Mepolizumab

Mepolizumab is an IL-5 antagonist (IgG1 kappa). IL-5 is the major cytokine responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils.

• 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. ( 1.1 ) • Add-on maintenance treatment of adult patients aged 18 years and older with chronic rhinosinusitis with nasal polyps (CRSwNP).ICD-10: J45.909

• NUCALA is contraindicated in patients with a history of hypersensitivity to mepolizumab or excipients in the formulation [see Warnings and Precautions ( 5.1 ), Description ( 11 )] . History of hypersensitivity to mepolizumab or excipients in the formulation.contraindicated

• Severe asthma in patients aged 12 years and older: 100 mg administered subcutaneously once every 4 weeks. ( 2.1 ) • Severe asthma in patients aged 6 to 11 years: 40 mg administered subcutaneously once every 4 weeks. ( 2.1 ) • CRSwNP: 100 mg administered subcutaneously once every 4 weeks. ( 2.1 ) • COPD: 100 mg administered subcutaneously once every 4 weeks. ( 2.1 ) • EGPA: 300 mg administered subcutaneously once every 4 weeks. ( 2.1 ) • HES: 300 mg administered subcutaneously once every 4 weeks. ( 2.1 ) 2.1 Recommended Dosage NUCALA is for subcutaneous use only, and should be injected into the upper arm, thigh, or abdomen [see Dosage and Administration ( 2.2 , 2.3 )]. Table 1. Recommended Dosage of NUCALA a 300 mg dose is administered as 3 separate 100 mg dose injections administered at least 5 cm (approximately 2 inches) apart. Indication Adults Pediatric Patients Severe asthma 100 mg every 4 weeks • 12 to 17 years of age: 100 mg every 4 weeks • 6 to 11 years of age: 40 mg every 4 weeks Chronic rhinosinusitis with nasal polyps 100 mg every 4 weeks Not applicable Chronic obstructive pulmonary disease 100 mg every 4 weeks Not applicable Eosinophilic granulomatosis with polyangiitis 300 mg a every 4 weeks Not applicable Hypereosinophilic syndrome 300 mg a every 4 weeks 12 to 17 years of age: 300 mg a every 4 weeks 2.2 Preparation and Administration of NUCALA for Injection Vial NUCALA for injection should be reconstituted and administered by a healthcare professional.

• Hypersensitivity reactions (e.g., anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred after administration of NUCALA. Discontinue NUCALA in the event of a hypersensitivity reaction. ( 5.1 ) • Herpes zoster infections have occurred in patients receiving NUCALA. Consider vaccination if medically appropriate. ( 5.3 ) • Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with NUCALA. Decrease corticosteroids gradually, if appropriate. ( 5.4 ) • Treat patients with pre-existing helminth infections before therapy with NUCALA. If patients become infected while receiving treatment with NUCALA and do not respond to anti-helminth treatment, discontinue NUCALA until parasitic infection resolves. ( 5.5 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions (e.g., anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred following administration of NUCALA. These reactions generally occur within hours of administration, but in some instances can have a delayed onset (i.e., days). In the event of a hypersensitivity reaction, NUCALA should be discontinued [see Contraindications ( 4 )] . 5.2 Acute Symptoms of Asthma or Chronic Obstructive Pulmonary Disease or Acute Deteriorating Disease NUCALA should not be used to treat acute symptoms or acute exacerbations of asthma or COPD. Do not use NUCALA to treat acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma or COPD remains uncontrolled or worsens after initiation of treatment with NUCALA.

The following adverse reactions are described in greater detail in other sections: • Hypersensitivity reactions [see Warnings and Precautions ( 5.1 )] • Opportunistic infections: herpes zoster [see Warnings and Precautions ( 5.3 )] Most common adverse reactions (incidence ≥5%): • Asthma: Headache, injection site reaction, back pain, and fatigue. ( 6.1 ) • CRSwNP: Oropharyngeal pain and arthralgia. ( 6.1 ) • COPD: Back pain, diarrhea, and cough. ( 6.1 ) • EGPA and HES: Most common adverse reactions are similar to asthma. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adult and Adolescent Patients Aged 12 Years and Older with Severe Asthma A total of 1,327 patients with severe asthma were evaluated in 3 randomized, placebo-controlled, multicenter trials of 24 to 52 weeks’ duration (Severe Asthma Trials DREAM, MENSA, and SIRIUS).

8.1 Pregnancy Risk Summary The data on pregnancy exposure are insufficient to inform on drug-associated risk. Monoclonal antibodies, such as mepolizumab, are transported across the placenta in a linear fashion as pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimester of pregnancy. In a prenatal and postnatal development study conducted in cynomolgus monkeys, there was no evidence of fetal harm with intravenous administration of mepolizumab throughout pregnancy at doses that produced exposures up to approximately 9 times the exposure at the maximum recommended human dose (MRHD) of 300 mg subcutaneous (see Data) . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryofetal Risk: In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. The level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control.

