Nucala® (Mepolizumab) — Anti-IL-5 Biologic for Severe Eosinophilic Asthma

First Approved Anti-IL-5 Monoclonal Antibody for Severe Eosinophilic Asthma

Nucala® (Mepolizumab) is a humanised anti-interleukin-5 (anti-IL-5) monoclonal antibody used as add-on maintenance treatment for severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis (EGPA), hypereosinophilic syndrome (HES), and chronic rhinosinusitis with nasal polyps (CRSwNP). By targeting IL-5 — the primary cytokine driving eosinophil production and survival — Nucala reduces blood and tissue eosinophil counts, significantly decreasing asthma exacerbations and improving lung function in patients with severe eosinophilic disease.

A.K. Pharma is a trusted medicine distributor in Delhi supplying genuine Nucala (Mepolizumab) to hospitals, respiratory medicine centres, allergy clinics, and pharmacies across India. Manufactured by GSK (GlaxoSmithKline), Nucala is one of the most important biologic therapies for severe eosinophilic asthma — a disease segment where conventional inhaled corticosteroids and bronchodilators are insufficient.

What is Nucala (Mepolizumab)?

Nucala contains Mepolizumab — a humanised IgG1 kappa monoclonal antibody that specifically binds to and neutralises interleukin-5 (IL-5). IL-5 is the principal cytokine responsible for the growth, differentiation, recruitment, activation, and survival of eosinophils — the white blood cells central to eosinophilic inflammation.

In severe eosinophilic asthma elevated IL-5 drives persistent eosinophilic airway inflammation that is inadequately controlled by inhaled corticosteroids — leading to recurrent exacerbations, progressive airway remodelling, and declining lung function. By blocking IL-5 signalling, Nucala dramatically reduces eosinophil counts in blood and airways — addressing the fundamental pathological mechanism of severe eosinophilic asthma.

Full prescribing information is available at the FDA label for Mepolizumab.

Clinical Studies and Evidence

MENSA Trial (Mepolizumab for Severe Eosinophilic Asthma) Published in the New England Journal of Medicine (2014), the MENSA trial demonstrated that Mepolizumab significantly reduced the annual rate of asthma exacerbations by 47% (SC) compared to placebo, and significantly improved FEV1, asthma control scores, and quality of life in patients with severe eosinophilic asthma.

SIRIUS Trial (Mepolizumab OCS-Sparing) Published in the New England Journal of Medicine (2014), the SIRIUS trial demonstrated that Mepolizumab significantly reduced oral corticosteroid (OCS) doses by a median of 50% compared to placebo in OCS-dependent severe asthma patients — with 32% of Mepolizumab patients achieving complete OCS elimination vs 9% for placebo.

DREAM Trial (Mepolizumab Dose-Ranging) Published in The Lancet (2012), the DREAM trial confirmed Mepolizumab’s significant exacerbation reduction across all doses in severe eosinophilic asthma and established blood eosinophil count as the key biomarker for patient selection.

EGPA Studies Published in the New England Journal of Medicine (2017), the MIRRA trial demonstrated Mepolizumab significantly increased the proportion of patients achieving sustained remission in EGPA (28% vs 3% placebo) and significantly reduced OCS doses — establishing Mepolizumab as the first approved treatment for EGPA.

HES Studies Clinical trials demonstrated significant reductions in HES flares and OCS requirements with Mepolizumab in hypereosinophilic syndrome — leading to FDA approval for this rare indication.

Available Strengths

Nucala is available as:

• 100mg/mL solution in a prefilled syringe (for subcutaneous injection)
• 100mg powder for solution for injection (lyophilised vial — for healthcare professional reconstitution)

The recommended dose is 100mg subcutaneously every 4 weeks — administered by a healthcare professional. After appropriate training patients may self-inject using the prefilled syringe or autoinjector.

Indications — What Nucala is Used For

Severe Eosinophilic Asthma:

• Add-on maintenance treatment of severe eosinophilic asthma in adults and adolescents aged 12 years and older
• For patients with blood eosinophil count ≥150 cells/µL at initiation or ≥300 cells/µL in the past 12 months
• In patients with inadequate control on high-dose inhaled corticosteroids plus additional controller medicines

Eosinophilic Granulomatosis with Polyangiitis (EGPA):

• Add-on treatment for adults with EGPA — formerly known as Churg-Strauss syndrome

Hypereosinophilic Syndrome (HES):

• Treatment of adults with HES for 6 or more months without an identifiable non-haematologic secondary cause

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP):

• Add-on maintenance treatment in adults with inadequately controlled CRSwNP

For detailed indication information refer to MedlinePlus Mepolizumab.

