Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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.
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.
Like all medications, Nucala can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: