For US HCPs
For US Healthcare Professionals
Elevated eosinophils play a key role in HES
Each patient with hypereosinophilic syndrome (HES) may present differently, and since HES is a rare disease (estimated prevalence of 5000 in the US*), it may be more difficult to diagnose.1,2 A thorough workup is essential for evaluating a patient who is presenting with hypereosinophilia.1 Below are some factors to consider when identifying patients with HES.
Defining hypereosinophilic syndrome3
Peripheral blood hypereosinophilia (>1500 cells/μL) on 2 exams (interval ≥1 month†)
Eosinophil-mediated organ dysfunction and/or damage
Exclusion of other disorders as a major reason for organ damage
All HES patients are different. Patients may present with single- or multiple-organ involvement. Organs and organ systems that may be impacted by HES include:
*Estimate based on the National Hospital Discharge Survey of ~6000 discharges with at least 1 discharge diagnosis with the ICD code for eosinophilia; ~2000 cases were compatible with HES. The ratio of outpatients to inpatients (2.5:1) from a US claims database was applied to determine the final estimate.2
†Diagnosis can be made immediately to avoid delay in therapy in the case of life-threatening organ damage.3
Characteristics and clinical manifestations of HES overlap with those of eosinophilic granulomatosis with polyangiitis (EGPA). See below for similarities and differences between these two conditions.5
| Features of HES include: | Features of EGPA include: | ||
|---|---|---|---|
| Peripheral blood hypereosinophilia (>1500 cells/μL on ≥2 occasions at least 1 month apart)3 | Eosinophilia >10%6 | ||
| Vasculitic complications are rare6 | Eosinophil-rich, necrotizing granulomatous vasculitis affecting small-to-medium sized vessels7 | ||
| Pulmonary manifestations occur; presence of asthma and nasal polyps is rare6 | Frequent asthma and nasal polyps6 | ||
| ANCA-negative6 | ~40% of patients have ANCA antibodies8,9 | ||
| Patients may experience systemic manifestations | Patients may experience systemic manifestations |
See the results of NUCALA on eosinophil reduction
NUCALA is indicated for the treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for ≥6 months without an identifiable non-hematologic secondary cause.
NUCALA is indicated for the treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for ≥6 months without an identifiable non-hematologic secondary cause.
NUCALA is indicated for the:
CONTRAINDICATIONS
NUCALA should not be administered to patients with a history of hypersensitivity to mepolizumab or excipients in the formulation.
CONTRAINDICATIONS
NUCALA should not be administered to patients with a history of hypersensitivity to mepolizumab or excipients in the formulation.
CONTRAINDICATIONS
NUCALA should not be administered to patients with a history of hypersensitivity to mepolizumab or excipients in the formulation.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions (eg, anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred with NUCALA. These reactions generally occur within hours of administration but can have a delayed onset (ie, days). If a hypersensitivity reaction occurs, discontinue NUCALA.
Acute Asthma Symptoms or Deteriorating Disease
NUCALA should not be used to treat acute asthma symptoms, acute exacerbations, or acute bronchospasm.
Opportunistic Infections: Herpes Zoster
Herpes zoster infections have occurred in patients receiving NUCALA. Consider vaccination if medically appropriate.
Reduction of Corticosteroid Dosage
Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with NUCALA. Decreases in corticosteroid doses, if appropriate, should be gradual and under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
Parasitic (Helminth) Infection
Treat patients with pre-existing helminth infections before initiating therapy with NUCALA. If patients become infected while receiving NUCALA and do not respond to anti-helminth treatment, discontinue NUCALA until infection resolves.
ADVERSE REACTIONS
In clinical trials in patients with severe asthma (100 mg of NUCALA), the most common adverse reactions (≥5%) were headache, injection site reaction, back pain, and fatigue.
In clinical trials in patients with HES (300 mg of NUCALA), no additional adverse reactions were identified to those reported in severe asthma clinical trials. Systemic reactions, including hypersensitivity, also occurred. The manifestation reported was multifocal skin reaction, experienced on the day of dosing.
USE IN SPECIFIC POPULATIONS
The data on pregnancy exposures are insufficient to inform on drug-associated risk. Monoclonal antibodies, such as mepolizumab, are transported across the placenta in a linear fashion as the pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimesters.
Please see full Prescribing Information and Patient Information for NUCALA.
MPLWCNT210003 May 2021
To report SUSPECTED ADVERSE REACTIONS, contact GSK at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Trademarks are owned by or licensed to the GSK group of companies.
This website is funded and developed by GSK.
This site is intended for healthcare professionals only.
©2021 GSK or licensor.
MPLWCNT220028 May 2022
Produced in USA.
