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Concise Prescribing Info
Contents
Mepolizumab
Indications/Uses
Add-on treatment for severe refractory eosinophilic asthma in adults & adolescents ≥12 yr. Add-on therapy w/ intranasal corticosteroids for the treatment of adults w/ severe chronic rhinosinusitis w/ nasal polyps (CRSwNP) for whom therapy w/ systemic corticosteroids &/or surgery do not provide adequate disease control. Add-on treatment for adults w/ relapsing-remitting or refractory eosinophilic granulomatosis w/ polyangiitis (EGPA). Add-on treatment for adults w/ inadequately controlled hypereosinophilic syndrome (HES) w/o an identifiable non-haematologic secondary cause.
Dosage/Direction for Use
SC Adult & adolescent ≥12 yr Severe eosinophilic asthma 100 mg once every 4 wk. Adult CRSwNP 100 mg once every 4 wk. EGPA 300 mg once every 4 wk. HES 300 mg once every 4 wk.
Overdosage
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Contraindications
Hypersensitivity.
Special Precautions
Should not be used to treat acute asthma exacerbations. Asthma-related adverse symptoms or exacerbations may occur. Abrupt discontinuation of corticosteroids after initiation of Nucala therapy is not recommended. Risk of acute & delayed systemic reactions, including hypersensitivity reactions. Patients w/ pre-existing helminth infections should be treated before treatment initiation. Has not been studied in patients w/ organ- or life-threatening manifestations of EGPA & in patients w/ life-threatening manifestations of HES. Avoid use during pregnancy. Discontinue breast-feeding or discontinue Nucala therapy. Severe eosinophilic asthma: Safety & efficacy have not yet been established in childn <12 yr. CRSwNP/EGPA/HES: Safety & efficacy have not yet been established in childn <18 yr.
Use In Pregnancy & Lactation
Adverse Reactions
Headache. Lower resp tract infection, UTI, pharyngitis; hypersensitivity reactions (systemic allergic); nasal congestion; upper abdominal pain; eczema; back pain; administration-related reactions (systemic non-allergic), local inj site reactions, pyrexia.
Caution For Usage
For caution against possible variation of physical aspect of medicine... Click to view Nucala detailed prescribing information
Storage
View Nucala storage conditions for details to ensure optimal shelf-life.
Description
View Nucala description for details of the chemical structure and excipients (inactive components).
Action
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ATC Classification
R03DX09 - mepolizumab ; Belongs to the class of other systemic drugs used in the treatment of obstructive airway diseases.
P1S1S3
Patient Counseling Information
Presentation/Packing
Form
Nucala powd for soln for inj 100 mg
Packing/Price
1's
Form
Nucala soln for inj 100 mg/mL
Packing/Price
1's
