NUCALA (mepolizumab) injection

Nucala is a brand-name prescription medication. It’s used to treat two conditions: severe eosinophilic asthma in adults and children ages 12 years and older. With this kind of severe asthma, you have high levels of eosinophils (a type of white blood cell). Brand Name: NUCALA (mepolizumab) injection, for subcutaneous use Initial U.S. Approval: 2015

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NUCALA (mepolizumab) injection Price In India and Overseas
NUCALA (mepolizumab) injection

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NUCALA (mepolizumab) injection

Mepolizumab, sold under the brand name Nucala by GlaxoSmithKline, is a humanized monoclonal antibody used for the treatment of severe eosinophilic asthma, eosinophilic granulomatosis, and hypereosinophilic syndrome (HES).

NUCALA is an interleukin-5 (IL-5) antagonist monoclonal antibody (IgG1 kappa) indicated for:
• Add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype.
• Add-on maintenance treatment of adult patients 18 years and older with chronic rhinosinusitis with nasal polyps (CRSwNP).
• The treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
• The treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for ≥6 months without an identifiable non-hematologic secondary cause.

Mepolizumab is approved by the U.S. Food and Drug Administration (FDA) for the maintenance treatment of severe asthma in patients aged six years or older and with an eosinophilic phenotype in combination with other medicines used to treat asthma.[6] In the European Union it is approved as an add-on treatment for severe refractory eosinophilic asthma in adults.

In studies, mepolizumab cut the necessity for hospitalisation due to asthma exacerbations in half, as compared to placebo.

In December 2017, the FDA expanded mepolizumab’s indication to treat adults with eosinophilic granulomatosis with polyangiitis, which is a rare autoimmune condition that can cause vasculitis.

In September 2020, the FDA expanded mepolizumab’s indication to treat adults and children aged twelve years and older with hypereosinophilic syndrome (HES) for six months or longer without another identifiable non-blood related cause of the disease.

Drug (Brand / Generic): NUCALA / mepolizumab
Current Indications: eosinophilic asthma, eosinophilic granulomatosis, and hypereosinophilic syndrome (HES).
Marketed by:: GlaxoSmithKline
Approval Date: 2015

Dosage forms and strengths of NUCALA (mepolizumab) injection
For injection: 100 mg of lyophilized powder in a single-dose vial for reconstitution.
• Injection: 100 mg/mL, single-dose prefilled autoinjector or single-dose prefilled syringe.
• Injection: 40 mg/0.4 mL, single-dose prefilled syringe.

For more highlights of prescribing information regarding Indications and usage, dosage and administration, dosage forms and strengths, patient counseling information and medication guide. Click Here

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