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Treating Severe Eosinophilic Asthma Patients Who Are OCS-Dependent

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How can we achieve better exacerbation control in our severe eosinophilic asthma patients who are oral corticosteroid dependent? 

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  • Overview

    NUCALA (mepolizumab) is for the add-on treatment of patients 6+ with severe eosinophilic asthma. Not for acute bronchospasm or status asthmaticus. 

    Please See Important Safety Information below.

    Treating severe eosinophilic asthma patients who are oral corticosteroid (OCS) dependent is a significant challenge that pulmonologists like Dr. Yaron Goldman encounter in their practice. Fortunately, there is NUCALA, an additional therapeutic option for appropriate patients, as Dr. Goldman explains along with a patient case and data from clinical trials.

    MPLWCNT210102 October 2021
    Produced In USA.

  • INDICATION

    NUCALA is indicated for the add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype. NUCALA is not indicated for the relief of acute bronchospasm or status asthmaticus.

  • IMPORTANT SAFETY INFORMATION

    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
    In controlled clinical trials, 2 serious adverse reactions of herpes zoster occurred with NUCALA compared to none with placebo. 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 receiving NUCALA, the most common adverse reactions (≥5%) were headache, injection site reaction, back pain, and fatigue. Systemic reactions, including hypersensitivity, also occurred. Manifestations included rash, pruritus, headache, myalgia, and flushing; the majority were experienced the day of dosing.

    USE IN SPECIFIC POPULATIONS
    A pregnancy exposure registry monitors pregnancy outcomes in women exposed to NUCALA during pregnancy. To enroll call 1-877-311-8972 or visit www.mothertobaby.org/asthma.

    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.

Schedule18 May 2022
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