Product Details

NUCALA 100MG 1ML SDV EA

Manufacturer: Glaxo Smith Kline

MFG#: 00173-0881-01

NDC: 00173-0881-01

PID: 666376

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Additional Information

Product NameNucala 100 Mg 1ml SDV Ea
ApplicationInterleukin-5 (IL-5) Antagonist
Generic Drug NameMepolizumab
Mechanism of ActionInhibits IL-5, reducing eosinophil activation and inflammation
Strength100 mg
Dosage FormInjection
TypeSubcutaneous
Administration Schedule100 mg subcutaneously every 4 weeks
Common Side EffectsHeadache, injection site reactions, fatigue, back pain
Serious ReactionsAnaphylaxis, hypersensitivity reactions, increased infection risk
PrecautionsMonitor for hypersensitivity reactions and parasitic infections
Storage RequirementsRequires Refrigeration (2°C to 8°C / 36°F to 46°F)
Container TypeSingle-Dose Vial
UsesSevere eosinophilic asthma, eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES)

Description

Nucala (mepolizumab) is a monoclonal antibody that functions as an interleukin-5 (IL-5) antagonist. It is indicated as an add-on maintenance treatment for patients aged 6 years and older with severe eosinophilic asthma. By targeting IL-5, which plays a critical role in the growth, activation, and survival of eosinophils, Nucala helps reduce airway inflammation, thereby lowering the frequency of asthma exacerbations and improving respiratory function.

Nucala is approved for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune condition characterized by eosinophilic inflammation and vasculitis. It is also indicated for the treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) that has persisted for at least six months without an identifiable non-hematologic secondary cause. 

Nucala is supplied as a sterile, lyophilized powder in a single-use vial containing 100 mg of mepolizumab. It requires reconstitution with sterile water before administration as a subcutaneous injection. The injection is typically given once every four weeks into the upper arm, thigh, or abdomen. 


 

Frequently Asked Questions (FAQs)

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NUCALA 100MG 1ML SDV EA is manufactured by Glaxo Smith Kline.

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