Finished product reference
Mepolizomab
Injection, Powder, for Solution · Parenteral · 100 mg
- List code
- 50765
- Pharmacologic class
- Monoclonal antibody: anti-interleukin-5 (IL-5)
What it is and how it works
Mepolizumab is a humanised IgG1 monoclonal antibody that binds interleukin-5 and prevents it from binding to its receptor on eosinophils. This reduces the production, maturation and survival of eosinophils, lowering blood and tissue eosinophil counts and eosinophilic inflammation.
Indications
Add-on maintenance treatment of severe refractory eosinophilic asthma; chronic rhinosinusitis with nasal polyps inadequately controlled by standard therapy; eosinophilic granulomatosis with polyangiitis (EGPA); hypereosinophilic syndrome.
Dosage and administration (summary)
Severe eosinophilic asthma and nasal polyps: 100 mg by subcutaneous injection every 4 weeks. EGPA and hypereosinophilic syndrome: 300 mg subcutaneously every 4 weeks.
Contraindications
Hypersensitivity to mepolizumab or excipients.
Warnings and precautions
Not for treatment of acute asthma exacerbations or acute bronchospasm; systemic or inhaled corticosteroids should not be stopped abruptly after starting treatment. Hypersensitivity reactions, including anaphylaxis, may occur. Pre-existing helminth infections should be treated before starting; herpes zoster has been reported and vaccination may be considered.
Pregnancy
IgG antibodies cross the placenta; use in pregnancy only if the expected benefit outweighs the possible risk.
Storage and supply
Store at 2–8 °C (lyophilised powder vials may be stored below 25 °C where the product information permits); do not freeze; protect from light.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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