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Pick section Severe Eosinophilic Asthma (SEA)

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Severe Eosinophilic Asthma (SEA)

NUCALA IN PEDIATRIC PATIENTS

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IMPROVED ASTHMA CONTROL FOR PEDIATRIC PATIENTS

AIM FOR HEALTHY LEVEL OF BLOOD EOSINOPHILS

IMPROVED ASTHMA CONTROL FOR PEDIATRIC PATIENTS

NUCALA is the biological available in 1 fixed dosage (40 mg), to treat SEA in children 6-11 years old, independent from weight.^3

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*Open-label, uncontrolled, repeat-dose extension study with children aged 6 to 11 years with severe asthma with an eosinophilic phenotype received a body weight-dependent dose of SC mepolizumab of 40mg (<40 kg) or 100mg (≥40 kg) over 52 weeks.1
^Nucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older.3
The recommended dose of mepolizumab is 100 mg administered SC once every 4 weeks in adults and adolescents 12 years and older.3

Licensed dose of mepolizumab in SEA patients aged 6 to 11 years old is 40mg SC, regardless of weight.3

ACQ-5, asthma control questionnaire 5 items; CI, confidence interval; MCID, minimal clinically important difference; SC, subcutaneous; SEA, severe eosinophilic asthma.

AIM FOR HEALTHY LEVEL OF BLOOD EOSINOPHILS

NUCALA is the anti-IL-5 that reduces blood eosinophils and maintains them at normal healthy levels1,2*

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*Normal healthy levels: 30-395 eosinophils/µL (5th-95th percentile), from LEAD study: longitudinal, observational, population-based Austrian cohort. General population that had eosinophil count measured: n=11,042. Healthy sub-population: n=3,641. Geometric mean value within the healthy sub­population: 107 eosinophils/µL (95% Cl: 105, 110).2

BL, baseline; Cl, confidence interval; IL, interleukin; GM, geometric mean; LEAD, lung hEart sociAI body; µL, microlitre; SEA, severe eosinophilic asthma.

SELECTED SAFETY INFORMATION

Warnings/Precautions: Should not be used to treat acute asthma exacerbations. Patients should be instructed to seek medical advice if their asthma remains uncontrolled or worsens after starting treatment. Abrupt discontinuation of corticosteroids after initiation of mepolizumab treatment is not recommended.

Allergic reactions: Acute and delayed systemic reactions, including hypersensitivity reactions, have occurred following administration of mepolizumab. Patients should be instructed to seek medical attention immediately if allergic reactions occur. In the event of a hypersensitivity reaction, appropriate treatment as clinically indicated should be initiated.

Parasitic infections: 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.

Adverse reactions: In clinical studies in patients with severe refractory eosinophilic asthma, headache, injection site reactions and back pain were the most commonly reported adverse reactions during treatment.

Refusjon: 1H-resept: R03D X09_1 Mepolizumab.

Refusjonsberettiget bruk: Der det er utarbeidet nasjonale handlingsprogrammer/nasjonal faglig retningslinje og/eller anbefalinger fra RHF/LIS spesialistgruppe skal rekvirering gjøres i tråd med disse.

Vilkår: 216 Refusjon ytes kun etter resept fra sykehuslege eller avtalespesialist.

Maksimalpriser: 100 mg 1 stk ferdigfylt penn/sprøyte 11967,30 kr. 40 mg 1 stk ferdigfylt sprøyte 4808,70 kr. 100 mg pulver til injeksjonsvæske 1 stk (hettegl.) 12133,10 kr. Avtalepris inngår i Sykehusinnkjøp anbud LIS 2022 Alvorlig ukontrollert T2-høy astma fra 01.04.2022.4

Anbudet inneholder rabatterte priser. Nucala (mepolizumab) er besluttet innført av Beslutningsforum til behandling av alvorlig eosinofil astma, kronisk rhinosinusitt med nasal polypose (CRSwNP) og hypereosinofilt syndrom (HES). Indikasjonen EGPA er til vurdering i nye metoder. Beslutning om innføring foreligger ikke.

References

  1. Gupta A, Ikeda M, Geng B, et al. Long-term safety and pharmacodynamics of mepolizumab in children with severe asthma with an eosinophilic phenotype. J Allergy C/in lmmunol. 2019;144(5):1336-1342.e7.
  2. Hartl S, Breyer MK, Burghuber OC, et al. Blood eosinophil count in the general population: typical values and potential confounders. Eur Respir J 2020;55(5):1901874.
  3. SmPC Nucala
  4. https://nyemetoder.no/metoder/mepolizumab-nucala-indikasjon-iii

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PM-NO-MPL-WCNT-230029 - Oktober 2023