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This video includes instructions for the manual reconstitution of NUCALA.
NUCALA is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older with an eosinophilic phenotype.
NUCALA is not indicated for treatment of other eosinophilic conditions.
NUCALA is not indicated for the relief of acute bronchospasm or status asthmaticus.
Important Safety Information
NUCALA should not be administered to patients with a history of hypersensitivity to mepolizumab or excipients in the formulation.
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions (eg, 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 (ie, days). In the event of a hypersensitivity reaction, NUCALA should be discontinued.
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 in subjects treated with NUCALA compared to none in placebo. Consider varicella vaccination, if medically appropriate, prior to starting therapy with NUCALA.
Reduction of Corticosteroid Dosage
Do not discontinue systemic or inhaled corticosteroids (ICS) 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
It is unknown if NUCALA will influence a patient’s response against parasites. Treat patients with pre-existing helminth infections before initiating therapy with NUCALA. If patients become infected while receiving treatment with NUCALA and do not respond to anti-helminth treatment, discontinue treatment with NUCALA until infection resolves.
The most common adverse reactions (≥3% and more common than placebo) reported in the first 24 weeks of 2 clinical trials with NUCALA (and placebo) were: headache, 19% (18%); injection site reaction, 8% (3%); back pain, 5% (4%); fatigue, 5% (4%); influenza, 3% (2%); urinary tract infection, 3% (2%); abdominal pain upper, 3% (2%); pruritus, 3% (2%); eczema, 3% (<1%); and muscle spasm, 3% (<1%).
Systemic Reactions, including Hypersensitivity Reactions: In 3 clinical trials, 3% of subjects who received NUCALA experienced systemic (allergic and nonallergic) reactions, compared to 5% in the placebo group. Systemic allergic/hypersensitivity reactions were reported by 1% of subjects who received NUCALA, compared to 2% of subjects in the placebo group. Manifestations included rash, pruritus, headache, and myalgia. Systemic nonallergic reactions were reported by 2% of subjects who received NUCALA and 3% of subjects in the placebo group. Manifestations included rash, flushing, and myalgia. A majority of the systemic reactions were experienced on the day of dosing.
Injection site reactions (eg, pain, erythema, swelling, itching, burning sensation) occurred at a rate of 8% in subjects treated with NUCALA, compared with 3% in subjects treated with placebo.
USE IN SPECIFIC POPULATIONS
A pregnancy exposure registry monitors pregnancy outcomes in women exposed to NUCALA during pregnancy. Healthcare providers can enroll patients or encourage patients to enroll themselves by calling 1-877-311-8972 or visiting www.mothertobaby.org/asthma.
The data on pregnancy exposures from the clinical trials are insufficient to inform on drug-associated risk. Monoclonal antibodies, such as mepolizumab, are progressively 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 trimesters of pregnancy.