Metabolism

Following subcutaneous dosing in adult subjects with asthma, mepolizumab exhibited approximately dose‑proportional pharmacokinetics over a dose range of 12.5 to 250 mg. The pharmacokinetic properties of mepolizumab observed in subjects with CRSwNP (adults), COPD (adults), EGPA (adults), or HES (adults and adolescents) were similar to the pharmacokinetic properties observed in subjects with severe asthma (adults and adolescents).

There is no specific treatment for an overdose with mepolizumab. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

• Nov 4, 2015BLABLA125526Glaxosmithkline Llc
• Jun 6, 2019BLABLA761122Glaxosmithkline

1. 1Asthma12,63526%
2. 2Dyspnoea10,41822%
3. 3Wheezing7,03615%
4. 4Product Dose Omission Issue6,42713%
5. 5Cough5,03810%
6. 6Therapeutic Product Effect Incomplete5,00410%
7. 7Pneumonia4,5359.4%
8. 8Drug Ineffective4,5219.4%
9. 9Loss Of Personal Independence In Daily Activities4,2068.7%
10. 10Sleep Disorder Due To A General Medical Condition3,0906.4%
11. 11Off Label Use3,0046.2%
12. 12Fatigue2,9986.2%
13. 13Malaise2,7105.6%
14. 14Condition Aggravated2,6705.5%
15. 15Headache2,6195.4%

The 10 most recently updated of 141 ClinicalTrials.gov registrations naming Mepolizumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Biologics in Chronic Rhinosinusitis With Nasal Polyposis
  Recruiting · Phase 4 · Interventional · 504 enrolled · Medical University of South Carolina
  NCT06824649updated 2026-06-09
• Blood Exosomal Multi-omics and Lung Radiomics for Predicting Efficacy and Prognosis of Severe Eosinophilic ACOS With Biologics
  Not yet recruiting · Observational · 500 enrolled · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  NCT07602881updated 2026-05-22
• Taiwan Severe Asthma Biologic Registry
  Recruiting · Observational · 500 enrolled · Taichung Veterans General Hospital
  NCT06456450updated 2026-05-19
• Long-Term Safety and Effectiveness of Mepolizumab 300 mg in Europe (Mepo LTF Study)
  Completed · Observational · 591 enrolled · European EGPA Study Group
  NCT07591753updated 2026-05-18
• A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype
  Completed · Phase 3 · Interventional · 1,717 enrolled · GlaxoSmithKline
  NCT04718389updated 2026-05-18
• Effectiveness on Sino-Nasal Symptoms Of Mepolizumab 300
  Completed · Observational · 52 enrolled · Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  NCT07592104updated 2026-05-18
• BIOlogics in Severe Nasal POlyposis SurvEy.: a French Registry
  Recruiting · Interventional · 900 enrolled · University Hospital, Lille
  NCT06501807updated 2026-05-18
• Dupilumab as Add-On Therapy for Hypereosinophilic Syndrome With Partial Clinical Response to Eosinophil-Depleting Biologic Agents
  Recruiting · Phase 2 · Interventional · 30 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT06477653updated 2026-05-11
• Efficacy and Safety of Benralizumab in EGPA Compared to Mepolizumab.
  Active not recruiting · Phase 3 · Interventional · 140 enrolled · AstraZeneca
  NCT04157348updated 2026-05-11
• A Pilot Study of the Use of 129Xe and 1H MRI to Measure the Modulation of Eosinophil-Related Inflammation by Mepolizumab In COPD
  Completed · Phase 3 · Interventional · 31 enrolled · Sheffield Teaching Hospitals NHS Foundation Trust
  NCT05138250updated 2026-05-07

Frequently asked questions

How does Mepolizumab work?

Mepolizumab is an IL-5 antagonist (IgG1 kappa). IL-5 is the major cytokine responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils.

What is Mepolizumab used for?

According to FDA labeling, Mepolizumab carries indications including: 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. ( 1.1 ) • Add-on maintenance treatment of adult patients aged 18 years and older with chronic rhinosinusitis with nasal polyps (CRSwNP).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Mepolizumab?

Mepolizumab is classified as Other systemic drugs for obstructive airway diseases, Interleukin-5 Antagonist, Interleukin-5 Antagonists.

What are the brand names for Mepolizumab?

Mepolizumab is marketed under brand names including Nucala.

What are the contraindications for Mepolizumab?

Mepolizumab labeling lists contraindications including: NUCALA is contraindicated in patients with a history of hypersensitivity to mepolizumab or excipients in the formulation [see Warnings and Precautions ( 5.1 ), Description ( 11 )] . History of hypersensitivity to mepolizumab or excipients in the formulation.. Always consult the full prescribing information and a clinician.