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warnings and cautions
5 WARNINGS AND PRECAUTIONS • 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. 5.3 Opportunistic Infections: Herpes Zoster Herpes zoster has occurred in subjects receiving NUCALA 100 mg in controlled clinical trials [see Adverse Reactions ( 6.1 )] . Consider vaccination if medically appropriate. 5.4 Reduction of Corticosteroid Dosage Do not discontinue systemic or inhaled corticosteroids (ICS) abruptly upon initiation of therapy with NUCALA. Reductions in corticosteroid dosage, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dosage may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy. 5.5 Parasitic (Helminth) Infection Eosinophils may be involved in the immunological response to some helminth infect...
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adverse reactions
6 ADVERSE REACTIONS 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). Of these, 1,192 had a history of 2 or more exacerbations in the year prior to enrollment despite regular use of high-dose ICS plus additional controller(s) (Severe Asthma Trials DREAM and MENSA), and 135 patients required daily oral corticosteroids (OCS) in addition to regular use of high-dose ICS plus additional controller(s) to maintain asthma control (Severe Asthma Trial SIRIUS). All patients had markers of eosinophilic airway inflammation [see Clinical Studies ( 14.1 )] . Of the patients enrolled, 59% were female, 85% were White, and ages ranged from 12 to 82 years. Mepolizumab was administered subcutaneously or intravenously once every 4 weeks; 263 patients received NUCALA (mepolizumab 100 mg subcutaneously) for at least 24 weeks. Serious adverse events that occurred in more than 1 patient and in a greater percentage of patients receiving NUCALA 100 mg (n = 263) than placebo (n = 257) included 1 event, herpes zoster (2 patients vs. 0 patients, respectively). The incidence of adverse reactions in the first 24 weeks of treatment in the 2 confirmatory efficacy and safety trials MENSA and SIRIUS with NUCALA 10...
adverse reactions table
Table 2. Adverse Reactions with NUCALA with ≥3% Incidence and More Common than Placebo in Patients with Severe Asthma (MENSA and SIRIUS)Adverse ReactionNUCALA(Mepolizumab 100 mg Subcutaneous)(n = 263)%Placebo(n = 257)%Headache1918Injection site reaction83Back pain54Fatigue54Influenza32Urinary tract infection32Abdominal pain upper32Pruritus32Eczema3<1Muscle spasms3<1