Product Overview – Nucala▼ (mepolizumab, 100 mg SC)
Nucala is indicated as an add-on treatment for adults, adolescents and children aged 6 years and older with severe refractory eosinophilic asthma.1
Information provided here can help you to determine if your patients are eligible for Nucala and find key information about Nucala and its safety profile.
Severe eosinophilic asthma is a distinct severe asthma phenotype
Severe asthma is a heterogeneous disease comprised of different phenotypes with specific clinical and pathophysiological features.2
Up to 10% of patients with asthma are estimated to have severe asthma.3
Identify patients, who most likely will benefit from treatment with Nucala, based on the following criteria:
- Severe, uncontrolled asthma despite high-level therapy1
High dose of inhaled corticosteroids (ICS) and other controller medication(s)
Two or more exacerbations in the previous 12 months and/or dependency on systemic corticosteroids
≥150 cells/µL at initiation of treatment
≥300 cells/µL in the prior 12 months (determined through a routine blood test)
And a consistent reduction in hospitalisations and/or ED visits resulting from exacerbations vs. placebo, in MENSA and MUSCA studies*7,8:
- 61% reduction (95% CI, 10 to 88) vs. placebo in MENSA at Week 32 (0.08/year vs. 0.20/year; p=0.02)7
- 68% reduction (95% CI, 10 to 88) vs. placebo in MUSCA at Week 24 (0.03/year vs. 0.10/year; p=0.031)8
SC, subcutaneous; SoC, standard of care, ED, emergency department
*MENSA: 53% reduction (95% CI, 36 to 65) vs. placebo at Week 32 (0.83/year vs. 1.74/year; p<0.001)7
MUSCA: 58% reduction (95% CI, 44 to 69) vs. placebo at Week 24 (0.51/year vs. 1.21/year; p<0.0001)8
Nucala consistently reduced exacerbations vs. placebo in patients with blood eosinophil counts as low as 150 cells/μL6
Clinically significant reductions in exacerbations shown consistently in patients with blood eosinophil levels of ≥150 cells/μL and ≥2 exacerbations in the past year.6
IV, intravenous; SC, subcutaneous; SoC, standard of care
Nucala has shown a safety profile established for at least 1.5 years9
Adverse reactions from the MENSA and SIRIUS placebo-controlled studies in patients receiving Nucala 100mg SC (n=263)1, as well as spontaneous post-marketing reporting.
Very common (≥1/10), common (≥1/100 to <1/10), rare (≥1/10,000 to <1/1,000)
*Systemic reactions including hypersensitivity have been reported at an overall incidence comparable to that of placebo.1
**From spontaneous post-marketing reporting.1
†The most common manifestations associated with reports of systemic non-allergic administration-related reactions were rash, flushing and myalgia; these manifestations were reported infrequently and in <1% of subjects receiving Nucala 100 mg subcutaneously.1
Nucala has a similar incidence of adverse events vs. placebo, with the exception of injection site reactions (8% for Nucala, 3% for placebo). The most common manifestations associated with reports of systemic non-allergic administration-related reactions were rash, flushing and myalgia; these manifestations were reported infrequently and in <1% of subjects receiving Nucala 100mg subcutaneously. When both treatments were added to high-dose ICS and additional maintenance treatment(s).
Local injection site reactions occurred mainly at the start of treatment and within the first 3 injections, with fewer reports on subsequent injection.
Special warnings and precautions for use
- Nucala should not be used to treat acute asthma exacerbations.
- Asthma-related adverse events 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.
- Abrupt discontinuation of corticosteroids after initiation of Nucala is not recommended. Reduction in corticosteroid doses, if required, should be gradual and performed under the supervision of a physician.
- Hypersensitivity and administration-related reactions: Acute and delayed systemic reactions, including hypersensitivity reactions (e.g. anaphylaxis, urticaria, angioedema, rash, bronchospasm, hypotension), have occurred following administration of Nucala. These reactions generally occur within hours of administration, but in some instances have a delayed onset (i.e., typically within several days). These reactions may occur for the first time after a long duration of treatment.
- Parasitic infections: Patients with pre-existing helminth infections should be treated before starting therapy. If patients become infected whilst receiving treatment with Nucala and do not respond to anti-helminth treatment, temporary discontinuation of Nucala should be considered.
Nucala offers the convenience of a single, fixed dose
- Nucala preparatomtale
- Chung KF, Wenzel SE, Brozek JL et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J 2014; 43:343–373.
- Moore WC, Bleecker ER, Curran-Everett D et al. Characterization of the severe asthma phenotype by the National Heart, Lung, and Blood Institute's Severe Asthma Research Program. J Allergy Clin Immunol 2007; 119:405–413.
- Rosenberg HF Phipps S, Foster PS. Eosinophil trafficking in allergy and asthma. J Allergy Clin Immunol 2007; 119: 1303–1310.
- Ortega H, CChupp G, Bardin P et al. The role of mepolizumab in atopic and nonatopic severe asthma with persistent eosinophilia.Eur Respir J 2014; 44:239–241.
- Ortega HG, Yancey SW, Mayer B et al. Severe eosinophilic asthma treated with mepolizumab stratified by baseline eosinophil thresholds: a secondary analysis of the DREAM and MENSA studies. Lancet Respir Med 2016; 4:549–556
- Ortega H, Liu MC, Pavord ID, et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med 2014; 371:1198–1207.
- Chupp GL, Bradford ES, Albers FC et al. Efficacy of mepolizumab add-on therapy on health-related quality of life and markers of asthma control in severe eosinophilic asthma (MUSCA): a randomised, double-blind, placebo-controlled, parallel-group, multicentre, phase 3b trial. Lancet Respir Med 2017; 5:390–400.
- Lugogo N, Domingo C, Chanez P et al. Long-term Efficacy and Safety of Mepolizumab in Patients With Severe Eosinophilic Asthma: A Multi-center, Open-label, Phase IIIb Study. Clin Ther 2016; 38:2058–2070.