Key Benefits of Nucala

Significant Exacerbation Reduction The MENSA trial demonstrated a 47% reduction in asthma exacerbations with Nucala — a clinically and statistically significant benefit that reduces hospitalisations, emergency department visits, and oral corticosteroid courses.

Oral Corticosteroid Sparing The SIRIUS trial demonstrated Nucala reduces OCS doses by 50% and achieves complete OCS elimination in 32% of OCS-dependent patients — dramatically reducing the long-term burden of chronic corticosteroid side effects.

Improvement in Lung Function Nucala significantly improves FEV1 and other lung function parameters in severe eosinophilic asthma — reflecting reduced airway inflammation and remodelling.

First Approved Treatment for EGPA Nucala is the first and only medicine approved specifically for EGPA — a rare and serious eosinophilic vasculitis — providing a targeted treatment option for a disease with significant unmet need.

Convenient Monthly Dosing A single subcutaneous injection every 4 weeks maintains therapeutic IL-5 suppression — providing convenient, consistent disease control with minimal treatment burden.

Validated Biomarker-Guided Patient Selection Blood eosinophil count is a validated predictive biomarker for Nucala response — enabling precision medicine patient selection and predicting treatment benefit.

How Nucala Works

Eosinophils are white blood cells that play a central role in allergic and eosinophilic inflammation. In severe eosinophilic asthma the IL-5 pathway drives persistent eosinophilic airway inflammation:

• Th2 cells and ILC2s produce IL-5 in response to allergens and inflammatory stimuli
• IL-5 binds to IL-5 receptors on eosinophil precursors in bone marrow — driving differentiation and production
• IL-5 promotes eosinophil release from bone marrow into circulation
• IL-5 activates mature eosinophils in airways — enhancing their inflammatory activity
• Activated eosinophils release toxic granule proteins, cytokines, and reactive oxygen species
• This eosinophilic inflammation causes airway hyperresponsiveness, mucus hypersecretion, and airway remodelling

Nucala works by:

• Binding with high affinity to IL-5 — neutralising its biological activity
• Preventing IL-5 from binding to IL-5 receptor alpha on eosinophil precursors
• Reducing eosinophil production in bone marrow
• Decreasing eosinophil release into circulation
• Reducing tissue eosinophilia in airways, blood, and other organs
• Attenuating eosinophilic airway inflammation

For a detailed mechanism overview refer to the Global Initiative for Asthma (GINA) guidelines and British Thoracic Society asthma guidelines.

Patient Selection — Who Responds Best to Nucala

Blood eosinophil count is the key biomarker predicting Nucala response:

Additional factors favouring Nucala:

• History of frequent exacerbations (≥2 per year) despite high-dose ICS
• OCS-dependent asthma
• Late-onset asthma (adult-onset)
• Non-allergic or mixed asthma phenotype
• Comorbid nasal polyps or EGPA

Nucala vs Fasenra — Choosing the Right Anti-Eosinophil Biologic

Dosage and Administration

Severe Eosinophilic Asthma / CRSwNP:

• 100mg subcutaneously every 4 weeks
• Administered in upper arm, thigh, or abdomen
• By healthcare professional or trained patient/carer

EGPA:

• 300mg subcutaneously every 4 weeks
• Administered as three separate 100mg injections at the same visit

HES:

• 300mg subcutaneously every 4 weeks
• Administered as three separate 100mg injections

Administration Points:

• Allow prefilled syringe to reach room temperature (30 minutes) before injection
• Do not inject into areas that are bruised, red, tender, or hard
• Rotate injection sites
• Do not shake the syringe or autoinjector
• Do not continue maintenance oral corticosteroids without medical advice when starting Nucala — dose taper should be gradual and supervised

Full dosing guidelines available at Drugs.com Mepolizumab Dosage.

Who Should Use Nucala

Nucala is prescribed for:

• Adults and adolescents (≥12 years) with severe eosinophilic asthma not controlled on high-dose ICS + LABA
• Patients with blood eosinophil count ≥150 cells/µL at initiation
• OCS-dependent severe asthma patients requiring steroid-sparing therapy
• Adults with EGPA requiring disease control
• Adults with HES requiring long-term management
• Adults with inadequately controlled CRSwNP

Nucala is prescribed by respiratory physicians, allergists, immunologists, and rheumatologists. A.K. Pharma supplies Nucala to hospitals, respiratory medicine centres, and pharmacies across Delhi and India.

