ≥300 cells/mcL in the previous 12 months.
2). 2). Excipients This medicinal product contains polysorbate 80 (see section 2), which may cause allergic reactions. This medicinal product contains less than 1 mmol sodium (23 mg) per 100 mg dose, that is to say essentially “sodium-free”.
1.
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Patients who develop life-threatening manifestations of HES must also be evaluated for the need for continued therapy, as Nucala has not been studied in this population. 2). 2). 5 Paediatric population Severe eosinophilic asthma Children aged 6 to 11 years old Nucala 100 mg powder for solution for injection and 40 mg solution for injection in pre-filled syringe are appropriate for administration to this population.
Nucala 100 mg solution for injection in pre-filled pen and 100 mg solution for injection in pre-filled syringe are not indicated for administration to this population. Children less than 6 years old The safety and efficacy of mepolizumab in children less than 6 years old have not yet been established.
No data are available. CRSwNP in children less than 18 years old The safety and efficacy in children with CRSwNP below the age of 18 years have not been established. No data are available. COPD in children less than 18 years old There is no relevant use of mepolizumab in the paediatric population (under 18 years of age) for the indication of COPD.
EGPA in children less than 6 years old The safety and efficacy of mepolizumab has not been established in children below the age of 6 years old. No data are available. HES in children aged less than 18 years old The safety and efficacy of mepolizumab in children and adolescents aged less than 18 years old have not yet been established.
2 but no recommendation on a posology can be made. Method of administration Nucala 100 mg solution for injection in pre-filled pen or pre-filled syringe The pre-filled pen or pre-filled syringe must be used for subcutaneous injection only.
Nucala may be self-administered by the patient or administered by a caregiver if their healthcare professional determines that it is appropriate, and the patient or caregiver are trained in injection techniques. For children aged 6 to 11 years old, administration must be carried out by a healthcare professional or a trained caregiver.
6 For self-administration the recommended injection sites are the abdomen or thigh. A caregiver can also inject Nucala into the upper arm. For doses which require more than one injection, it is recommended that each injection is administered at least 5 cm apart.
Comprehensive instructions for subcutaneous administration of Nucala in a pre-filled pen or pre-filled syringe are provided in the instructions for use in the package leaflet. Nucala 40 mg solution for injection in pre-filled syringe The pre-filled syringe must be used for subcutaneous injection only.
Nucala must be administered by a healthcare professional or a caregiver. It may be administered by a caregiver if a healthcare professional determines that it is appropriate, and the caregiver is trained in injection techniques. The recommended injection sites are the upper arm, abdomen or thigh.
Comprehensive instructions for subcutaneous administration of Nucala in a […]
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. System Organ Class Adverse reactions Frequency Infections and infestations Lower respiratory tract infection Urinary tract infection Pharyngitis Herpes zoster** Common Immune system disorders Hypersensitivity reactions (systemic allergic)* Anaphylaxis** Common Rare Nervous system disorders Headache Very common Respiratory, thoracic and mediastinal disorders Nasal congestion Common Gastrointestinal disorders Abdominal pain upper Common Skin and subcutaneous tissue disorders Eczema Common Musculoskeletal and connective tissue disorders Back pain Arthralgia** Common General disorders and administration site conditions Administration-related reactions (systemic non allergic)*** Local injection site reactions Pyrexia Common * Systemic reactions including hypersensitivity have been reported at an overall incidence comparable to that of placebo in the severe eosinophilic asthma and COPD studies.
4. **From spontaneous post marketing reporting. Herpes zoster was reported uncommonly in severe asthma studies. *** The most common manifestations associated with reports of systemic non-allergic administration- related reactions from patients in the severe eosinophilic asthma and COPD studies were rash, flushing, myalgia and fatigue; these manifestations were reported infrequently and in <1% of patients receiving mepolizumab 100 mg subcutaneously.
Description of selected adverse reactions Systemic reactions, including hypersensitivity reactions, in CRSwNP In the 52-week placebo-controlled study, systemic allergic (type I hypersensitivity) reactions were reported in 2 patients (<1%) in the group receiving mepolizumab 100 mg and in no patients in the placebo group.
Other systemic reactions were reported by no patients in the group receiving mepolizumab 100 mg and in 1 patient (<1%) in the placebo group. 10 Systemic reactions, including hypersensitivity reactions, in COPD In the 52- to 104-week placebo-controlled study, systemic allergic (type I hypersensitivity) reactions were reported in 1 patient (<1%) in the group receiving mepolizumab 100 mg and in no patients in the placebo group.
Other systemic reactions were reported by 4 patients (<1%) in the group receiving mepolizumab 100 mg and in 4 patients (<1%) in the placebo group. In the two 52-week placebo-controlled studies, systemic allergic/hypersensitivity reactions were reported in 4 patients (<1%) in the groups receiving mepolizumab 100 mg and in 3 patients (<1%) in the placebo groups.
Systemic non-allergic reactions were reported by 7 patients (1%) in the groups receiving mepolizumab 100 mg and in 10 patients (2%) in the placebo groups. Systemic reactions, including hypersensitivity reactions, in EGPA In the 52-week placebo-controlled study the percentage of patients who experienced systemic (allergic and non-allergic) reactions was 6% in the group receiving 300 mg of mepolizumab and 1% in the placebo group.
Systemic allergic/hypersensitivity reactions were reported by 4% of patients in the group receiving 300 mg of mepolizumab and 1% of patients in the placebo group. Systemic non- allergic reactions (angioedema) were reported by 1 (1%) patient in the group receiving 300 mg of mepolizumab and no patients in the placebo group.
Systemic reactions, including hypersensitivity reactions, in HES In the 32-week […]