Possible Side Effects

Common side effects include headache, injection site reactions (pain, redness, swelling), back pain, fatigue, and nasopharyngitis.

Serious side effects include:

• Hypersensitivity reactions including anaphylaxis — observe patients for at least 30 minutes after injection
• Herpes zoster — increased risk reported
• Opportunistic infections — monitor for parasitic infections (helminth) before and during treatment

Full side effect information available at FDA Mepolizumab Safety Information.

Precautions

• Do not use to treat acute asthma attacks or status asthmaticus
• Do not abruptly discontinue oral corticosteroids when initiating Nucala — taper gradually under supervision
• Screen for and treat pre-existing helminth infections before starting Nucala
• Monitor for hypersensitivity reactions after each injection — particularly first few doses
• Vaccinations — administer live vaccines with caution during Nucala treatment
• Continue all existing asthma controller medicines when starting Nucala
• Refer to GINA Severe Asthma Guidelines for complete management context

Storage and Handling

• Store in refrigerator between 2°C and 8°C
• Do not freeze
• Protect from light — keep in original carton
• Allow to reach room temperature before injection — approximately 30 minutes
• Do not use heating devices to warm syringe
• Use immediately after removing from refrigerator

As a responsible medicine distributor in Delhi, A.K. Pharma maintains full cold chain requirements during storage and supply of Nucala ensuring product integrity for every unit supplied.

Manufacturer Information

Nucala (Mepolizumab) is manufactured by GSK (GlaxoSmithKline), a global pharmaceutical and vaccines company. Mepolizumab received FDA approval in November 2015 for severe eosinophilic asthma. A.K. Pharma supplies only genuine Nucala sourced from authorized GSK distributors.

Related Lung and Allergy Medicines Available at A.K. Pharma

• Fasenra 30mg (Benralizumab) — anti-IL-5 receptor biologic for severe eosinophilic asthma
• Dupixent (Dupilumab) — anti-IL-4/IL-13 biologic for asthma, atopic dermatitis, and CRSwNP
• Browse all Lungs Medicines available at A.K. Pharma
• Browse all Allergy Medicines available at A.K. Pharma

Frequently Asked Questions

Q. What is Nucala used for? Nucala (Mepolizumab) is used as add-on maintenance treatment for severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis (EGPA), hypereosinophilic syndrome (HES), and chronic rhinosinusitis with nasal polyps. More information available at MedlinePlus.

Q. What is the generic name of Nucala? The generic name of Nucala is Mepolizumab. It is a humanised anti-IL-5 monoclonal antibody.

Q. What blood eosinophil count is needed to qualify for Nucala? Patients should have blood eosinophil count ≥150 cells/µL at initiation or ≥300 cells/µL in the past 12 months. Higher eosinophil counts predict greater treatment benefit.

Q. How is Nucala different from Fasenra? Both target the IL-5 pathway but differently. Nucala neutralises IL-5 itself while Fasenra targets the IL-5 receptor alpha — depleting eosinophils more completely through ADCC. Nucala has additional approvals for EGPA and HES that Fasenra does not. Fasenra offers less frequent dosing (every 8 weeks after initiation).

Q. Is Nucala available in India? Nucala can be supplied to hospitals, respiratory medicine centres, and pharmacies across India through licensed pharmaceutical distributors. Contact A.K. Pharma — medicine distributor in Delhi — for availability and pricing.

Q. What is the price of Nucala in India? Nucala price in India varies by pack size. Contact A.K. Pharma at 011 4172 6999 or WhatsApp +91 9810034827 for current pricing and bulk supply rates.

Q. How to order Nucala from A.K. Pharma? You can request a quote directly from this page, call us at 011 4172 6999, or WhatsApp us at +91 9810034827 with your requirements and we will respond promptly.

Q. Does A.K. Pharma supply Nucala in bulk? Yes. A.K. Pharma supplies Nucala in bulk to hospitals, respiratory medicine centres, and pharmacies across Delhi and India. Contact us for bulk pricing and availability.

Why Order Nucala from A.K. Pharma?

• Licensed medicine distributor in Delhi with all required drug licenses
• 100% genuine Nucala sourced from authorized GSK distributors
• Cold chain maintained throughout storage and delivery
• Bulk supply available for hospitals and respiratory centres
• Prompt response to all quote requests
• Serving respiratory physicians and allergists across Delhi NCR and India

Contact A.K. Pharma for Nucala Supply 📍 E-2/257A, 2nd Floor, Shastri Nagar, New Delhi 110052 📞 011 4172 6999 📱 WhatsApp: +91 9810034827 🌐 akpharma.in